Seeking Biotech Alpha February 2020 Insight

CABOMETYX® (cabozantinib)

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Exelixis Announces First 100 Patients Enrolled in Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Relapsed Radioiodine-Refractory Differentiated Thyroid Cancer

Tue February 25, 2020 4:06 PM|Business Wire|About: EXEL

– Analysis for the co-primary endpoint of objective response rate and an interim analysis of progression-free survival expected in the second half of 2020 –

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL) (NASDAQ: EXEL)


 https://www.businesswire.com/news/home/20200225005987/en/ 


 

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-targeted Therapy

 https://clinicaltrials.gov/ct2/show/NCT03690388 


 https://cabometyx.com/downloads/CABOMETYXUSPI.pdf 


 https://www.exelixis.com/ 


 https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-first-100-patients-enrolled-phase-3-cosmic 


 https://www.businesswire.com/news/home/20200225005987/en/ 


 https://seekingalpha.com/symbol/EXEL 



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Seeking Biotech Alpha February 2020 Insight

Nexletol (bempedoic acid)

 

Esperion Wins FDA Approval for First Heart Medicine, Nexletol

Feb. 21, 2020, 2:30 PM 


 

FDA OKs Esperion's cholesterol med Nexletol

Feb. 21, 2020 3:08 PM ET|About: Esperion Therapeutics,... (ESPR)|By: , SA News Editor 

 https://seekingalpha.com/news/3544573-fda-oks-esperions-cholesterol-med-nexletol 


 https://seekingalpha.com/symbol/ESPR 


 https://pi.esperion.com/nexletol/nexletol-pi.pdf 


 https://www.esperion.com/science/bempedoic-acid/ 


 

Esperion Announces FDA Approval of NEXLETOL™ (bempedoic acid) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine

Fri February 21, 2020 4:38 PM|GlobeNewswire|About: ESPR

– First Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Approved in the U.S. in Nearly 20 Years for Indicated Patients –
– NEXLETOL Lowers LDL-Cholesterol with a First-in-Class Mechanism –
– Fills an Unmet Need for Affordable Medicines for Millions of Patients with ASCVD or HeFH –
– NEXLETOL will be Commercially Available in the U.S. March 30, 2020
– Conference Call and Webcast on Monday, February 24 at 8:00 a.m. Eastern Time

ANN ARBOR, Mich., Feb. 21, 2020 (GLOBE NEWSWIRE) -- Esperion (ESPR)

 https://seekingalpha.com/pr/17787122-esperion-announces-fda-approval-of-nexletol-bempedoic-acid-tablet-oral-daily-non-statin-ldl 

YESCARTA® (Axicabtagene Ciloleucel)

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 Fosun Kite’s New Drug Application (NDA) Filing for Axicabtagene Ciloleucel Accepted for Review by China NMPA 

 (24 February, 2020, Shanghai) Today, Fosun Kite Biotechnology(“Fosun Kite”) based in Shanghai, a company invested by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK), 


 Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* Announcement in Relation to Acceptance of New Drug Application Filing from Fosun Kite Biotechnology Co., Ltd.* 

 https://www1.hkexnews.hk/listedco/listconews/sehk/2020/0224/2020022400822.pdf 


 

Gilead JV application for CAR-T cancer therapy accepted in China

Feb. 24, 2020 7:46 AM ET|About: Gilead Sciences, Inc. (GILD)|By: , SA News Editor 

 https://seekingalpha.com/news/3544746-gilead-jv-application-for-car-t-cancer-therapy-accepted-in-china 


 https://www.yescarta.com/ 


 https://seekingalpha.com/symbol/GILD 



ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

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Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX®2-73 (blarcamesine) in Multiple Sclerosis (MS)

Mon February 24, 2020 7:00 AM|GlobeNewswire|About: AVXL

Published in Journal of Neuroimmunology, Results Highlight ANAVEX®2-73 (blarcamesine) Shown to Protect and Repair Myelin Forming Cells

ANAVEX®2-73 (blarcamesine) Provides optimal Protection of Oligodendroglia against Glutamate Toxicity

NEW YORK, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (AVXL) (“Anavex” or the “Company”) (Nasdaq: AVXL)


 https://www.sciencedirect.com/science/article/abs/pii/S0165572819305831 


 https://www.anavex.com/ 


 https://seekingalpha.com/symbol/AVXL 


 https://www.anavex.com/anavex-life-sciences-announces-publication-of-foundational-data-for-anavex2-73-blarcamesine-in-multiple-sclerosis-ms/ 



Seeking Biotech Alpha February 2020 Insight

ruxolitinib cream 0.75% or 1.5%

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Incyte Announces Positive Topline Results From Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients With Atopic Dermatitis

Wed February 19, 2020 7:30 AM|Business Wire|About: INCY 


 

For more information about the TRuE-AD studies, please visit http://clinicaltrials.gov/ct2/show/NCT03745638 and http://clinicaltrials.gov/ct2/show/NCT03745651.

