seeking biotech alpha January 2019 insight

GW Pharmaceuticals (NASDAQ:GWPH)

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GW Pharma files for mixed shelf offering

Jan. 19, 2019 2:18 PM ET|About: GW Pharmaceuticals plc (GWPH)|By: , SA News Editor 

GW PHARMACEUTICALS PLC As filed with the Securities and Exchange Commission on January 18, 2019
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seeking biotech alpha January 2019 insight

Boston Scientific Corporation (BSX)

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 Boston Scientific (BSX) Investor Presentation - Slideshow

Jan. 18, 2019 12:20 PM ET|1 comment | About: Boston Scientific Corporation (BSX) 

Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

Immunomedics (IMMU)

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 FDA rejection of Immunomedics' TNBC candidate not related to clinical data

Jan. 18, 2019 1:56 PM ET|By: , SA News Editor  

Here's Why Immunomedics Plummeted on Friday The FDA sent the biotech back to the drawing board. Brian Orelli (TMFBiologyFool) Jan 18, 2019 at 1:49PM

seeking biotech alpha January 2019 insight

SynchroMed(TM) II

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Medtronic Enrolls First Patient in Clinical Study to Assess Pain Control and Oral Opioid Elimination with Targeted Drug Delivery

Thu January 17, 2019 9:00 AM|InPublic US|About: MDT 

Medtronic SynchroMed™ II pump and catheter are part of an implantable, programmable drug infusion system that stores and delivers medication into the intrathecal space. Combined with the Control WorkflowSM, we are working to eliminate systemic opioids and provide effective pain relief.1

Guselkumab (Tremfya(R))

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MorphoSys Announces that its Licensee Janssen has Expanded Clinical Development of Guselkumab (Tremfya(R)) into Ulcerative Colitis

Thu January 17, 2019 4:25 PM|Accesswire|About: JNJ, MOR, MPSYF 

MorphoSys Announces that its Licensee Janssen has Expanded Clinical Development of Guselkumab (Tremfya(R)) into Ulcerative Colitis January 17, 2019 / 10:01 pm, CET Planegg/Munich, Germany, January 17, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR)

Sacituzumab Govitecan

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 Immunomedics Receives Complete Response Letter From FDA for Sacituzumab Govitecan Biologics License Application

Thu January 17, 2019 8:12 PM|GlobeNewswire|About: IMMU

MORRIS PLAINS, N.J., Jan. 17, 2019 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU), (NASDAQ: IMMU) 

Immunomedics is deeply committed to becoming the leading antibody drug conjugate (ADC) company worldwide, delivering breakthrough therapies to treat complex cancers and transform patient outcomes.

Zynquista(TM) (sotagliflozin)

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 Sanofi: FDA advisory committee votes on Zynquista(TM) (sotagliflozin) as treatment for adults with type 1 diabetes

Thu January 17, 2019 6:20 PM|GlobeNewswire|About: SNY 

FDA advisory committee votes on Zynquista™ (sotagliflozin) as treatment for adults with type 1 diabetes PARIS and THE WOODLANDS, TX – January 17, 2019

seeking biotech alpha January 2019 insight

OPSUMIT® (Macitentan)

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 Actelion Receives Complete Response Letter from U.S. FDA for OPSUMIT® (Macitentan) Supplemental New Drug Application

Wed January 16, 2019 4:30 PM|PR Newswire|About: JNJ 

Actelion Receives Complete Response Letter from U.S. FDA for OPSUMIT® (Macitentan) Supplemental New Drug Application SOUTH SAN FRANCISCO, Calif., Jan. 16, 2019 /PRNewswire/ -- Actelion Pharmaceuticals Ltd,

Tecentriq Plus Chemotherapy (Abraxane and Carboplatin)

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FDA Accepts Genentech’s Supplemental Biologics License Application for Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

Thu January 17, 2019 1:00 AM|Business Wire|About: RHHBY 

FDA Accepts Genentech’s Supplemental Biologics License Application for Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer January 17, 2019 01:00 AM Eastern Standard Time SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

seeking biotech alpha January 2019 insight

EVINITY (romosozumab)

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FDA advisory committees back Amgen's romosozumab

Jan. 16, 2019 3:50 PM ET|About: Amgen Inc. (AMGN)|By: , SA News Editor 

romosozumab

seeking biotech alpha January 2019 insight

Combination BRAFTOVI®, MEKTOVI® and ERBITUX®

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Array BioPharma Announces 15.3 Months Median Overall Survival from the Safety Lead-in of the Phase 3 BEACON CRC Trial of the Combination BRAFTOVI®, MEKTOVI® and ERBITUX® in BRAF-Mutant Metastatic Colorectal Cancer

