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2020

Thank You FOR VISITING SEEKING BIOTECH ALPHA

Wonderful Biotech & Medtech news continues in 2020

Seeking Biotech Alpha JANUARY 2020 Insight

AXL Inhibitor Bemcentinib in Combination With Keytruda®

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BerGenBio Meets Efficacy Endpoint For First Stage Of Phase II Trial With AXL Inhibitor Bemcentinib in Combination With Keytruda® in NSCLC Patients Progressing on Immune Checkpoint Inhibitors

Wed January 15, 2020 11:30 AM|PR Newswire

- Criteria were met for expansion of this cohort to a second stage

PR Newswire

BERGEN, Norway, Jan. 15, 2020 /PRNewswire/ -- BerGenBio ASA (BRRGF) (OSE: BGBIO) 


 (ClinicalTrials.gov Identifier: NCT03184571) 


 https://www.bergenbio.com/ 


 https://www.prnewswire.com/news-releases/bergenbio-meets-efficacy-endpoint-for-first-stage-of-phase-ii-trial-with-axl-inhibitor-bemcentinib-in-combination-with-keytruda-in-nsclc-patients-progressing-on-immune-checkpoint-inhibitors-300987587.html 


 

BerGenBio's bemcentinib shows positive action in mid-stage lung cancer study

Jan. 15, 2020 11:57 AM ET|About: BerGenBio ASA (BRRGF)|By: , SA News Editor  

 https://seekingalpha.com/news/3532096-bergenbios-bemcentinib-shows-positive-action-in-mid-stage-lung-cancer-study 

t:slim X2 Insulin Pump with Control-IQ Technology

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Tandem Diabetes Care Announces Commercial Launch of the t:slim X2 Insulin Pump with Control-IQ Technology in the United States

Wed January 15, 2020 4:05 PM|Business Wire|About: TNDM

SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (TNDM)


 https://www.tandemdiabetes.com/products/tandem-device-updater/control-iq 


 https://www.tandemdiabetes.com/products/t-simulator-demo-app 


 https://www.tandemdiabetes.com/ 


 https://www.tandemdiabetes.com/legal/important-safety-information 


 https://www.businesswire.com/news/home/20200115005808/en/ 


 https://seekingalpha.com/symbol/TNDM 

China says infections spreading as it reports third death from Wuhan virus

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China says infections spreading as it reports third death from Wuhan virus; WHO indicates human transmission likely

  • Authorities find 136 new infections in Wuhan, confirm first cases in other cities – one in Shenzhen and two in Beijing
  • World Health Organisation says there could be some limited human-to-human infection

SCMP Reporters

Published: 8:58am, 20 Jan, 2020



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Seeking Biotech Alpha JANUARY 2020 Insight

LibtayoTM (cemiplimab)

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Libtayo™ (cemiplimab) Receives Positive Recommendation from the pan-Canadian Oncology Drug Review Expert Review Committee for the Treatment of Metastatic Cutaneous Squamous Cell Carcinoma

Thu January 16, 2020 8:00 AM|Canada Newswire

  • Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer accounting for approximately 20% of all skin cancer cases in Canada.1

OAKVILLE, ON, Jan. 16, 2020 /CNW Telbec/ - The Melanoma Network of Canada


 https://www.melanomanetwork.ca/ 


 http://products.sanofi.ca/en/libtayo.pdf 


Tafasitamab (MOR208, formerly Xmab®5574) is an investigational monoclonal antibody

 

MorphoSys AG: Ad hoc: MorphoSys and Incyte Sign Global Collaboration and License Agreement, including U.S. Co-Commercialization and Ex-U.S. Commercialization Rights, for Tafasitamab

Mon January 13, 2020 2:25 AM|Accesswire|About: MOR

PLANEGG/MUNICH, GERMANY / ACCESSWIRE / January 13, 2020 / MorphoSys AG (MPSYF) (FSE: MOR;


 https://www.morphosys.com/ 


 https://www.incyte.com/ 


 https://www.accesswire.com/572835/MorphoSys-AG-Ad-hoc-MorphoSys-and-Incyte-Sign-Global-Collaboration-and-License-Agreement-including-US-Co-Commercialization-and-Ex-US-Commercialization-Rights-for-Tafasitamab 


 https://seekingalpha.com/symbol/MOR 

Ozempic® (semaglutide) injection 0.5 mg or 1 mg

 

FDA approves Ozempic® for cardiovascular risk reduction in adults with type 2 diabetes and known heart disease, updates Rybelsus® label

PLAINSBORO, N.J., Jan. 16, 2020 /PRNewswire/ -- Novo Nordisk


 https://www.novonordisk-us.com/ 


 https://www.novo-pi.com/rybelsus.pdf 


 

Novo Nordisk says FDA approves new indication for Ozempic

Jan. 16, 2020 7:11 PM ET|About: Novo Nordisk A/S (NVO)|By: , SA News Editor  

 https://seekingalpha.com/news/3532608-novo-nordisk-says-fda-approves-new-indication-for-ozempic 

Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020

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 BUSINESS NEWSJANUARY 16, 2020 / 6:25 PM / UPDATED 13 HOURS AGO

Eli Lilly targets quarterly deals of $1 billion-$5 billion in 2020: CFO

Carl O'Donnell

3 MIN READ

SAN FRANCISCO (Reuters) - Eli Lilly and Co (LLY.N)


 https://seekingalpha.com/news/3532615-eli-lilly-targets-buying-spree-in-2020 


 https://seekingalpha.com/symbol/LLY 

Seeking Biotech Alpha JANUARY 2020 Insight

LRRK2 inhibitor

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Denali Therapeutics Announces Broad Pipeline Progress Including Positive Results From Its LRRK2 Program for Parkinson’s Disease

Tue January 14, 2020 9:00 AM|GlobeNewswire|About: DNLI

  • LRRK2 inhibitor DNL201 Phase 1b demonstrated high levels of target and pathway engagement and improvement of lysosomal biomarkers in patients with Parkinson’s disease 
  • LRRK2 inhibitor DNL151 Phase 1 demonstrated high levels of target and pathway engagement and modulation of lysosomal biomarkers in healthy volunteers and continues in an expanded Phase 1b study in patients with Parkinson’s disease
  • IND submitted for DNL310 (ETV:IDS) for Hunter syndrome, Denali’s first clinical submission for a large molecule therapeutic enabled by its Transport Vehicle platform technology
  • CTA approved for DNL343, a small molecule activator of EIF2B for ALS and other neurodegenerative diseases
  • RIPK1 inhibitor DNL747 Phase 1b trials in Alzheimer’s and ALS fully enrolled and open label extension in ALS ongoing with data readouts on track for mid-2020

SOUTH SAN FRANCISCO, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (DNLI) (NASDAQ: DNLI)


 https://clinicaltrials.gov/ct2/show/NCT04056689 


 https://denalitherapeutics.com/ 


 https://denalitherapeutics.com/partnering 



Opdivo (nivolumab) Plus Yervoy (ipilimumab)

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U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in First-Line Non-Small Cell Lung Cancer

Wed January 15, 2020 6:59 AM|Business Wire|About: BMY

Application based on results from Part 1 of Phase 3 CheckMate -227 study

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


 https://www.bms.com/ 


 https://packageinserts.bms.com/pi/pi_opdivo.pdf 


 https://packageinserts.bms.com/pi/pi_yervoy.pdf 


 https://www.businesswire.com/news/home/20200115005245/en/ 


 https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bris-1 


 https://www.opdivo.com/ 


 

Indications

YERVOY® (ipilimumab) is a prescription medicine used in adults and children 12 years of age and older to treat melanoma (a kind of skin cancer) that has spread (metastatic) or cannot be removed by surgery (unresectable)

 https://www.yervoy.com/ 

Rubraca® (rucaparib)

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Clovis Oncology’s Rubraca® (rucaparib) Granted FDA Priority Review for Advanced Prostate Cancer

Wed January 15, 2020 8:00 AM|Business Wire|About: CLVS

- Clovis seeks U.S. approval for rucaparib as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer

- FDA submission based on data from TRITON clinical program in advanced prostate cancer

- FDA has assigned PDUFA date of May 15, 2020

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


 https://www.clovisoncology.com/ 


 https://www.clovisoncology.com/pipeline/rucaparib/ 


 https://www.businesswire.com/news/home/20200115005158/en/ 


 

Rubraca® (rucaparib) tablets are a prescription medicine used for:

  • The maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy
  • The treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and who have been treated with 2 or more chemotherapy medicines for their cancer. Your healthcare provider will perform a test to make sure Rubraca is right for you

 https://www.rubraca.com/ 

Dovato (dolutegravir 50 mg/lamivudine 300 mg)

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15 January 2020

Dovato (dolutegravir/lamivudine), the once-daily, single-pill, 2-drug regimen for the treatment of HIV-1 infection, granted marketing approval by Japan Ministry of Health, Labour and Welfare

Issued: Japan and UK

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited 


 https://www.medicines.org.uk/emc/product/10446 


 https://www.dovato.com/ 


 

ViiV Healthcare's Dovato OK'd in Japan

Jan. 15, 2020 6:49 AM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor  

 https://seekingalpha.com/news/3531913-viiv-healthcares-dovato-okd-in-japan 

SPRAVATO®▼ (esketamine) nasal spray

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Janssen Seeks Expanded Use of SPRAVATO®▼ (Esketamine) Nasal Spray in Europe as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent

In two pivotal Phase 3 trials, SPRAVATO®▼ combined with comprehensive standard of care achieved statistically significant rapid reduction of depressive symptoms in patients with major depressive disorder who have current suicidal ideation with intent compared to comprehensive standard of care alone

January 15, 2020 07:40 AM Eastern Standard Time

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


 https://www.janssen.com/ 


 

