AstraZeneca concludes agreement with the European Commission for the supply of up to 400 million doses of AZD1222 COVID-19 vaccine

AstraZeneca is responding to the COVID-19 (novel coronavirus) outbreak, consistent with our values to follow the science, put patients first and do the right thing. Our priorities are to ensure the continued supply of our medicines to patients, and to safeguard the health and wellbeing of all our employees and communities. On this page we provide an overview of AstraZeneca news and relevant information.

Please visit astrazeneca.com

NVX-CoV2373, Novavax’ COVID-19 vaccine

Production of AstraZeneca COVID-19 vaccine in Latin America to launch early 2021

NVX-CoV2373, Novavax’ COVID-19 vaccine

Novavax and UK Government Announce Collaboration and Purchase Agreement for Novavax’ COVID-19 Vaccine Candidate

Fri August 14, 2020 1:07 AM|GlobeNewswire|About: NVAX

UK government to purchase 60 million doses of NVX-CoV2373
Novavax (NVAX) to partner with FUJIFILM Diosynth Biotechnologies to manufacture antigen component of NVX-CoV2373 in the UK
Novavax and UK government to collaborate on Phase 3 clinical trial in UK commencing in the third quarter of this year
Novavax intends to make additional capacity available to global markets

GAITHERSBURG, Md., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc.

For more information, visit www.novavax.com

Novavax to supply 60M COVID-19 vaccine doses to UK

Aug. 14, 2020 4:35 AM ET|About: Novavax, Inc. (NVAX)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3605584-novavax-to-supply-60m-covidminus-19-vaccine-doses-to-uk

Novavax and UK Government Announce Collaboration and Purchase Agreement for Novavax’ COVID-19 Vaccine Candidate

Aug 14, 2020 at 1:07 AM EDTDownload PDF

UK government to purchase 60 million doses of NVX-CoV2373
Novavax to partner with FUJIFILM Diosynth Biotechnologies to manufacture antigen component of NVX-CoV2373 in the UK
Novavax and UK government to collaborate on Phase 3 clinical trial in UK commencing in the third quarter of this year
Novavax intends to make additional capacity available to global markets

GAITHERSBURG, Md., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX

https://ir.novavax.com/news-releases/news-release-details/novavax-and-uk-government-announce-collaboration-and-purchase

https://seekingalpha.com/symbol/NVAX

Using the power of our technology to create tomorrow’s vaccines today.

Production of AstraZeneca COVID-19 vaccine in Latin America to launch early 2021

HEALTH NEWSAUGUST 13, 2020 / 9:15 AM / UPDATED 7 MINUTES AGO

AstraZeneca set to start making 400 million COVID-19 vaccines for Latam early in 2021

Raul Cortes, Daina Beth Solomon

3 MIN READ

MEXICO CITY (Reuters)

Production of AstraZeneca COVID-19 vaccine in Latin America to launch early 2021

Aug. 13, 2020 1:25 PM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3605288-production-of-astrazeneca-covidminus-19-vaccine-in-latin-america-to-launch-early-2021

https://www.emergentbiosolutions.com/

Emergent BioSolutions Signs Agreement with AstraZeneca to Expand Manufacturing for COVID-19 Vaccine Candidate

Emergent will provide contract development and manufacturing services beginning in 2020 to produce drug substance at large scale for commercial supply
Agreement is valued at approximately $174 million through 2021 and brings the total AstraZeneca commitment to $261 million
Parties may enter into additional commercial manufacturing commitments as the candidate progresses over three years through Emergent’s flexible capacity deployment model

GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an agreement to provide contract development and manufacturing (CDMO) services for large-scale commercial drug substance manufacturing for AstraZeneca’s COVID-19 vaccine candidate, AZD1222.

https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-signs-agreement-astrazeneca-expand

COVID-19 Information Hub

CanSino Coronavirus Vaccine Shows Promise in Mid-Stage Study

Production of AstraZeneca COVID-19 vaccine in Latin America to launch early 2021

Jul 22, 2020 04:47 AMBUSINESS & TECH

CanSino Coronavirus Vaccine Shows Promise in Mid-Stage Study

(Bloomberg) — CanSino Biologics Inc.’s

http://www.cansinotech.com/

Tianjin-based CanSino emerged as one of the fastest movers on a vaccine in May

CanSinoBIO’s Successful Listing on STAR Market Makes it the Initial Dual Listing Vaccine Company

SHANGHAI, CHINA, August 13, 2020, CanSino Biologics Inc. (“CanSinoBIO”) (SHSE: 688185, HKEX:06185

http://www.cansinotech.com/homes/article/show/56/196.html

CANSINO BIOLOGICS INC. - B - H SHARES (6185)

https://www.hkex.com.hk/Market-Data/Securities-Prices/Equities/Equities-Quote?sym=6185&sc_lang=en

At CanSinoBIO, our main research and development focus is vaccines.

http://www.cansinotech.com/homes/onepage/index/46.html

Pipeline

FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal)

CanSino Coronavirus Vaccine Shows Promise in Mid-Stage Study

FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal)

AstraZeneca Ships FLUMIST® QUADRIVALENT Vaccine in the US for 2020-2021 Flu Season

Thu August 13, 2020 7:30 AM|Business Wire|About: AZN

Production increased in anticipation of higher demand due to COVID-19; Over 25% more US doses of the only nasal-spray vaccine to be available as soon as early August

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca today announced the first shipment of FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal) doses in the US for the 2020-2021 influenza season.

https://www.flumistquadrivalent.com/

Please see accompanying full Prescribing Information, including Patient Information.

https://www.businesswire.com/news/home/20200813005173/en/

Please visit www.astrazeneca-us.com

https://seekingalpha.com/news/3605128-astrazeneca-ships-flu-vaccine-nasal-spray-to-u-s-for-upcoming-season

AstraZeneca ships flu vaccine nasal spray to U.S. for upcoming season

Aug. 13, 2020 8:27 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

APPROVED USE FLUMIST QUADRIVALENT is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in people 2 through 49 years old. FLUMIST QUADRIVALENT may not prevent influenza in everyone who gets vaccinated. FLUMIST QUADRIVALENT is the only nasal spray flu vaccine available for eligible children and adults ages 2-49

Xolair (omalizumab)

CanSino Coronavirus Vaccine Shows Promise in Mid-Stage Study

FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal)

FDA Accepts Application for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Thu August 13, 2020 1:07 AM|Business Wire|About: RHHBY

– If approved, Xolair self-administration would offer a more flexible option to help select patients manage their treatment needs –

– Filing acceptance is based on the well-established efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

Please see full Prescribing Information, including Medication Guide at http://www.xolair.com for additional Important Safety Information.

For additional information about the company, please visit http://www.gene.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200812005780/en/

https://seekingalpha.com/news/3605013-fda-accepts-genentech-application-for-xolair-across-all-indications

FDA accepts Genentech application for Xolair across all indications

Aug. 13, 2020 6:38 AM ET|About: Roche Holding AG (RHHBY)|By: Mamta Mayani, SA News Editor

Novartis receives EC approval for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps

Aug 06, 2020

EC approves Xolair® (omalizumab) as an add-on therapy for severe chronic rhinosinusitis with nasal polyps, the first anti-immunoglobulin E antibody approved in this indication1
Chronic rhinosinusitis with nasal polyps is a debilitating condition for many patients, with symptoms including nasal blockage, difficulty breathing and sleeping, and loss of sense of smell, which reduce quality of life2–4

https://www.novartis.com/news/media-releases/novartis-receives-ec-approval-new-xolair-indication-treat-severe-chronic-rhinosinusitis-nasal-polyps

https://www.xolair.com/

What is XOLAIR? XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat moderate to severe persistent asthma in patients 6 years of age or older whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older who continue to have hives that are not controlled by H1 antihistamine treatment. XOLAIR is not used to treat other allergic conditions, other forms of urticaria, acute bronchospasm or status asthmaticus.

PIQRAY® (alpelisib) in combination with fulvestrant

TUKYSA® (tucatinib) combined with trastuzumab (branded as Herceptin

PIQRAY® is approved and now available in Canada as the first and only treatment specifically for patients with a PIK3CA mutation in HR-positive, HER2-negative advanced breast cancer

Thu August 13, 2020 7:00 AM|Canada Newswire

Approval is based on results from SOLAR-1, where PIQRAY® in combination with fulvestrant nearly doubled median progression-free survival (PFS) compared to fulvestrant alone

Breast cancer is the most common cancer in Canadian women.1
While overall 5-year survival rates for female breast cancer are relatively high at 87%, women with metastatic breast cancer face a 22% survival rate over 5 years.2
Approximately 40% of patients with HR-positive, HER2-negative advanced breast cancer may face worse disease prognosis due to the presence of PIK3CA mutations in their tumours.3-9

DORVAL, QC, Aug. 13, 2020 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that PIQRAY® (alpelisib) is approved and now available in Canada

For further information, please consult www.novartis.ca.

Novartis launches Piqray in Canada for certain breast cancer patients

Aug. 13, 2020 7:08 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3605045-novartis-launches-piqray-in-canada-for-certain-breast-cancer-patients

https://seekingalpha.com/symbol/NVS

https://www.faslodex.com/what-is-faslodex.html

https://www.hcp.novartis.com/products/piqray/metastatic-breast-cancer/

https://www.hcp.novartis.com/

https://www.novartis.com/investors

Indication PIQRAY is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

TUKYSA® (tucatinib) combined with trastuzumab (branded as Herceptin

Seattle Genetics Announces TUKYSA® (tucatinib) Approved Within Months for All Countries Participating in FDA’s Project Orbis Initiative

Wed August 12, 2020 8:00 AM|Business Wire|About: SGEN

- Australia Joins U.S., Switzerland, Canada and Singapore in Approval of TUKYSA for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer -

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN) (Nasdaq:SGEN)

https://www.seattlegenetics.com/

visit www.seattlegenetics.com

https://www.tukysa.com/

https://www.businesswire.com/news/home/20200812005234/en/

https://seekingalpha.com/symbol/SGEN

TUKYSA Indication

TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

https://www.seattlegenetics.com/products/tukysa

Seattle Genetics' tucatinib OK'd in Australia for type of breast cancer

Aug. 12, 2020 8:17 AM ET|About: Seattle Genetics, Inc. (SGEN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3604548-seattle-genetics-tucatinib-okd-in-australia-for-type-of-breast-cancer

INDICATION: TUKYSA is a prescription medicine used with the medicines trastuzumab and capecitabine to treat adults with human epidermal growth factor receptor-2 (HER2) positive breast cancer that has spread to other parts of the body such as the brain (metastatic), or that cannot be removed by surgery, and who have received one or more anti-HER2 breast cancer treatments. It is not known if TUKYSA is safe and effective in children.

COVID-19 vaccine candidate BNT162b1

TUKYSA® (tucatinib) combined with trastuzumab (branded as Herceptin

Evinacumab is a fully human monoclonal antibody that binds to a protein called ANGPTL3

Pfizer/BioNTech COVID-19 vaccine continues to show strong effect in early-stage study

Aug. 12, 2020 7:46 AM ET|About: Pfizer Inc. (PFE)|By: Douglas W. House, SA News Editor

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults

https://clinicaltrials.gov/ct2/show/NCT04368728

The companies first reported preliminary data from the trial on July 1. The highest neutralizing titers reported then were 1.8x (10 µg) and 2.8x (30 µg).

Published: 12 August 2020 This is an unedited manuscript that has been accepted for publication. Nature Research are providing this early version of the manuscript as a service to our authors and readers. The manuscript will undergo copyediting, typesetting and a proof review before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers apply. Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults

Evinacumab is a fully human monoclonal antibody that binds to a protein called ANGPTL3

Healthcare

FDA accepts Regeneron application for evinacumab for inherited cholesterol disorder

Aug. 12, 2020 7:18 AM ET|About: Regeneron Pharmaceutic... (REGN)|By: Douglas W. House, SA News Editor

https://www.regeneron.com/

https://seekingalpha.com/symbol/REGN

What Is Homozygous Familial Hypercholesterolemia?

January 2, 2015 /

By Marie Louise Brumit /

2 Comments

Homozygous Familial Hypercholesterolemia (HoFH) is a rare but serious genetic condition that leads to aggressive and premature heart disease, heart attacks, and strokes in patients as young as teenagers.

https://thefhfoundation.org/homozygous-familial-hypercholesterolemia

REGENERON ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 3 TRIAL OF EVINACUMAB IN PATIENTS WITH SEVERE, INHERITED FORM OF HIGH CHOLESTEROL TARRYTOWN, N.Y., Aug. 14, 2019 /PRNewswire/ -- Adding evinacumab reduced LDL cholesterol by 49% in patients with homozygous familial hypercholesterolemia, compared to lipid-lowering therapies alone Evinacumab was generally well-tolerated, and all evinacumab patients completed the six-month treatment period Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

TYVYT® (Sintilimab Injection) in Combination with Gemcitabine and Platinum

Evinacumab is a fully human monoclonal antibody that binds to a protein called ANGPTL3

TYVYT® (Sintilimab Injection) in Combination with Gemcitabine and Platinum

Innovent and Eli Lilly Announce Acceptance of a Supplemental New Drug Application of TYVYT® (Sintilimab Injection) in Combination with Gemcitabine and Platinum as First-Line Therapy in Squamous Non-Small Cell Lung Cancer in China

Wed August 12, 2020 4:40 AM|PR Newswire|About: IVBIY, LLY

SUZHOU, China, Aug. 12, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801)

NSCLC (ClinicalTrials.gov, NCT03629925)

(ClinicalTrials.gov, NCT03607539)

please visit：www.innoventbio.com.

http://innoventbio.com/#/

please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

https://www.prnewswire.com/news-releases/innovent-and-eli-lilly-announce-acceptance-of-a-supplemental-new-drug-application-of-tyvyt-sintilimab-injection-in-combination-with-gemcitabine-and-platinum-as-first-line-therapy-in-squamous-non-small-cell-lung-cancer-in-china-301110629.html

https://www.breastcancer.org/treatment/druglist/gemzar

https://seekingalpha.com/symbol/IVBIY

产品中心信达生物已建立起了一条包括23个新药品种的产品链，覆盖肿瘤、代谢疾病、自身免疫等多个疾病领域，其中19个品种进入临床研究，5个品种进入临床III期或关键性临床研究，2个单抗产品上市申请被NMPA受理，均被纳入优先审评。已有2个产品（信迪利单抗注射液，商品名：达伯舒®，英文商标：TYVYT®；贝伐珠单抗生物类似药，商品名：达攸同®，英文商标：BYVASDA®）获得NMPA批准上市销售。信迪利单抗已于2019年11月成功进入国家医保目录，成为唯一一个进入新版国家医保目录的PD-1抑制剂。

mRNA-1273

Evinacumab is a fully human monoclonal antibody that binds to a protein called ANGPTL3

TYVYT® (Sintilimab Injection) in Combination with Gemcitabine and Platinum

Moderna Announces Supply Agreement with U.S. Government for Initial 100 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273)

Tue August 11, 2020 5:49 PM|Business Wire|About: MRNA

New U.S. government award up to $1.525 billion for 100 million doses

Option granted to U.S. government to purchase up to an additional 400 million doses

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc. (MRNA), (Nasdaq: MRNA)

https://www.niaid.nih.gov/news-events/atomic-structure-novel-coronavirus-protein

On July 8, the Phase 2 study completed enrollment.

published in The New England Journal of Medicine.

https://www.modernatx.com/

https://www.businesswire.com/news/home/20200811005852/en/

https://seekingalpha.com/symbol/MRNA

https://www.modernatx.com/pipeline/therapeutic-areas/mrna-therapeutic-areas-infectious-diseases

Moderna +10% on $1.5B vaccine supply deal with U.S.