About Ruxolitinib Cream

 Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of patients with mild-to-moderate atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream. 


 https://www.incyte.com/ 


 https://www.businesswire.com/news/home/20200219005204/en/ 


 https://seekingalpha.com/symbol/INCY 



FreeStyle Libre system

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New Real-World Data Show that Abbott's FreeStyle Libre System Delivers Positive Health Outcomes for People with Type 1 and Type 2 Diabetes

Thu February 20, 2020 8:00 AM|PR Newswire|About: ABT

- People in Germany living with Type 1 or Type 2 diabetes on insulin showed a sustained reduction in HbA1c over one year following use of the FreeStyle Libre technology

PR Newswire

MADRID, Feb. 20, 2020 /PRNewswire/ -- Abbott (ABT)


 https://www.abbott.com/ 


 https://www.prnewswire.com/news-releases/new-real-world-data-show-that-abbotts-freestyle-libre-system-delivers-positive-health-outcomes-for-people-with-type-1-and-type-2-diabetes-301007694.html 


 https://seekingalpha.com/symbol/ABT 



valoctocogene roxaparvovec

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BioMarin's Biologics License Application for Valoctocogene Roxaparvovec Accepted for Priority Review by FDA with Review Action Date of August 21, 2020

Thu February 20, 2020 4:05 PM|PR Newswire|About: BMRN

If approved, 1st Gene Therapy in U.S. for the Treatment of Any Type of Hemophilia

FDA Also Accepts Premarket Approval (PMA) Application for Companion Diagnostic Test, a 1st for a Gene Therapy

PR Newswire

SAN RAFAEL, Calif., Feb. 20, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (BMRN)


 https://www.biomarin.com/products/pipeline/bmn-270/ 


 https://investors.biomarin.com/2020-02-20-BioMarins-Biologics-License-Application-for-Valoctocogene-Roxaparvovec-Accepted-for-Priority-Review-by-FDA-with-Review-Action-Date-of-August-21-2020 


 https://www.prnewswire.com/news-releases/biomarins-biologics-license-application-for-valoctocogene-roxaparvovec-accepted-for-priority-review-by-fda-with-review-action-date-of-august-21-2020-301008771.html 


 https://seekingalpha.com/symbol/BMRN 

Seeking Biotech Alpha February 2020 Insight

Beovu® (brolucizumab) injection

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Novartis receives EC Approval for Beovu®, a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

Feb 17, 2020

  • Beovu (brolucizumab) is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option to start eligible patients on three-month dosing intervals immediately after the loading phase1
     
  • For the more than 20 million people worldwide who are living with wet AMD, frequent injections are a common reason patients drop off existing treatments2-4
     
  • Approval is based on two head-to-head clinical trials, HAWK and HARRIER, in which Beovu achieved robust vision gains that were non-inferior to aflibercept at year one (primary endpoint)1,5
     
  • Beovu also demonstrated superior fluid resolution versus aflibercept at week 16 and year one (secondary endpoints)1,5

 Basel, February 17, 2020 


 https://www.beovu.com/?utm_medium=paid&utm_term=Branded_Exact%20|%20beovu&utm_source=google&utm_campaign=Branded_Exact 


 https://www.novartis.com/ 


 https://seekingalpha.com/symbol/NVS 



Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)

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FDA approves GSK's Voltaren Arthritis Pain for over-the-counter use in the United States

Mon February 17, 2020 10:00 AM|PR Newswire|About: GSKPR Newswire

WARREN, N.J., Feb. 17, 2020 /PRNewswire/ -- GlaxoSmithKline (GLAXF) (LSE/NYSE: GSK)


 https://www.voltarengel.com/ 


 https://www.voltarengel.com/ 


 https://www.gsk.com/ 


 https://seekingalpha.com/symbol/GSK 

VYNDAQEL® (tafamidis)

 

European Commission Approves VYNDAQEL®, the First Treatment in the EU for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Tue February 18, 2020 6:45 AM|Business Wire|About: PFE

—VYNDAQEL is the only EC-approved medicine proven to reduce mortality and frequency of cardiovascular-related hospitalizations in adults with wild-type or hereditary ATTR-CM—

—VYNDAQEL is the first approved medicine in the EU to treat both ATTR-CM and stage 1 symptomatic transthyretin amyloid polyneuropathy (ATTR-PN)—

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)


 http://labeling.pfizer.com/ShowLabeling.aspx?id=11685 


 https://www.pfizer.com/ 


 https://www.pfizer.com/news/press-release/press-release-detail/european_commission_approves_vyndaqel_the_first_treatment_in_the_eu_for_transthyretin_amyloid_cardiomyopathy_attr_cm 


 https://www.businesswire.com/news/home/20200218005225/en/ 


 https://seekingalpha.com/symbol/PFE 



Gallant™ implantable cardioverter defibrillator & cardiac resynchronization therapy defibrillator

 

Abbott Introduces Next-Generation Heart Rhythm Management Devices in Europe, Featuring State-of-the-Art Patient App and Bluetooth Connectivity

Tue February 18, 2020 7:45 AM|PR Newswire|About: ABT

- Gallant ICD and CRT-D devices feature a more comfortable design, preferred by patients without compromising on battery longevity or high-voltage output, which remain among the highest in the industry

PR Newswire

ABBOTT PARK, Ill., Feb. 18, 2020 /PRNewswire/ -- Abbott (ABT)


 https://www.abbott.com/ 


 https://www.prnewswire.com/news-releases/abbott-introduces-next-generation-heart-rhythm-management-devices-in-europe-featuring-state-of-the-art-patient-app-and-bluetooth-connectivity-301006253.html 


 https://seekingalpha.com/symbol/ABT 


 https://www.abbott.com/consumer/cardiovascular.html 

PROCYSBI® (Cysteamine Bitartrate)

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Horizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for PROCYSBI® (Cysteamine Bitartrate) Delayed-Release Oral Granules

Tue February 18, 2020 8:00 AM|Business Wire|About: HZNP

-- Oral granules in packets provide an additional, tear-open option for people living with cystinosis --

DUBLIN--(BUSINESS WIRE)-- Horizon Therapeutics plc (Nasdaq: HZNP)


 https://www.businesswire.com/news/home/20200218005293/en/ 


 https://www.hzndocs.com/PROCYSBI-Prescribing-Information.pdf 


 https://www.horizontherapeutics.com/ 


 https://seekingalpha.com/symbol/HZNP 


 

