seeking biotech alpha August 2019 & November 2018 insight

KEYTRUDA® (pembrolizumab)

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 Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Compared to Chemotherapy in Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma Whose Tumors Express PD-L1 (CPS ≥10)

Wed November 14, 2018 6:45 AM|Business Wire|About: MRK 

Emgality® (galcanezumab-gnlm)

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  Lilly Announces Positive Results for Emgality® (galcanezumab-gnlm) from the CONQUER Study in Patients who Failed Previous Migraine Preventive Treatments

08/05/2019 

 Failure to respond to migraine preventive treatments is a common occurrence; internationally it is estimated that more than 40% of patients who use migraine preventive medications have a history of failure or switching treatments(1)

INDIANAPOLIS, Aug. 5, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) 

V920 (rVSV∆G-ZEBOV-GP)

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 Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration

Tue November 13, 2018 4:35 PM|Business Wire|About: MRK 

Celgene (CELG)

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 Lyfebulb Partners with Celgene to Inspire Patient-Driven Innovation in the Management of Multiple Sclerosis

Wed November 14, 2018 7:58 AM|PR Newswire|About: CELG

NEW YORK, Nov. 14, 2018 /PRNewswire/

Elagolix

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 November 14, 2018 

AbbVie Presents Positive Phase 3 Data Demonstrating Investigational Elagolix Reduces Heavy Menstrual Bleeding in Women with Uterine Fibroids at 2018 AAGL Global Congress

 NORTH CHICAGO, Ill., Nov. 14, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV) 

seeking biotech alpha August 2019 & November 2018 insight

Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab)

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  Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma

Thu August 1, 2019 7:00 AM|PR Newswire|About: BMY, NKTR 

 SAN FRANCISCO, Aug. 1, 2019 /PRNewswire/ -- Nektar Therapeutics (NKTR) and Bristol-Myers Squibb (BMY

Triple Combination of VX-659, Tezacaftor and Ivacaftor

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 Two Phase 3 Studies of the Triple Combination of VX-659, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis

Tue November 27, 2018 8:00 AM|Business Wire|About: VRTX 

CALQUENCE® (acalabrutinib) and LUMOXITI™ (moxetumomab pasudotox-tdfk)

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 AstraZeneca Presents Clinical Research Advances for Blood Cancer Patients at 2018 American Society of Hematology Annual Meeting

Tue November 27, 2018 7:00 AM|Business Wire|About: AZN 


 

CALQUENCE® (acalabrutinib) Granted US Breakthrough Therapy Designation for Chronic Lymphocytic Leukemia

Wed August 14, 2019 8:00 AM|Business Wire|About: AZN

Designation based on positive results from two Phase III trials

WILMINGTON, Del.--(BUSINESS WIRE)

 https://seekingalpha.com/pr/17603088-calquence-acalabrutinib-granted-us-breakthrough-therapy-designation-chronic-lymphocytic 

generic version of EpiPen®1 (epinephrine injection, USP) Auto-Injector, 0.3 mg

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Teva’s Generic Version of EpiPen® (Epinephrine Injection, USP) Auto-Injector 0.3 mg Now Available in Limited Quantity in the United States

Tue November 27, 2018 10:06 AM|Business Wire|About: TEVA

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceutical Industries (TEVA

seeking biotech alpha August 2019 & November 2018 insight

Valiant Navion thoracic stent graft system

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 Medtronic's Valiant Navion stent CE Mark'd

Nov. 13, 2018 10:23 AM ET|About: Medtronic plc (MDT)|By: , SA News Editor  

(GILD) antiviral Remdesivir and 3 monoclonal antibody: ZMapp, mAb 114 and (REGN) 3470-3471-3479

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 Ebola clinical trial to begin in DRC

Nov. 13, 2018 4:49 AM ET|By: , SA News Editor  

 
Helen Branswell 

MAVYRET™ (glecaprevir/pibrentasvir)

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 Enanta’s HCV Collaboration Partner AbbVie receives Approval by the European Commission for MAVIRET™ (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve HCV Patients with Compensated Cirrhosis

Fri August 2, 2019 8:51 AM|Business Wire|About: ENTA 

 WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (ENTA

NovoCure (NVCR)

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 Novocure Announces More than 70 Presentations on Tumor Treating Fields at 23rd Annual Meeting of the Society for Neuro-Oncology

