seeking biotech alpha Sept 2019 & December 2018 insight

Nplate® (Romiplostim)

image37

 FDA Approves Nplate® (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia

Fri December 14, 2018 4:00 PM|PR Newswire|About: AMGN 

HERZUMA® (trastuzumab-pkrb), a Biosimilar to HERCEPTIN®

image39

 Celltrion and Teva Announce FDA Approval of HERZUMA® (trastuzumab-pkrb), a Biosimilar to HERCEPTIN®, for the Treatment of HER2-Overexpressing Breast Cancer for Certain Indications

Fri December 14, 2018 6:31 PM|Business Wire|About: TEVA 

INGREZZA® (valbenazine)

image41

  

Neurocrine Biosciences to Present Data on INGREZZA® (valbenazine) for Tardive Dyskinesia; Opicapone and VY-AADC for Parkinson's Disease, at the 2019 International Congress of Parkinson's Disease and Movement Disorders®

Tue September 17, 2019 4:11 PM|PR Newswire|About: NBIX

- Data Examine Effect of Opicapone on COMT Enzyme and Levodopa Concentration in Patients with Parkinson's Disease

- Phase 1b Data Analyze Parkinson's Disease Progression in Patients Treated with Gene Therapy, VY-AADC

PR Newswire

SAN DIEGO, Sept.17, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NBIX)


 https://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-data-on-ingrezza-valbenazine-for-tardive-dyskinesia-opicapone-and-vy-aadc-for-parkinsons-disease-at-the-2019-international-congress-of-parkinsons-disease-and-movement-disorders-300920167.html 

Enfortumab Vedotin Plus Pembrolizumab

image42

 

Seattle Genetics Announces Presentations of New Clinical Data from Multiple Studies of Novel Targeted Therapies at the European Society for Medical Oncology (ESMO) 2019 Congress

Tue September 17, 2019 8:00 AM|Business Wire|About: SGEN

– First Presentation of Initial Data from a Phase 1 Trial of Enfortumab Vedotin Plus Pembrolizumab in Locally Advanced or Metastatic Urothelial Cancer Featured in an Oral Session –

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (SGEN)


 https://www.seattlegenetics.com/pipeline/enfortumab-vedotin 

seeking biotech alpha Sept 2019 & December 2018 insight

Amgen (AMGN)

image44

 Amgen Announces 10 Percent Increase In 2019 First Quarter Dividend

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

V920 is Merck's Investigational Vaccine for Ebola Zaire

 

FDA Accepts Merck’s Biologics License Application (BLA) and Grants Priority Review for V920, the Company’s Investigational Vaccine for Ebola Zaire Virus

Tue September 17, 2019 6:45 AM|Business Wire|About: MRK

Merck (MRK) Continues to Expand Investigational Supply to Support International Ebola Outbreak Response

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck, known as MSD outside the United States and Canada 


Opdivo in combination with Vedanta Biosciences’ VE800

image45

 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 

anti-PD-1 antibody tislelizumab

image47

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 

seeking biotech alpha Sept 2019 & Dec 2018 insight

Lenti-D™ Gene Therapy

image48

 

bluebird bio Presents Updated Data from Phase 2/3 Clinical Study of Lenti-D™ Gene Therapy for Cerebral Adrenoleukodystrophy (CALD) at the 13th European Pediatric Neurology Society (EPNS) Congress

Wed September 18, 2019 9:25 AM|Business Wire|About: BLUE

Long-Term Follow-up Data Show That the 88% of Patients Treated in the Starbeam Study (ALD-102) Were Free of Major Functional Disabilities (MFDs) at Two Years, and Continued to Remain MFD-Free at up to Five Years of Follow-up

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- bluebird bio, Inc. (Nasdaq: BLUE)


 https://www.businesswire.com/news/home/20190918005480/en/ 

Rubraca®▼ (rucaparib)

image49

 

Clovis Oncology to Highlight Expanded Data from Rubraca® (rucaparib) TRITON and ARIEL Clinical Programs in Prostate and Ovarian Cancers at the ESMO Congress 2019

  • Updated data from the Phase 2 TRITON2 trial of Rubraca in patients with advanced metastatic castration-resistant prostate cancer (mCRPC)
  • Exploratory ARIEL3 analysis for Rubraca maintenance treatment regimen in ovarian cancer based on response to prior platinum-based chemotherapy
  • Integrated safety analysis of Rubraca in ovarian cancer treatment and maintenance treatment settings