J&J files application in Europe for expanded use of Spravato

Jan. 15, 2020 7:56 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Editor  

 https://seekingalpha.com/news/3531956-j-and-j-files-application-in-europe-for-expanded-use-of-spravato 


 https://www.ema.europa.eu/en/documents/product-information/spravato-epar-product-information_en.pdf 

Stealth Autoguide™ Cranial Robotic Guidance Platform

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Phoenix Children’s Is the First-Ever Health System in the U.S to Use Medtronic Stealth Autoguide™ Cranial Robotic Guidance Platform for Neurosurgery

Thu January 16, 2020 7:00 AM|GlobeNewswire|About: MDT

Pediatric Health System First to Use Groundbreaking Cranial Robotic System in a Patient Surgery

DUBLIN and PHOENIX, Jan. 16, 2020 (GLOBE NEWSWIRE) 


 https://www.phoenixchildrens.org/ 


 https://www.medtronic.com/us-en/index.html 



Seeking Biotech Alpha JANUARY 2020 Insight

Exonate & Janssen to Develop a New Eye Drop for Treatment of Retinal Vascular Diseases

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Exonate Announces Collaboration With Janssen to Develop a New Eye Drop for the Treatment of Retinal Vascular Diseases Including Wet Age-related Macular degeneration (AMD) and Diabetic Macular Oedema (DMO)

Mon January 13, 2020 3:00 AM|PR NewswirePR Newswire

CAMBRIDGE, England, Jan. 13, 2020 /PRNewswire/ -- Exonate,


 https://www.exonate.com/ 


 https://www.prnewswire.com/news-releases/exonate-announces-collaboration-with-janssen-to-develop-a-new-eye-drop-for-the-treatment-of-retinal-vascular-diseases-including-wet-age-related-macular-degeneration-amd-and-diabetic-macular-oedema-dmo-300984951.html 


 

J&J to collaborate with Exonate in eye diseases

Jan. 13, 2020 11:24 AM ET|About: Johnson & Johnson (JNJ)|By: , SA News Editor  

 https://seekingalpha.com/news/3531385-j-and-j-to-collaborate-exonate-in-eye-diseases 


Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®

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Lilly expands insulin affordability options with lower-priced versions of Humalog® Mix75/25™ KwikPen® and Humalog® Junior KwikPen®

Tue January 14, 2020 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Jan. 14, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY)


 https://www.humalog.com/index.aspx 


 https://www.lillyinsulinlispro.com/ 


 https://www.lillydiabetes.com/ 


 https://www.lilly.com/ 


 https://lillypad.lilly.com/entry.php?e=11640 


 https://www.prnewswire.com/news-releases/lilly-expands-insulin-affordability-options-with-lower-priced-versions-of-humalog-mix7525-kwikpen-and-humalog-junior-kwikpen-300986041.html 

ELZONRIS® (tagraxofusp)

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Stemline Therapeutics Announces Preliminary 2019 Net Revenues for ELZONRIS® (tagraxofusp) and Highlights Commercial and Clinical Growth Drivers

Mon January 13, 2020 4:15 PM|GlobeNewswire|About: STML

NEW YORK, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Stemline Therapeutics, Inc. (STML)


 https://stemline.com/ 


 https://bpdcninfo.com/ 



SKYRIZI™ (risankizumab)

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New Head-to-Head Phase 3 Data Show SKYRIZI™ (risankizumab) Superior to Cosentyx® (secukinumab) Across Primary and All Ranked Secondary Endpoints in Adults with Moderate to Severe Plaque Psoriasis at 52 Weeks

Tue January 14, 2020 8:45 AM|PR Newswire|About: ABBV

- Of patients treated with SKYRIZI, 87 percent achieved PASI 90 compared to 57 percent of Cosentyx-treated patients at 52 weeks (p<0.001)[1]

- No new safety signals were observed[1]

PR Newswire

NORTH CHICAGO, Ill., Jan. 14, 2020 /PRNewswire/ -- AbbVie (ABBV)


 More information on this trial can be found at www.clinicaltrials.gov (NCT03478787). 


 https://www.abbvie.com/ 


 https://clinicaltrials.gov/ct2/show/NCT03478787 


 https://www.prnewswire.com/news-releases/new-head-to-head-phase-3-data-show-skyrizi-risankizumab-superior-to-cosentyx-secukinumab-across-primary-and-all-ranked-secondary-endpoints-in-adults-with-moderate-to-severe-plaque-psoriasis-at-52-weeks-300986617.html 



Seeking Biotech Alpha JANUARY 2020 Insight

antibody cytokine engrafted protein, referred to as IOV-3001

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Iovance Biotherapeutics Obtains License to Develop and Commercialize a Novel IL-2 Analog

Sun January 12, 2020 4:30 PM|GlobeNewswire|About: IOVA

SAN CARLOS, Calif., Jan. 12, 2020 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (IOVA)


 https://www.iovance.com/ 


 https://seekingalpha.com/symbol/IOVA 


 