Tue November 13, 2018 8:24 AM|Business Wire|About: NVCR

 ST. HELIER, Jersey--(BUSINESS 

WIRE)-- Novocure (NVCR)  


Eliquis® (apixaban)

image83

 Real-World Evidence on Patients Aged 80 and Older Presented From ARISTOPHANES, the Largest Real-World Data Study Evaluating Oral Anticoagulants Among Patients with Non-Valvular Atrial Fibrillation

Eliquis® (apixaban) was associated with lower rates of stroke or systemic embolism and major bleeding in elderly patient populations when compared to rivaroxaban and dabigatran

 (PRINCETON, N.J. & NEW YORK) November 11, 2018 – The Bristol-Myers Squibb-Pfizer Alliance  

seeking biotech alpha August 2019 & November 2018 insight

LENVIMA® (lenvatinib), in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab)

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 New Data from Investigational Study of LENVIMA® (lenvatinib) and KEYTRUDA® (pembrolizumab) Combination in Three Different Tumor Types Presented at the Society for Immunotherapy of Cancer’s 33rd Annual Meeting

Fri November 9, 2018 6:45 AM|Business Wire|About: MRK 

 TOKYO & KENILWORTH, N.J.--(BUSINESS WIRE)-- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck (MRK), known as MSD outside the United States and Canada,  

FARXIGA (dapagliflozin)

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 FARXIGA Significantly Reduced Hospitalization for Heart Failure or CV Death in a Broad Patient Population with Type 2 Diabetes in the Landmark DECLARE-TIMI 58 Trial

Sat November 10, 2018 4:45 PM|Business Wire|About: AZN 

LYNPARZA® (olaparib)

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Lynparza Phase III PROfound trial in HRR* mutation-selected metastatic castration-resistant prostate cancer met primary endpoint

PUBLISHED7 August 2019 


 7 August 2019 07:00 BST

AstraZeneca and MSD’s Lynparza met the primary endpoint of significantly increasing the time patients selected for BRCA1/2 or ATM mutations live without radiographic disease progression vs. standard of care treatment

Only PARP inhibitor with positive Phase III results in four different cancer types (ovarian, breast, pancreatic and prostate)

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc


 AstraZeneca and Merck's Lynparza shows treatment benefit in late-stage prostate cancer study

Aug. 7, 2019 7:04 AM ET|About: AstraZeneca PLC (AZN)|By: , SA News Editor 


 https://seekingalpha.com/news/3488293-astrazeneca-mercks-lynparza-shows-treatment-benefit-late-stage-prostate-cancer-study 


 Lynparza Phase III PAOLA-1 trial met primary endpoint as 1st-line maintenance treatment with bevacizumab for advanced ovarian cancer 

 

14 August 2019 07:00 BST

AstraZeneca and MSD’s Lynparza, when added to standard-of-care bevacizumab, significantly increased the time women lived without disease progression

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada)

 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-phase-iii-paola-1-trial-met-primary-endpoint-as-1st-line-maintenance-treatment-with-bevacizumab-for-advanced-ovarian-cancer-14082019.html 

Repatha® (Evolocumab)

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 Amgen Presents Results Highlighting The Long-Term Safety And Efficacy Of Repatha® (Evolocumab) In The Longest Duration Study Of A PCSK9 Inhibitor To Date At AHA Scientific Sessions 2018

Mon November 12, 2018 4:00 PM|PR Newswire|About: AMGN 

 THOUSAND OAKS, Calif., Nov. 12, 2018 /PRNewswire/ -- Amgen (AMGN)  

Praluent® (alirocumab)

image89

 ODYSSEY OUTCOMES Investigators Highlight at AHA that Praluent® (alirocumab) Injection Was Associated with Fewer Deaths from Any Cause

Sun November 11, 2018 8:14 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, Nov. 11, 2018 /PRNewswire/ --

seeking biotech alpha Sept/Aug 2019 & Nov 2018 insight

Repatha® (Evolocumab)

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 Amgen Announces Presentation Of Research Reinforcing The Long-Term Safety And Efficacy Of Repatha® (Evolocumab) In High-Risk Patients At AHA Scientific Sessions 2018

Mon November 5, 2018 4:00 PM|PR Newswire|About: AMGN 

Selpercatinib (LOXO-292)