Our Pipeline

We are relentless in pursuing breakthroughs that boldly change the lives of the communities we serve.

 https://www.horizontherapeutics.com/our-pipeline/ 

Tecentriq® (atezolizumab)

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FDA Grants Priority Review to Genentech’s Tecentriq Monotherapy as First-line Treatment of Certain People With Advanced Non-small Cell Lung Cancer

Wed February 19, 2020 1:00 AM|Business Wire|About: RHHBY

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


 https://www.businesswire.com/news/home/20200218006211/en/ 


 https://www.gene.com/ 


 https://www.gene.com/topics/cancer-immunotherapy 


 https://www.tecentriq.com/ 


 https://seekingalpha.com/symbol/RHHBY 

Seeking Biotech Alpha February 2020 Insight

Tecentriq in combination with chemotherapy

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China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

  • This marks the first approval for a Tecentriq-based therapy in China, less than a year after the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in this indication
  • Tecentriq with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy combination approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
  • The combination significantly improved overall survival (OS) and progression-free survival (PFS) for the first time in over 20 years

Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) 


 https://www.tecentriq.com/ 


 

Roche's Tecentriq OK'd in China for first-line lung cancer

Feb. 14, 2020 7:00 AM ET|About: Roche Holding AG (RHHBY)|By: , SA News Editor  

 https://seekingalpha.com/news/3542132-roches-tecentriq-okd-in-china-for-first-line-lung-cancer 


 https://seekingalpha.com/symbol/RHHBY 


 https://www.gene.com/medical-professionals/pipeline 



STELARA® (ustekinumab)

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New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn's Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)

Fri February 14, 2020 2:00 AM|PR Newswire

First Study to Evaluate Intestinal Ultrasound Monitoring in an Interventional Setting

PR Newswire

VIENNA, Feb. 14, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson 


 http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf 


 https://www.janssen.com/ 


 https://www.jnj.com/ 


 

Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab (STARDUST)

 https://clinicaltrials.gov/ct2/show/NCT03107793 


 https://www.prnewswire.com/news-releases/new-phase-3b-interim-data-from-stardust-study-show-two-thirds-of-patients-with-moderately-to-severely-active-crohns-disease-achieved-clinical-remission-after-two-doses-of-stelara-ustekinumab-301005006.html 


 

Overview of Crohn's Disease

ESPAÑOL

Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract. Understanding Crohn’s disease can help you and your loved ones navigate the uncertainty that comes with a new diagnosis.

 https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview 


 

New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn's Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)

Feb 14, 2020Austria 

 https://www.janssen.com/new-phase-3b-interim-data-stardust-study-show-two-thirds-patients-moderately-severely-active-crohns 


 https://seekingalpha.com/symbol/JNJ 

nelipepimut-S (NPS)

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SELLAS Life Sciences Provides Regulatory Update for Nelipepimut-S (NPS) for Triple Negative Breast Cancer (TNBC) Following FDA Feedback

Fri February 14, 2020 8:30 AM|GlobeNewswire|About: SLSGlobeNewswire

NEW YORK, Feb. 14, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (SLS)


 https://www.sellaslifesciences.com/Home/default.aspx 


 https://seekingalpha.com/symbol/SLS 



ERVEBO® (Ebola Zaire Vaccine, Live)

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ERVEBO® (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification

Fri February 14, 2020 11:20 AM|Business Wire|About: MRK

Democratic Republic of the Congo One of the First African Countries to Register ERVEBO

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


 https://www.businesswire.com/news/home/20200214005376/en/ 


 https://www.merck.com/index.html 


 https://www.fda.gov/vaccines-blood-biologics/ervebo 



Remdesivir (GS-5734, Nuc inhibitor)

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 Feb 16, 2020 11:16 AM

Second Batch of Experimental Gilead Coronavirus Drug Arrives in Wuhan

By Jia Tianqiong, Di Ning, Lu Yutong and Flynn Murphy 

 The remdesivir trials are backed by Capital Medical University in collaboration with the Chinese Academy of Medical Sciences. 


Seeking Biotech Alpha February 2020 Insight

OTEZLA® (apremilast)

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Amgen Canada Receives Approval of Marketing Authorization Transfer of OTEZLA® for the Treatment of Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

Wed February 12, 2020 7:00 AM|Canada Newswire|About: AMGN

Addition of OTEZLA Strengthens Amgen (AMGN)'s Long-Standing Expertise in Inflammation

MISSISSAUGA, ON, Feb. 12, 2020 /CNW/ - Today, Amgen Canada Inc.


 https://www.amgen.ca/ 


 https://www.otezla.com/ 


 https://seekingalpha.com/symbol/AMGN 


Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

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Vir Biotechnology Identifies Two Antibodies That Bind to the Spike Protein of 2019-nCoV, Newly Named as SARS-CoV-2

Wed February 12, 2020 8:30 AM|GlobeNewswire|About: VIR

SAN FRANCISCO, Feb. 12, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (VIR)


 https://www.vir.bio/ 


 https://investors.vir.bio/news-releases/news-release-details/vir-biotechnology-identifies-two-antibodies-bind-spike-protein 


 https://www.vir.bio/pipeline/ 


 https://seekingalpha.com/symbol/VIR 



KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

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Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC)

Wed February 12, 2020 6:45 AM|Business Wire|About: MRK 


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

 

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)

 https://clinicaltrials.gov/ct2/show/NCT02819518 


 https://www.businesswire.com/news/home/20200212005254/en/ 


 https://www.merck.com/clinical-trials/index.html 


 https://seekingalpha.com/symbol/MRK 

ADXS-PSA in combination with KEYTRUDA®

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Advaxis Announces Updated Survival Data in Phase 1/2 ADXS-PSA Trial at the ASCO Genitourinary Cancers Symposium

