seeking biotech alpha February 2019 insight

Sprycel (dasatinib) in Combination with Chemotherapy

image110

European Commission Approves Bristol-Myers Squibb’s Sprycel (dasatinib) in Combination with Chemotherapy for Treatment of Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Mon February 11, 2019 6:59 AM|Business Wire|About: BMY 

European Commission Approves Bristol-Myers Squibb’s Sprycel (dasatinib) in Combination with Chemotherapy for Treatment of Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia February 11, 2019 06:59 AM Eastern Standard Time PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY)

PRALUENT® (ALIROCUMAB)

image112

 February 11, 2019 at 6:59 AM EST 

REGENERON AND SANOFI OFFER PRALUENT® (ALIROCUMAB) AT A NEW REDUCED U.S. LIST PRICE

TARRYTOWN, N.Y. and BRIDGEWATER, N.J., Feb. 11, 2019 /PRNewswire/ --

This is the latest step by the companies to help make Praluent more accessible and affordable for appropriate patients

Beginning in early March 2019, new U.S. National Drug Code (NDC) options will be available at approximately 60% less than the original price

PRALUENT is an injectable prescription medicine called a PCSK9 inhibitor. PRALUENT is used along with diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) or atherosclerotic heart problems, who need additional lowering of LDL cholesterol.

ADU-S100 (MIW815), a stimulator of interferon genes (STING) pathway activator + YERVOY® (ipilimumab)

image114

 Aduro Announces First Patient Dosed in Phase 1 Study of ADU-S100 (MIW815) in Combination with YERVOY (ipilimumab) for the Treatment of Relapsed and Refractory Melanoma

Mon February 11, 2019 8:00 AM|GlobeNewswire|About: ADRO 

Partnerships and Collaborations

seeking biotech alpha February 2019 insight

Regeneron Pharmaceutical (REGN)

image117

 February 6, 2019 at 6:30 AM EST 

REGENERON REPORTS FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL AND OPERATING RESULTS

TARRYTOWN, N.Y., Feb. 6, 2019 /PRNewswire/ --

  • Fourth quarter 2018 revenues were $1.93 billion, an increase of 22%

Regeneron Pharmaceuticals beats by $1.23, beats on revenue Feb. 6, 2019 6:32 AM ET|About: Regeneron Pharmaceutical... (REGN)|By: Gaurav Batavia, SA News Editor Regeneron Pharmaceuticals (NASDAQ:REGN): Q4 Non-GAAP EPS of $6.84 beats by $1.23; GAAP EPS of $7.15 beats by $1.73. Revenue of $1.93B (+22.2% Y/Y) beats by $210M.

ADCETRIS® (Brentuximab Vedotin)

image118

Seattle Genetics Achieves $30 Million Milestone Payment for European Commission Approval of ADCETRIS® (Brentuximab Vedotin) in Frontline Hodgkin Lymphoma

Mon February 11, 2019 8:00 AM|Business Wire|About: SGEN 

Seattle Genetics Achieves $30 Million Milestone Payment for European Commission Approval of ADCETRIS® (Brentuximab Vedotin) in Frontline Hodgkin Lymphoma February 11, 2019 08:00 AM Eastern Standard Time BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited

PRGN-3005 UltraCAR-T™ to Treat Advanced Stage Platinum Resistant Ovarian Cancer Patients

image119

 Precigen Announces Clearance of IND to Initiate Phase 1 Study for First-in-Class PRGN-3005 UltraCAR-T™ to Treat Advanced Stage Platinum Resistant Ovarian Cancer Patients

Mon February 11, 2019 7:30 AM|PR Newswire|About: XON 

Precigen Announces Clearance of IND to Initiate Phase 1 Study for First-in-Class PRGN-3005 UltraCAR-T™ to Treat Advanced Stage Platinum Resistant Ovarian Cancer Patients - First UltraCAR-T targeting solid tumors to enter the clinic - First-in-class therapy using autologous CAR-T cells targeting advanced ovarian cancer GERMANTOWN, Md., Feb. 11, 2019 /PRNewswire/ -- Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON)

seeking biotech alpha February 2019 insight

Fasenra (benralizumab)

image121

 US FDA grants Fasenra Orphan Drug Designation for hypereosinophilic syndrome   PUBLISHED6 February 2019 


 AstraZeneca Group plc (AZN) 

FASENRA IS DESIGNED TO WORK WITH THE BODY TO HELP REMOVE EOSINOPHILS, A KEY CAUSE OF SEVERE ASTHMA. THE MECHANISM OF ACTION OF FASENRA IN ASTHMA IS NOT FULLY UNDERSTOOD

Ruxolitinib (Jakafi®)

image126

 Incyte Announces U.S. FDA Has Extended the Review Period for Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease