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Lilly Announces Positive Results for Selpercatinib (LOXO-292), Demonstrating a 68 Percent Objective Response Rate and Sustained Durability in Heavily Pretreated RET Fusion-Positive Non-Small Cell Lung Cancer

Mon September 9, 2019 3:20 AM|PR Newswire|About: LLY 

 PR Newswire

INDIANAPOLIS, Sept. 9, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY


 https://www.prnewswire.com/news-releases/lilly-announces-positive-results-for-selpercatinib-loxo-292-demonstrating-a-68-percent-objective-response-rate-and-sustained-durability-in-heavily-pretreated-ret-fusion-positive-non-small-cell-lung-cancer-300913590.html 

Icosapent Ethyl Recognized as Only Non-LDL-Cholesterol Lipid Management Treatment with Cardiovascula

image93

  

National Lipid Association’s New Position Statement on Use of Icosapent Ethyl in High and Very-High-Risk Patients Recognizes Importance of Addressing Residual Cardiovascular Risk in Patients on Statins

Mon September 16, 2019 6:00 AM|GlobeNewswire|About: AMRN

Millions of Patients on Statins with Elevated Triglycerides Are at Risk of Cardiovascular Events, Such as Heart Attack, Stroke or Death

Icosapent Ethyl Recognized as Only Non-LDL-Cholesterol Lipid Management Treatment with Cardiovascular Risk Reduction Outcomes Results

DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 16, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

Eli Lilly and Company (LLY) and NextCure, Inc.

image94

 Lilly and NextCure Announce Collaboration to Discover and Develop Novel Immuno-Oncology Medicines

Mon November 5, 2018 4:30 PM|PR Newswire|About: LLY 

seeking biotech alpha August 2019 & November 2018 insight

Illumina, Inc. (ILMN) and Pacific Biosciences (PACB)

image96

 Illumina to Acquire Pacific Biosciences for Approximately $1.2 Billion, Broadening Access to Long-Read Sequencing and Accelerating Scientific Discovery

Thu November 1, 2018 4:02 PM|Business Wire|About: ILMN, PACB 

Amgen (AMGN)

image97

  

Amgen Wins Patent Case On Enbrel® (etanercept)

Fri August 9, 2019 4:05 PM|PR Newswire|About: AMGN

Preliminary Injunction to Remain in Place

PR Newswire

THOUSAND OAKS, Calif., Aug. 9, 2019 /PRNewswire/ -- Amgen (AMGN)


 https://www.enbrel.com/ 

Tecentriq® (ATEZOLIZUMAB)

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 Genentech’s Tecentriq® (ATEZOLIZUMAB) Plus Platinum-based Chemotherapy Reduced the Risk of Disease Worsening or Death in People With Previously Untreated Advanced Bladder Cancer

Mon August 5, 2019 1:00 AM|Business Wire|About: RHHBY

– IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer –

– Data will be shared with health authorities globally, including the U.S. Food and Drug Administration (FDA) –

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

 https://www.businesswire.com/news/home/20190804005062/en/ 

Bavarian Nordic A/S's (BVNKF) CV301, combined with (AZN) PD-L1 inhibitor IMFINZI (durvalumab)

image99

 Bavarian Nordic launches Phase 1/2 study of prime/boost vaccine CV301 in colorectal and pancreatic cancers

Nov. 2, 2018 11:47 AM ET|By: , SA News Editor  

Elagolix

image100

 AbbVie Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women

Mon August 5, 2019 8:30 AM|PR Newswire|About: ABBV, NBIX 


 PR Newswire

NORTH CHICAGO, Ill., Aug. 5, 2019 /PRNewswire/ -- AbbVie (ABBV)

.


 https://www.prnewswire.com/news-releases/abbvie-submits-new-drug-application-to-us-fda-for-investigational-elagolix-for-management-of-heavy-menstrual-bleeding-associated-with-uterine-fibroids-in-women-300896046.html 

BioArctic and AbbVie - BAN0805

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 BioArctic's Partner AbbVie Exercises its Option to License the Alpha-synuclein Antibody Portfolio for Parkinson's  Disease