Aug. 11, 2020 5:57 PM ET|About: Moderna, Inc. (MRNA)|By: Jason Aycock, SA News Editor

https://seekingalpha.com/news/3604369-modernaplus-10-on-1_5b-vaccine-supply-deal-u-s

Prognosis

Moderna, U.S. Reach Deal for 100 Million Covid-19 Vaccine Doses

It’s the latest in a string of supply deals reached to stockpile the most advanced vaccines in testing.

8/11/2020, 6:36:39 PM

https://www.bloomberg.com/news/articles/2020-08-11/moderna-u-s-in-covid-19-vaccine-deal-for-up-to-1-5-billion?srnd=premium

Moderna’s Work on a COVID-19 Vaccine Candidate

biotecMAX™ August/July 2020 insight

OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) Combined with Limited Chemotherapy

Health Canada Approves OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) Combined with Limited Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer

Tue August 11, 2020 12:07 PM|Canada Newswire|About: BMY

CheckMate -9LA trial results demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumor histology1

MONTREAL, Aug. 11, 2020 /CNW/ - Today, Bristol Myers Squibb Canada (BMS) announces Health Canada's approval of OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) with two cycles of platinum-double chemotherapy

For more information, please visit https://www.bms.com/ca/en.

Health Canada Approves OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) Combined with Limited Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer

CheckMate -9LA trial results demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumor histology1

OPDIVO

11/08/20

MONTREAL, QUEBEC – August 11, 2020 – Today, Bristol Myers Squibb Canada (BMS) announces Health Canada’s approval of OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab) with two cycles of platinum-double chemotherapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC)

https://www.bms.com/ca/en/media/press-release-listing/2020-08-11-press-release.html

https://seekingalpha.com/news/3604126-expanded-use-of-bristol-myers-o-y-in-lung-cancer-okd-in-canada

For more information about Bristol Myers Squibb, visit us at BMS.com

How do OPDIVO® (nivolumab) and YERVOY® (ipilimumab) team up to fight cancer differently than chemotherapy? OPDIVO + YERVOY works by helping your immune system to fight cancer. It does this by combining 2 immunotherapy medications that work in different but complementary ways. Together, OPDIVO and YERVOY can help your immune system launch a response against cancer that's greater than when either medication is used alone. Learning more about this treatment can help you have better conversations with your healthcare team when discussing treatment decisions.

OPDIVO® (nivolumab)

OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) Combined with Limited Chemotherapy

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

Tue August 11, 2020 6:59 AM|Business Wire|About: BMY

Opdivo is the first and only treatment to demonstrate superior efficacy in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and resection

Second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

https://www.businesswire.com/news/home/20200811005248/en/

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY

CheckMate -577, a Phase 3 Trial Evaluating Opdivo (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer, Meets Primary Endpoint of Disease-Free Survival

Opdivo is the first and only treatment to demonstrate superior efficacy in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and resection

Second tumor, in addition to melanoma, where Opdivo has demonstrated a benefit in the adjuvant setting

CATEGORY:

CORPORATE/FINANCIAL NEWSTUESDAY, AUGUST 11, 2020 6:59 AM EDT

https://news.bms.com/press-release/corporatefinancial-news/checkmate-577-phase-3-trial-evaluating-opdivo-nivolumab-adjuva

Bristol Myers' Opdivo successful in two late-stage studies

Aug. 11, 2020 7:31 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3603939-bristol-myers-opdivo-successful-in-two-late-stage-studies

CheckMate-577: Opdivo as adjuvant therapy in patients with resected esophageal or gastroesophageal junction (GEJ) cancer.

OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer BACK ADVANCED LUNG CANCER NON-SMALL CELL LUNG CANCER OPDIVO + YERVOY for certain adults with newly diagnosed advanced non-small cell lung cancer that tests positive for PD-L1 OPDIVO + YERVOY, in combination with chemotherapy, for adults with newly diagnosed advanced non-small cell lung cancer OPDIVO for people who have had prior treatments for non-small cell lung cancer SMALL CELL LUNG CANCER OPDIVO for people who have had prior treatments for small cell lung cancer Choose your condition: Advanced Lung Cancer Advanced Kidney Cancer Advanced Liver Cancer Colorectal Cancer (MSI-H/dMMR) Melanoma Head and Neck Squamous Cell Cancer Advanced Bladder Cancer Classical Hodgkin Lymphoma OPDIVO + YERVOY is now approved for people with newly diagnosed advanc

Evrysdi (risdiplam)

OPDIVO® (nivolumab) plus YERVOY® (ipilimumab) Combined with Limited Chemotherapy

Veklury® (Remdesivir)

FDA approves Roche’s Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older

Basel, 10 August 2020

In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA
Evrysdi helped infants survive without permanent ventilation and achieve the ability to sit without support, a key motor milestone not normally seen in the natural course of the disease
Evrysdi is the first and only medicine for SMA that can be taken at home

Basel, 10 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY)

https://www.gene.com/patients/medicines/evrysdi

FIREFISH (NCT02913482)

SUNFISH (NCT02908685

JEWELFISH (NCT03032172):

RAINBOWFISH (NCT03779334)

https://seekingalpha.com/news/3602982-fda-oks-ptc-therapeutics-spinal-muscular-atrophy-treatment-evrysdi

https://seekingalpha.com/symbol/PTCT

https://seekingalpha.com/pr/17964426-ptc-therapeutics-announces-fda-approval-of-evrysdi-risdiplam-for-treatment-of-spinal-muscular

https://www.ptcbio.com/

PTC Therapeutics Announces FDA Approval of Evrysdi™ (risdiplam) for the Treatment of Spinal Muscular Atrophy in Adults and Children 2 months and older

Fri August 7, 2020 1:54 PM|PR Newswire|About: PTCT

EVRYSDI™ (RISDIPLAM)

Veklury® (Remdesivir)

Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)

Veklury® (Remdesivir)

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury® (Remdesivir) for the Treatment of COVID-19

Mon August 10, 2020 11:00 AM|Business Wire|About: GILD

-- Veklury is Currently Available in the U.S. for the Treatment of Severe COVID-19 Under an Emergency Use Authorization --

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

https://www.gilead.com/remdesivir

COVID-19

Gilead Sciences Update On The Company’s Ongoing Response To COVID-19

https://www.gilead.com/purpose/advancing-global-health/covid-19

For more information about the emergency use of Veklury (remdesivir) in the United States, please see the Emergency Use Authorization Fact Sheets available at www.gilead.com/remdesivir.

https://www.businesswire.com/news/home/20200810005486/en/

Remdesivir is an investigational drug that has not been approved by the FDA for any use. It is not yet known if remdesivir is safe and effective for the treatment of COVID-19. The distribution of remdesivir has been authorized only for the treatment of hospitalized patients with severe COVID-19. It is not authorized for the treatment of any other viruses or pathogens. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner. The FDA issued this EUA, requested by Gilead Sciences and based on their submitted data. The FDA Letter of Authorization for the EUA is available here.

Aducanumab (BIIB037)

Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)

FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review

Fri August 7, 2020 7:30 AM|GlobeNewswire|About: BIIB

Priority Review accelerates FDA review time, with a Prescription Drug User Fee Act (PDUFA) target action on March 7, 2021
If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease

CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)

https://www.biogen.com/

FDA ACCEPTS BIOGEN’S ADUCANUMAB BIOLOGICS LICENSE APPLICATION FOR ALZHEIMER'S DISEASE WITH PRIORITY REVIEW

August 7, 2020 at 7:30 AM EDT

Priority Review accelerates FDA review time, with a Prescription Drug User Fee Act (PDUFA) target action on March 7, 2021
If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease

CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan)

https://investors.biogen.com/news-releases/news-release-details/fda-accepts-biogens-aducanumab-biologics-license-application

https://www.eisai.com/index.html

https://alzheimersnewstoday.com/aducanumab/

https://biogenalzheimers.com/

https://www.biogen.com/en_us/home.html

https://seekingalpha.com/symbol/BIIB

Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021. Learn more.

Opdivo® (nivolumab) Plus Yervoy® (ipilimumab)

Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma

Sat August 8, 2020 7:00 AM|Business Wire|About: BMY

https://www.businesswire.com/news/home/20200808005001/en/

Phase 3 clinical trial, CheckMate-743, comparing the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) (O+Y) to platinum-based chemo in patients with unresectable malignant pleural mesothelioma (MPM) in a first-line setting.

https://seekingalpha.com/news/3603107-bristol-myers-o-y-extends-survival-in-rare-type-of-thoracic-cancer

Opdivo® (nivolumab) Plus Yervoy® (ipilimumab) Demonstrates Durable Survival Benefit vs. Chemotherapy in Patients with Previously Untreated Malignant Pleural Mesothelioma

CheckMate -743 is the first and only Phase 3 trial in which first-line immunotherapy treatment improved survival in patients with malignant pleural mesothelioma

With these positive results, Opdivo plus Yervoy has now shown clinical benefit in six different tumor types, including durable, superior overall survival vs. chemotherapy in two thoracic cancers

Lilly's sintilimab shows treatment benefit in first-line lung cancer

Aug. 8, 2020 5:44 PM ET|About: Eli Lilly and Company (LLY)|By: Douglas W. House, SA News Editor

Innovent and Lilly Release Clinical Trial Results of Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum Chemotherapy as First-Line Treatment for Nonsquamous NSCLC in an Oral Presentation at IASLC WCLC 2020 Virtual Presidential Symposium

Sat August 8, 2020 9:00 AM|PR Newswire|About: IVBIY, LLY

SUZHOU, China, Aug. 8, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (IVBIY) ("Innovent") (HKEX: 01801)

https://seekingalpha.com/pr/17964759-innovent-and-lilly-release-clinical-trial-results-of-sintilimab-in-combination-alimta

China-based Phase 3 clinical trial, ORIENT-11, evaluating the combination of PD-1 inhibitor Tyvyt (sintilimab), Alimta (pemetrexed) and platinum chemo for the first-line treatment of patients with nonsquamous non-small cell lung cancer (NSCLC) without sensitive EGFR mutation or ALK rearrangement.

Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Recurrent Non-squamous NSCLC

https://clinicaltrials.gov/ct2/show/NCT03607539?term=orient-11&draw=2&rank=1

https://seekingalpha.com/symbol/IVBIY

https://www.prnewswire.com/news-releases/innovent-and-lilly-release-clinical-trial-results-of-sintilimab-in-combination-with-alimta-pemetrexed-and-platinum-chemotherapy-as-first-line-treatment-for-nonsquamous-nsclc-in-an-oral-presentation-at-iaslc-wclc-2020-virtual-pr-301108704.html

https://www.lilly.com/

http://innoventbio.com/en/#/

https://www.alimta.com/

ROBUST PIPELINE ACROSS NOVEL THERAPEUTICS AND BIOSIMILARS

BLENREP (belantamab mafodotin-blmf)

Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum Chemotherapy

06 August 2020

FDA approves GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma

For media and investors only

Issued: London, UK

BLENREP is a first-in-class anti-BCMA (B-cell maturation antigen) therapy for patients whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody
BLENREP is the fifth major medicine approval for GSK in 2020

GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.

FDA OKs Glaxo antibody-drug conjugate for last-line multiple myeloma

Aug. 6, 2020 8:55 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3601949-fda-oks-glaxo-antibody-drug-conjugate-for-last-line-multiple-myeloma

https://www.blenrephcp.com/?cc=ps_A97AOALOIS639575&mcm=40003

Additional information about the BLENREP REMS can be found at www.blenreprems.com or 1-855-209-9188.

BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BLENREP REMS.

Pfizer and BioNTech ink COVID-19 vaccine supply deal in Canada

Sintilimab in Combination with ALIMTA® (Pemetrexed) and Platinum Chemotherapy

Pfizer and BioNTech ink COVID-19 vaccine supply deal in Canada

Pfizer and BioNTech to Supply Canada with their BNT162 mRNA- Based Vaccine Candidate

Wed August 5, 2020 8:00 AM|Canada Newswire|About: BNTX

Supply to be provided over the course of 2021, subject to Health Canada approval
Agreement is part of Pfizer's and BioNTech's global commitment to help address the pandemic
Pfizer and BioNTech (NTGN) began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021

KIRKLAND, QC, and MAINZ, Germany, Aug. 5, 2020 /CNW/ - Pfizer Canada and BioNTech SE (BNTX)

visit pfizer.ca

www.pfizer.com.