Iovance in-licenses engineered protein candidate from Novartis

Jan. 12, 2020 6:19 PM ET|About: Iovance Biotherapeutic... (IOVA)|By: , SA News Editor  

 https://seekingalpha.com/news/3531139-iovance-in-licenses-engineered-protein-candidate-from-novartis 


ZW25 in Combination with Ibrance® (palbociclib)

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Zymeworks Announces Agreement with Pfizer and Initiation of a New Phase 2 Trial Evaluating ZW25 in Combination with Ibrance® (palbociclib)

Sun January 12, 2020 10:00 AM|Business Wire|About: ZYME

  • Potential for a Novel Chemotherapy-Free Treatment Option for People with Advanced HER2-positive, HR-positive Breast Cancer

VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (ZYME)


 https://seekingalpha.com/symbol/ZYME 


 (clinicaltrials.gov: NCT04224272) 


 https://clinicaltrials.gov/ct2/show/NCT02892123?cond=zw25&rank=1 


 https://www.zymeworks.com/ 


 https://www.businesswire.com/news/home/20200112005029/en/ 


Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed)

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Tyvyt® (Sintilimab Injection) Combined with ALIMTA® (Pemetrexed) and Platinum Met Predefined Primary Endpoint in Phase 3 ORIENT-11 Study as First-Line Therapy in Nonsquamous NSCLC

Mon January 13, 2020 6:30 AM|PR Newswire|About: LLY

INDIANAPOLIS, Jan. 13, 2020 /PRNewswire/ -- Today, Eli Lilly and Company (LLY) jointly announced with Innovent Biologics


 http://innoventbio.com/#/ 


 https://www.prnewswire.com/news-releases/tyvyt-sintilimab-injection-combined-with-alimta-pemetrexed-and-platinum-met-predefined-primary-endpoint-in-phase-3-orient-11-study-as-first-line-therapy-in-nonsquamous-nsclc-300985366.html 


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


 https://www.lillyoncology.com/ 


 

Lilly's Tyvyt + Alimta successful in lung cancer study

Jan. 13, 2020 7:06 AM ET|About: Eli Lilly and Company (LLY)|By: , SA News Editor  

 https://seekingalpha.com/news/3531196-lillys-tyvyt-alimta-successful-in-lung-cancer-study 

ARAZLO™ (tazarotene) Lotion

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Ortho Dermatologics Announces Publication Of Pivotal Phase 3 Data On ARAZLO™ (tazarotene) Lotion, 0.045% In The Journal Of Drugs In Dermatology (JDD)

Mon January 13, 2020 6:45 AM|PR Newswire|About: BHC

ARAZLO Lotion Demonstrated Statistically Significant Superiority Over Placebo with Favorable Efficacy, Safety and Tolerability Profile

Post Hoc Analysis of the Two Phase 3 Studies Also Published in JDD

BRIDGEWATER, N.J., Jan. 13, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (BHC) and its dermatology business, Ortho Dermatologics


 https://ortho-dermatologics.com/ 


 https://www.bauschhealth.com/ 


 https://www.prnewswire.com/news-releases/ortho-dermatologics-announces-publication-of-pivotal-phase-3-data-on-arazlo-tazarotene-lotion-0-045-in-the-journal-of-drugs-in-dermatology-jdd-300985477.html 



PF-05251749 is a CNS-penetrant regulator of circadian rhythm

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Biogen to Acquire Novel Clinical Stage Asset with Application in Alzheimer’s Disease and Parkinson’s Disease from Pfizer Inc.

Mon January 13, 2020 7:30 AM|GlobeNewswire|About: BIIB, PFE

  • PF-05251749 is a CNS-penetrant regulator of circadian rhythm with potential to address behavioral and neurological symptoms across various psychiatric and neurological diseases
     
  • Biogen to pay Pfizer (PFE) $75 million upfront plus potential milestones of up to $635 million, and royalties
     
  • PF-05251749 complements the Company’s pipeline of potential disease-modifying therapies for Alzheimer’s and Parkinson’s diseases

CAMBRIDGE, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Biogen Inc. (BIIB) today announced an agreement to acquire from Pfizer Inc. PF-05251749


 https://www.biogen.com/ 


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




SYLVANT® and QARZIBA®

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EUSA Pharma and BeiGene Announce Exclusive Development and Commercialization Agreement for SYLVANT® and QARZIBA®▼ in Greater China

Mon January 13, 2020 7:00 AM|GlobeNewswire|About: BGNE

- SYLVANT® and QARZIBA®▼ recently listed for fast-track approval in China

- Expands EUSA’s global product offering; broadens BeiGene’s portfolio –

HEMEL HEMPSTEAD, England and CAMBRIDGE, Mass. and BEIJING, China, Jan. 13, 2020 (GLOBE NEWSWIRE) -- EUSA Pharma (EUSA) and BeiGene, Ltd. (BGNE)


 https://www.eusapharma.com/ 


 https://www.sylvant.com/index.html 


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


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

Seeking Biotech Alpha JANUARY 2020 Insight

(mRNA-1647)