Thu February 7, 2019 7:00 AM|Business Wire|About: INCY 

Incyte Announces U.S. FDA Has Extended the Review Period for Ruxolitinib (Jakafi®) in Acute Graft-Versus-Host Disease February 07, 2019 07:00 AM Eastern Standard Time WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY

seeking biotech alpha February 2019 insight

baricitinib

image127

 Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis

Mon February 4, 2019 6:45 AM|PR Newswire|About: INCY, LLY 

Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis INDIANAPOLIS, Feb. 4, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY)

Praluent® (alirocumab) Injection

image130

 CHMP Recommends Approval of Praluent® (alirocumab) Injection to Reduce Cardiovascular Risk in People with Established Atherosclerotic Cardiovascular Disease

Mon February 4, 2019 12:59 AM|PR Newswire|About: REGN 

https://www.praluent.com/

CHMP Recommends Approval of Praluent® (alirocumab) Injection to Reduce Cardiovascular Risk in People with Established Atherosclerotic Cardiovascular Disease TARRYTOWN, N.Y. and PARIS, Feb. 4, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi

ENB-003, a first-in class endothelin B receptor ("ETBR") inhibitor & KEYTRUDA® (pembrolizumab)

image131

  • ENB Therapeutics Announces Clinical Trial Collaboration with Merck to Evaluate ENB-003 in combination with KEYTRUDA(R) (pembrolizumab) for Advanced Solid Tumors

Mon February 4, 2019 8:00 AM|Accesswire|About: MRK 

ENB003 Second generation NCE deuterated ETBR antagonist. Pre-clinical POC for reversing anti-PD1 resistance. To be developed for expansion into broad oncology indications.

Alexion Pharmaceuticals, Inc. (ALXN)

image132

 Alexion Pharmaceuticals, Inc. 2018 Q4 - Results - Earnings Call Slides

Feb. 4, 2019 10:05 AM ET | About: Alexion Pharmaceuticals, Inc. (ALXN) 

Alexion Pharmaceuticals (ALXN ) Q4 results: Revenues: $1,128.8M (+24.1%); SOLIRIS: $976.7M (+23.3%); STRENSIQ: $126.1M (+31.9%); KANUMA: $25.7M (+17.4%).

seeking biotech alpha February 2019 insight

Merck & Co Inc. (MRK)

image134

Merck Announces Fourth-Quarter and Full-Year 2018 Financial Results

Fri February 1, 2019 6:45 AM|Business Wire|About: MRK 

 

EPS of $1.04 beats by $0.01

Revenue of $11B (+ 5.5% Y/Y) beats by $50M

Merck & Co Inc. 2018 Q4 - Results - Earnings Call Slides Feb. 1, 2019 10:00 AM ET | About: Merck & Co Inc. (MRK)

Bausch Health Companies Inc. (BHC), https://www.sightmatters.com/

image136

 Bausch + Lomb Launches SightMatters.com To Help People Living With Age-Related Macular Degeneration Take Control Of Their Condition

Mon February 4, 2019 8:00 AM|Canada Newswire|About: BHC 

https://www.sightmatters.com/

Bausch + Lomb Launches SightMatters.com To Help People Living With Age-Related Macular Degeneration Take Control Of Their Condition New Website offers Comprehensive, Educational Resources to Navigate Life with AMD BRIDGEWATER, N.J., Feb. 4, 2019 /PRNewswire/ -- Bausch + Lomb

seeking biotech alpha January 2019 insight

ALIMTA® (pemetrexed for injection) in combination with KEYTRUDA® (pembrolizumab)

image139

FDA Expands Lilly's ALIMTA® (pemetrexed) Label with Combination of KEYTRUDA® (pembrolizumab) and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

Thu January 31, 2019 6:45 AM|PR Newswire|About: LLY 

FDA Expands Lilly's ALIMTA® (pemetrexed) Label with Combination of KEYTRUDA® (pembrolizumab) and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer New approval based on Phase 3 KEYNOTE-189 results INDIANAPOLIS, Jan. 31, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

mRNA-2752, combined with AstraZeneca's (AZN +1.7%) IMFINZI (durvalumab) or tremelimumab

image140

Moderna up 15% on mRNA-2752 data

Jan. 31, 2019 1:06 PM ET|By: , SA News Editor  

Moderna Pipeline

Impella Connect

image141

 Impella Connect Achieves Regulatory Milestone

Cloud-based monitoring platform gains CE Mark, adding to FDA PMA approval

 Impella Connect allows medical professionals to view the Impella console, in real-time, from any Internet-connected computer or mobile device.  

 anuary 31, 2019 08:00 AM Eastern Standard Time

DANVERS, Mass.--(BUSINESS WIRE)--Abiomed (NASDAQ:ABMD)