For more information, please visit www.BioNTech.de.

https://seekingalpha.com/news/3600754-pfizer-and-biontech-ink-covidminus-19-vaccine-supply-deal-in-canada

Pfizer and BioNTech ink COVID-19 vaccine supply deal in Canada

Aug. 5, 2020 8:34 AM ET|About: Pfizer Inc. (PFE)|By: Douglas W. House, SA News Editor

https://biontech.de/covid-19

Pfizer and BioNTech to Supply Canada with their BNT162 mRNA-Based Vaccine Candidate

PDF Version

Supply to be provided over the course of 2021, subject to Health Canada approval
Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic
Pfizer and BioNTech began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October 2020, and to manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021

KIRKLAND, Quebec and MAINZ, Germany, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Pfizer Canada and BioNTech SE (Nasdaq: BNTX,

https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-supply-canada-their-bnt162-mrna-based

Aiming to address the global coronavirus pandemic: Project Lightspeed

biotecMAX™ August/July 2020 insight

J&J inks deal with feds to supply 100M doses of COVID-19 vaccine

TactiFlex™ Ablation Catheter, Sensor Enabled™ (SE) for people whose atrial fibrillation (AFib) symp

Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine

Wed August 5, 2020 8:30 AM|PR Newswire|About: JNJ

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators

NEW BRUNSWICK, N.J., Aug. 5, 2020 /PRNewswire/ -- Johnson & Johnson (JNJ)

J&J inks deal with feds to supply 100M doses of COVID-19 vaccine

https://seekingalpha.com/news/3600773-j-and-j-inks-deal-feds-to-supply-100m-doses-of-covidminus-19-vaccine

Johnson & Johnson's SARS-CoV-2 vaccine program leverages Janssen's AdVac® technology.

Learn more at www.jnj.com.

Learn more at www.janssen.com.

www.jnj.com

https://www.prnewswire.com/news-releases/johnson--johnson-announces-agreement-with-us-government-for-100-million-doses-of-investigational-covid-19-vaccine-301106593.html

Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators New Brunswick, N.J., August 05, 2020 – Johnson & Johnson (NYSE: JNJ)

TactiFlex™ Ablation Catheter, Sensor Enabled™ (SE) for people whose atrial fibrillation (AFib) symp

Abbott Announces Start of Study to Evaluate New Device to Treat Recurrent Atrial Fibrillation

Tue August 4, 2020 9:00 AM|PR Newswire|About: ABT

- Trial supports Abbott's focus on being the best partner for electrophysiologists treating people living with atrial fibrillation

PR Newswire

ABBOTT PARK, Ill., Aug. 4, 2020 /PRNewswire/ -- Abbott (ABT)

Additionally, physicians use magnetically sensor enabled technology, such as the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™, for precise location and navigation within the heart.

Connect with us at www.abbott.com

https://www.prnewswire.com/news-releases/abbott-announces-start-of-study-to-evaluate-new-device-to-treat-recurrent-atrial-fibrillation-301105138.html

TactiFlex PAF IDE Trial

https://clinicaltrials.gov/ct2/show/NCT04356040?titles=TactiFlex+PAF&lead=abbott&draw=2&rank=1

ABBOTT ANNOUNCES START OF STUDY TO EVALUATE NEW DEVICE TO TREAT RECURRENT ATRIAL FIBRILLATION- Recurrent irregular heartbeat--also known as atrial fibrillation--impacts more than 16 million people globally- Trial supports Abbott's focus on being the best partner for electrophysiologists treating people living with atrial fibrillation

https://abbott.mediaroom.com/2020-08-04-Abbott-Announces-Start-of-Study-to-Evaluate-New-Device-to-Treat-Recurrent-Atrial-Fibrillation

https://seekingalpha.com/symbol/ABT

ADVISOR™ HD GRID MAPPING CATHETER, SENSOR ENABLED™

https://www.cardiovascular.abbott/int/en/hcp/products/electrophysiology/advisor-hd-grid.html

TACTICATH ABLATION CATHETER, SENSOR ENABLED

EXPAREL® (bupivacaine liposome injectable suspension)

TactiFlex™ Ablation Catheter, Sensor Enabled™ (SE) for people whose atrial fibrillation (AFib) symp

Ripretinib is a switch-control tyrosine kinase inhibitor

Pacira BioSciences Announces FDA Acceptance of sNDA for EXPAREL Use in Pediatric Patients

Tue August 4, 2020 7:30 AM|GlobeNewswire|About: PCRX

sNDA submission based on positive Phase 3 data supporting expansion of the EXPAREL label to include use in children aged six and over

PARSIPPANY, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (PCRX)

visit www.pacira.com.

https://www.exparel.com/patient/index

Additional information is available at www.EXPAREL.com.

FDA accepts Pacira's supplement application for expanded use of EXPAREL for post operative pain

Aug. 4, 2020 9:54 AM ET|About: Pacira BioSciences, Inc. (PCRX)|By: Vandana Singh, SA News Editor

https://seekingalpha.com/news/3599880-fda-accepts-paciras-supplement-application-for-expanded-use-of-exparel-for-post-operative

https://seekingalpha.com/symbol/PCRX

PACIRA BIOSCIENCES ANNOUNCES FDA ACCEPTANCE OF SNDA FOR EXPAREL USE IN PEDIATRIC PATIENTS

PDF Version

sNDA submission based on positive Phase 3 data supporting expansion of the EXPAREL label to include use in children aged six and over

PARSIPPANY, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX)

https://investor.pacira.com/news-releases/news-release-details/pacira-biosciences-announces-fda-acceptance-snda-exparel-use

EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.

Ripretinib is a switch-control tyrosine kinase inhibitor

Zai Lab Announces NDA for Ripretinib Granted Priority Review by China’s NMPA

Tue August 4, 2020 7:30 AM|GlobeNewswire|About: ZLAB

SHANGHAI and SAN FRANCISCO, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited (ZLAB)

http://www.zailaboratory.com/

https://www.deciphera.com/

https://www.deciphera.com/pipeline/ripretinib-dcc-2618/

Ripretinib Becomes the First Unregistered Drug in Mainland China Approved for the Named Patient Program Outside the Pilot Zone of Hainan Province

July 30, 2020 at 10:45 AM CSTPDF Version

SHANGHAI, July 30, 2020 --

https://zailab.gcs-web.com/news-releases/news-release-details/ripretinib-becomes-first-unregistered-drug-mainland-china

https://seekingalpha.com/symbol/ZLAB

Ripretinib (DCC-2618) is an investigational, orally administered kinase switch control inhibitor being developed for the treatment of gastrointestinal stromal tumors (GIST), advanced systemic mastocytosis (ASM), gliomas, and other solid tumors driven by tyrosine-protein kinase KIT (KIT) or platelet derived growth factor alpha (PDGFRα) kinase (where genetic mutations or alterations in these kinases play a crucial role in the biology of these tumors leading to drug-resistance and disease progression). Deciphera is focusing the development of ripretinib in patient subgroups where significant unmet medical need exists despite currently available therapies.

DARZALEX® and DARZALEX® SC DARZALEX® (daratumumab)

Ripretinib is a switch-control tyrosine kinase inhibitor

DARZALEX® and DARZALEX® SC DARZALEX® (daratumumab)

**Janssen Announces Health Canada Approval of DARZALEX®* SC, a New Subcutaneous Formulation for the Treatment of Patients with Multiple Myeloma**

Tue August 4, 2020 7:30 AM|Canada Newswire

DARZALEX® SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions compared to intravenous DARZALEX® (daratumumab)

TORONTO, Aug. 4, 2020 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson

https://www.darzalex.com/

https://www.jnj.com/

https://www.janssen.com/canada/

Subcutaneous version of J&J's Darzalex OK'd in Canada

Aug. 4, 2020 7:59 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3599784-subcutaneous-version-of-j-and-js-darzalex-okd-in-canada

What is DARZALEX® (daratumumab)? DARZALEX® is a prescription medicine used to treat adults with multiple myeloma: In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people who have received at least one prior medicine to treat multiple myeloma In combination with the medicines bortezomib, melphalan, and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) In combination with the medicines bortezomib, thalidomide, and dexamethasone in newly diagnosed people who are eligible to receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) In combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma In combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor Alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent

Impella 2.5® and Impella CP® devices

Ripretinib is a switch-control tyrosine kinase inhibitor

DARZALEX® and DARZALEX® SC DARZALEX® (daratumumab)

FDA Issues Emergency Use Authorization for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients

Tue August 4, 2020 7:00 AM|Business Wire|About: ABMD

DANVERS, Mass.--(BUSINESS WIRE)-

https://www.businesswire.com/news/home/20200804005379/en/

http://www.abiomed.com/impella

What is ECMO?

https://www.thoracic.org/patients/patient-resources/resources/what-is-ecmo.pdf

please visit www.impella.com.

please visit: www.abiomed.com.

https://seekingalpha.com/news/3599755-fda-oks-emergency-use-of-abiomed-heart-pumps-to-support-covidminus-19-patients

FDA Issues Emergency Use Authorization for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients

DANVERS, Mass.--(BUSINESS WIRE)--Aug. 4, 2020-

http://investors.abiomed.com/news-releases/news-release-details/fda-issues-emergency-use-authorization-impella-heart-pumps

https://seekingalpha.com/symbol/ABMD

Impella® The World's Smallest Heart Pump

efinopegdutide (formerly HM12525A)

REGN-COV2 cocktail of two monoclonal antibodies

Merck and Hanmi Pharmaceutical Enter into Licensing Agreement to Develop Efinopegdutide, an Investigational Once-Weekly Therapy for Nonalcoholic Steatohepatitis (NASH)

Tue August 4, 2020 5:00 AM|Business Wire|About: MRK

www.merck.com

https://www.businesswire.com/news/home/20200804005172/en/

https://seekingalpha.com/symbol/MRK

http://www.hanmipharm.com/ehanmi/handler/Home-Start

Hanmi Pharmaceutical is developing in the areas of anti-cancer,
obesity, diabetes, and rare diseases.

http://www.hanmipharm.com/ehanmi/handler/Rnd-Pipeline

Merck and Hanmi Pharmaceutical Enter into Licensing Agreement to Develop Efinopegdutide, an Investigational Once-Weekly Therapy for Nonalcoholic Steatohepatitis (NASH) Tuesday, August 4, 2020 5:00 am ET

REGN-COV2 cocktail of two monoclonal antibodies

AUGUST 3, 2020 / 7:10 PM / UPDATED 2 HOURS AGO

Regeneron says antibody cocktail prevents and treats COVID-19 in animals

Michael Erman

Regeneron says COVID cocktail prevents, treats virus in animals

Aug. 3, 2020 9:21 PM ET|About: Regeneron Pharmaceuticals, ... (REGN)|By: Carl Surran, SA News Editor

https://seekingalpha.com/news/3599588-regeneron-says-covid-cocktail-prevents-treats-virus-in-animals?utm_medium=email&utm_source=seeking_alpha&mail_subject=regn-regeneron-says-covid-cocktail-prevents-treats-virus-in-animals&utm_campaign=rta-stock-news&utm_content=link-1

https://www.regeneron.com/

OUR COVID-19 RAPID RESPONSE PROGRAM

https://www.regeneron.com/covid19

https://seekingalpha.com/symbol/REGN

Developing REGN-COV2 A Novel Anti-Viral Antibody Cocktail

Rozlytrek® (entrectinib)

REGN-COV2 cocktail of two monoclonal antibodies

Sanofi, GSK to supply 300M COVID-19 vaccine doses to EU

Rozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for people with NTRK fusion-positive solid tumours and for people with ROS1-positive advanced non-small cell lung cancer

Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain
This approval shows the value of combining genomic profiling with precision medicine to offer patients with rare and hard-to-treat cancers a personalised treatment option

Basel, 03 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY)

https://www.rozlytrek.com/

please visit www.roche.com.

Roche's first tumor agnostic therapy OK'd in Europe

Aug. 3, 2020 6:47 AM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3598798-roches-first-tumor-agnostic-therapy-okd-in-europe

What is ROZLYTREK®? ROZLYTREK is a prescription medicine used to treat: Adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by an abnormal ROS1 gene. Adults and children 12 years and older with solid tumors (cancer) that: are caused by certain abnormal NTRK genes and have spread or if surgery to remove their cancer is likely to cause severe complications, and there is no satisfactory alternative treatment option or the cancer grew or spread on other treatment. It is not known if ROZLYTREK is safe and effective for use in children less than 12 years of age. ROZLYTREK was approved through a faster FDA review process based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of ROZLYTREK for this use.

https://www.gene.com/

Sanofi, GSK to supply 300M COVID-19 vaccine doses to EU

Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide

Sanofi, GSK to supply 300M COVID-19 vaccine doses to EU

31 July 2020

Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccine

For media and investors only

Issued: London, UK and Paris, France

Discussions relate to vaccine candidate using Sanofi’s recombinant protein-based technology combined with GSK’s pandemic adjuvant system
Both companies are committed to making their COVID-19 vaccine affordable and available globally

Sanofi and GSK are in advanced discussions with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine.

https://www.gsk.com/en-gb/

Sanofi, GSK to supply 300M COVID-19 vaccine doses to EU

Aug. 3, 2020 3:38 AM ET|About: Sanofi (SNY)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3598768-sanofi-gsk-to-supply-300m-covidminus-19-vaccine-doses-to-eu

July 31 2020 Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccine

https://www.sanofi.com/

Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide

FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Fri July 31, 2020 8:20 PM|Accesswire|About: MOR

- First FDA approval of a second-line treatment for adult patients with relapsed or refractory DLBCL, helping fill a high unmet medical need
- FDA granted Monjuvi Fast Track, Breakthrough Therapy and Priority Review designations
- MorphoSys (MPHSF) and Incyte will co-commercialize Monjuvi in the United States
- Joint analyst and investor conference call and webcast scheduled for Monday, August 3, 2020 at 8:00 a.m. EDT / 2:00 p.m. CEST

PLANEGG & MUNICH, GERMANY & WILMINGTON, DE / ACCESSWIRE / July 31, 2020 / MorphoSys AG (MPSYF) (FSE:MOR)(Prime Standard Segment; MDAX & TecDAX)(NASDAQ:MOR) and Incyte (INCY)

Program information will be available online at www.MyMissionSupport.com.

www.morphosys.com

A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL (L-MIND)

https://clinicaltrials.gov/ct2/show/NCT02399085

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

For additional information on Incyte, please visit Incyte.com

https://www.accesswire.com/599927/FDA-Approves-MonjuviR-tafasitamab-cxix-in-Combination-with-Lenalidomide-for-the-Treatment-of-Adult-Patients-with-Relapsed-or-Refractory-Diffuse-Large-B-cell-Lymphoma-DLBCL

https://seekingalpha.com/symbol/MOR

https://www.morphosys.com/

https://seekingalpha.com/symbol/INCY

Xencor earns $25M milestone payment on FDA nod for lymphoma treatment

Aug. 2, 2020 2:40 PM ET|About: Xencor, Inc. (XNCR)|By: Brad Olesen, SA News Editor

https://seekingalpha.com/news/3598739-xencor-earns-25m-milestone-payment-on-fda-nod-for-lymphoma-treatment

https://seekingalpha.com/symbol/XNCR

FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) 31 July, 2020

Epidiolex (cannabidiol)

Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide

FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease

Fri July 31, 2020 9:06 PM|PR Newswire

SILVER SPRING, Md., July 31, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.