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Moderna Announces Additional Positive Phase 1 Data from Cytomegalovirus (CMV) Vaccine (mRNA-1647) and First Participant Dosed in Phase 2 Study

Thu January 9, 2020 4:01 PM|Business Wire|About: MRNA

New interim analysis after third and final vaccination shows continued boosting of neutralizing antibody titers in both seronegative participants (exceeding seropositive baseline levels 10-fold at 90 and 180 µg) and seropositive participants (exceeding baseline levels by 20- to 40-fold at 90 and 180 µg)

Phase 2 interim data at three months, expected in 2H 2020, intended to inform Phase 3 dose selection

Pivotal Phase 3 study manufacturing and planning already underway; study start expected in 2021

CMV is the most common infectious cause of birth defects in the U.S.; there is no approved vaccine to prevent CMV

Conference call to be held at 8:00 a.m. ET on Friday, January 10, 2020

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


 https://www.modernatx.com/ 


 https://www.modernatx.com/pipeline 


 https://www.businesswire.com/news/home/20200109005801/en/ 


 https://seekingalpha.com/symbol/MRNA 


 https://investors.modernatx.com/news-releases/news-release-details/moderna-receives-fda-fast-track-designation-zika-vaccine-mrna 



bempegaldesleukin Plus Opdivo (nivolumab)

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Nektar Therapeutics and Bristol-Myers Squibb Amend Strategic Collaboration Agreement for bempegaldesleukin Plus Opdivo (nivolumab)

Fri January 10, 2020 6:59 AM|Business Wire|About: BMY, NKTR

SAN FRANCISCO & NEW YORK--(BUSINESS WIRE)-- Nektar Therapeutics (NKTR) (Nasdaq:NKTR) and Bristol-Myers Squibb Company (BMY) (NYSE:BMY)


 https://www.businesswire.com/news/home/20200110005103/en/ 


 https://packageinserts.bms.com/pi/pi_opdivo.pdf 


 https://www.nektar.com/ 


 https://seekingalpha.com/symbol/NKTR?s=nktr 


 https://seekingalpha.com/symbol/BMY 



Acquisition also includes QBREXZA, Dermira's medicated cloth for primary axillary hyperhidrosis

 

Lilly Announces Agreement to Acquire Dermira

Fri January 10, 2020 6:30 AM|PR Newswire|About: DERM, LLY

Acquisition also includes QBREXZA, Dermira's medicated cloth for primary axillary hyperhidrosis

PR Newswire

INDIANAPOLIS and MENLO PARK, Calif., Jan. 10, 2020 /PRNewswire/ -- Eli Lilly and Company (LLY) and Dermira, Inc. (DERM)


 https://www.dermira.com/ 


 https://investor.lilly.com/news-releases/news-release-details/lilly-announces-agreement-acquire-dermira 


 https://www.prnewswire.com/news-releases/lilly-announces-agreement-to-acquire-dermira-300984850.html 


 

Eli Lilly to acquire Dermira for $1.1B

Jan. 10, 2020 6:44 AM ET|About: Eli Lilly and Company (LLY)|By: , SA News Editor 

 https://seekingalpha.com/news/3530903-eli-lilly-to-acquire-dermira-for-1_1b 

fostemsavir, an investigational, first-in-class attachment inhibitor

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10 January 2020

ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available

Issued: London, UK


 https://viivhealthcare.com/en-gb/media/press-releases/2019/july/viiv-healthcare-presents-positive-96-week-data-from-phase-iii-st/ 


 https://viivhealthcare.com/en-us/ 


 https://www.gsk.com/en-gb/products/ 


 

Viiv Healthcare files fostemsavir application in Europe

Jan. 10, 2020 9:00 AM ET|About: GlaxoSmithKline plc (GSK)|By: , SA News Editor 

 https://seekingalpha.com/news/3530955-viiv-healthcare-files-fostemsavir-application-in-europe 

First Death From New SARS-like Virus Reported in Central China’s Wuhan

 Hong Kong / Health & Environment

Wuhan pneumonia: Hong Kong set to develop new test for mystery virus after obtaining genetic sequence from mainland China

  • A team of experts will also fly over to the mainland city to be briefed on the situation and learn about control measures
  • News comes after China confirms first death from novel coronavirus strain

 Ng Kang-chung

Published: 8:35pm, 12 Jan, 2020


 

Wuhan pneumonia: new strain ‘bears close similarity to Sars’ as Hong Kong health minister assures public city is prepared

  • Secretary for Food and Health Sophia Chan says Hong Kong has plenty of beds and protective gear, but appeals to retailers not to jack up prices of masks

 Victor Ting

Published: 2:21pm, 11 Jan, 2020


 Caixin Global Limited. All Rights Reserved.  

