seeking biotech alpha December 2018 insight

Rubraca®▼ (rucaparib)

 CHMP Grants Positive Opinion for New Indication of Clovis Oncology’s Rubraca®▼ (rucaparib) Tablets as Maintenance Treatment for Women with Relapsed Ovarian Cancer

Thu December 13, 2018 12:46 PM|Business Wire|About: CLVS 

CHMP Grants Positive Opinion for New Indication of Clovis Oncology’s Rubraca®▼ (rucaparib) Tablets as Maintenance Treatment for Women with Relapsed Ovarian Cancer December 13, 2018 12:46 PM Eastern Standard Time BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ: CLVS)

BioArctic's alpha-synuclein antibody portfolio for Parkinson's disease

 BioArctic Outlicenses its Alpha-synuclein Antibody Portfolio for Parkinson's Disease to AbbVie After Receiving Clearance

Fri December 14, 2018 2:13 AM|PR Newswire|About: ABBV, B, BIOA 

BioArctic Outlicenses its Alpha-synuclein Antibody Portfolio for Parkinson's Disease to AbbVie After Receiving Clearance

“Alzheimer’s Biomarkers From Multiple Modalities Selectively Discriminate Clinical Status:

 Saliva-Based Test Proposed to Diagnose Alzheimer’s, Mild Cognitive Impairment

  DECEMBER 14, 2018 Jonathan GrinsteinBY JONATHAN GRINSTEIN 

IN NEWS.

20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077

Pfizer Initiates Phase 3 Program for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older

Fri December 14, 2018 8:00 AM|Business Wire|About: PFE 

Pfizer Initiates Phase 3 Program for 20-Valent Pneumococcal Conjugate Vaccine for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older December 14, 2018 08:00 AM Eastern Standard Time NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE)

seeking biotech alpha December 2018 insight

Baricitinib

 FDA Grants Fast Track Designation to the Baricitinib Development Program for the Treatment of Systemic Lupus Erythematosus (SLE)

Thu December 13, 2018 6:45 AM|PR Newswire|About: INCY, LLY 

FDA Grants Fast Track Designation to the Baricitinib Development Program for the Treatment of Systemic Lupus Erythematosus (SLE) INDIANAPOLIS, Dec. 13, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY)

Amgen & Magellan Rx

 Amgen And Magellan Rx Management Collaborate To Improve Patient Care For Chronic, Difficult-To-Treat Conditions

Tue December 11, 2018 4:00 PM|PR Newswire|About: AMGN 

Amgen And Magellan Rx Management Collaborate To Improve Patient Care For Chronic, Difficult-To-Treat Conditions THOUSAND OAKS, Calif., Dec. 11, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN)

Boehringer Ingelheim and Lilly Partner with Duke Clinical Research Institute

 Boehringer Ingelheim and Lilly Partner with Duke Clinical Research Institute to Advance Multidisciplinary Care for People with Type 2 Diabetes and Cardiovascular Disease

Thu December 13, 2018 6:30 AM|PR Newswire|About: LLY 

Boehringer Ingelheim and Lilly Partner with Duke Clinical Research Institute to Advance Multidisciplinary Care for People with Type 2 Diabetes and Cardiovascular Disease RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 13, 2018 /PRNewswire/ -

ORKAMBI® (lumacaftor/ivacaftor)

Health Canada Grants Market Authorization for ORKAMBI® (lumacaftor/ivacaftor) for Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease

Thu December 13, 2018 8:00 AM|Business Wire|About: VRTX 

Health Canada Grants Market Authorization for ORKAMBI® (lumacaftor/ivacaftor) for Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease December 13, 2018 08:00 AM Eastern Standard Time BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX)

TREMFYA® (guselkumab)

New Phase 3 data demonstrate superiority of TREMFYA® (guselkumab) vs Cosentyx® (secukinumab) in delivering PASI 90 responses in the treatment of moderate to severe plaque psoriasis at week 48

Wed December 12, 2018 7:00 AM|PR Newswire|About: JNJ 

TREMFYA® is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light or UV light).

seeking biotech alpha December 2018 insight

Medtronic plc (MDT)

 Medtronic Named One of America's Best Corporate Citizens in 2018 by Forbes Magazine

Mon December 10, 2018 10:30 AM|InPublic|About: MDT 

Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland

Entera Bio and Amgen

Entera Bio and Amgen Enter Strategic Research Collaboration in Inflammatory Disease and Other Serious Illnesses