 Thu November 1, 2018 11:09 PM|PR Newswire|About: ABBV, B, BIOA

STOCKHOLM, Oct. 2, 2018 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B)

seeking biotech alpha August 2019 November 2018 insight

Tivicay (dolutegravir) + lamivudine

image103

 European advisory group backs ViiV Healthcare's Tivicay + lamivudine in HIV-1

Nov. 19, 2018 7:14 AM ET|By: , SA News Editor  

Descovy for PrEP™

image104

 August 08, 2019

Gilead Sciences Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™

FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 7, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD


 https://seekingalpha.com/pr/17597519-gilead-sciences-statement-u-s-food-drug-administration-advisory-committee-s-recommendation 

TAGRISSO® (OSIMERTINIB)

image105

  

TAGRISSO® (OSIMERTINIB) Significantly Improves Overall Survival in the Phase III FLAURA Trial for 1st-line EGFR-mutated Non-small Cell Lung Cancer

Fri August 9, 2019 7:00 AM|Business Wire|About: AZN

TAGRISSO is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived without disease progression

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

Bria-IMT™ in combination with pembrolizumab [KEYTRUDA®

image106

 BriaCell to Present Updated Clinical Data Including Early Safety Data in KEYTRUDA® Combination Study and Positive Phase IIa Monotherapy Efficacy Data at 2018 San Antonio Breast Cancer Symposium

Mon November 19, 2018 6:30 AM|GlobeNewswire|About: BCTXF, MRK 

Nucala (mepolizumab)

image107

Glaxo files U.S. marketing application for expanded use of Nucala

Nov. 19, 2018 7:46 AM ET|By: , SA News Editor 

seeking biotech alpha August 2019 & November 2018 insight

DAURISMO™ (glasdegib)

image108

 U.S. FDA Approves DAURISMO™ (glasdegib) for Adult Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML) for Whom Intensive Chemotherapy is Not an Option

Wed November 21, 2018 1:40 PM|Business Wire|About: PFE 

VENCLEXTA® (venetoclax)

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 AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

Wed November 21, 2018 2:14 PM|PR Newswire|About: ABBV 

SIRTURO® (bedaquiline)

image110

 Janssen Announces U.S. FDA Accelerated Approval for SIRTURO® (bedaquiline) as Part of Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis

Label expansion marks important milestone in Johnson & Johnson’s pediatric research and development program for bedaquiline

TITUSVILLE, NJ, August 9, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson

BeiGene BGNE

image111

 Analysts Take Action on Health Care Stocks

JPMorgan initiates coverage of BeiGene, Brookline Capital Markets starts covering Celsion and Cellectar Biosciences 

November 21, 2018 

 Alberto Abaterusso 

 BGNE CLSN CLRB 

Bria-IMT™ with KEYTRUDA®

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 UPDATE - BriaCell to Present Updated Clinical Data Including Early Safety Data in KEYTRUDA® Combination Study and Positive Phase IIa Monotherapy Efficacy Data at 2018 San Antonio Breast Cancer Symposium

November 20, 2018 | About: BCTXF +0% MRK +0%

Note: This Press Release contains amendments to the press release previously issued on Nov. 19, 2018

BRACAnalysis CDx

image113

 Myriad Will Seek FDA Approval of BRACAnalysis CDx® As a Companion Diagnostic for Lynparza® (olaparib) In Men with Metastatic Castrate-Resistant Prostate Cancer

Wed August 7, 2019 7:05 AM|GlobeNewswire|About: AZN, MYGN

SALT LAKE CITY, Aug. 07, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics (MYGN), Inc. (NASDAQ: MYGN)

seeking biotech alpha August 2019 & November 2018 insight

EYLEA® (aflibercept) Injection Prefilled Syringe

image114

  

FDA Approves EYLEA® (aflibercept) Injection Prefilled Syringe

Tue August 13, 2019 7:00 AM|PR Newswire|About: REGNQ2: 08-06-19 Earnings Summary

EPS of $6.02 beats by $0.60 Revenue of $1.93B (20.25% Y/Y) beats by $131.71M

TARRYTOWN, N.Y., Aug. 13, 2019 /PRNewswire/ -


 https://www.prnewswire.com/news-releases/fda-approves-eylea-aflibercept-injection-prefilled-syringe-300900436.html 

Zanubrutinib and Tislelizumab

image115

 Priority Review Granted to BeiGene’s New Drug Applications for Zanubrutinib and Tislelizumab in China

Thu November 15, 2018 7:00 AM|GlobeNewswire|About: BGNE 

CABOMETYX® (cabozantinib)

image116

 Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) Tablets for the Treatment of Hepatocellular Carcinoma in Adults Previously Treated with Sorafenib