No new cases reported since January 3; World Health Organization praises China’s response to outbreak of mysterious new virus

mRNA-6231 & mRNA-6981

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Moderna Builds on Clinical Validation of Systemic Delivery with Two Additional Development Candidates in New Autoimmune Therapeutic Area

Sun January 12, 2020 2:00 PM|Business Wire|About: AZN, MRK, MRNA

mRNA-6231 encodes a long-acting selective IL-2 to preferentially expand regulatory T cells that suppress immune activity in autoimmune diseases

mRNA-6981 encodes PD-L1 to treat autoimmune disease, initially to be developed in autoimmune hepatitis

Company to expand pipeline of innovative vaccines in the near term based on clinical success of infectious disease vaccine portfolio to date

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


 https://seekingalpha.com/symbol/MRNA 


 https://www.modernatx.com/pipeline 


 https://www.nasdaq.com/press-release/annual-changes-to-the-nasdaq-biotechnology-index-2019-12-13 


 https://www.modernatx.com/ 


 https://www.businesswire.com/news/home/20200112005052/en/ 

Seeking Biotech Alpha JANUARY 2020 Insight

KEYTRUDA® (pembrolizumab)

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ With or Without Papillary Tumors Who Are Ineligible for or Have Elected Not to Undergo Cystectomy

Wed January 8, 2020 4:31 PM|Business Wire|About: MRK

KEYTRUDA Is the First Anti-PD-1 Therapy Approved for Certain Patients With High-Risk, Non-Muscle Invasive Bladder Cancer

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


 KEYNOTE-057 (NCT02625961

 https://clinicaltrials.gov/ct2/show/NCT02625961 


 https://www.merckaccessprogram-keytruda.com/hcc/ 


 https://www.mrknewsroom.com/news-release/oncology/fda-approves-mercks-keytruda-pembrolizumab-patients-bcg-unresponsive-high-risk 


 https://www.businesswire.com/news/home/20200108005864/en/ 


garetosmab (REGN2477)

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Regeneron Announces Encouraging Garetosmab Phase 2 Results in Patients with Ultra-Rare Debilitating Bone Disease

Thu January 9, 2020 7:00 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Jan. 9, 2020 /PRNewswire/ -- 

Approximately 25% decrease in total bone lesions (both new and existing) driven by nearly 90% reduction in formation of new lesions in patients with fibrodysplasia ossificans progressiva (FOP)

Regeneron plans to discuss regulatory submission with regulatory authorities; pediatric trial planning underway

Regeneron Pharmaceuticals, Inc. (REGN) (NASDAQ: REGN)


 https://www.regeneron.com/ 


 https://www.regeneron.com/pipeline 


 https://www.prnewswire.com/news-releases/regeneron-announces-encouraging-garetosmab-phase-2-results-in-patients-with-ultra-rare-debilitating-bone-disease-300984302.html 


 https://clinicaltrials.gov/ct2/show/NCT03188666 


 

Regeneron's garetosmab shows benefit in patients with rare bone growth disorder

Jan. 9, 2020 7:39 AM ET|About: Regeneron Pharmaceutic... (REGN)|By: , SA News Editor  

 https://seekingalpha.com/news/3530636-regenerons-garetosmab-shows-benefit-in-patients-rare-bone-growth-disorder 

Optune®

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Zai Lab and Novocure Announce First Patient Enrolled in a Phase 2 Pilot Trial of Tumor Treating Fields Together with Chemotherapy as First-Line Treatment of Gastric Cancer

Thu January 9, 2020 7:30 AM|Business Wire|About: NVCR, ZLAB

SHANGHAI & ST. HELIER, Jersey--(BUSINESS WIRE)-- Zai Lab Limited (ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, and Novocure (NVCR)


 https://www.novocure.com/ 


 https://www.businesswire.com/news/home/20200109005409/en/ 


 http://www.zailaboratory.com/index.aspx 


 http://www.zailaboratory.com/pipeline/list.aspx 


 https://www.optune.com/hcp 


Reblozyl® (luspatercept-aamt)

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New England Journal of Medicine Publishes Results of Pivotal Phase 3 Reblozyl® (luspatercept-aamt) MEDALIST Trial

Thu January 9, 2020 6:59 AM|Business Wire|About: BMY, XLRN

Data from MEDALIST showed significant clinical benefit of Reblozyl in treating anemia in adults with myelodysplastic syndromes

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE:BMY) and Acceleron Pharma Inc. (XLRN)


 https://www.bms.com/patient-and-caregivers/our-medicines.html 


 https://www.reblozylpro.com/ 


 https://media.celgene.com/content/uploads/reblozyl-pi.pdf 


 http://acceleronpharma.com/ 


 

New England Journal of Medicine Publishes Results of Pivotal Phase 3 Reblozyl® (luspatercept-aamt) MEDALIST Trial

Data from MEDALIST showed significant clinical benefit of Reblozyl in treating anemia in adults with myelodysplastic syndromes

CATEGORY: 

CORPORATE/FINANCIAL NEWSTHURSDAY, JANUARY 9, 2020 6:59 AM EST 

 https://news.bms.com/press-release/corporatefinancial-news/new-england-journal-medicine-publishes-results-pivotal-phase-

 

Luspatercept-aamt

Novel erythroid maturation agent in development for treatment of serious and chronic anemias

Luspatercept-aamt is a first-in-class erythroid (red blood cell) maturation agent being developed to treat patients who have serious blood disorders associated with ineffective erythropoiesis.