 JERUSALEM, Dec. 11, 2018 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (Nasdaq: ENTX) 

Entera Bio and Amgen Enter Strategic Research Collaboration in Inflammatory Disease and Other Serious Illnesses December 11, 2018 at 7:00 AM EST

seeking biotech alpha December 2018 insight

Amgen (AMGN)

 Amgen Announces 10 Percent Increase In 2019 First Quarter Dividend

Fri December 7, 2018 4:00 PM|PR Newswire|About: AMGN 

Amgen Announces 10 Percent Increase In 2019 First Quarter Dividend THOUSAND OAKS, Calif., Dec. 7, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN)

Opdivo in combination with Vedanta Biosciences’ VE800

 Bristol-Myers Squibb and Vedanta Biosciences Announce a New Clinical Collaboration to Evaluate OPDIVO (Nivolumab) and VE800 in Patients with Advanced or Metastatic Cancers

Mon December 10, 2018 2:00 AM|Business Wire|About: BMY 

Bristol-Myers Squibb and Vedanta Biosciences Announce a New Clinical Collaboration to Evaluate OPDIVO (Nivolumab) and VE800 in Patients with Advanced or Metastatic Cancers December 10, 2018 02:00 AM Eastern Standard Time NEW YORK & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Vedanta Biosciences

anti-PD-1 antibody tislelizumab

BeiGene to Present Clinical Data on Anti-PD-1 Antibody Tislelizumab at the European Society for Medical Oncology Immuno-Oncology Congress

Mon December 10, 2018 6:05 AM|GlobeNewswire|About: BGNE 

Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors.

seeking biotech alpha December 2018 insight

BIIB067 (IONIS-SOD1RX),

Biogen Exercises Option with Ionis to Develop and Commercialize Investigational Treatment BIIB067 for a Subtype of Familial Amyotrophic Lateral Sclerosis (ALS) Based on Positive Phase 1 Data

Thu December 6, 2018 7:30 AM|GlobeNewswire|About: AKCA, BIIB, IONS 

Ionis is the leading company in RNA-targeted drug discovery and development focused on developing drugs for patients who have the highest unmet medical needs, such as those patients with severe and rare diseases.

Bria-IMT™, with pembrolizumab [KEYTRUDA®

 BriaCell Presents Positive Efficacy Data with Lead Cancer Drug Candidate in Phase IIa Monotherapy and Excellent Initial Safety Data in Combination with KEYTRUDA® at a Major Breast Cancer Conference

Thu December 6, 2018 8:30 AM|GlobeNewswire|About: BCTXF, MRK 

BriaCell Announces Positive Phase IIa Proof of Concept Data in Advanced Breast Cancer; Initiates Combination Study September 26, 2018

Illumina, Inc. (ILMN)

 Illumina Announces a New Genotyping Array and Scientific Contribution to Three Genome Centers to Support the All of Us Research Program

Thu December 6, 2018 4:05 PM|Business Wire|About: ILMN 

Illumina Announces a New Genotyping Array and Scientific Contribution to Three Genome Centers to Support the All of Us Research Program

PI3K inhibitor BYL719 (alpelisib)

Novartis' alpelisib improved PFS in certain breast cancer patients in late-stage study

Dec. 6, 2018 12:07 PM ET|By: , SA News Editor 

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. (SOLAR-1)

Bausch Health Companies Inc. (BHC)

 Bausch + Lomb Receives 510(K) Clearance From FDA For Bausch + Lomb Ultra® Multifocal For Astigmatism Contact Lenses

Wed December 5, 2018 8:00 AM|PR Newswire|About: BHC 

Bausch + Lomb Receives 510(K) Clearance From FDA For Bausch + Lomb Ultra® Multifocal For Astigmatism Contact Lenses

Bristol-Myers Squibb Company (BMY)

 Bristol-Myers Squibb Announces Dividend Increase

Thu December 6, 2018 4:15 PM|Business Wire|About: BMY 

Bristol-Myers Squibb Announces Dividend Increase NEW YORK--(BUSINESS WIRE)--The Board of Directors of Bristol-Myers Squibb Company (NYSE:BMY

seeking biotech alpha December 2018 insight

Stryker Corporation (SYK)