Thu November 15, 2018 1:32 AM|Business Wire|About: EXEL 

DRG Invisible Trial System

image118

 New Approvals Allow Chronic Pain Sufferers to Try Abbott's Non-Opioid Pain Therapy Before Getting Device Implant

Thu November 15, 2018 9:00 AM|PR Newswire|About: ABT 

CVS

image119

 CVS Health Teams Up with Philadelphia Job Corps, Philadelphia Works and Philadelphia Youth Network to Open New Mock Pharmacy for Aspiring Pharmacy Technicians

Thu November 15, 2018 8:00 AM|PR Newswire|About: CVS 

 PHILADELPHIA, Nov. 15, 2018 /PRNewswire/  

seeking biotech alpha August 2019 & November 2018 insight

LUXTURNA® (voretigene neparvovec)

image121

 European Commission Approves Spark Therapeutics’ LUXTURNA® (voretigene neparvovec), a One-time Gene Therapy for Inherited Retinal Disease Caused by Confirmed Biallelic RPE65 Mutations

Fri November 23, 2018 1:15 AM|GlobeNewswire 

 

Spark Therapeutics (ONCE) will manufacture and supply LUXTURNA for Novartis, while Novartis has exclusive rights to pursue development, registration and commercialization in all other countries outside the U.S.

PHILADELPHIA, Nov. 23, 2018 (GLOBE NEWSWIRE) -- Spark Therapeutics

Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd)

image124

 

European Commission Approves Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Tue August 27, 2019 4:16 PM|Business Wire|About: BMY 

seeking biotech alpha November 2018 insight

DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate) + once-daily PIFELTRO (doravirine)

image127

European Commission Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients

 Wednesday, November 28, 2018 4:30 pm EST  KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK) 


Xalatan

image128

 Eyenovia's micro-dose latanoprost shows positive effect in mid-stage study

Nov. 28, 2018 4:33 PM ET|By: , SA News Editor  

seeking biotech alpha November 2018 insight

ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab)

image132

 FDA Approves the ACTPen for Genentech’s Actemra, a Single-Dose, Prefilled Autoinjector for the Treatment of Rheumatoid Arthritis, Giant Cell Arteritis and Two Forms of Juvenile Arthritis

Mon November 26, 2018 11:35 AM|Business Wire|About: CHGCY, RHHBY 

NeuVax (nelipepimut-S), combined with Roche's (RHHBY) Herceptin (trastuzumab)

image134

 Opthea completes enrollment in mid-stage study of OPT-302 in wet AMD

Nov. 26, 2018 11:48 AM ET|About: Opthea Limited ADR (CKDXY)|By: , SA News Editor  

Zymeworks’ Azymetric™ and EFECT™

image135

 Zymeworks and BeiGene Announce License and Collaboration Agreement for Zymeworks’ HER2-Targeted Therapeutic Candidates, ZW25 and ZW49, in Asia-Pacific and Research and License Agreement for Zymeworks’ Azymetric™ and EFECT™ Platforms Globally

Tue November 27, 2018 6:30 AM|Business Wire|About: BGNE, ZYME 

Vitrakvi® (larotrectinib)

image136

 FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion(1,2)

Mon November 26, 2018 7:16 PM|GlobeNewswire|About: LOXO 

bb2121

image137

 Celgene Corporation and bluebird bio Complete Enrollment of Pivotal KarMMa Study of anti-BCMA Car T Cell Therapy bb2121 in Patients with Relapsed and Refractory Multiple Myeloma

Tue November 27, 2018 7:30 AM|Business Wire|About: BLUE, CELG

SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Celgene Corporation (CELG) and bluebird bio, Inc. (BLUE)

seeking biotech alpha August 2019 & November 2018 insight

Johnson & Johnson Vision

image140

 Two Studies Measure Performance of ACUVUE OASYS with Transitions Light Intelligent Technology Contact Lenses in Simulated Sunlight, Day and Night Driving Conditions

Tue November 6, 2018 9:19 AM|PR Newswire|About: JNJ 

ALKS 4230

image141

 Alkermes Presents New Data on ALKS 4230 at Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting

Tue November 6, 2018 8:01 AM|PR Newswire|About: ALKS 

anti-CEA CAR-T utilizing a Pressure-Enabled Drug Delivery (PEDD) by TriSalus™ Life Sciences.

image142

 Sorrento Therapeutics Anti-CEA CAR-T Demonstrates Significant Therapeutic Activity With Increased Overall Survival in Pancreatic Cancer Patients With Liver Metastases

Tue November 6, 2018 8:01 AM|GlobeNewswire|About: SRNE 

 SAN DIEGO, Nov. 06, 2018 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (SRNE) ("Sorrento") 

Insulet Corporation’s Omnipod® DASH™ Insulin Management System

image143

 TUV Rheinland OpenSky helps insulin pump by Insulet achieve cybersecurity certification by DTSec

Tue November 6, 2018 11:59 AM|GlobeNewswire|About: PODD 

 COLOGNE, Germany and LITTLETON, Mass., Nov. 06, 2018 (GLOBE NEWSWIRE)  


 

Insulet (PODD) Presents At Canaccord Genuity Growth Conference - Slideshow

Aug. 13, 2019 2:31 PM ET | About: Insulet Corporation (PODD) 

 https://seekingalpha.com/article/4285220-insulet-podd-presents-canaccord-genuity-growth-conference-slideshow 

seeking biotech alpha August 2019 & November 2018 insight

Rozlytrek™ (entrectinib)

image144

  

FDA Approves Genentech’s Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors

Thu August 15, 2019 4:10 PM|Business Wire|About: RHHBY

– First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer that has spread to the brain –

– Genentech’s first FDA-approved tumor-agnostic medicine –

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


 https://www.gene.com/download/pdf/rozlytrek_prescribing.pdf 

ibrutinib (Imbruvica®) & venetoclax (Venclexta®

image146

 AbbVie to Highlight Breadth of Innovative Science and Ongoing Commitment to Blood Cancer Patients with New Data From Studies of Ibrutinib and Venetoclax at 2018 American Society of Hematology Annual Meeting & Exposition

Tue November 20, 2018 8:32 AM|PR Newswire|About: ABBV 

MDT, MZOR, MZRTF

image148

 Mazor Robotics Shareholders Approve Merger Agreement With Medtronic

Mon November 19, 2018 5:30 PM|PR Newswire|About: MDT, MZOR, MZRTF 

seeking biotech alpha August 2019 & November 2018 insight

Impella CP®

image151

 FDA Safety Study of Unloading the Left Ventricle for 30 Minutes Prior to Reperfusion in Heart Attack Patients is Safe and Feasible

Abiomed will initiate pivotal randomized controlled trial with FDA

CHICAGO--(BUSINESS WIRE)--Nov. 11, 2018-- Abiomed (NASDAQ: ABMD)

Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI) and (JNJ) Vision

image152

 Singapore National Eye Centre, Singapore Eye Research Institute And Johnson & Johnson Vision Set Sights On Halting Global Myopia Epidemic

Mon November 12, 2018 1:30 AM|PR Newswire|About: JNJ 

 SINGAPORE, Nov. 12, 2018 /PRNewswire/ 

Illumina (ILMN)

image154

 Illumina’s Growth Shows No Signs of Slowing Down

Illumina's recent acquisition of Pacific Biosciences of California strongly strengthens its product offering and ensures growth for years to come

 Maxwell Koobatian 

 November 12, 2018 | About: ILMN +0% PAC 

filgotinib, an investigational, oral, selective JAK1 inhibitor

image155

 

European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis

Thu August 15, 2019 4:01 PM|Business Wire|About: GILD, GLPG

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

seeking biotech alpha August 2019 & November 2018 insight

LORBRENA® (lorlatinib)

image157

 U.S. FDA Approves LORBRENA® (lorlatinib) for Previously-Treated ALK-Positive Metastatic NSCLC

Fri November 2, 2018 4:42 PM|Business Wire|About: PFE 

evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody

image159

  August 14, 2019 at 7:00 AM EDT Back

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

SOLIRIS® (eculizumab)

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European Commission Approves SOLIRIS® (eculizumab) For the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Tue August 27, 2019 8:30 AM|Business Wire|About: ALXN

 - SOLIRIS® (eculizumab) is the first and only approved medication for NMOSD in Europe -

- 98% of adult anti-aquaporin-4 (AQP4) antibody-positive patients treated with SOLIRIS were relapse free compared to 63% receiving placebo at 48 weeks -

BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN

Pamiparib (BGB-290)

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 BeiGene to Present Clinical Data on PARP Inhibitor Pamiparib at Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology

Mon November 5, 2018 7:00 AM|GlobeNewswire|About: BGNE 

seeking biotech alpha November 2018 insight

Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab)

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 Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab) as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

Thu November 15, 2018 4:30 PM|Business Wire|About: BMY 

ACUVUE OASYS

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 ACUVUE OASYS with Transitions Light Intelligent Technology Named Among TIME's 'Best Inventions of 2018'

Fri November 16, 2018 7:03 AM|PR Newswire|About: JNJ 

 JACKSONVILLE, Fla., Nov. 16, 2018 /PRNewswire/ 

Agilent Technologies Inc (A)

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 Agilent Expands Cell Analysis R&D Capabilities in Ireland

Fri November 16, 2018 11:00 AM|Business Wire|About: A 

seeking biotech alpha November 2018 insight

Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel])

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 FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Abraxane for the Initial Treatment of People with PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

Tue November 13, 2018 1:06 AM|Business Wire|About: RHHBY 

JPOD @ PHILADELPHIA

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JPOD   @ Philadelphia officially launched at Pennovation Works
JPOD @ Philadelphia, the first of its kind in the   nation, is a networking hub that includes a secure telecommunications   conferencing system to connect regional innovators to the J&J Innovation   and JLABS network. It's about leveraging the talent-particularly in the health   sciences-that is rampant and unique to Philadelphia, as well as boosting it.
READ MORE › 

 November 13, 2018

 

Bausch Health Companies Inc. (BHC)

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 Bausch Health Will Expand Contact Lens Manufacturing Facilities In Rochester, NY And Waterford, Ireland

Tue November 13, 2018 7:00 AM|PR Newswire|About: BHC

LAVAL, Quebec, Nov. 13, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (BHC)

AKCEA-APO(a)-Lrx

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 Akcea up 3% on positive AKCEA-APO(a)-Lrx data

Nov. 12, 2018 2:08 PM ET|About: Akcea Therapeutics (AKCA)|By: , SA News Editor  

 collaboration partner Novartis (NVS)  

Intuitive Surgical, Inc. (ISRG)

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 Intuitive Surgical Is Ironman For Doctors

Nov. 12, 2018 9:02 AM ET|8 comments  | About: Intuitive Surgical, Inc. (ISRG) 

  

seeking biotech alpha November 2018 insight

Trulicity® (dulaglutide)

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 Trulicity® (dulaglutide) demonstrates superiority in reduction of cardiovascular events for broad range of people with type 2 diabetes

Mon November 5, 2018 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Nov. 5, 2018 /PRNewswire/ 

Amgen (AMGN) and Provention Bio, Inc. (PRVB)

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 Amgen And Provention Bio Announce Co-Development Collaboration In Celiac Disease

Mon November 5, 2018 9:00 AM|PR Newswire|About: AMGN, PRVB 

seeking biotech alpha November 2018 insight

Abiomed, Inc. (ABMD)

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 Abiomed Announces Q2 FY 2019 Record Revenue of $182 Million, up 37% Over Prior Year

Thu November 1, 2018 7:00 AM|GlobeNewswire|About: ABMD

DANVERS, Mass., Nov. 01, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (ABMD

VENCLYXTO® (venetoclax) Plus Rituximab

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 AbbVie Receives European Commission Approval of VENCLYXTO® (venetoclax) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy

Thu November 1, 2018 12:02 AM|PR Newswire|About: ABBV 

FARXIGA

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 The Landmark DECLARE-TIMI 58 Cardiovascular Outcomes Trial of FARXIGA in Patients with Type 2 Diabetes to Be Featured at AHA 2018

Thu November 1, 2018 7:00 AM|Business Wire|About: AZN 

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

umbralisib + ublituximab + Keytruda (pembrolizumab)

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 TG Therapeutics up 7% on positive umbralisib + ublituximab data

Nov. 1, 2018 11:04 AM ET|By: , SA News Editor  

 The overall response rate (ORR) was 89% (n=8/9) in BTK-refractory chronic lymphocytic leukemia (CLL) patients receiving the combination of umbralisib + ublituximab + Merck's (MRK +0.1%) Keytruda (pembrolizumab).