Impella Connect Achieves Regulatory Milestone Cloud-based monitoring platform gains CE Mark, adding to FDA PMA approval DANVERS, Mass.--(BUSINESS WIRE)--Jan. 31, 2019-- Abiomed (NASDAQ:ABMD)

cobas® HPV on the cobas® 6800/8800 Systems for cervical cancer screening in Canada.

image142

January is cervical cancer awareness month. Roche is committed to cervical cancer prevention and is proud to announce that the new Roche cobas® HPV assay for use on the cobas® 6800/8800 Systems is now Health Canada approved

Thu January 31, 2019 5:18 PM|Canada Newswire|About: CHGCY, RHHBY 

For more information about the Systems, visit http://www.rochecanada.com

Vizimpro® (dacomitinib)

image143

Pfizer Receives Positive CHMP Opinion for Vizimpro® (dacomitinib) for the First-line Treatment of Adult Patients with Locally Advanced Or Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations

Fri February 1, 2019 9:17 AM|Business Wire|About: PFE 

Pfizer Receives Positive CHMP Opinion for Vizimpro® (dacomitinib) for the First-line Treatment of Adult Patients with Locally Advanced Or Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations February 01, 2019 09:17 AM Eastern Standard Time NEW YORK--(BUSINESS WIRE)

seeking biotech alpha January 2019 insight

superDimension(TM)

 Medtronic Announces Positive Results from the Largest ENB Study to Aid in Lung Cancer Diagnosis, Staging, and Treatment Preparation in a Single Minimally Invasive Procedure

Wed January 30, 2019 8:30 AM|InPublic US|About: MDT 

Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study Presented at the 2018 American Thoracic Society International Conference and the IASLC 19th World Conference on Lung Cancer.

V114, the company’s investigational 15-valent pneumococcal conjugate vaccine,

image144

Merck Receives Breakthrough Therapy Designation from FDA for V114, the Company’s Investigational 15-Valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease, in Infants, Children, and Adolescents

Wed January 30, 2019 6:45 AM|Business Wire|About: MRK 

Merck Receives Breakthrough Therapy Designation from FDA for V114, the Company’s Investigational 15-Valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease, in Infants, Children, and Adolescents January 30, 2019 06:45 AM Eastern Standard Time KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK)

Medtronic Valiant(TM) Captivia(TM)

image146

Medtronic Valiant(TM) Captivia(TM) Demonstrates Durability, Safety, and Efficacy at Five Years in Transection Patients

Wed January 30, 2019 10:30 AM|InPublic US|About: MDT 

Select the Valiant™ thoracic stent graft with the Captivia™ delivery system for your TEVAR (thoracic endovascular aortic repair) procedures.

Amgen Inc. (AMGN)

image147

 Amgen Inc. 2018 Q4 - Results - Earnings Call Slides

Jan. 29, 2019 9:10 PM ET | About: Amgen Inc. (AMGN) 

Novartis AG (NVS)

image148

 Novartis expects to launch at least 10 blockbusters by 2020

Jan. 30, 2019 11:33 AM ET|About: Novartis AG (NVS)|By: , SA News Editor 

Q4 and FY 2018 Results Investor Presentation January 30, 2019

seeking biotech alpha January 2019 insight

tanezumab 2.5 mg or 5 mg

image150

 Pfizer and Lilly Announce Top-Line Results From Second Phase 3 Study of Tanezumab in Osteoarthritis Pain

Tue January 29, 2019 6:30 AM|Business Wire|About: LLY, PFE 

Pfizer and Lilly Announce Top-Line Results From Second Phase 3 Study of Tanezumab in Osteoarthritis Pain January 29, 2019 06:30 AM Eastern Standard Time NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY)

Biogen Inc. (BIIB)

image151

 Biogen beats Q4 consensus

Jan. 29, 2019 7:40 AM ET|About: Biogen Inc. (BIIB)|By: , SA News Editor 

Biogen (BIIB) Q4 results: Revenues: $3,526.3M (+6.6%); Product Sales: $2,825.7M (+4.2%); Anti-CD20 Revenues: $534.9M (+28.9%)

Biogen Inc. 2018 Q4 - Results - Earnings Call Slides Jan. 29, 2019 8:11 AM ET | About: Biogen Inc. (BIIB)

Pfizer Inc. (PFE)

PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2018 RESULTS

Tue January 29, 2019 6:45 AM|Business Wire|About: PFE 

EPS of $0.64 beats by $0.01

Revenue of $13.98B (+ 2.0% Y/Y) beats by $80M

Pfizer Inc. 2018 Q4 - Results - Earnings Call Slides Jan. 29, 2019 11:57 AM ET | About: Pfizer Inc. (PFE) Full-Year 2018 Revenues of $53.6 Billion, Reflecting 2% Operational Growth; Fourth-Quarter 2018 Revenues of $14.0 Billion, Reflecting 5% Operational Growth

Amgen Inc. (AMGN)

image153

 Amgen Reports Fourth Quarter And Full Year 2018 Financial Results

Tue January 29, 2019 4:01 PM|PR Newswire|About: AMGN 

 

Amgen (NASDAQ:AMGN): Q4 Non-GAAP EPS of $3.42 beats by $0.15; GAAP EPS of $3.01 beats by $0.14.