September 12, 2019 04:00 AM Eastern Daylight Time

BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ: CLVS) 


 https://seekingalpha.com/pr/17629630-clovis-oncology-highlight-expanded-data-rubraca-rucaparib-triton-ariel-clinical-programs 

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

image51

 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 

Tislelizumab (BGB-A317)

image52

 BeiGene Announces Updated Phase 1A/1B Data on Tislelizumab Presented at the European Society for Medical Oncology Immuno-Oncology Congress

Sat December 15, 2018 2:30 

 CAMBRIDGE, Mass. and BEIJING, China, Dec. 15, 2018 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) AM|GlobeNewswire|About: BGNE 

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

image53

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 

seeking biotech alpha January 2019 insight

Eli Lilly and Company (LLY) & Loxo Oncology, Inc. (LOXO)

image54

 Lilly Announces Agreement To Acquire Loxo Oncology

Mon January 7, 2019 6:30 AM|PR Newswire|About: LLY, LOXO

INDIANAPOLIS and STAMFORD, Conn., Jan. 7, 2019 /PRNewswire/ -

Abiomed, Inc. (ABMD)

image55

 Abiomed Announces Preliminary Q3 FY 2019 Revenue of $201 Million, Up 30% Over Prior Year and Increases Full Year Guidance

Mon January 7, 2019 7:00 AM|Business Wire|About: ABMD

DANVERS, Mass. & SAN FRANCISCO--(BUSINESS WIRE)-- Abiomed, Inc. (ABMD) (NASDAQ: ABMD)

Bimatoprost SR

image57

Allergan Announces Positive 3-Month Topline Results from Second Phase 3 Study of Bimatoprost SR (Sustained-Release) Implant for Lowering Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

Mon January 7, 2019 7:45 AM|PR Newswire|About: AGN 

Allergan (AGN)

image58

 01.07.2019 | Investors

Allergan to Establish R&D Presence in Cambridge, Massachusetts

- The facility, located in Kendall Square, is expected to open in 1Q2019 -

DUBLIN, Jan. 7, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN),

seeking biotech alpha January 2019 insight

oral JAK3 inhibitor, PF-06651600

image60

Pfizer Initiates Phase 2b/3 Clinical Trial for PF-06651600, an Oral JAK3 Inhibitor, for the Treatment of Patients with Moderate to Severe Alopecia Areata

Thu January 3, 2019 8:30 AM|Business Wire|About: PFE

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE)

VYZULTA™ (latanoprostene Bunod Ophthalmic Solution, 0.024%)

image61

 Bausch + Lomb Announces HEALTH CANADA Approval Of VYZULTA™ (latanoprostene Bunod Ophthalmic Solution, 0.024%) for the Treatment of Glaucoma

Thu January 3, 2019 7:30 AM|Canada Newswire|About: BHC

LAVAL, QC, Jan. 3, 2019 /CNW Telbec/ - Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health (BHC) (TSX : BHC) 

IQcast(TM)

image62

New Prediction Feature for Hypoglycemia Now Available in Sugar.IQ(TM) Personal Diabetes Assistant App, Developed by Medtronic and IBM Watson Health

Thu January 3, 2019 9:00 AM|InPublic US|About: MDT 

Rapastinel

image63

New Data Published in the International Journal of Neuropsychopharmacology Support that Rapastinel May Produce Rapid and Sustained Antidepressant Effects Through a Potentially Novel Mechanism of Action

Thu January 3, 2019 7:45 AM|PR Newswire|About: AGNPR Newswire

DUBLIN, Jan. 3, 2019 /PRNewswire/ -- Allergan plc  (AGN)

TYSABRI®, natalizumab 300 mg

image64

First Patient Enrolled in Biogen’s Phase 3b Study to Evaluate Extended Interval Dosing (EID) with Natalizumab in Multiple Sclerosis

Thu January 3, 2019 7:30 AM|GlobeNewswire|About: BIIB 

seeking biotech alpha January 2019 insight

novel frozen formulation of Bria-IMT™

image67

 BriaCell Announces Switch to Novel Frozen Formulation for Lead Cancer Drug Candidate, Upcoming Attendance at Biotech Showcase™ 2019 and Presentation at Keystone Symposia Conference