Discovered by scientists at Acceleron, luspatercept-aamt is a recombinant fusion protein that binds several TGF-beta superfamily ligands, thereby diminishing Smad2/3 signaling.

 http://acceleronpharma.com/science-pipeline/luspatercept/ 

NV-HHV-101

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NanoViricides Successfully Completes Required Genetic Toxicology Testing of Lead Drug Candidate NV-HHV-101

Thu January 9, 2020 8:00 AM|Accesswire|About: NNVC

SHELTON, CT / ACCESSWIRE / January 9, 2020 / NanoViricides, Inc. (NNVC)


 http://www.nanoviricides.com/ 



Microbiome Metabolic Therapies (MMT™)

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Kaleido Biosciences Announces Collaboration with Janssen to Explore the Potential for Microbiome Metabolic Therapies (MMT™) to Prevent Childhood-Onset of Atopic, Immune and Metabolic Conditions by Promoting Healthy Function of the Gut Microbiome

Thu January 9, 2020 8:00 AM|GlobeNewswire|About: KLDO

LEXINGTON, Mass., Jan. 09, 2020 (GLOBE NEWSWIRE) -- Kaleido Biosciences, Inc (KLDO). (Nasdaq: KLDO)


 https://kaleido.com/our-pipeline/ 


 

Kaleido Biosciences Announces Collaboration with Janssen to Explore the Potential for Microbiome Metabolic Therapies (MMT™) to Prevent Childhood-Onset of Atopic, Immune and Metabolic Conditions by Promoting Healthy Function of the Gut Microbiome

January 9, 2020 

 https://investors.kaleido.com/news-releases/news-release-details/kaleido-biosciences-announces-collaboration-janssen-explore 

Seeking Biotech Alpha JANUARY 2020 Insight

Pemigatinib

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Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Pemigatinib in Patients with Cholangiocarcinoma

Tue January 7, 2020 6:00 AM|Business Wire|About: INCY

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


 https://clinicaltrials.gov/ct2/show/NCT02924376 


 https://www.incyte.com/ 


 https://www.businesswire.com/news/home/20200107005093/en/ 



RINVOQ® (upadacitinib)

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AbbVie Receives Health Canada Approval of RINVOQ® (upadacitinib), an Oral Medication for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

Tue January 7, 2020 8:01 AM|Canada Newswire|About: ABBV

  • Approval supported by efficacy and safety data from the pivotal Phase 3 SELECT rheumatoid arthritis (RA) program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across five studies1-5
  • About one in every 100 adult Canadians, or approximately 300,000 people, are living with rheumatoid arthritis, the majority of whom don't achieve remission6,7

MONTREAL, Jan. 7, 2020 /CNW/ - AbbVie (ABBV


 http://www.abbvie.ca/ 


 https://abbviecare.ca/ 


 https://www.abbvie.com/ 



pegcetacoplan (APL-2)

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Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2) Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Tue January 7, 2020 7:00 AM|GlobeNewswire|About: APLS

  • Pegcetacoplan met the primary endpoint in the PEGASUS study, demonstrating superiority to eculizumab (p<0.0001) with an improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16
  • Safety profile of pegcetacoplan was comparable to eculizumab in this study
  • Conference call scheduled today at 8:30 a.m. ET

WALTHAM, Mass., Jan. 07, 2020 (GLOBE NEWSWIRE) --  Apellis Pharmaceuticals (APLS), Inc. (Nasdaq: APLS)


 https://www.apellis.com/our-science/clinical-trials 


 https://apellis.com/our-science/our-pipeline/ 



ADXS-504

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Advaxis Announces FDA Clearance of IND for ADXS-504 for Treatment of Prostate Cancer

Tue January 7, 2020 8:00 AM|GlobeNewswire|About: ADXSGlobeNewswire

PRINCETON, N.J., Jan. 07, 2020 (GLOBE NEWSWIRE) -- Advaxis, Inc. (ADXS)


 https://advaxis.com/ 


 https://advaxis.com/clinical-trials-3/ 


 https://seekingalpha.com/symbol/ADXS 


NV-HHV-101

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NanoViricides Has Initiated Genetic Toxicology Testing Required for an IND for Its Drug Candidate

Tue January 7, 2020 8:30 AM|Accesswire|About: NNVC

SHELTON, CT / ACCESSWIRE / January 7, 2020 / NanoViricides, Inc. (NNVC) (NYSE Amer.:NNVC)


 http://www.nanoviricides.com/ 


 https://seekingalpha.com/symbol/NNVC 

HEARTMATE 3™ LVAD

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FDA Approves Less Invasive Surgical Approach for Abbott's Heart Pump to Help Patients Avoid Open Heart Surgery