Revenue of $6.23B (+7.4% Y/Y) beats by $390M

Amgen Reports Fourth Quarter And Full Year 2018 Financial Results NEWS PROVIDED BY Amgen Jan 29, 2019, 16:01 ET THOUSAND OAKS, Calif., Jan. 29, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN)

seeking biotech alpha January 2019 insight

Intuitive Surgical (NASDAQ:ISRG)

image155

Intuitive Surgical Q4 EPS miss pressures shares, down 2%

Jan. 24, 2019 4:17 PM ET|About: Intuitive Surgical, Inc. (ISRG)|By: , SA News Editor 

Intuitive Surgical Announces Fourth Quarter Earnings January 24, 2019 at 4:05 PM EST

Mazor X Stealth(TM)

 Medtronic Announces U.S. Commercial Launch of Mazor X Stealth(TM) Edition for Robotic-Assisted Spine Surgery

Mon January 28, 2019 7:00 AM|InPublic US|About: MDT 

seeking biotech alpha January 2019 insight

Varian Medical Systems, Inc. (VAR)

Varian Medical Systems, Inc. 2019 Q1 - Results - Earnings Call Slides

Jan. 23, 2019 11:16 PM ET | About: Varian Medical Systems, Inc. (VAR) 

Varian Medical Systems, Inc. (VAR) CEO Dow Wilson on Q1 2019 Results - Earnings Call Transcript Jan. 23, 2019 11:13 PM ET | About: Varian Medical Systems, Inc. (VAR)

two DNA-dependent protein kinase (DNA-PK) inhibitors - M9831 (formerly known as VX-984)

image161

Merck Grants Exclusive License to Vertex for Two DNA Damage Response Inhibitors

Thu January 24, 2019 8:00 AM|Canada Newswire|About: MRK 

Merck KGaA, Darmstadt, Germany, Grants Exclusive License to Vertex for Two DNA Damage Response Inhibitors Merck KGaA, Darmstadt, Germany, today announced that it has entered into an exclusive licensing agreement with Vertex Pharmaceuticals Incorporated, Boston, USA 24 JAN 2019 | DARMSTADT, GERMANY

Gilead Sciences, Inc. (GILD), Agenus (AGEN)

image162

Agenus Closes $150 Million Immuno-Oncology Transaction with Gilead

Thu January 24, 2019 8:30 AM|PR Newswire|About: AGEN, GILD 

Agenus Closes $150 Million Immuno-Oncology Transaction with Gilead LEXINGTON, Mass., Jan. 24, 2019 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN),

seeking biotech alpha January 2019 insight

itacitinib, Incyte’s novel and selective JAK1 inhibitor

image165

Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease

Tue January 22, 2019 7:30 AM|Business Wire|About: INCY 

Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease January 22, 2019 07:30 AM Eastern Standard Time WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY

Johnson & Johnson (JNJ)

image168

Johnson & Johnson 2018 Q4 - Results - Earnings Call Slides

Jan. 22, 2019 2:56 PM ET | About: Johnson & Johnson (JNJ) 

Johnson & Johnson (JNJ) CEO Alex Gorsky on Q4 2018 Results - Earnings Call Transcript Jan. 22, 2019 2:44 PM ET | About: Johnson & Johnson (JNJ)

Xultophy® (insulin degludec + liraglutide injection)

image169

 Xultophy® now available in Canada to support improved glycemic control, an issue facing 50 per cent of Canadians with type 2 diabetes

Wed January 23, 2019 8:00 AM|Canada Newswire|About: NVO 

Novo Nordisk Canada Inc. Xultophy® Product Monograph. June 8, 2018. Accessed Dec 21, 2018.

seeking biotech alpha January 2019 insight

GW Pharmaceuticals (NASDAQ:GWPH)

image172

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

seeking biotech alpha January 2019 insight

Boston Scientific Corporation (BSX)

image178

 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)

image180

 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

image181

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))

image184

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

image185

 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)

image186

 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)

image187

 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)

image189

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)

image197

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®

image202

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)

image206

 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)

image212

 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)

image213

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)

image217

 

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

image218

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)

image219

 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)

image221

 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.

image222

 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),