Thu February 13, 2020 8:00 AM|GlobeNewswire|About: ADXS

Median overall survival of 16.4 months for advanced prostate cancer patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA® compared to an estimated 11 months with Standard of Care

Median overall survival of 33.7 months in all patients treated with ADXS-PSA in combination with KEYTRUDA®

PRINCETON, N.J., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (ADXS)


 https://advaxis.com/ 


 https://advaxis.com/clinical-trials/ 


 About KEYNOTE-046
KEYNOTE-046 (NCT02325557) was a Phase 1/2 open-label, multicenter, dose-determination and expansion trial that evaluates the safety, tolerability and preliminary clinical activity of ADXS-PSA as monotherapy (Part A; n=14 [13 treated]), and in combination with KEYTRUDA® (Part B; n= 37) in heavily pretreated patients with progressive and refractory mCRPC. 


 https://seekingalpha.com/symbol/ADXS 



Seeking Biotech Alpha February 2020 Insight

PB2452

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PhaseBio Announces European Regulatory Update for PB2452

Tue February 11, 2020 8:00 AM|GlobeNewswire|About: PHAS

PB2452 granted PRIME Designation by the European Medicines Agency

PhaseBio receives written scientific advice confirming PB2452 clinical development plan

In Phase 1 and Phase 2a clinical trials, PB2452 provided immediate and sustained reversal of the antiplatelet effects of ticagrelor

MALVERN, Pa. and SAN DIEGO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- PhaseBio Pharmaceuticals, Inc (PHAS). (Nasdaq: PHAS)


 https://phasebio.com/ 


 https://phasebio.com/pipeline/ 


 The European Medicines Agency has granted PRIME status to PhaseBio Pharmaceuticals' (PHAS -2.1%) PB2452 as a reversal agent of AstraZeneca's (AZN) anticoagulant Brilinta (ticagrelor). 


 https://seekingalpha.com/symbol/PHAS 



JAK Inhibitor Baricitinib

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Lilly and Incyte Announce Positive Top-Line Results from the North American Phase 3 Study (BREEZE-AD5) of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate- to Severe Atopic Dermatitis

Tue February 11, 2020 6:24 PM|GlobeNewswire|About: LLY

  • Study met the primary endpoint of at least 75% improvement of skin inflammation and key secondary endpoints
  • Safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis
  • Results from this study conducted in North America continue to support regulatory submissions

TORONTO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Eli Lilly and Company (LLY) and Incyte 


 https://www.lilly.ca/en/index.aspx 


 https://www.incyte.com/ 


 https://seekingalpha.com/symbol/LLY 


 https://seekingalpha.com/symbol/JNJ 

Johnson & Johnson’s Response to the 2019-nCoV Crisis

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Johnson & Johnson Announces Collaboration with U.S. Department of Health & Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine

Tue February 11, 2020 4:30 PM|PR Newswire|About: JNJPR Newswire

NEW BRUNSWICK, N.J., Feb. 11, 2020 /PRNewswire/ -- Johnson & Johnson (JNJ) today announced that its Janssen Pharmaceutical Companies will further expedite its investigational coronavirus vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services.


 https://www.jnj.com/johnson-johnson-launches-multi-pronged-response-to-coronavirus-global-public-health-threat 


 https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-collaboration-with-us-department-of-health-and-human-services-to-fight-influenza 


 https://www.jnj.com/coronavirus 


 https://www.jnj.com/ 


 https://www.janssen.com/ 


 https://www.prnewswire.com/news-releases/johnson--johnson-announces-collaboration-with-us-department-of-health--human-services-to-accelerate-development-of-a-potential-novel-coronavirus-vaccine-301003251.html 

Seeking Biotech Alpha February 2020 Insight

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

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Exelixis Announces Encouraging Results for Cabozantinib in Combination With Atezolizumab in Metastatic Castration-Resistant Prostate Cancer

Mon February 10, 2020 5:00 PM|Business Wire|About: EXEL

Data from the COSMIC-021 trial will be presented on Thursday, February 13, 2020 at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL)


 Exelixis Further Expands Prostate Cancer Cohort in Phase 1b COSMIC-021 Trial of Cabozantinib in Combination with Atezolizumab in Patients with Advanced Solid TumorsPDF Version

Based on continued encouraging efficacy and safety data, metastatic castration-resistant prostate cancer cohort further expanded to 130 patients

– Initial data to be presented on February 13 at the 2020 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU 2020) in San Francisco, CA

ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 7, 2020-- Exelixis, Inc. (NASDAQ: EXEL)


 https://clinicaltrials.gov/ct2/show/NCT03170960 


 https://www.exelixis.com/ 


 https://www.businesswire.com/news/home/20200210005731/en/ 


 https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-cabozantinib-combination 

 https://ir.exelixis.com/news-releases/news-release-details/exelixis-further-expands-prostate-cancer-cohort-phase-1b-cosmic 


 https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-cabozantinib-combination 


 https://www.tecentriq.com/ 

Intuitive Acquires Orpheus Medical

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Intuitive Acquires Orpheus Medical to Expand Informatics Platform for Hospitals

Mon February 10, 2020 4:01 PM|GlobeNewswire|About: ISRG

SUNNYVALE, Calif., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Intuitive (Nasdaq: ISRG)


 https://www.intuitive.com/en-us 


 https://seekingalpha.com/symbol/ISRG 

MET inhibitor capmatinib (INC280)

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Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review