TSC is a rare genetic disease

https://www.prnewswire.com/news-releases/fda-approves-new-indication-for-drug-containing-an-active-ingredient-derived-from-cannabis-to-treat-seizures-in-rare-genetic-disease-301104233.html

https://seekingalpha.com/symbol/GWPH

https://www.epidiolex.com/

What is EPIDIOLEX (cannabidiol)? EPIDIOLEX is a prescription medicine that is used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

biotecMAX™ July 2020 insight

DARZALEX® (daratumumab) -Daratumumab in Combination with Pomalidomide and Dexamethasone in Relapsed

Genmab Announces European Myeloma Network and Janssen Achieve Positive Topline Results from Phase 3 APOLLO Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Fri July 31, 2020 3:38 PM|GlobeNewswire|About: GMAB

Company Announcement

Phase 3 APOLLO randomized study evaluating subcutaneous daratumumab in combination with pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in relapsed or refractory multiple myeloma met the primary endpoint of improving progression-free survival
Janssen intends to discuss the data with health authorities for potential regulatory submissions

Copenhagen, Denmark; July 31, 2020 – Genmab A/S (GNMSF) (Nasdaq: GMAB)

Phase 3 clinical trial, APOLLO, evaluating a subcutaneous formulation of licensor Janssen Biotech's [a unit of Johnson & Johnson (NYSE:JNJ)]

visit www.DARZALEX.com.

https://seekingalpha.com/news/3598588-j-and-js-subcutaneous-daratumumab-on-par-iv-version-in-multiple-myeloma-study

https://seekingalpha.com/symbol/GMAB

https://www.genmab.com/

Products in development

https://www.genmab.com/pipeline/#page-products

https://seekingalpha.com/symbol/GNMSF

What is DARZALEX® (daratumumab)? DARZALEX® is a prescription medicine used to treat adults with multiple myeloma: In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people who have received at least one prior medicine to treat multiple myeloma In combination with the medicines bortezomib, melphalan and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) In combination with the medicines bortezomib, thalidomide, and dexamethasone in people with newly diagnosed multiple myeloma who are eligible to receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) In combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma In combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor Alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent

Sanofi/Glaxo join Operation Warp Speed, to supply 100M COVID-19 vaccine doses to U.S.

DARZALEX® (daratumumab) -Daratumumab in Combination with Pomalidomide and Dexamethasone in Relapsed

Sanofi and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccine

Fri July 31, 2020 7:00 AM|GlobeNewswire|About: SNY

Sanofi (SNY) and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccine

Promising vaccine candidate selected by U.S. government’s Operation Warp Speed
U.S. government to provide funding up to $2.1 billion for development, including clinical trials and manufacturing scale-up, and delivery of an initial 100 million doses
Ongoing discussions with the European Commission, with France and Italy on the negotiation team, and other governments to ensure global access to a novel coronavirus vaccine

PARIS and LONDON – July 31, 2020 – Sanofi and GSK today announce a collaborative effort with the U.S. government to accelerate the development and manufacturing of a COVID-19 recombinant protein-based vaccine.

please visit www.gsk.com

https://seekingalpha.com/news/3598315-sanofi-glaxo-join-operation-warp-speed-to-supply-100m-covidminus-19-vaccine-doses-to-u-s

Sanofi/Glaxo join Operation Warp Speed, to supply 100M COVID-19 vaccine doses to U.S.

Jul. 31, 2020 7:20 AM ET|About: Sanofi (SNY)|By: Douglas W. House, SA News Editor

July 31 2020 Sanofi and GSK selected for Operation Warp Speed to supply United States government with 100 million doses of COVID-19 vaccine

Tecentriq (atezolizumab), Cotellic (cobimetinib) and Zelboraf (vemurafenib) for advanced melanoma.

DARZALEX® (daratumumab) -Daratumumab in Combination with Pomalidomide and Dexamethasone in Relapsed

Tecentriq (atezolizumab), Cotellic (cobimetinib) and Zelboraf (vemurafenib) for advanced melanoma.

FDA approves Roche’s Tecentriq plus Cotellic and Zelboraf for people with advanced melanoma

Basel, 31 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients. The safety profile observed in the Tecentriq combination was consistent with the known safety profiles of the individual medicines.

FDA OKs Roche triplet therapy for certain type of melanoma

Jul. 31, 2020 6:38 AM ET|About: Roche Holding AG (RHHBY)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3598270-fda-oks-roche-triplet-therapy-for-certain-type-of-melanoma

IMspire150 is a Phase III, multi-center, double-blind, placebo-controlled randomised study in people with previously untreated BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma. The study compared the efficacy and safety of Tecentriq plus Cotellic and Zelboraf to the combination of placebo plus Cotellic and Zelboraf

https://www.tecentriq.com/

https://www.cotellic.com/

https://www.gene.com/patients/medicines/zelboraf

https://www.roche.com/

https://www.gene.com/

COTELLIC is a prescription medicine that is used with the medicine ZELBORAF, to treat a type of skin cancer called melanoma: that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene Your healthcare provider will perform a test to make sure that COTELLIC is right for you. It is not known if COTELLIC is safe and effective in children under 18 years of age.

BNT162 mRNA-based Vaccine Candidate

Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor.

Tecentriq (atezolizumab), Cotellic (cobimetinib) and Zelboraf (vemurafenib) for advanced melanoma.

Pfizer and BioNTech to Supply Japan with 120 Million Doses of their BNT162 mRNA-based Vaccine Candidate

Fri July 31, 2020 5:15 AM|Business Wire|About: BNTX, PFE

Supply of 120 million doses to be provided in the first half of 2021, subject to regulatory approval
Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic
Pfizer (PFE) and BioNTech (NTGN) began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. and BioNTech SE (BNTX)

View the full release here: https://www.businesswire.com/news/home/20200731005116/en/

please visit us on www.Pfizer.com

please visit www.BioNTech.de.

PFIZER AND BIONTECH TO SUPPLY JAPAN WITH 120 MILLION DOSES OF THEIR BNT162 MRNA-BASED VACCINE CANDIDATE Friday, July 31, 2020 - 05:15am Supply of 120 million doses to be provided in the first half of 2021, subject to regulatory approval Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic Pfizer and BioNTech began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021 NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)

REGN-EB3 Investigational Ebola Treatment

Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor.

Expand Portfolio

BARDA Procures Regeneron's REGN-EB3 Investigational Ebola Treatment for National Preparedness

Wed July 29, 2020 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., July 29, 2020 /PRNewswire/ --

REGN-EB3 is a novel anti-viral antibody cocktail developed using the same rapid response technologies as REGN-COV2, Regeneron's investigational COVID-19 antibody cocktail

Regeneron Pharmaceuticals, Inc. (REGN)

For additional information about the company, please visit www.regeneron.com

https://www.prnewswire.com/news-releases/barda-procures-regenerons-regn-eb3-investigational-ebola-treatment-for-national-preparedness-301101733.html

https://seekingalpha.com/symbol/REGN

https://investor.regeneron.com/news-releases/news-release-details/barda-procures-regenerons-regn-eb3-investigational-ebola

A POWERFUL RESEARCH AND DEVELOPMENT ENGINE

Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor.

Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS)

Thu July 30, 2020 6:55 AM|Business Wire|About: TAK

– Designation Based on Phase 2 Data and Reinforces Significant Treatment Need for HR-MDS –

– Pevonedistat Could be First Novel Treatment Option for HR-MDS in More Than a Decade –

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TKPHF) (TSE:4502/NYSE:TAK)

Takeda presented results of the Pevonedistat-2001 trial during oral sessions at the virtual 56th American Society of Clinical Oncology (ASCO) Annual Meeting and virtual 25th European Hematology Association (EHA) Annual Congress.

visit www.takedaoncology.com.

For more information, visit https://www.takeda.com

https://www.businesswire.com/news/home/20200730005233/en/

https://seekingalpha.com/symbol/TAK

https://seekingalpha.com/symbol/TKPHF

https://www.takeda.com/newsroom/newsreleases/2020/takeda-announces-u.s.-fda-breakthrough-therapy-designation-granted-for-pevonedistat-for-the-treatment-of-patients-with-higher-risk-myelodysplastic-syndromes-hr-mds/

Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS) July 30, 2020 – Designation Based on Phase 2 Data and Reinforces Significant Treatment Need for HR-MDS – Pevonedistat Could be First Novel Treatment Option for HR-MDS in More Than a Decade Cambridge, Mass. and Osaka, Japan, July 30, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)

KEYTRUDA® (pembrolizumab)

recombinant adenovirus serotype 26 (Ad26)-based COVID-19 vaccine candidate

Jardiance® (empagliflozin)

Merck Announces Two US Regulatory Milestones for KEYTRUDA® (pembrolizumab) in Triple-Negative Breast Cancer (TNBC)

Thu July 30, 2020 6:45 AM|Business Wire|About: MRK

FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for KEYTRUDA Plus Chemotherapy for the Treatment of Certain Patients With Metastatic TNBC Based on KEYNOTE-355 Trial

FDA Accepts sBLA for KEYTRUDA for the Treatment of Patients with High-Risk Early-Stage TNBC Based on KEYNOTE-522 Trial

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK)

https://www.keytruda.com/

KEYNOTE-355 is a randomized, double-blinded, Phase 3 trial (ClinicalTrials.gov, NCT02819518) evaluating KEYTRUDA in combination with one of three different chemotherapies (investigator’s choice of nab-paclitaxel, paclitaxel or gemcitabine/carboplatin)

KEYNOTE-522 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03036488) evaluating KEYTRUDA in combination with chemotherapy compared with placebo plus chemotherapy as neoadjuvant therapy

https://seekingalpha.com/symbol/MRK

https://www.businesswire.com/news/home/20200730005275/en/

https://www.mrknewsroom.com/newsroom/news-releases/news-details/2020/Merck-Announces-Two-US-Regulatory-Milestones-for-KEYTRUDA-pembrolizumab-in-Triple-Negative-Breast-Cancer-TNBC/default.aspx

AN IMMUNOTHERAPY THAT MAY HELP FIGHT YOUR CANCER IT’S TRU. KEYTRUDA. SELECT A TYPE OF CANCER Search by cancer type or name Advanced non–small cell lung cancer Melanoma Head and neck squamous cell cancer High-risk non-muscle invasive bladder cancer (NMIBC) Advanced urothelial bladder cancer Advanced kidney cancer (RCC) Microsatellite instability-high cancer Classical Hodgkin lymphoma Advanced gastric cancer Advanced cervical cancer Primary mediastinal B‑cell lymphoma Advanced liver cancer (HCC) Advanced Merkel cell carcinoma Advanced esophageal squamous cell carcinoma

Jardiance® (empagliflozin)

recombinant adenovirus serotype 26 (Ad26)-based COVID-19 vaccine candidate

Jardiance® (empagliflozin)

Jardiance® meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in phase III trial in adults with and without diabetes

Thu July 30, 2020 6:15 AM|PR Newswire|About: LLY

- Treatment of heart failure is an important unmet need with over half of those diagnosed dying within five years

PR Newswire

RIDGEFIELD, Conn. and INDIANAPOLIS, July 30, 2020 /PRNewswire/ -

EMPEROR-Reduced [NCT03057977]

EMPEROR-Preserved [NCT03057951]

For more information, please see Prescribing Information and Medication Guide.

For more information, please visit www.boehringer-ingelheim.us

visit http://www.lillydiabetes.com/

please visit us at www.lilly.com

https://www.prnewswire.com/news-releases/jardiance-meets-primary-endpoint-in-reducing-risk-of-cardiovascular-death-or-hospitalization-for-heart-failure-in-phase-iii-trial-in-adults-with-and-without-diabetes-301102692.html

https://www.jardiance.com/

JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease. JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

recombinant adenovirus serotype 26 (Ad26)-based COVID-19 vaccine candidate

Johnson & Johnson’s Coronavirus Vaccine Protects Monkeys, Study Finds

It’s the second study in a week to report promising results in monkeys for a vaccine candidate. But the real test will come with human trials that are now underway.

By Carl Zimmer

July 30, 2020, 5:00 a.m. ET

J&J COVID-19 vaccine candidate shows positive effect in primate study; shares gain premarket

Jul. 30, 2020 7:20 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3597509-j-and-j-covidminus-19-vaccine-candidate-shows-positive-effect-in-primate-study-shares-gain

https://www.jnj.com/latest-news/latest-facts-news-about-johnson-johnson-covid-19-vaccine-candidate

https://www.jnj.com/

4 Latest Facts About Johnson & Johnson’s Investigational COVID-19 Vaccine

A preclinical study just published in Nature shows that the company's investigational vaccine has shown positive early data for eliciting an immune response against SARS-CoV-2, the virus that causes COVID-19. We share more about the findings from the recent preclinical study, along with other up-to-date information about the potential vaccine candidate.By Amanda Kelly, Staff Content Strategist, Global Content LabJuly 30, 2020

Jul 30, 2020

J&J's COVID vaccine protected primates with single shot

Riley Griffin and Marthe Fourcade, Bloomberg News

https://www.bnnbloomberg.ca/j-j-s-covid-vaccine-protected-primates-with-single-shot-1.1472999

Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies Jul 30, 2020 Study published in Nature shows J&J's investigational SARS-CoV-2 vaccine elicits a strong immune response that protects against subsequent infection First-in-human Phase 1/2a clinical trial now underway in United States and Belgium; Phase 3 clinical trial expected to commence in September NEW BRUNSWICK, N.J., July 30, 2020 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ)

nirsevimab

Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma

recombinant adenovirus serotype 26 (Ad26)-based COVID-19 vaccine candidate

Nirsevimab reduced respiratory syncytial virus infections and hospitalisations in preterm infants in Phase IIb trial

PUBLISHED30 July 2020

Nirsevimab is the first potential passive immunisation for infants to demonstrate sustained protection across the entire RSV season with a single dose

Results published in the New England Journal of Medicine

Nirsevimab showed a significant reduction in medically-attended lower respiratory tract infections (LRTI) and hospitalisations caused by respiratory syncytial virus (RSV) in healthy preterm infants in a positive Phase IIb trial published in the New England Journal of Medicine.