 Stryker increases dividend 11%, declaring a $0.52 per share quarterly dividend

Tue December 4, 2018 3:30 PM|GlobeNewswire|About: SYK 

Stryker increases dividend 11%, declaring a $0.52 per share quarterly dividend << Back Kalamazoo, Michigan, Dec. 04, 2018 (GLOBE NEWSWIRE) -- Kalamazoo, Michigan – December 4, 2018 – Stryker Corporation (NYSE:SYK)

IMBRUVICA® (ibrutinib) plus rituximab

 IMBRUVICA® (ibrutinib) Combination Regimen Significantly Improved Survival Versus the Chemoimmunotherapy FCR (Fludarabine, Cyclophosphamide and Rituximab) in Previously Untreated and Younger Chronic Lymphocytic Leukemia (CLL) Patients; Late-Breaking Phase 3 Data at ASH 2018

Tue December 4, 2018 11:52 AM|PR Newswire|About: ABBV 

IMBRUVICA® (ibrutinib) Combination Regimen Significantly Improved Survival Versus the Chemoimmunotherapy FCR (Fludarabine, Cyclophosphamide and Rituximab) in Previously Untreated and Younger Chronic Lymphocytic Leukemia (CLL) Patients; Late-Breaking Phase 3 Data at ASH 2018 NORTH CHICAGO, Ill., Dec. 4, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV

Kadcyla® (ado-trastuzumab emtansine)

 Genentech’s Kadcyla Cut the Risk of Disease Recurring by Half Compared to Herceptin in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment

Wed December 5, 2018 8:15 AM|Business Wire|About: RHHBY 

Genentech’s Kadcyla Cut the Risk of Disease Recurring by Half Compared to Herceptin in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment

Tecentriq® (atezolizumab)

FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Chemotherapy for the Initial Treatment of Extensive-Stage Small Cell Lung Cancer

Wed December 5, 2018 1:00 AM|Business Wire|About: RHHBY 

FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Chemotherapy for the Initial Treatment of Extensive-Stage Small Cell Lung Cancer

cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®)

Exelixis and Ipsen Initiate Phase 3 Pivotal Trial (COSMIC-312) of Cabozantinib in Combination with Atezolizumab versus Sorafenib in Previously Untreated Advanced Hepatocellular Carcinoma

Wed December 5, 2018 1:30 AM|Business Wire|About: EXEL, IPSEY 

Exelixis and Ipsen Initiate Phase 3 Pivotal Trial (COSMIC-312) of Cabozantinib in Combination with Atezolizumab versus Sorafenib in Previously Untreated Advanced Hepatocellular Carcinoma – Clinical trial will also explore single-agent activity of cabozantinib in the first-line setting

seeking biotech alpha December 2018 insight

CAR-T therapy JCARH125

 Celgene's CAR-T JCARH125 shows positive action in early-stage multiple myeloma study

Dec. 4, 2018 7:35 AM ET|About: Celgene Corporation (CELG)|By: , SA News Editor 

Celgene Corporation Announces Initial Clinical Data from Ongoing Phase 1/2 Evolve Trial with Anti-BCMA CAR T Therapy JCARH125 in Relapsed/Refractory Multiple Myeloma at ASH 2018 December 03, 2018

FDA Grants Fast Track Designation for AMG 420

 Amgen Announces First-In-Human Data Evaluating Investigational Novel BiTE® Immunotherapies AMG 420 And AMG 330 At ASH 2018

Mon December 3, 2018 9:15 PM|PR

Newswire|About: AMGN 

 PR Newswire

THOUSAND OAKS, Calif., Dec. 3, 2018 /PRNewswire/ -- Amgen (AMGN)

Amgen Announces First-In-Human Data Evaluating Investigational Novel BiTE® Immunotherapies AMG 420 And AMG 330 At ASH 2018 Phase 1 Results of Amgen's BiTE® Platform in Heavily Pre-Treated Patients With Multiple Myeloma and Acute Myeloid Leukemia FDA Grants Fast Track Designation for AMG 420 THOUSAND OAKS, Calif., Dec. 3, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN)

seeking biotech alpha December 2018 insight

IMBRUVICA® (ibrutinib) plus obinutuzumab (Gazyva®)

 December 3, 2018

IMBRUVICA® (ibrutinib) Phase 3 Combination Data with Obinutuzumab Finds Significant Improvement in Progression-Free Survival (PFS) Over Standard Chemoimmunotherapy of Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

 NORTH CHICAGO, Ill., Dec. 3, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV 

