seeking biotech alpha February 2019 insight

Sprycel (dasatinib) in Combination with Chemotherapy

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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 

PRALUENT® (ALIROCUMAB)

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 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

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

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 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 

seeking biotech alpha February 2019 insight

Regeneron Pharmaceutical (REGN)

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 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%

ADCETRIS® (Brentuximab Vedotin)

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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 

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

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 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 

seeking biotech alpha February 2019 insight

Fasenra (benralizumab)

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


 AstraZeneca Group plc (AZN) 

Ruxolitinib (Jakafi®)

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 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 

seeking biotech alpha February 2019 insight

baricitinib

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 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 

Praluent® (alirocumab) Injection

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 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/

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

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  • 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 

Alexion Pharmaceuticals, Inc. (ALXN)

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

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

seeking biotech alpha February 2019 insight

Merck & Co Inc. (MRK)

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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

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

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 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/

seeking biotech alpha January 2019 insight

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

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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 

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

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Moderna up 15% on mRNA-2752 data

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

Impella Connect

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 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)

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

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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 

Vizimpro® (dacomitinib)

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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 

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 

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

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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 

Medtronic Valiant(TM) Captivia(TM)

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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 

Amgen Inc. (AMGN)

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 Amgen Inc. 2018 Q4 - Results - Earnings Call Slides

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

Novartis AG (NVS)

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 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 

seeking biotech alpha January 2019 insight

tanezumab 2.5 mg or 5 mg

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 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 

Biogen Inc. (BIIB)

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 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%)

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

Amgen Inc. (AMGN)

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 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

seeking biotech alpha January 2019 insight

Intuitive Surgical (NASDAQ:ISRG)

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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 

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) 

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

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

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

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

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Agenus Closes $150 Million Immuno-Oncology Transaction with Gilead

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

seeking biotech alpha January 2019 insight

itacitinib, Incyte’s novel and selective JAK1 inhibitor

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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 

Johnson & Johnson (JNJ)

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Johnson & Johnson 2018 Q4 - Results - Earnings Call Slides

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

Xultophy® (insulin degludec + liraglutide injection)

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 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 

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 

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) 

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  

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 

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 

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) 

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 

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 

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 

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 

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 

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 

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

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 

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)

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 

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)

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

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)