AstraZeneca and Sanofi's nirsevimab successful in mid-stage study

Jul. 30, 2020 7:01 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3597466-astrazeneca-and-sanofis-nirsevimab-successful-in-mid-stage-study

https://www.sanofi.com/en

July 30 2020 Nirsevimab reduced respiratory syncytial virus infections requiring medical care in healthy premature infants in Phase 2b trial

Tagrisso (osimertinib)

Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma

Tagrisso granted Breakthrough Therapy Designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR-mutated lung cancer

PUBLISHED30 July 2020

30 July 2020 07:05 BST

Designation based on unprecedented results from the Phase III ADAURA trial where Tagrisso reduced the risk of disease recurrence or death by c. 80%

AstraZeneca’s Tagrisso (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

AstraZeneca's Tagrisso nabs accelerated review in U.S. for type of lung cancer

Jul. 30, 2020 6:40 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3597432-astrazenecas-tagrisso-nabs-accelerated-review-in-u-s-for-type-of-lung-cancer

https://www.tagrisso.com/

Please see full Prescribing Information including Patient Information.

What is TAGRISSO? TAGRISSO is a prescription medicine for non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). TAGRISSO is used: as a first treatment if tumors have a certain abnormal epidermal growth factor receptor (EGFR) gene(s) or if you have a certain type of EGFR gene and were previously treated with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working Your doctor will perform a test to make sure that TAGRISSO is right for you.

Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma

Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma

Wed July 29, 2020 4:16 PM|Business Wire|About: BLUE, BMY

BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient population

Companies are committed to working with the FDA to rapidly advance ide-cel through the regulatory review process

PRINCETON, N.J., & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE)

https://www.bluebirdbio.com/our-science/pipeline

Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE)

View source version on businesswire.com: https://www.businesswire.com/news/home/20200729005776/en/

https://seekingalpha.com/symbol/BLUE

https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-and-bluebird-bio-announce-submission-biol

Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma

BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient population

Companies are committed to working with the FDA to rapidly advance ide-cel through the regulatory review process

CATEGORY:

CORPORATE/FINANCIAL NEWSWEDNESDAY, JULY 29, 2020 4:16 PM EDT

pipeline

biotecMAX™ July 2020 insight

Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine

World

U.K. Builds Up Covid Vaccine Supply With Glaxo, Sanofi Deal

By James Paton and Suzi RingJuly 29, 2020, 1:17 AM EDT Updated on July 29, 2020, 5:56 AM EDT

Britain races ahead in dash for doses with multiple pacts
Government secures up to 60 million doses from partners

Sanofi, Glaxo confirm 60M COVID vaccine dose deal with the U.K.

Jul. 29, 2020 3:59 AM ET|About: Sanofi (SNY)|By: Yoel Minkoff, SA News Editor

https://seekingalpha.com/news/3596461-sanofi-glaxo-confirm-60m-covid-vaccine-dose-deal-u-k

29 July 2020 Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine For media and investors only Issued: London, UK and Paris, France Agreement relates to vaccine candidate using Sanofi’s recombinant protein-based technology combined with GSK’s pandemic adjuvant system Both companies are committed to making their COVID-19 vaccine candidate affordable and available globally Sanofi and GSK have reached an agreement, subject to final contract, with the UK government for the supply of up to 60 million doses of a COVID-19 vaccine.

MK-6482, a novel investigational candidate

Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine

FDA Grants Breakthrough Therapy Designation to Merck’s Novel HIF-2α Inhibitor MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma

Wed July 29, 2020 6:45 AM|Business Wire|About: MRK

Reinforces Important Progress in Merck’s Oncology Pipeline to Advance Novel Therapeutic Candidates

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK),

MK-6482 (formerly PT2977) is an investigational, novel, potent, selective, oral HIF-2α inhibitor that is currently being evaluated in a Phase 3 trial in advanced RCC (NCT04195750), a Phase 2 trial in VHL-associated RCC (NCT03401788), and a Phase 1/2 dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC (NCT02974738).

For more information, visit www.merck.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20200729005246/en/

von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size

https://seekingalpha.com/symbol/MRK

FDA Grants Breakthrough Therapy Designation to Merck’s Novel HIF-2α Inhibitor MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma Wednesday, July 29, 2020 6:45 am ET

Moderna COVID-19 vaccine shows robust effect in preclinical study

Sanofi and GSK agree with the UK government to supply up to 60 million doses of COVID-19 vaccine

Pfizer to seek FDA emergency use nod for COVID-19 vaccine as early as October

Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates

Moderna COVID-19 vaccine shows robust effect in preclinical study

Jul. 28, 2020 3:54 PM ET|About: Moderna, Inc. (MRNA)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3596177-moderna-covidminus-19-vaccine-shows-robust-effect-in-preclinical-study

The data were just published in the New England Journal of Medicine.

A large-scale in-human study should be fully enrolled in 4-6 weeks.

https://seekingalpha.com/symbol/MRNA

https://www.modernatx.com/

ORIGINAL ARTICLE

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

July 14, 2020
DOI: 10.1056/NEJMoa2022483

BACKGROUND

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein.

https://www.nejm.org/doi/full/10.1056/NEJMoa2022483?query=featured_home

Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19)

https://clinicaltrials.gov/ct2/show/NCT04283461

Moderna Announces Publication in The New England Journal of Medicine of Non-Human Primate Preclinical Viral Challenge Study of its mRNA Vaccine Against COVID-19 (mRNA-1273) July 28, 2020 at 3:23 PM EDT PDF Version mRNA-1273 induced robust neutralizing antibodies and dose dependent increases in T cell responses mRNA-1273 led to protection against SARS-CoV-2 infection in the lungs and nose of non-human primates No evidence of vaccine-associated enhanced disease (VAERD) observed Conference call to be held on Wednesday, July 29, 2020 at 8:00 a.m. ET CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul. 28, 2020-- Moderna, Inc. (Nasdaq: MRNA),

Pfizer to seek FDA emergency use nod for COVID-19 vaccine as early as October

Jul. 28, 2020 2:25 PM ET|About: Pfizer Inc. (PFE)|By: Douglas W. House, SA News Editor

Pfizer CEO Bourla on coronavirus vaccine timeline

CNBC’s Meg Tirrell talks with Pfizer CEO Albert Bourla about the company’s ambitious coronavirus vaccine timeline.

https://www.cnbc.com/video/2020/07/28/pfizer-ceo-bourla-on-coronavirus-vaccine-timeline.html

https://www.prnewswire.com/news-releases/lillys-p-tau217-blood-test-shows-high-accuracy-in-diagnosis-of-alzheimers-disease-in-data-published-in-jama-301101419.html

P-tau217 (phosphorylated tau at threonine-217)

Pfizer to seek FDA emergency use nod for COVID-19 vaccine as early as October

RINVOQ™ (upadacitinib) Plus Topical Corticosteroids

Lilly's P-tau217 Blood Test Shows High Accuracy in Diagnosis of Alzheimer's Disease in Data Published in JAMA

Tue July 28, 2020 1:13 PM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, July 28, 2020 /PRNewswire/ -- A new study on Lilly's blood test for Alzheimer's disease (AD), P-tau217 (phosphorylated tau at threonine-217), was published today in JAMA.

A new study on Lilly's blood test for Alzheimer's disease (AD), P-tau217 (phosphorylated tau at threonine-217), was published today in JAMA.

please visit us at lilly.com

Lilly's P-tau217 Blood Test Shows High Accuracy in Diagnosis of Alzheimer's Disease in Data Published in JAMA 07/28/2020 New Alzheimer's disease blood test could enable early diagnosis and advance understanding of how disease impacts those living with it INDIANAPOLIS, July 28, 2020 /PRNewswire/ -- A new study on Lilly's blood test for Alzheimer's disease (AD), P-tau217 (phosphorylated tau at threonine-217), was published today in JAMA.

RINVOQ™ (upadacitinib) Plus Topical Corticosteroids

Pfizer to seek FDA emergency use nod for COVID-19 vaccine as early as October

RINVOQ™ (upadacitinib) Plus Topical Corticosteroids

Third Pivotal Phase 3 Study Shows RINVOQ™ (upadacitinib) Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients

Tue July 28, 2020 8:45 AM|PR Newswire|About: ABBV

- Safety results were consistent with the other two studies in the Phase 3 program for atopic dermatitis[1-3]

- RINVOQ, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is currently approved for moderate to severe rheumatoid arthritis and continues to be evaluated across multiple immune-mediated inflammatory diseases[1,4-11]

PR Newswire

NORTH CHICAGO, Ill., July 28, 2020 /PRNewswire/ -- AbbVie (ABBV)

More information on this trial can be found at www.clinicaltrials.gov (NCT03568318).

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (AD Up)

https://clinicaltrials.gov/ct2/show/NCT03568318?titles=ad+up&lead=abbvie&phase=2&draw=2&rank=1

https://seekingalpha.com/symbol/ABBV

https://www.rinvoq.com/

https://www.abbvie.com/

July 28, 2020

Third Pivotal Phase 3 Study Shows RINVOQ™ (upadacitinib) Plus Topical Corticosteroids Improves Skin and Itch Symptoms in Atopic Dermatitis Patients

https://news.abbvie.com/news/press-releases/third-pivotal-phase-3-study-shows-rinvoq-upadacitinib-plus-topical-corticosteroids-improves-skin-and-itch-symptoms-in-atopic-dermatitis-patients.htm

USE RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

Veklury® (Remdesivir)

Farxiga (dapagliflozin)

Veklury® (Remdesivir)

Health Canada Grants Marketing Authorization with Conditions (NOC/c) for Gilead's Veklury® (Remdesivir) for the Treatment of Coronavirus Disease 2019 (COVID-19)

Tue July 28, 2020 10:30 AM|Canada Newswire

-- Veklury is the First Approved Treatment Option for COVID-19 in Canada --

MISSISSAUGA, ON, July 28, 2020 /CNW/ - Gilead Sciences Canada, Inc.

For more information about Gilead Sciences, visit the company's website at www.gilead.com

https://www.gilead.com/purpose/advancing-global-health/covid-19

Access to Remdesivir and Future Study

XENLETA® (lefamulin)

Farxiga (dapagliflozin)

Veklury® (Remdesivir)

NABRIVA Receives European Approval for XENLETA® (lefamulin) for Treatment of Community-Acquired Pneumonia (CAP)

Tue July 28, 2020 10:02 AM|GlobeNewswire|About: NBRV

-XENLETA represents the first new antibiotic class approved for patients with CAP in Europe in nearly 20 years

-XENLETA approval provides urgently needed short-course, empiric monotherapy treatment option for CAP aligned with core principles of antimicrobial stewardship

DUBLIN, July 28, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV)

For more information about Xenleta please refer to the Summary of Product Characteristics [SmPc] at: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/xenleta

https://www.nabriva.com/

Our Goal is to Develop Novel Antibiotics

https://www.nabriva.com/pipeline-research

https://www.xenleta.com/

https://seekingalpha.com/symbol/NBRV

Indication XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Farxiga (dapagliflozin)

Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins

Farxiga met all primary and secondary endpoints in groundbreaking Phase III DAPA-CKD trial for the treatment of patients with chronic kidney disease

PUBLISHED28 July 2020

This announcement contains inside information

28 July 2020 07:00 BST

Farxiga significantly reduced the worsening of renal function or risk of death in patients with chronic kidney disease with and without type-2 diabetes

https://seekingalpha.com/news/3595720-astrazenecas-farxiga-successful-in-late-stage-kidney-disease-study

AstraZeneca's Farxiga successful in late-stage kidney disease study

Jul. 28, 2020 6:50 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

Phase 3 clinical trial, DAPA-CKD, evaluating the effect of Farxiga (dapagliflozin) on renal outcomes and cardiovascular mortality in chronic kidney disease (CKD) patients with and without type 2 diabetes (T2D).

What is FARXIGA? FARXIGA is a prescription medicine used to: improve blood sugar control along with diet and exercise in adults with type 2 diabetes reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and known cardiovascular disease or multiple cardiovascular risk factors reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (when the heart is weak and cannot pump enough blood to the rest of your body) FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

https://www.farxiga.com/

Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins

BIOTECH AND PHARMA

The world’s biggest coronavirus vaccine study begins, a U.S. trial that will include 30,000 people to see if the shots really work

PUBLISHED MON, JUL 27 20207:29 AM EDTUPDATED MON, JUL 27 20209:43 AM EDT

Large-scale study Moderna COVID-19 vaccine to be fully enrolled in 4-6 weeks - CEO

Jul. 27, 2020 8:14 AM ET|About: Moderna, Inc. (MRNA)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3595143-large-scale-study-moderna-covidminus-19-vaccine-to-be-fully-enrolled-in-4minus-6-weeks-ceo

Moderna's Covid-19 BARDA contract gets added $472M modification

Jul. 26, 2020 1:23 PM ET|About: Moderna, Inc. (MRNA)|By: Brad Olesen, SA News Editor

https://seekingalpha.com/news/3595035-modernas-covidminus-19-barda-contract-gets-added-472m-modification

https://www.modernatx.com/

https://www.modernatx.com/pipeline/modernas-mrna-clinical-trials-cmv-mma-zika-several-types-cancer-and-other-diseases

https://www.scmp.com/news/world/united-states-canada/article/3094922/moderna-coronavirus-vaccine-could-be-ready-end-year

Moderna coronavirus vaccine could be ready by end of year, US says as drug maker begins final-stage trial

Phase three study with 30,000 subjects is first such trial under Trump’s Operation Warp Speed programme
Moderna could have tens of millions of doses ready when and if vaccine is deemed safe and effective

Reuters

Published: 1:21am, 28 Jul, 2020
https://seekingalpha.com/symbol/MRNA

Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins July 27, 2020 at 6:52 AM EDT PDF Version Phase 3 study being conducted in collaboration with NIH and BARDA Expected to enroll 30,000 participants in the U.S. CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul. 27, 2020-- Moderna, Inc., (Nasdaq: MRNA)

VASCEPA® (icosapent ethyl)

Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins

BNT162b1 and BNT162b2 candidates

VASCEPA® (icosapent ethyl) Data from REDUCE-IT® REVASC, Including New Data on Timeframe to Demonstrated Benefit, Presented as Encore at The American Society for Preventive Cardiology 2020 Virtual Summit on CVD (Cardiovascular Disease) Prevention

Mon July 27, 2020 7:00 AM|GlobeNewswire|About: AMRN

VASCEPA showed significant reduction in coronary revascularization, including coronary stenting and cardiac bypass surgery, in prespecified and post hoc analyses of landmark REDUCE-IT study

First and total coronary revascularization event reductions of 34% and 36%, respectively, shown with VASCEPA in prespecified tertiary endpoint analyses, with results consistent across different types of coronary revascularization procedures, including elective, urgent, and emergent interventions

In newly presented data, early coronary revascularization benefit signal shown in a prespecified exploratory analysis, with sustained statistical significance attained by 11 months

DUBLIN, Ireland and BRIDGEWATER, N.J., July 27, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

The presentation is available at https://www.aspcvirtualsummit.org/abstract-106.

about Amarin, visit www.amarincorp.com.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

https://www.vascepa.com/

VASCEPA® (ICOSAPENT ETHYL) DATA FROM REDUCE-IT® REVASC, INCLUDING NEW DATA ON TIMEFRAME TO DEMONSTRATED BENEFIT, PRESENTED AS ENCORE AT THE AMERICAN SOCIETY FOR PREVENTIVE CARDIOLOGY 2020 VIRTUAL SUMMIT ON CVD (CARDIOVASCULAR DISEASE) PREVENTION

https://investor.amarincorp.com/news-releases/news-release-details/vascepar-icosapent-ethyl-data-reduce-itr-revasc-including-new

https://seekingalpha.com/news/3595113-amarin-up-3-on-new-vascepa-data-from-reduce-study

https://seekingalpha.com/symbol/AMRN

INDICATIONS WHAT IS VASCEPA? VASCEPA is a prescription medicine used: along with certain medicines (statins) to reduce the risk of heart attack, stroke and certain types of heart issues requiring hospitalization in adults with heart (cardiovascular) disease, or diabetes and 2 or more additional risk factors for heart disease. along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults. It is not known if VASCEPA changes your risk of having inflammation of your pancreas (pancreatitis). It is not known if VASCEPA is safe and effective in children.