IMBRUVICA® (ibrutinib) Phase 3 Combination Data with Obinutuzumab Finds Significant Improvement in Progression-Free Survival (PFS) Over Standard Chemoimmunotherapy of Chlorambucil Plus Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Ruxolitinib (Jakafi®)

 Results of REACH1 Study of Ruxolitinib (Jakafi®) for the Treatment of Acute Graft-Versus-Host Disease Demonstrate Rapid and Durable Patient Benefit

Mon December 3, 2018 10:00 AM|Business Wire|About: INCY 

Jakafi is a prescription medicine used to treat people with polycythemia vera who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it. Jakafi is also used to treat certain types of myelofibrosis.

tislelizumab

 BeiGene Presents Clinical Results of Tislelizumab in Relapsed/Refractory Classical Hodgkin’s Lymphoma at the 60th American Society of Hematology Annual Meeting

Mon December 3, 2018 2:15 PM|GlobeNewswire|About: BGNE 

BeiGene Pipeline

Hemlibra® (emicizumab-kxwh)

Genentech’s Hemlibra (emicizumab-kxwh) Provided Sustained Bleed Control in the Largest Pivotal Study to Date of Children With Hemophilia A With Factor VIII Inhibitors

Mon December 3, 2018 1:30 PM|Business Wire|About: CHGCY, RHHBY 

Genentech’s Hemlibra (emicizumab-kxwh) Provided Sustained Bleed Control in the Largest Pivotal Study to Date of Children With Hemophilia A With Factor VIII Inhibitors

NCCN Oncology Research

 NCCN Oncology Research Program Awarded $2 Million from Lilly to Study Mechanisms of Resistance to CDK4 & 6 Inhibitors in Breast Cancer Treatment

Mon December 3, 2018 10:15 AM|PR Newswire|About: LLY 

NCCN Oncology Research Program Awarded $2 Million from Lilly to Study Mechanisms of Resistance to CDK4 & 6 Inhibitors in Breast Cancer Treatment Project to focus on preclinical and clinical research with cyclin dependent kinase (CDK)4 & 6 inhibitors

seeking biotech alpha December 2018 insight

REGN1979

 Regeneron Presents Positive Data at ASH for REGN1979 CD20xCD3 Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Sat December 1, 2018 12:00 PM|PR Newswire|About: REGN

TARRYTOWN, N.Y., Dec. 1, 2018 /PRNewswire/

December 1, 2018 at 12:00 PM EST Back REGENERON PRESENTS POSITIVE DATA AT ASH FOR REGN1979 CD20XCD3 BISPECIFIC ANTIBODY IN RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA TARRYTOWN, N.Y., Dec. 1, 2018 /PRNewswire/ --

venetoclax (VENCLEXTA® or VENCLYXTO®) in combination with rituximab (VenR)

 AbbVie Presents New Data from Phase 3 MURANO Trial of VENCLEXTA®/VENCLYXTO® (venetoclax) in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Who Completed the Fixed Treatment Course

Sat December 1, 2018 5:47 PM|PR Newswire|About: ABBV 

VENCLEXTA is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least 1 prior treatment. in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who: are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy.

REFLECTIONS B328-06,

Pfizer's Rituxan biosimilar successful in late-stage study; shares up 1% premarket

Dec. 3, 2018 7:08 AM ET|About: Pfizer Inc. (PFE)|By: , SA News Editor  

A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

REVLIMID® (lenalidomide) in combination with rituximab (R2)

 Celgene Corporation Announces Results of AUGMENT Evaluating REVLIMID® In Combination with Rituximab (R²) In Patients with Relapsed/Refractory Indolent Lymphoma At ASH 2018

Sun December 2, 2018 7:35 PM|Business Wire|About: CELG 

Celgene Corporation Announces Results of AUGMENT Evaluating REVLIMID® In Combination with Rituximab (R2) In Patients with Relapsed/Refractory Indolent Lymphoma At ASH 2018

ADCETRIS® (Brentuximab Vedotin) and Opdivo® (Nivolumab)

 Seattle Genetics Highlights Multiple Data Sets Evaluating the Combination of ADCETRIS® (Brentuximab Vedotin) and Opdivo® (Nivolumab) at ASH Annual Meeting

Sat December 1, 2018 12:00 PM|Business Wire|About: SGEN 

Seattle Genetics Highlights Multiple Data Sets Evaluating the Combination of ADCETRIS® (Brentuximab Vedotin) and Opdivo® (Nivolumab) at ASH Annual Meeting