Tue January 7, 2020 10:04 AM|PR Newswire|About: ABT

- New, less invasive technique provides cardiac surgeons with the ability to choose the optimal surgical method for their patients

PR Newswire

ABBOTT PARK, Ill., Jan. 7, 2020 /PRNewswire/ -- Abbott (ABT)


 NEW LONG-TERM DATA SHOW IMPROVED SURVIVAL AND LOWER RATES OF STROKE AND PUMP THROMBOSIS FOR ABBOTT'S HEARTMATE 3 HEART PUMP 

 https://abbott.mediaroom.com/2018-03-11-New-Long-Term-Data-Show-Improved-Survival-and-Lower-Rates-of-Stroke-and-Pump-Thrombosis-for-Abbotts-HeartMate-3-Heart-Pump 


 https://www.prnewswire.com/news-releases/fda-approves-less-invasive-surgical-approach-for-abbotts-heart-pump-to-help-patients-avoid-open-heart-surgery-300982723.html 



Seeking Biotech Alpha JANUARY 2020 Insight

BAVENCIO® (avelumab)

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BAVENCIO Significantly Improved Overall Survival in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Mon January 6, 2020 7:00 AM|PR Newswire|About: MKKGY, PFE

- At the planned interim analysis, Phase III JAVELIN Bladder 100 study met the primary endpoint of prolonging overall survival (OS) as a first-line maintenance treatment versus standard of care

- BAVENCIO is the first immunotherapy to significantly prolong OS in locally advanced or metastatic urothelial carcinoma (UC) in the first-line setting in a Phase III trial

PR Newswire

ROCKLAND, Mass. and NEW YORK, Jan. 6, 2020 /PRNewswire/ -- EMD Serono,


 https://www.bavencio.com/patients-and-caregivers/rcc 


 https://www.emdgroup.com/en/research.html 


 https://www.emdserono.com/us-en 


 https://www.pfizer.com/ 


 https://www.prnewswire.com/news-releases/bavencio-significantly-improved-overall-survival-in-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-300981078.html 

LOKELMA® (sodium zirconium cyclosilicate) 10 g FOR ORAL SUSPENSION

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Lokelma approved in China for the treatment of adult patients with hyperkalaemia

PUBLISHED6 January 2020

6 January 2020 07:00 GMT
 

Patients in China will benefit from Lokelma’s rapid reduction
of potassium in the blood and the sustained treatment effect
 

AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) has been approved in China for the treatment of adult patients with hyperkalaemia (elevated levels of potassium in the blood).


 https://www.lokelma-hcp.com/ 


 

AstraZeneca's Lokelma OK'd in China

Jan. 6, 2020 6:30 AM ET|About: AstraZeneca PLC (AZN)|By: , SA News Editor  


 https://www.astrazeneca.com/ 

 https://seekingalpha.com/news/3529679-astrazenecas-lokelma-okd-in-china 

FARXIGA® (dapagliflozin)

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FARXIGA Granted FDA Priority Review For Patients With Heart Failure With Reduced Ejection Fraction

Mon January 6, 2020 7:00 AM|Business Wire|About: AZN

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca 


 https://www.nejm.org/doi/full/10.1056/NEJMoa1911303?query=main_nav_lg 


 https://www.azpicentral.com/farxiga/farxiga.pdf#page=1 


 https://www.astrazeneca-us.com/ 


 https://www.astrazeneca.com/ 


 

FARXIGA Granted FDA Priority Review For Patients With Heart Failure With Reduced Ejection Fraction

January 06, 2020 07:00 AM Eastern Standard Time

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca

 https://www.businesswire.com/news/home/20200106005339/en/ 



Biotrue® ONEday contact lenses

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Bausch + Lomb Launches Expanded Parameters for Biotrue® ONEday for Astigmatism Daily Disposable Contact Lenses

Mon January 6, 2020 8:28 AM|Canada Newswire|About: BHC

Lens Parameters Expanded by Nearly 60 percent, Providing Eye Care Professionals the Broadest Offering Among All Daily Disposable Toric Lenses  

BRIDGEWATER, N.J., Jan. 6, 2020 /CNW/ -- Bausch + Lomb,


 https://www.biotrueonedaylenses.com/ 


 https://www.bausch.com/ 


 https://www.bauschhealth.com/ 


 https://www.prnewswire.com/news-releases/bausch--lomb-launches-expanded-parameters-for-biotrue-oneday-for-astigmatism-daily-disposable-contact-lenses-300981349.html 


KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy

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Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Significantly Improved Progression-Free Survival Compared to Chemotherapy Alone as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Mon January 6, 2020 4:05 PM|Business Wire|About: MRK

Phase 3 KEYNOTE-604 Study Did Not Meet Other Dual Primary Endpoint of Overall Survival; Results to be Presented at Upcoming Medical Meeting

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


 (ClinicalTrials.gov, NCT03066778) 


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


 https://www.merck.com/index.html 


 https://www.businesswire.com/news/home/20200106005955/en/