BNT162b1 and BNT162b2 candidates

Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins

BNT162b1 and BNT162b2 candidates

Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study

Mon July 27, 2020 5:15 PM|Business Wire|About: BNTX, PFE

Companies advance nucleoside-modified messenger RNA (modRNA) candidate BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30 µg dose level in a 2 dose regimen into Phase 2/3 Study
Candidate and dose level selection informed by preclinical and clinical data obtained in Phase 1/2 studies conducted in the U.S. (C4591001) and Germany (BNT162-01)
The Phase 2/3 study protocol follows all the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies.
Phase 2/3 study of up to 30,000 participants aged 18 – 85 years started in the U.S. and expected to include approximately 120 sites globally
Trial regions to include areas with significant expected SARS-CoV-2 transmission to assess whether investigational vaccine candidate, BNT162b2, is effective in preventing COVID-19
Assuming clinical success, Pfizer (PFE) and BioNTech (NTGN) on track to seek regulatory review as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (BNTX) (Nasdaq: BNTX)

https://www.businesswire.com/news/home/20200727005800/en/

For further information about this trial, visit ClinicalTrials.gov using the number NCT04368728.

www.Pfizer.com

www.BioNTech.de

https://www.statnews.com/2020/07/27/pfizer-biontech-pick-covid19-vaccine-begin-pivotal-study/

PHARMA

Pfizer and BioNTech pick Covid-19 vaccine and begin pivotal study

By MATTHEW HERPER @matthewherper and DAMIAN GARDE @damiangarde

JULY 27, 2020

Prognosis

Pfizer, BioNTech Start Late-Stage Study of Lead Covid Shot

By Riley GriffinJuly 27, 2020, 5:36 PM EDT Updated on July 27, 2020, 7:15 PM EDT

Companies set October as goal for seeking regulatory review
Moderna announced its final-state vaccine trial earlier Monday

https://www.bloomberg.com/news/articles/2020-07-27/pfizer-and-biontech-start-late-stage-study-of-lead-covid-shot

PFIZER AND BIONTECH CHOOSE LEAD MRNA VACCINE CANDIDATE AGAINST COVID-19 AND COMMENCE PIVOTAL PHASE 2/3 GLOBAL STUDY July 27, 2020

biotecMAX™ July 2020 insight

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2

SRP-9001 = investigational gene transfer therapy designed to deliver the micro-dystrophin-encoding g

Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China

Mon July 27, 2020 9:15 AM|GlobeNewswire|About: BGNE

BEIJING, China and CAMBRIDGE, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

https://www.beigene.com/

https://www.beigene.com/science-and-product-portfolio/pipeline

Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China

July 27, 2020 at 9:15 AM EDT

BEIJING, China and CAMBRIDGE, Mass., July 27, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160)

http://ir.beigene.com/news-releases/news-release-details/priority-review-granted-beigenes-new-drug-application-pamiparib

https://seekingalpha.com/symbol/BGNE

Pamiparib

Pamiparib (BGB-290) is an investigational small molecule inhibitor of PARP1 and PARP2. Pamiparib is being evaluated as a monotherapy in pivotal clinical trials in China in recurrent platinum-sensitive and BRCA1/2 mutated ovarian cancers. It is currently in global clinical development as a monotherapy, and in combination with other agents, including BeiGene’s investigational anti-PD1 antibody, tislelizumab (BGB-A317), for a variety of solid tumor malignancies.

For more clinical trial information please visit CLINICALTRIALS.GOV.

https://www.beigene.com/science-and-product-portfolio/pipeline/pamiparib

BeiGene Pipeline

SRP-9001 = investigational gene transfer therapy designed to deliver the micro-dystrophin-encoding g

Sarepta Therapeutics Receives Fast Track Designation for SRP-9001 Micro-Dystrophin Gene Therapy for the Treatment of Duchenne Muscular Dystrophy

Fri July 24, 2020 8:30 AM|GlobeNewswire|About: SRPT

CAMBRIDGE, Mass., July 24, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (SRPT)

https://www.sarepta.com/products-pipeline/pipeline

please visit www.sarepta.com

Sarepta gene therapy Fast Track'd for Duchenne muscular dystrophy

Jul. 24, 2020 8:57 AM ET|About: Sarepta Therapeutics, ... (SRPT)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3594777-sarepta-gene-therapy-fast-trackd-for-duchenne-muscular-dystrophy

https://www.sarepta.com/products-pipeline/pipeline

https://seekingalpha.com/symbol/SRPT

Sarepta Therapeutics Receives Fast Track Designation for SRP-9001 Micro-Dystrophin Gene Therapy for the Treatment of Duchenne Muscular Dystrophy

07/24/20 8:30 AM EDT

CAMBRIDGE, Mass., July 24, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT)

https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-receives-fast-track-designation-srp-9001

Building an industry-leading genetic medicine pipeline

Emergent Bio inks deal with AstraZeneca for manufacture of COVID-19 vaccine

SRP-9001 = investigational gene transfer therapy designed to deliver the micro-dystrophin-encoding g

Emergent Bio inks deal with AstraZeneca for manufacture of COVID-19 vaccine

Emergent BioSolutions Signs Agreement with AstraZeneca to Expand Manufacturing for COVID-19 Vaccine Candidate

Mon July 27, 2020 6:30 AM|GlobeNewswire|About: EBS

Emergent will provide contract development and manufacturing services beginning in 2020 to produce drug substance at large scale for commercial supply
Agreement is valued at approximately $174 million through 2021 and brings the total AstraZeneca commitment to $261 million
Parties may enter into additional commercial manufacturing commitments as the candidate progresses over three years through Emergent’s flexible capacity deployment model

GAITHERSBURG, Md., July 27, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (EBS)

https://www.emergentbiosolutions.com/

https://seekingalpha.com/symbol/EBS

Emergent Bio inks deal with AstraZeneca for manufacture of COVID-19 vaccine

Jul. 27, 2020 7:23 AM ET|About: Emergent BioSolutions Inc. (EBS)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3595106-emergent-bio-inks-deal-astrazeneca-for-manufacture-of-covidminus-19-vaccine

Manufacturing Expertise: Protecting and Enhancing Life in Every Single Dose

CRYSVITA® (burosumab)

CALQUENCE® (acalabrutinib) capsules

Emergent Bio inks deal with AstraZeneca for manufacture of COVID-19 vaccine

Kyowa Kirin Receives Positive CHMP Opinion for the Expanded Use of CRYSVITA® (burosumab) to Include Older Adolescents and Adults for the Treatment of X-Linked Hypophosphataemia (XLH)

Fri July 24, 2020 8:35 AM|Business Wire|About: KNBWY, KYKOY

XLH is a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints1,2,3

TOKYO--(BUSINESS WIRE)-- Kyowa Kirin Co., Ltd. (KYKOF) (TSE:4151, Kyowa Kirin)

You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/

Kyowa Kirin International
http://www.international.kyowa-kirin.com / www.kyowakirin.com

https://www.businesswire.com/news/home/20200724005256/en/

https://seekingalpha.com/symbol/KYKOF

https://seekingalpha.com/symbol/RARE

https://rarediseases.info.nih.gov/diseases/12943/x-linked-hypophosphatemia

What CRYSVITA is CRYSVITA contains the active substance burosumab. This is a type of medicine called a human monoclonal antibody. What is CRYSVITA used for CRYSVITA is used to treat X-linked hypophosphataemia (XLH). It is used in children of 1 year and older, and adolescents who are still growing.

CALQUENCE® (acalabrutinib) capsules

European advisory group backs AstraZeneca's Calquence for leukemia treatment

Jul. 24, 2020 10:54 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

Calquence

acalabrutinib

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Calquence,1 intended for the treatment of chronic lymphocytic leukaemia (CLL). The applicant for this medicinal product is AstraZeneca AB.

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/calquence

https://www.calquence.com/

Please see full Prescribing Information, including Patient Information

What is CALQUENCE? CALQUENCE is a prescription medicine used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer, or adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is not known if CALQUENCE is safe and effective in children.

Jyseleca® (Filgotinib)

CALQUENCE® (acalabrutinib) capsules

Gilead and Galapagos Announce Positive European CHMP Opinion for Jyseleca® (Filgotinib) for the Treatment of Adults With Moderate to Severe Rheumatoid Arthritis

Fri July 24, 2020 8:10 AM|Business Wire|About: GILD, GLPG

-- Clinical Development Program of Filgotinib Demonstrated Durable Efficacy Balanced with a Consistent Safety Profile in Rheumatoid Arthritis Through 52 Weeks --

FOSTER CITY, Calif., & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF) (Euronext & Nasdaq: GLPG)

https://www.businesswire.com/news/home/20200724005236/en/

at www.gilead.com.

More information at www.glpg.com

https://seekingalpha.com/symbol/GLPG

July 24, 2020 Gilead and Galapagos Announce Positive European CHMP Opinion for Jyseleca® (Filgotinib) for the Treatment of Adults With Moderate to Severe Rheumatoid Arthritis -- Clinical Development Program of Filgotinib Demonstrated Durable Efficacy Balanced with a Consistent Safety Profile in Rheumatoid Arthritis Through 52 Weeks -- FOSTER CITY, Calif., & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG)

Adakveo (crizanlizumab)

Blenrep (belantamab mafodotin)

European advisory group backs Novartis sickle cell drug

Jul. 24, 2020 8:03 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor

https://www.hcp.novartis.com/products/adakveo/sickle-cell-disease/?site=CZB-1230280GK100087&source=01030&gclid=CjwKCAjw0_T4BRBlEiwAwoEiAdQjGJF0H2PolFfCqFdpqNiHiAgVah6s2c6vUrCjfVUh-K-MxWzpoBoCURkQAvD_BwE&gclsrc=aw.ds

https://seekingalpha.com/symbol/NVS

https://www.hcp.novartis.com/

https://www.novartis.com/

Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease

Jul 24, 2020

If approved, Adakveo would be the first targeted sickle cell disease therapy available for use in Europe
CHMP opinion supported by data showing Adakveo significantly reduced the rate of vaso-occlusive crises, with patients on Adakveo spending fewer days in hospital
Vaso-occlusive crises are sudden, unpredictable, and associated with an increased risk of organ damage and mortality1

Basel, July 24, 2020 — Novartis

https://www.novartis.com/news/media-releases/novartis-adakveo-receives-positive-chmp-opinion-prevention-recurrent-vaso-occlusive-crises-patients-sickle-cell-disease

Indication ADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.

Blenrep (belantamab mafodotin)

European advisory group backs Glaxo antibody-drug conjugate for multiple myeloma

Jul. 24, 2020 10:41 AM ET|About: GlaxoSmithKline plc (GSK)|By: Douglas W. House, SA News Editor

Blenrep

belantamab mafodotin

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/blenrep

24 July 2020 GSK receives positive CHMP opinion recommending approval of belantamab mafodotin for the treatment of relapsed and refractory multiple myeloma For media and investors only Issued: London, UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)

PREZISTA® (darunavir)

Blenrep (belantamab mafodotin)

PREZISTA® (darunavir)

European advisory backs expanded label for J&J's HIV med Prezista

Jul. 24, 2020 12:02 PM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor

Prezista

darunavir

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prezista. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/prezista

https://www.prezista.com/

What is PREZISTA®? PREZISTA® (darunavir) is a prescription HIV-1 (Human Immunodeficiency Virus type-1) medicine used with NORVIR® (ritonavir) and other antiretroviral medicines to treat HIV-1 infection in adults. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). PREZISTA® should not be used in children under 3 years of age. When used with other antiretroviral medicines to treat HIV-1 infection, PREZISTA® may help: reduce the amount of HIV-1 in your blood. This is called "viral load." increase the number of CD4+ (T) cells in your blood that help fight off other infections. PREZISTA® is always taken with and at the same time as NORVIR® (ritonavir) in combination with other HIV-1 medicines for the treatment of HIV-1 infection in adults. PREZISTA® should also be taken with food. PREZISTA® does not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.