Tue February 11, 2020 1:18 AM|PR Newswire

- Substantial unmet need exists among patients with METex14 mutated advanced NSCLC as there are no treatment options approved to specifically target this aggressive form of lung cancer

- Capmatinib review expected to be completed within six months

PR Newswire

EAST HANOVER, N.J., Feb. 11, 2020 /PRNewswire


 https://www.novartis.com/ 


 https://www.prnewswire.com/news-releases/novartis-announces-met-inhibitor-capmatinib-inc280-the-first-potential-treatment-for-metex14-mutated-advanced-non-small-cell-lung-cancer-granted-priority-fda-review-301002504.html 


 https://seekingalpha.com/symbol/NVS 


 https://www.incyte.com/ 


 https://www.businesswire.com/news/home/20200210005864/en/ 


 https://seekingalpha.com/symbol/INCY 

 

Incyte Announces Acceptance and Priority Review of NDA for Capmatinib for Advanced Non-Small Cell Lung Cancer

Tue February 11, 2020 1:17 AM|Business Wire|About: INCY

  • The U.S. Food and Drug Administration (FDA) Priority Review for capmatinib is based on Phase 2 data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer (NSCLC)1
  • Novartis has exclusive worldwide development and commercialization rights to capmatinib

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

 https://seekingalpha.com/pr/17774676-incyte-announces-acceptance-and-priority-review-of-nda-for-capmatinib-for-advanced-non-small 

TALTZ® (ixekizumab)

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Health Canada has approved TALTZ® (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

Tue February 11, 2020 6:45 AM|GlobeNewswire|About: LLY

TORONTO, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Eli Lilly Canada 


 https://www.lilly.ca/en/index.aspx 


 https://seekingalpha.com/symbol/LLY 

Seeking Biotech Alpha February 2020 Insight

BTK (Bruton's tyrosine kinase) inhibitor (SAR442168)

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Sanofi : Sanofi brain-penetrant BTK inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis

Thu February 6, 2020 1:00 AM|GlobeNewswire|About: SNY

Sanofi (SNY) brain-penetrant BTK inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis 

  • Sanofi’s BTK inhibitor will potentially be first disease-modifying therapy to address sources of multiple sclerosis (MS) damage in the brain
  • Sanofi to initiate four Phase 3 clinical trials in relapsing and progressive forms of MS

PARIS – February 6, 2020 


 https://clinicaltrials.gov/ct2/show/NCT03889639 


 

SAR442168 is an investigational, oral, brain-penetrant, selective small-molecule inhibitor of BTK. SAR442168 has shown BTK binding as well as cerebrospinal fluid exposure in Phase 1 studies. The efficacy and safety of SA442168 has not been reviewed by any regulatory authority.

Sanofi obtained global rights to develop and commercialize SAR442168 under a license agreement with Principia Biopharma, Inc.



Leronlimab (PRO 140)

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CytoDyn Files a Phase 2 Basket Trial with Leronlimab (PRO 140) for Treatment of All Solid Tumor Cancers

Thu February 6, 2020 6:00 AM|GlobeNewswire|About: CYDY

VANCOUVER, Washington, Feb. 06, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY)


 https://www.cytodyn.com/ 


 https://www.cytodyn.com/newsroom/press-releases/detail/382/cytodyn-files-a-phase-2-basket-trial-with-leronlimab-pro 


 https://seekingalpha.com/symbol/CYDY 


 https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/fda-modernizes-clinical-trials-master-protocols-february-26-2019-issue 

mRNA-1273 to prevent novel coronavirus (2019-nCoV)

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Moderna Announces Progress in Prophylactic Vaccines Modality with CMV Vaccine Phase 2 Study Data Now Expected in Third Quarter 2020 and Expands Investment in This Core Modality with Three New Development Candidates

Mon February 10, 2020 5:11 PM|Business Wire|About: AZN, MRK, MRNA 


 

Phase 2 CMV vaccine dose-confirmation study more than sixty percent enrolled

mRNA-1189 to prevent infectious mononucleosis and Epstein-Barr virus (EBV) infection

mRNA-1345 to prevent respiratory syncytial virus (RSV) disease in young children, with the intent to combine with mRNA-1653 to create a pediatric respiratory vaccine against RSV, hMPV and PIV3

mRNA-1273 to prevent novel coronavirus (2019-nCoV) disease, in collaboration with the National Institutes of Health; physical manufacturing of first batch complete, awaiting analytical testing

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


 https://www.businesswire.com/news/home/20200210005823/en/ 


 https://seekingalpha.com/symbol/MRNA 


 https://cepi.net/ 


 https://www.modernatx.com/ 



DARZALEX® (Daratumumab)

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Janssen Announces Submission to U.S. FDA for New DARZALEX® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

Mon February 10, 2020 4:30 PM|PR NewswirePR Newswire

RARITAN, N.J., Feb. 10, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson


 CANDOR is an Amgen-sponsored study and is co-funded by Janssen Research & Development, LLC. For more information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT03158688. 


 https://www.janssen.com/ 


 https://www.janssen.com/janssen-announces-submission-us-fda-new-darzalexr-daratumumab-based-combination-regimen-patients 


 https://www.jnj.com/ 


 https://www.prnewswire.com/news-releases/janssen-announces-submission-to-us-fda-for-new-darzalex-daratumumab-based-combination-regimen-for-patients-with-relapsedrefractory-multiple-myeloma-301002129.html 

Seeking Biotech Alpha February 2020 Insight

EXPANDED COLLABORATION WITH HHS TO DEVELOP ANTIBODY TREATMENTS FOR NEW CORONAVIRUS

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 February 4, 2020 at 9:00 AM EST Back