Mon January 14, 2019 5:03 PM|PR Newswire|About: ARRY 

Array BioPharma Announces 15.3 Months Median Overall Survival from the Safety Lead-in of the Phase 3 BEACON CRC Trial of the Combination BRAFTOVI®, MEKTOVI® and ERBITUX® in BRAF-Mutant Metastatic Colorectal Cancer - Data will be presented at ASCO 2019 Gastrointestinal Cancers Symposium - - Updated confirmed ORR remains 48% and updated median PFS remains 8.0 months - BOULDER, Colo., Jan. 14, 2019 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY)

seeking biotech alpha January 2019 insight

KEYTRUDA® (pembrolizumab)

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 Merck’s KEYTRUDA® (pembrolizumab) Reduced Risk of Death by 31 Percent Compared to Chemotherapy in Previously Treated Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma Whose Tumors Expressed PD-L1 (CPS ≥10)

Mon January 14, 2019 5:00 PM|Business Wire|About: MRK 

Merck’s KEYTRUDA® (pembrolizumab) Reduced Risk of Death by 31 Percent Compared to Chemotherapy in Previously Treated Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma Whose Tumors Expressed PD-L1 (CPS ≥10) Results from Phase 3 KEYNOTE-181 Trial to be Presented at 2019 Gastrointestinal Cancers Symposium (ASCO GI) January 14, 2019 05:00 PM Eastern Standard Time KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK)

seeking biotech alpha January 2019 insight

Heat Biologics, Inc. (HTBX)

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 Heat Biologics Doses First Patient in New Cohort of its Expanded Phase 2 Trial of HS-110 in Combination with Merck's KEYTRUDA(R) in Non-Small Cell Lung Cancer Trial

Mon January 14, 2019 8:00 AM|Accesswire|About: BMY, HTBX, MRK 

 www.heatbio.com

Combination Therapies Designed to Activate the Body’s Own T-cells to Fight Cancer www.heatbio.com. Heat Biologics, Inc. (HTBX)

Abbott (ABT)

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FDA Approves World's First Device for Treatment of Premature Babies and Newborns with an Opening in Their Hearts (a Common Congenital Defect)

Mon January 14, 2019 9:00 AM|PR Newswire|About: ABT 

FDA Approves World's First Device for Treatment of Premature Babies and Newborns with an Opening in Their Hearts (a Common Congenital Defect) ABBOTT PARK, Ill., Jan. 14, 2019 /PRNewswire/ -- Abbott (NYSE: ABT

seeking biotech alpha January 2019 insight

Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg)

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January 08, 2019

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir)

- Epclusa is the First Approved Treatment for Adults with Chronic Hepatitis C Virus with Decompensated Cirrhosis in Japan -

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 8, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD)

EPCLUSA is a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C (Hep C) genotype 1, 2, 3, 4, 5, or 6 infection with or without cirrhosis (compensated). In those with advanced cirrhosis (decompensated), EPCLUSA is used with ribavirin.

crizanlizumab

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FDA tags Novartis' crizanlizumab a Breakthrough Therapy for sickle cell pain crises

Jan. 8, 2019 6:26 AM ET|About: Novartis AG (NVS)|By: , SA News Editor 

Breakthrough status for Novartis’ crizanlizumab 08-01-2019 The Pharma Letter

MINNEBRO™ (Esaxerenone)

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 Exelixis’ Collaborator Daiichi Sankyo Receives Regulatory Approval For MINNEBRO™ (Esaxerenone) Tablets for the Treatment of Hypertension in Japan

Tue January 8, 2019 6:00 AM|Business Wire|About: EXEL

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

Exelixis’ Collaborator Daiichi Sankyo Receives Regulatory Approval For MINNEBRO™ (Esaxerenone) Tablets for the Treatment of Hypertension in Japan January 08, 2019 06:00 AM Eastern Standard Time ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL)

Boston Scientific Corporation (BSX)

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 Boston Scientific Announces Preliminary Unaudited Sales for the Fourth Quarter and Full Year 2018

Tue January 8, 2019 6:30 AM|PR Newswire|About: BSX

MARLBOROUGH, Mass., Jan. 8, 2019 /PRNewswire/ -- Boston Scientific Corporation (BSX

Boston Scientific Announces Preliminary Unaudited Sales for the Fourth Quarter and Full Year 2018 MARLBOROUGH, Mass., Jan. 8, 2019 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX)

revenues $3.724B (+19%). Da Vinci procedures up 18%, surpassing 1M/year - Shipments up 35% to 926.

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 Intuitive Surgical Announces Preliminary Fourth Quarter and Full Year 2018 Results

Wed January 9, 2019 9:05 AM|GlobeNewswire|About: ISRG

SUNNYVALE, Calif., Jan. 09, 2019 (GLOBE NEWSWIRE) -- Intuitive Surgical, Inc. (ISRG) (“Intuitive”) (Nasdaq: ISRG)

Intuitive Surgical Announces Preliminary Fourth Quarter and Full Year 2018 Results SUNNYVALE, Calif., Jan. 09, 2019 (GLOBE NEWSWIRE) -- Intuitive Surgical, Inc. (“Intuitive”) (Nasdaq: ISRG),