IMFINZI® (durvalumab)

Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19)

PREZISTA® (darunavir)

European advisory group backs AstraZeneca's Imfinzi for first-line lung cancer

Jul. 24, 2020 11:51 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

Imfinzi

durvalumab

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Imfinzi. The marketing authorisation holder for this medicinal product is AstraZeneca AB.

https://www.ema.europa.eu/en/medicines/human/summaries-opinion/imfinzi

IMFINZI® (durvalumab) is a prescription medicine used to treat adults with a type of cancer in the bladder and urinary tract called urothelial carcinoma. IMFINZI may be used when your urothelial carcinoma has spread or cannot be removed by surgery, and chemotherapy containing platinum did not work or is no longer working. IMFINZI was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. The study is ongoing to confirm clinical benefit. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). IMFINZI may be used with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC).

https://www.imfinzi.com/

Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19)

U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma

Fri July 24, 2020 1:25 PM|Business Wire|About: GILD

-- 87 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus --

-- Kite Becomes First Company with Multiple Approved CAR T Therapies --

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD)

https://www.businesswire.com/news/home/20200724005428/en/

https://www.yescartatecartusrems.com/

July 24, 2020

U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma

-- 87 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus --

-- Kite Becomes First Company with Multiple Approved CAR T Therapies --

SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD)

https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/us-fda-approves-kites-tecartus-the-first-and-only-car-t-treatment-for-relapsed-or-refractory-mantle-cell-lymphoma

Kite Konnect at www.KiteKonnect.com or 1-844-454-KITE (1-844-454-5483).

The Tecartus REMS has been combined with the Yescarta REMS and is now called the “Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) REMS Program” (www.YescartaTecartusREMS.com).

visit www.kitepharma.com.

www.gilead.com.

https://seekingalpha.com/news/3594908-fda-oks-gilead-car-t-for-rare-type-of-lymphoma

FDA OKs Gilead CAR T for rare type of lymphoma

Jul. 24, 2020 1:41 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor

INDICATION YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

IMBRUVICA® (ibrutinib) in Combination with Rituximab

Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19)

Janssen Receives CHMP Positive Opinion for Expanded Use of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL)

Fri July 24, 2020 9:13 AM|Business Wire|About: JNJ

Positive Opinion is supported by Phase 3 E1912 study evaluating ibrutinib-rituximab combination versus chemo-immunotherapy in first-line treatment of CLL

BEERSE, Belgium--(BUSINESS WIRE)-- The Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ)

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

https://www.janssen.com/emea/

https://www.jnj.com/

View source version on businesswire.com: https://www.businesswire.com/news/home/20200724005286/en/

https://www.janssen.com/

https://imbruvica.com/

https://seekingalpha.com/symbol/ABBV

https://www.rituxan.com/

European advisory groups backs expanded use of Imbruvica

Jul. 24, 2020 9:43 AM ET|About: Johnson & Johnson (JNJ)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3594817-european-advisory-groups-backs-expanded-use-of-imbruvica

What is IMBRUVICA® (ibrutinib)? IMBRUVICA® (ibrutinib) is a prescription medicine used to treat adults with: Mantle cell lymphoma (MCL) who have received at least one prior treatment Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion Waldenström’s macroglobulinemia (WM) Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy

biotecMAX™ July 2020 insight

Breztri Aerosphere for COPD

NVX–CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS–CoV–2

Breztri Aerosphere approved in the US for the maintenance treatment of COPD

PUBLISHED24 July 2020

24 July 2020 07:00 BST

Approval based on Phase III ETHOS trial which showed a statistically significant reduction in the rate of exacerbations compared with dual-combination therapies

AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD

https://www.nejm.org/doi/full/10.1056/NEJMoa1916046

ARTICLES| VOLUME 6, ISSUE 10, P747-758, OCTOBER 01, 2018

PDF [1 MB]

Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30327-8/fulltext

https://breztrihcp.com/

FDA OKs AstraZeneca's Breztri Aerosphere for pulmonary disease

Jul. 24, 2020 7:06 AM ET|About: AstraZeneca PLC (AZN)|By: Mamta Mayani, SA News Editor

https://seekingalpha.com/news/3594696-fda-oks-astrazenecas-breztri-aerosphere-for-pulmonary-disease

The FDA approval was based on positive results from the Phase 3 ETHOS trial and Phase 3 KRONOS study.

Breztri Aerosphere approved in the US for the maintenance treatment of COPD

NVX–CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS–CoV–2

Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate

Thu July 23, 2020 4:04 PM|PR Newswire|About: NVAX

GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 /PRNewswire/ -- Novavax, Inc. (NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB)

Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate

Jul 23, 2020 at 4:02 PM EDTDownload PDF

GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX),

https://ir.novavax.com/news-releases/news-release-details/novavax-and-fujifilm-diosynth-biotechnologies-initiate-large

https://novavax.com/

https://fujifilmdiosynth.com/

For more information, visit www.novavax.com

For more information, go to: www.fujifilmdiosynth.com

https://www.prnewswire.com/news-releases/novavax-and-fujifilm-diosynth-biotechnologies-initiate-large-scale-manufacturing-of-covid-19-vaccine-candidate-301099139.html

https://seekingalpha.com/symbol/NVAX

We have successfully produced NVX-CoV2373, a vaccine candidate that is designed to provide protection against COVID-19. Engineered from the genetic sequence of COVID-19, we used our recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein. In combination with our proprietary Matrix-M™ adjuvant, NVX-CoV2373 has demonstrated in preclinical studies that it binds efficiently with human receptors targeted by the virus, a critical aspect for effective vaccine protection

Vosoritide (BMN 111) for Achondroplasia

NVX–CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS–CoV–2

Vosoritide (BMN 111) for Achondroplasia

BioMarin Submits Marketing Authorization Application to European Medicines Agency for Vosoritide to Treat Children with Achondroplasia

Thu July 23, 2020 4:07 PM|PR Newswire|About: BMRNPR Newswire

SAN RAFAEL, Calif., July 23, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)

For additional information, please visit www.biomarin.com.

https://www.prnewswire.com/news-releases/biomarin-submits-marketing-authorization-application-to-european-medicines-agency-for-vosoritide-to-treat-children-with-achondroplasia-301099141.html

https://seekingalpha.com/symbol/BMRN

https://www.biomarin.com/products/pipeline/bmn-111/

BioMarin Submits Marketing Authorization Application to European Medicines Agency for Vosoritide to Treat Children with Achondroplasia

If approved, vosoritide would be the first medicine to treat Achondroplasia in EU

Jul 23, 2020

https://investors.biomarin.com/2020-07-23-BioMarin-Submits-Marketing-Authorization-Application-to-European-Medicines-Agency-for-Vosoritide-to-Treat-Children-with-Achondroplasia

Vosoritide (BMN 111) for Achondroplasia Vosoritide is designed for the treatment of achondroplasia, the most common form of dwarfism.

XENLETA® (lefamulin)

Dojolvi™ (triheptanoin)

Vosoritide (BMN 111) for Achondroplasia

Lefamulin Demonstrates Anti-Inflammatory Activity in Pre-Clinical Study

Thu July 23, 2020 7:00 AM|GlobeNewswire|About: NBRV

-In pre-clinical model, lefamulin shows anti-inflammatory activity comparable to dexamethasone

-Nabriva awarded grant funding from the Austrian Research Promotion Agency to further characterize the anti-inflammatory and immunomodulatory properties of Lefamulin

DUBLIN, Ireland, July 23, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV)

https://www.xenleta.com/

https://www.nabriva.com/

lipopolysaccharide (LPS)-induced lung neutrophilia (induced lung inflammation via intranasal administration of LPS).

https://seekingalpha.com/symbol/NBRV

https://www.nabriva.com/pipeline-research

Jakafi® (ruxolitinib)

Dojolvi™ (triheptanoin)

Incyte Announces REACH3 Trial of Ruxolitinib (Jakafi®) in Patients with Chronic Graft-Versus-Host Disease Met Primary and Both Key Secondary Endpoints

Thu July 23, 2020 7:15 AM|Business Wire|About: INCY

- Jakafi® demonstrated superior overall response rate in patients with steroid-refractory chronic graft-versus-host disease (GVHD) at Week 24 compared to best available therapy

- The study also met both key secondary endpoints, significantly improving patient-reported symptoms and failure-free survival

- GVHD is a serious and common complication of allogeneic stem cell transplants with no widely approved treatment options for patients who do not respond to steroids

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)

These topline results build on previously-reported positive data from the REACH1 and REACH2 trials, which demonstrated that Jakafi improved outcomes across a range of efficacy measures in patients with steroid-refractory acute GVHD.

A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)

https://clinicaltrials.gov/ct2/show/NCT03112603

A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)

https://clinicaltrials.gov/ct2/show/NCT02953678

https://www.jakafi.com/

https://www.incyte.com/

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-reach3-trial-ruxolitinib-jakafir-patients

https://www.businesswire.com/news/home/20200723005089/en/

https://seekingalpha.com/symbol/INCY

INDICATIONS AND USAGE Jakafi is a prescription medicine used to treat adults with polycythemia vera who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it. Jakafi is used to treat adults with certain types of myelofibrosis. Jakafi is also used to treat adults and children 12 years of age and older with acute graft-versus-host disease (GVHD) who have taken corticosteroids and they did not work well enough.

Dojolvi™ (triheptanoin)

Ultragenyx Announces U.S. Commercial Launch of Dojolvi™ (triheptanoin), the First FDA-Approved Therapy for the Treatment of Long-chain Fatty Acid Oxidation Disorders

Wed July 22, 2020 8:35 AM|GlobeNewswire|About: RAREGlobeNewswire

NOVATO, Calif., July 22, 2020 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (RARE)

Please see full Prescribing Information, including the Patient Information leaflet, for a complete discussion of the risks associated with Dojolvi.

https://www.ultragenyx.com/

https://www.ultragenyx.com/medicines/dojolvi/

https://www.dojolvi.com/

https://seekingalpha.com/news/3593585-ultragenyx-launches-triheptanoin-in-u-s-for-rare-metabolic-disorders

https://seekingalpha.com/symbol/RARE

Pipeline

https://www.ultragenyx.com/pipeline/

INDICATION: DOJOLVI is a medium-chain triglyceride indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).

TEGSEDI® (inotersen)

Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution

Akcea Announces Approval for Reimbursement of TEGSEDI® (inotersen) in Austria for Treatment of Hereditary Transthyretin Amyloidosis with Polyneuropathy

Wed July 22, 2020 7:00 AM|PR Newswire|About: AKCA, IONS

TEGSEDI is now commercially available in 15 countries

PR Newswire

BOSTON, July 22, 2020 /PRNewswire/ -- Akcea Therapeutics, Inc. (AKCA)

https://tegsedi.com/

https://akceatx.com/

https://seekingalpha.com/symbol/AKCA

https://seekingalpha.com/symbol/IONS

Please see full Prescribing Information, including boxed WARNING, at TEGSEDIhcp.com.

Akcea is available at www.akceatx.com

https://www.prnewswire.com/news-releases/akcea-announces-approval-for-reimbursement-of-tegsedi-inotersen-in-austria-for-treatment-of-hereditary-transthyretin-amyloidosis-with-polyneuropathy-301096646.html

https://akceatx.com/our-products/tegsedi/

INDICATION TEGSEDI is a medicine that treats the polyneuropathy caused by hereditary transthyretin-mediated amyloidosis. TEGSEDI is for use in adults only.

Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution

Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy

Wed July 22, 2020 7:30 AM|PR Newswire|About: JAZZ

Xywav contains 92 percent less sodium per nightly dose than sodium oxybate, a current standard of care for this patient population as designated by the American Academy of Sleep Medicine Guidelines

Narcolepsy is a chronic sleep disorder and is associated with an increased prevalence of certain comorbid conditions, including hypertension and cardiovascular disease

PR Newswire

DUBLIN, July 22, 2020 /PRNewswire/ -- Jazz Pharmaceuticals plc (JAZZ)

https://www.jazzpharma.com/

https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-us-fda-approval-of-xywav-calcium-magnesium-potassium-and-sodium-oxybates-oral-solution-for-cataplexy-or-excessive-daytime-sleepiness-associated-with-narcolepsy-301097861.html

https://seekingalpha.com/symbol/JAZZ

Pipeline

https://www.jazzpharma.com/research/pipeline/

Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy July 22, 2020

mRNA-based Vaccine Candidate Against SARS-CoV-2

Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution

WATCHMAN FLX™ Left Atrial Appendage Closure Device

Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

Wed July 22, 2020 7:10 AM|Business Wire|About: BNTX, PFE

U.S. government placed an initial order of 100 million doses for $1.95 billion and can acquire up to 500 million additional doses
Americans to receive the vaccine for free consistent with U.S. government’s commitment for free access for COVID-19 vaccines
Pfizer (PFE) and BioNTech (NTGN) remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. and BioNTech SE (BNTX)

https://www.businesswire.com/news/home/20200722005438/en/

https://www.pfizer.com/

https://biontech.de/

https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-announce-agreement-u-s-government-600

Pfizer and BioNTech Announce an Agreement with U. S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

Pfizer Vaccine Deal at $20 a Dose Sets Ceiling for Rivals
https://www.bloomberg.com/news/articles/2020-07-22/pfizer-biontech-receive-u-s-order-for-covid-vaccine

PFIZER AND BIONTECH ANNOUNCE EARLY POSITIVE UPDATE FROM GERMAN PHASE 1/2 COVID-19 VACCINE STUDY, INCLUDING FIRST T CELL RESPONSE DATA Monday, July 20, 2020 - 08:45am The data further demonstrated the ability of BNT162b1 to elicit high SARS-CoV-2 neutralizing titers BNT162b1 elicited strong CD4+ and CD8+ T cell responses against SARS-CoV-2-receptor binding domain (RBD), compared to baseline The RBD-specific, interferon-γ+, IL-2+, CD8+ T cells elicited by BNT162b1 in immunized participants indicate a strong potential for cell mediated anti-viral activity T cell cytokine profile shows vaccine elicited T cells exhibit a Th1 phenotype, which is associated with antiviral properties BNT162b1 induced antibodies had broadly neutralizing activity in pseudovirus neutralization assays across a panel of sixteen SARS-CoV-2 RBD variants identified in published SARS-CoV-2 sequences and against the newly dominant D614G strain Robust specific antibody and T cell responses, (both of which are considered by experts as key to a vaccine ensuring protection against disease) elicited by the BNT162b1 mRNA vaccine against RBD suggest a potential for multiple beneficial protective mechanisms against COVID-19 Local reactions and systemic events after immunization with BNT162b1 were dose-dependent, generally mild to moderate and transient, with occasional severe adverse events (Grade 3, e.g. flu-like symptoms and injection site reactions) that resolved spontaneously or could be managed with simple measures - no serious adverse events were reported MAINZ, Germany & NEW YORK--(BUSINESS WIRE)-- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc. (NYSE: PFE)