REGENERON ANNOUNCES EXPANDED COLLABORATION WITH HHS TO DEVELOP ANTIBODY TREATMENTS FOR NEW CORONAVIRUS

TARRYTOWN, N.Y., Feb. 4, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN


 

Regeneron Announces Expanded Collaboration with HHS to Develop Antibody Treatments for New Coronavirus

Tue February 4, 2020 9:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Feb. 4, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (REGN


 https://www.prnewswire.com/news-releases/regeneron-announces-expanded-collaboration-with-hhs-to-develop-antibody-treatments-for-new-coronavirus-300998140.html 


 August 12, 2019 at 10:01 AM EDT Back

PALM EBOLA CLINICAL TRIAL STOPPED EARLY AS REGENERON'S REGN-EB3 THERAPY SHOWS SUPERIORITY TO ZMAPP IN PREVENTING EBOLA DEATHS

TARRYTOWN, N.Y., Aug. 12, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)


 https://seekingalpha.com/symbol/REGN 


 https://www.regeneron.com/technology 

 

 

VELOCISUITE®

 
VelociMouse® is a breakthrough technology that enables the immediate generation of genetically altered mice directly from modified embryonic stem cells, thereby avoiding the need to breed multiple generations. This technology has dramatically shortened the time needed to engineer genetically modified mice, while at the same time reducing costs and improving precision. 

 https://newsroom.regeneron.com/news-releases/news-release-details/palm-ebola-clinical-trial-stopped-early-regenerons-regn-eb3 

 https://seekingalpha.com/pr/17768295-regeneron-announces-expanded-collaboration-hhs-to-develop-antibody-treatments-for-new 

BioMotiv and Bristol-Myers Squibb Announce the Launch of Anteros Pharmaceuticals

 

BioMotiv and Bristol-Myers Squibb Announce the Launch of Anteros Pharmaceuticals

Tue February 4, 2020 7:00 AM|Business Wire|About: BMY

CLEVELAND & NEW YORK--(BUSINESS WIRE)-- BioMotiv, a mission-driven drug development accelerator associated with The Harrington Project for discovery and development, that advances breakthrough discoveries from research institutions into therapeutics, and Bristol-Myers Squibb Company (BMY) today announced the launch of Anteros Pharmaceuticals


 https://www.biomotiv.com/news-posts/2019/9/4/biomotiv-and-bristol-myers-squibb-form-strategic-partnership 


 https://www.businesswire.com/news/home/20200204005078/en/ 


 https://www.biomotiv.com/ 


 https://www.biomotiv.com/news-posts/2020/2/4/biomotiv-and-bristol-myers-squibb-announce-the-launch-of-anteros-pharmaceuticals 


 https://www.biomotiv.com/portfolio 


 https://seekingalpha.com/symbol/BMY 


 Under the terms of the venture, BMY will contribute intellectual property, data and reagents for a series of small molecules against an undisclosed mechanism. BioMotiv, working with Yale University, will be responsible for R&D. Once Anteros nominates a preclinical candidate, BMY will have the option to acquire Anteros from BioMotiv under pre-agreed terms 

RINVOQ™ (upadacitinib)

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RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis

Wed February 5, 2020 8:45 AM|PR Newswire|About: ABBV

- The 30 mg dose of RINVOQ achieved superiority to adalimumab in terms of ACR20 response at week 12, whereas both doses achieved non-inferiority versus adalimumab[1]

- Both doses of RINVOQ also significantly inhibited radiographic progression at week 24 compared to placebo[1]

- Significantly more patients receiving either dose of RINVOQ achieved PASI 75 at week 16 compared to placebo[1]

- The safety profile of RINVOQ was consistent with previously reported results across indications, with no new safety risks detected[1,2]

PR Newswire

NORTH CHICAGO, Ill., Feb. 5, 2020 /PRNewswire/ -- AbbVie (ABBV)


 https://www.prnewswire.com/news-releases/rinvoq-upadacitinib-meets-primary-and-key-secondary-endpoints-in-phase-3-study-in-psoriatic-arthritis-300999462.html 


 https://www.rxabbvie.com/pdf/humira.pdf?_ga=2.11852404.1718545564.1580836838-223150130.157991395 


 https://www.abbvie.com/ 


 https://www.abbvie.com/our-science/pipeline.html 


 

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1)

 https://clinicaltrials.gov/ct2/show/NCT03104400?cond=Psoriatic+Arthritis&lead=abbvie&phase=2&draw=2&rank=4 


 https://seekingalpha.com/symbol/ABBV 

SKYRIZI™ (risankizumab)

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AbbVie's SKYRIZI™ Now Publicly Reimbursed in Ontario, Alberta, Saskatchewan and Quebec for the Treatment of Moderate to Severe Plaque Psoriasis

Thu February 6, 2020 6:00 AM|Canada Newswire|About: ABBV

  • SKYRIZI™ is an interleukin-23 (IL-23) inhibitor used for the treatment of moderate to severe psoriasis.1
  • In clinical studies, SKYRIZI™ significantly improved levels of skin clearance after just 16 weeks and maintained clearance at one year (52 weeks).1
  • SKYRIZI™ is the only IL-23 inhibitor to arrive at a positive conclusion with the pCPA and is currently listed on the provincial formularies of Ontario, Alberta, Saskatchewan and Quebec.
  • Ontario lists SKYRIZI™ on its provincial formulary effective January 31, 2020.
  • Alberta lists SKYRIZI™ on its provincial formulary effective February 01, 2020.
  • Saskatchewan lists SKYRIZI™ on its provincial formulary effective February 01, 2020.
  • Quebec lists SKYRIZI™ on its provincial formulary effective February 05, 2020.