WATCHMAN FLX™ Left Atrial Appendage Closure Device

Boston Scientific Receives FDA Approval for Next-Generation WATCHMAN FLX™ Left Atrial Appendage Closure Device

Tue July 21, 2020 4:24 PM|PR Newswire|About: BSXPR Newswire

MARLBOROUGH, Mass., July 21, 2020 /PRNewswire/ -- Boston Scientific Corporation (BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device.

https://www.watchman.com/en-us/home.html

https://www.prnewswire.com/news-releases/boston-scientific-receives-fda-approval-for-next-generation-watchman-flx-left-atrial-appendage-closure-device-301097439.html

https://seekingalpha.com/symbol/BSX

https://www.bostonscientific.com/en-US/Home.html

Boston Scientific Receives FDA Approval for Next-Generation WATCHMAN FLX™ Left Atrial Appendage Closure DeviceNew stroke risk reduction technology designed to advance procedural performance and safety, treat wider range of patients with non-valvular atrial fibrillation

MARLBOROUGH, Mass., July 21, 2020 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX)

https://news.bostonscientific.com/2020-07-21-Boston-Scientific-Receives-FDA-Approval-for-Next-Generation-WATCHMAN-FLX-TM-Left-Atrial-Appendage-Closure-Device

WATCHMAN Reduces the Risk of Stroke from Non‑valvular AFib There’s an alternative to warfarin for people who need one. It’s called WATCHMAN. The only FDA-approved implant proven to reduce stroke risk in people with atrial fibrillation not caused by a heart valve problem (also referred to as non-valvular AFib). Watch the video to learn more and talk to your cardiologist about WATCHMAN. 04:33

RINVOQ™ (upadacitinib)

WATCHMAN FLX™ Left Atrial Appendage Closure Device

NUPLAZID® (pimavanserin)

RINVOQ™ (upadacitinib) Monotherapy Meets All Primary and Secondary Endpoints in Second Phase 3 Study for Atopic Dermatitis

Tue July 21, 2020 8:45 AM|PR Newswire|About: ABBV

- Safety results were consistent with those of its replicate study, Measure Up 1[2]

- RINVOQ, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily oral therapy for moderate to severe atopic dermatitis and in several other immune-mediated diseases[1,3-10]

PR Newswire

NORTH CHICAGO, Ill., July 21, 2020 /PRNewswire/ -- AbbVie (ABBV)

More information on this trial can be found at www.clinicaltrials.gov (NCT03607422).

Please click here for the Full Prescribing Information and Medication Guide.

https://www.prnewswire.com/news-releases/rinvoq-upadacitinib-monotherapy-meets-all-primary-and-secondary-endpoints-in-second-phase-3-study-for-atopic-dermatitis-301096639.html

https://www.abbvie.com/

RINVOQ™ (upadacitinib) Monotherapy Meets All Primary and Secondary Endpoints in Second Phase 3 Study for Atopic Dermatitis

https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-monotherapy-meets-all-primary-and-secondary-endpoints-in-second-phase-3-study-for-atopic-dermatitis.htm

https://seekingalpha.com/symbol/ABBV

RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated.

NUPLAZID® (pimavanserin)

WATCHMAN FLX™ Left Atrial Appendage Closure Device

NUPLAZID® (pimavanserin)

ACADIA Pharmaceuticals Announces U.S. FDA Accepted for Filing the Supplemental New Drug Application for NUPLAZID® (pimavanserin) for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis

Mon July 20, 2020 4:03 PM|Business Wire|About: ACAD

- If approved, NUPLAZID would be the first and only treatment indicated for dementia-related psychosis

- Prescription Drug User Fee Act (PDUFA) date set for April 3, 2021

- Conference call and webcast to be held today at 4:30 p.m. Eastern Time

SAN DIEGO--(BUSINESS WIRE)-- ACADIA Pharmaceuticals Inc. (ACAD)

https://www.acadia-pharm.com/

https://seekingalpha.com/symbol/ACAD

https://www.nuplazid.com/

https://www.businesswire.com/news/home/20200720005745/en/

https://ir.acadia-pharm.com/news-releases/news-release-details/acadia-pharmaceuticals-announces-us-fda-accepted-filing?field_nir_news_date_value%5Bmin%5D=

NUPLAZID® (pimavanserin) is the only medicine FDA-approved to reduce the frequency and/or severity of hallucinations and delusions associated with Parkinson’s disease psychosis.

biotecMAX July 2020 insight

ripretinib (brand name Qinlock)

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

China NMPA Accepts NDA Submission of Ripretinib for Advanced Gastrointestinal Stromal Tumor

Mon July 20, 2020 7:30 AM|GlobeNewswire|About: DCPH, ZLAB

China NMPA acceptance of NDA follows recent U.S. FDA approval for the treatment of
adult patients with advanced GIST who have received prior treatment with 3 or more
kinase inhibitors, including imatinib

SHANGHAI, China and SAN FRANCISCO and WALTHAM, Mass., July 20, 2020 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB) and Deciphera Pharmaceuticals, Inc. (DCPH)

https://www.deciphera.com/pipeline/

https://qinlock.com/

http://www.zailaboratory.com/

www.deciphera.com

https://seekingalpha.com/symbol/DCPH

https://seekingalpha.com/symbol/ZLAB

Ripretinib is approved by the U.S. FDA under the brand name QINLOCK™ for the treatment of adult patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

What is QINLOCK? QINLOCK is a prescription medicine used to treat adults with advanced gastrointestinal stromal tumor (GIST) who have received 3 or more prior treatments for their GIST.

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

Exelixis Announces Initiation of CONTACT-03 Phase 3 Pivotal Trial of Cabozantinib in Combination With Atezolizumab in Previously Treated Metastatic Renal Cell Carcinoma

Mon July 20, 2020 8:00 AM|Business Wire|About: EXEL

– CONTACT-03 is the third of three phase 3 pivotal trials that are part of a clinical collaboration with Roche –

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL) (NASDAQ: EXEL) today announced the initiation of CONTACT-03, a global phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

Exelixis Announces Initiation of CONTACT-01 Phase 3 Pivotal Trial of Cabozantinib in Combination With Atezolizumab in Previously Treated Metastatic Non-small Cell Lung CancerPDF Version

– Initiation follows positive results from cohort 7 of phase 1b COSMIC-021 trial –

– CONTACT-01 is the first of three phase 3 pivotal trials that are part of a previously announced clinical collaboration with Roche –

ALAMEDA, Calif.--(BUSINESS WIRE)--Jun. 11, 2020-- Exelixis, Inc. (NASDAQ: EXEL) today announced the initiation of CONTACT-01,

https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-initiation-contact-01-phase-3-pivotal-trial

https://www.exelixis.com/

Exelixis, Inc. (EXEL) (NASDAQ: EXEL)

CONTACT-03 is available at ClinicalTrials.gov (NCT04338269).

https://www.businesswire.com/news/home/20200720005068/en/

CONTACT-03 is part of a clinical trial collaboration between Exelixis and Roche (OTCQX:RHHBY) that includes two additional phase 3 pivotal trials in lung and prostate cancer.

https://seekingalpha.com/symbol/EXEL

https://www.tecentriq.com/

https://www.cabometyx.com/

What is CABOMETYX? CABOMETYX is a prescription medicine used to treat people with: Advanced kidney cancer (renal cell carcinoma) Liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

AZD1222 COVID-19 vaccine candidate

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

AZD1222 COVID-19 vaccine candidate

AstraZeneca/Oxford COVID-19 vaccine candidate shows robust action in early-stage study

Jul. 20, 2020 9:40 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

Phase 1 clinical trial, just published online in The Lancet

https://marlin-prod.literatumonline.com/pb-assets/Lancet/pdfs/S0140673620316056.pdf

AstraZeneca/Oxford COVID-19 vaccine shows positive effect in early-stage study

Jul. 21, 2020 11:51 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor

https://seekingalpha.com/news/3593161-astrazeneca-oxford-covidminus-19-vaccine-shows-positive-effect-in-early-stage-study

Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2820%2931604-4/fulltext

COVID-19 vaccine AZD1222 showed robust immune responses in all participants in Phase I/II trial PUBLISHED 20 July 2020

BNT162b1 mRNA vaccine

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2

AZD1222 COVID-19 vaccine candidate

Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data

Mon July 20, 2020 8:45 AM|Business Wire|About: BNTX, PFE

The data further demonstrated the ability of BNT162b1 to elicit high SARS-CoV-2 neutralizing titers
BNT162b1 elicited strong CD4+ and CD8+ T cell responses against SARS-CoV-2- receptor binding domain (RBD), compared to baseline
The RBD-specific, interferon-γ+, IL-2+, CD8+ T cells elicited by BNT162b1 in immunized participants indicate a strong potential for cell mediated anti-viral activity
T cell cytokine profile shows vaccine elicited T cells exhibit a Th1 phenotype, which is associated with antiviral properties
BNT162b1 induced antibodies had broadly neutralizing activity in pseudovirus neutralization assays across a panel of sixteen SARS-CoV-2 RBD variants identified in published SARS-CoV-2 sequences and against the newly dominant D614G strain
Robust specific antibody and T cell responses, (both of which are considered by experts as key to a vaccine ensuring protection against disease) elicited by the BNT162b1 mRNA vaccine against RBD suggest a potential for multiple beneficial protective mechanisms against COVID-19
Local reactions and systemic events after immunization with BNT162b1 were dose-dependent, generally mild to moderate and transient, with occasional severe adverse events (Grade 3, e.g. flu-like symptoms and injection site reactions) that resolved spontaneously or could be managed with simple measures - no serious adverse events were reported

MAINZ, Germany & NEW YORK--(BUSINESS WIRE)-- BioNTech SE (BNTX) (Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc (PFE). (NYSE: PFE)

https://biontech.de/

https://www.pfizer.de/

https://www.businesswire.com/news/home/20200720005408/en/

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-early-positive-update-german

Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data PDF Version The data further demonstrated the ability of BNT162b1 to elicit high SARS-CoV-2 neutralizing titers BNT162b1 elicited strong CD4+ and CD8+ T cell responses against SARS-CoV-2- receptor binding domain (RBD), compared to baseline The RBD-specific, interferon-g+, IL-2+, CD8+ T cells elicited by BNT162b1 in immunized participants indicate a strong potential for cell mediated anti-viral activity T cell cytokine profile shows vaccine elicited T cells exhibit a Th1 phenotype, which is associated with antiviral properties BNT162b1 induced antibodies had broadly neutralizing activity in pseudovirus neutralization assays across a panel of sixteen SARS-CoV-2 RBD variants identified in published SARS-CoV-2 sequences and against the newly dominant D614G strain Robust specific antibody and T cell responses, (both of which are considered by experts as key to a vaccine ensuring protection against disease) elicited by the BNT162b1 mRNA vaccine against RBD suggest a potential for multiple beneficial protective mechanisms against COVID-19 Local reactions and systemic events after immunization with BNT162b1 were dose-dependent, generally mild to moderate and transient, with occasional severe adverse events (Grade 3, e.g. flu-like symptoms and injection site reactions) that resolved spontaneously or could be managed with simple measures - no serious adverse events were reported MAINZ, Germany and NEW YORK, July 20, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) and Pfizer Inc. (NYSE: PFE)

BNT162 mRNA-based vaccine candidate against SARS-CoV-2.

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2

Pfizer and BioNTech Announce Agreement with the United Kingdom for 30 Million Doses of mRNA-based Vaccine Candidate against SARS-CoV-2

Mon July 20, 2020 1:00 AM|Business Wire|About: BNTX, PFE

Thirty million doses expected to be delivered in 2020 and 2021, subject to regulatory approval or authorization
Pfizer (PFE) and BioNTech (NTGN) remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020 and manufacture globally up to 100 million doses by the end of 2020 and more than 1.3 billion doses by the end of 2021
Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. and BioNTech SE (BNTX)

https://www.businesswire.com/news/home/20200719005057/en/

www.Pfizer.com

www.BioNTech.de.

PFIZER AND BIONTECH ANNOUNCE AGREEMENT WITH THE UNITED KINGDOM FOR 30 MILLION DOSES OF MRNA-BASED VACCINE CANDIDATE AGAINST SARS-COV-2 Monday, July 20, 2020 - 12:00am Thirty million doses expected to be delivered in 2020 and 2021, subject to regulatory approval or authorization Pfizer and BioNTech remain on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020 and manufacture globally up to 100 million doses by the end of 2020 and more than 1.3 billion doses by the end of 2021 Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2

BeiGene Announces Acceptance of a New Drug Application of Pamiparib in Ovarian Cancer in China

Fri July 17, 2020 9:00 AM|GlobeNewswire|About: BGNE

BEIJING, China and CAMBRIDGE, Mass., July 17, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (BGNE)

https://www.beigene.com/

https://seekingalpha.com/symbol/BGNE

BeiGene Announces Acceptance of a New Drug Application of Pamiparib in Ovarian Cancer in China

July 17, 2020 at 9:00 AM EDT

BEIJING, China and CAMBRIDGE, Mass., July 17, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160),

http://ir.beigene.com/news-releases/news-release-details/beigene-announces-acceptance-new-drug-application-pamiparib

Pamiparib

For more clinical trial information please visit CLINICALTRIALS.GOV.

https://www.beigene.com/science-and-product-portfolio/pipeline/pamiparib

Pamiparib Pamiparib (BGB-290) is an investigational small molecule inhibitor of PARP1 and PARP2. Pamiparib is being evaluated as a monotherapy in pivotal clinical trials in China in recurrent platinum-sensitive and BRCA1/2 mutated ovarian cancers. It is currently in global clinical development as a monotherapy, and in combination with other agents, including BeiGene’s investigational anti-PD1 antibody, tislelizumab (BGB-A317), for a variety of solid tumor malignancies.

Lisocabtagene Maraleucel (liso-cel)

Automated Impella Controller, the external console used with its Impella heart pumps

Lisocabtagene Maraleucel (liso-cel)

European Medicines Agency Validates Bristol Myers Squibb’s Application for CAR T Cell Therapy Lisocabtagene Maraleucel (liso-cel)

Fri July 17, 2020 6:59 AM|Business Wire|About: BMY

MAA is for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade 3B

Application based on positive results from TRANSCEND NHL 001 study and additional TRANSCEND WORLD 001 study

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)

businesswire.com: https://www.businesswire.com/news/home/20200717005025/en/