MONTREAL, Feb. 6, 2020 /CNW/ - AbbVie (ABBV)


 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31713-6/fulltext 


 https://abbviecare.ca/ 


 http://www.abbvie.ca/ 


 https://www.abbvie.com/ 


 https://www.skyrizi.com/ 


 https://seekingalpha.com/symbol/ABBV 

risdiplam, investigational, orally administered survival motor neuron-2 (SMN-2) splicing modifier

 

Genentech’s Risdiplam Showed Significant Improvement in Motor Function in People Aged 2-25 With Type 2 or 3 Spinal Muscular Atrophy

Thu February 6, 2020 5:00 AM|Business Wire|About: RHHBY

– First placebo-controlled trial to include adults with SMA demonstrates risdiplam improved or stabilized motor function –

– Medically-meaningful and statistically significant results in primary and key secondary endpoints –

– Pivotal SUNFISH Part 2 study population represents broad, real-world spectrum of people living with SMA –

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


 https://www.businesswire.com/news/home/20200206005333/en/ 


 https://www.gene.com/scientists/oncology 


 https://seekingalpha.com/symbol/RHHBY 


 https://www.gene.com/medical-professionals/pipeline 

Seeking Biotech Alpha February 2020 Insight

belantamab mafodotin

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GSK announces European Medicines Agency (EMA) accepted marketing authorisation application for belantamab mafodotin for the treatment of relapsed or refractory multiple myeloma

Mon February 3, 2020 4:00 AM|PR Newswire

- Belantamab mafodotin accepted for accelerated assessment by the EMA's Committee for Human Medicinal Products (CHMP)

- Submission based on data from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) recently published in The Lancet Oncology

LONDON, Feb. 3, 2020 /PRNewswire/ -- GlaxoSmithKline plc 


 https://www.prnewswire.com/news-releases/gsk-announces-european-medicines-agency-ema-accepted-marketing-authorisation-application-for-belantamab-mafodotin-for-the-treatment-of-relapsed-or-refractory-multiple-myeloma-300996514.html 


 https://www.gsk.com/en-gb/ 


 https://www.gsk.com/en-gb/media/press-releases/pivotal-dreamm-2-study-demonstrated-a-clinically-meaningful-overall-response-rate-with-belantamab-mafodotin-gsk2857916-for-patients-with-relapsedrefractory-multiple-myeloma/ 


 https://seekingalpha.com/symbol/GSK 

Rubraca® (rucaparib)

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Clovis Oncology Announces Availability and Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in France

Mon February 3, 2020 4:00 AM|Business Wire|About: CLVS

  • Rubraca® (rucaparib) offers a new monotherapy maintenance treatment option for eligible women with relapsed, platinum-sensitive ovarian cancer, who harbor either a BRCA1/2 mutation or are BRCA wild-type
  • Rucaparib provided statistically significant improvement in progression-free survival (PFS) versus placebo in all ovarian cancer patients studied1
  • Some patients with residual disease at ARIEL3 study entry who were treated with rucaparib showed further reduction in tumor burden, including complete responses1
  • Most common Grade ≥3 adverse reaction was anemia; the only serious adverse reaction occurring in >2 percent of patients was anemia2
  • Rucaparib now available in multiple countries across Europe

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (CLVS)


 https://www.clovisoncology.com/ 


 https://ir.clovisoncology.com/investors-and-news/news-releases/press-release-details/2020/Clovis-Oncology-Announces-Availability-and-Reimbursement-for-Rubraca-rucaparib-Tablets-for-Women-with-Relapsed-Ovarian-Cancer-in-France/default.aspx 


 https://www.businesswire.com/news/home/20200203005135/en/ 


 https://clovisoncology.com/ 


 https://seekingalpha.com/symbol/CLVS 

NKTR-214, bempegaldesleukin (bempeg)

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Nektar Therapeutics Announces Publication of Two Manuscripts on Lead Immuno-oncology Candidate, Bempegaldesleukin (Bempeg) in Nature Communications

Mon February 3, 2020 8:00 AM|PR Newswire|About: NKTRPR Newswire

SAN FRANCISCO, Feb. 3, 2020 /PRNewswire/ -- Nektar Therapeutics (NKTR)


 https://www.nektar.com/ 


 https://www.prnewswire.com/news-releases/nektar-therapeutics-announces-publication-of-two-manuscripts-on-lead-immuno-oncology-candidate-bempegaldesleukin-bempeg-in-nature-communications-300997406.html 


 https://ir.nektar.com/news-releases/news-release-details/nektar-therapeutics-announces-publication-two-manuscripts-lead 


 https://seekingalpha.com/symbol/NKTR 



Epidiolex® (cannabidiol)

image63

 

GW Pharmaceuticals and Greenwich Biosciences Submit Supplemental New Drug Application to U.S. FDA for Epidiolex® (cannabidiol) for the Treatment of Tuberous Sclerosis Complex

Mon February 3, 2020 7:00 AM|GlobeNewswire|About: GWPH

LONDON and CARLSBAD, Calif., Feb. 03, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPRF) (NASDAQ: GWPH


 https://www.epidiolex.com/ 


 https://www.gwpharm.com/ 


 http://ir.gwpharm.com/news-releases/news-release-details/gw-pharmaceuticals-and-greenwich-biosciences-submit-supplemental 


 https://seekingalpha.com/symbol/GWPH 

ANAVEX®2-73 (blarcamesine)

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Anavex Life Sciences Announces Fast Track Designation Granted by U.S. FDA for ANAVEX®2-73 (blarcamesine) Clinical Development Program for the Treatment of Rett Syndrome

Mon February 3, 2020 7:00 AM|GlobeNewswire|About: AVXL

NEW YORK, Feb. 03, 2020 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (AVXL) (“Anavex” or the “Company”) (Nasdaq: AVXL)


 https://www.anavex.com/ 


 https://www.anavex.com/anavex-life-sciences-announces-fast-track-designation-granted-by-u-s-fda-for-anavex2-73-blarcamesine-clinical-development-program-for-the-treatment-of-rett-syndrome/ 


 https://seekingalpha.com/symbol/AVXL 


 https://www.anavex.com/#!/home 

Seeking Biotech Alpha February 2020 Insight

testing of remdesivir against 2019-nCoV

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Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV)

Foster City, Calif., January 31, 2020


 "Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir.  

 Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are coronaviruses that are structurally similar to 2019-nCoV. 


 

Gilead mulls repositioning failed Ebola drug in China virus 

by Nick Paul Taylor | Jan 24, 2020 8:22am 

 https://www.fiercebiotech.com/biotech/gilead-mulls-repositioning-failed-ebola-drug-china-virus 


 https://www.wsj.com/articles/u-s-drugmakers-ship-therapies-to-china-seeking-to-treat-coronavirus-11580166592?mod=article_inline 


 

Gilead Sciences Offers Experimental Drug for Coronavirus Treatments, Testing

The U.S. biotech firm has formalized agreement with China to conduct clinical trial of remdesivir

By Joseph WalkerUpdated Jan. 31, 2020 8:33 pm ET

 https://www.wsj.com/articles/gilead-sciences-offers-experimental-drug-for-coronavirus-treatments-testing-11580511519 

lopinavir/ritonavir, in combination with flu drug oseltamivir

image66

 FEBRUARY 2, 2020 / 8:01 AM / UPDATED 9 HOURS AGO

Cocktail of flu, HIV drugs appears to help fight coronavirus: Thai doctors

Panu Wongcha-um

BANGKOK (Reuters)


 The drug treatment includes a mixture of anti-HIV drugs lopinavir and ritonavir, in combination with flu drug oseltamivir in large doses. 


lopinavir/ritonavir,

 https://www.kaletra.com/ 


oseltamivir 

 https://www.tamiflu.com/ 



PREZCOBIX® contains prescription medicines PREZISTA® (darunavir) and TYBOST® (cobicistat)

image67

 

Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat

Initiating Vaccine Development and Providing Supplies of Antiviral Medicines to China for Investigational Use

 NEW BRUNSWICK, N.J., January 29, 2020 Johnson & Johnson today announced that it is mobilizing resources at its Janssen Pharmaceutical Companies to launch a multi-pronged response to the novel coronavirus (also known as 2019-nCoV or Wuhan coronavirus) outbreak 


 PREZCOBIX® 

 https://www.prezcobix.com/home 


 

What You Need to Know About the Latest on the Coronavirus—and a Potential Preventive Vaccine

The coronavirus has made headlines as it has spread from China to other parts of the world. To help stop the global outbreak in its tracks, Johnson & Johnson is already hard at work on a potential preventive vaccine.By Johnson & JohnsonJanuary 28, 2020 

 https://www.jnj.com/latest-news/what-you-need-to-know-about-coronavirus-and-a-potential-johnson-johnson-vaccine 


 https://www.janssen.com/ 

RECARBRIO™ (imipenem, cilastatin, and relebactam)

image69

 

FDA Accepts For Review Supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the Treatment of Adults with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

Mon February 3, 2020 6:45 AM|Business Wire|About: MRK

Filing Receives Priority Review

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


 https://www.businesswire.com/news/home/20200203005253/en/ 


 https://www.merck.com/product/usa/pi_circulars/r/recarbrio/recarbrio_pi.pdf 


 https://www.merckconnect.com/recarbrio/dosing-administration/ 


 https://seekingalpha.com/symbol/MRK 

therascreen® PIK3CA RGQ PCR Kit

image70

 

QIAGEN Launches FFPE and Liquid Biopsy PIK3CA Diagnostics in Europe to Enhance Precision Medicine in Advanced Breast Cancer

Mon February 3, 2020 4:06 PM|Business Wire|About: QGEN

  • Innovative therascreen® PIK3CA RGQ PCR Kit CE-marked for use in guiding treatment decisions for breast cancer patients
  • Test detects activating mutations in the phosphatidyl 3-kinase catalytic subunit alpha (PIK3CA) gene
  • CE-IVD approved therascreen assay will be available to labs in Europe starting immediately

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)-- QIAGEN N.V. (QGEN)


 https://www.businesswire.com/news/home/20200203005744/en/ 


 https://seekingalpha.com/symbol/QGEN 


 https://www.qiagen.com/us/ 


 https://www.qiagen.com/us/products/diagnostics-and-clinical-research/oncology/therascreen-pik3ca-rgq-pcr-kit-us/?clear=true#orderinginformation 


 FEB 03 2020

QIAGEN launches FFPE and Liquid Biopsy PIK3CA diagnostics in Europe to enhance precision medicine in advanced breast cancer

• Innovative therascreen® PIK3CA RGQ PCR Kit CE-marked for use in guiding treatment decisions for breast cancer patients
• Test detects activating mutations in the phosphatidylinositol3-kinase catalytic subunit alpha (PIK3CA) gene
• CE-IVD approved therascreen assay will be available to labs in Europe starting immediately

Germantown, Maryland, and Hilden, Germany, February 3, 2019 – QIAGEN N.V. (NYSE: QGEN;

 https://corporate.qiagen.com/newsroom/press-releases/2020/20200203_pik3ca_ce_ivd