January 02, 2019 | About: BCTXF +0% MRK +0% 

 Marketwired 

 BERKELEY, Calif., and VANCOUVER, British Columbia, Jan. 02, 2019 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (TSX-V:BCT) (BCTXF) ("BriaCell" or the "Company")  

Cinacalcet is a calcium-sensing receptor agonist

image68

 Teva and Amgen Resolve Ongoing Dispute Over Teva’s Generic Cinacalet HCl Product

Wed January 2, 2019 8:28 PM|Business Wire|About: TEVA

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (TEVJF), (NYSE and TASE: TEVA)

Bristol-Myers Squibb to Acquire Celgene

image70

Bristol-Myers Squibb to Acquire Celgene to Create a Premier Innovative Biopharma Company

  • Highly Complementary Portfolios with Leading Franchises in Oncology, Immunology and Inflammation and Cardiovascular Disease
  • Significantly Expands Phase III Assets with Six Expected Near-Term Product Launches, Representing Greater Than $15 Billion in Revenue Potential
  • Registrational Trial Opportunities and Early-Stage Pipeline Position Combined Company for Sustained Leadership Underpinned by Cutting-Edge Technologies and Discovery Platforms
  • Strong Combined Cash Flows, Enhanced Margins and EPS Accretion of Greater Than 40% in First Full Year
  • Approximately $2.5 Billion of Expected Run-Rate Cost Synergies to Be Achieved by 2022

 THURSDAY, JANUARY 3, 2019 6:58 AM EST

NEW YORK & SUMMIT, N.J.,--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (NASDAQ:CELG) 

NGM313, an investigational monoclonal antibody agonist of the β-Klotho/FGFR1c receptor complex

image71

Merck Exercises Option for NGM Bio’s Investigational Insulin Sensitizer, NGM313, for the Treatment of NASH and Type 2 Diabetes

Thu January 3, 2019 6:30 AM|Business Wire|About: MRK

KENILWORTH, N.J. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Merck (MRK)

seeking biotech alpha Sept 2019 & December 2018 insight

SPINRAZA™ (nusinersen)

image72

 Biogen Applauds Quebec Decision to Cover SPINRAZA™ (nusinersen) for a broad population of SMA Patients

Thu December 20, 2018 12:19 PM|GlobeNewswire|About: BIIB 

PRGN-3006 UltraCAR-T is an autologous chimeric antigen receptor T-cell (CAR-T) therapy

image74

Precigen Announces Clearance of IND to Initiate Phase 1/1b Study for First-in-Class PRGN-3006 UltraCAR-T™ Therapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) and Higher Risk Myelodysplastic Syndrome (MDS)

Fri December 21, 2018 12:35 PM|PR Newswire|About: XON 

pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor,

image75

 

Incyte Announces Positive Updated Results from Phase 2 Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma

Fri September 27, 2019 8:00 AM|Business Wire|About: INCY

  • Data presented at ESMO support the planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pemigatinib before the end of 2019
  • Investor conference call and webcast scheduled for today, September 27, at 5:00 p.m. CEST (11:00 a.m. EDT)

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (INCY)

seeking biotech alpha December 2018 insight

Upadacitinib (ABT-494)

image78

 AbbVie Submits New Drug Application to U.S. FDA and Marketing Authorization Application to EMA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis

Thu December 20, 2018 8:50 AM|PR Newswire|About: ABBV 

XTANDI® (enzalutamide)

image79

 Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer

Thu December 20, 2018 9:00 AM|Business Wire|About: ALPMY, PFE 

Gilead Sciences, Inc. (GILD) and Agenus Inc. (NASDAQ: AGEN)

 

December 20, 2018

Gilead and Agenus Enter Into Collaboration to Develop Immuno-Oncology Therapies

 FOSTER CITY, Calif. & LEXINGTON, Mass.--(BUSINESS WIRE)--Dec. 20, 2018-- Gilead Sciences, Inc. (NASDAQ: GILD) and Agenus Inc.(NASDAQ: AGEN)  

Gilead Sciences, Inc. (GILD) and Scholar Rock Holding Corporation (NASDAQ: SRRK)

image81

 Gilead Sciences and Scholar Rock Announce Strategic Collaboration to Develop Novel Therapies for Fibrotic Diseases

Wed December 19, 2018 8:01 AM|Business Wire|About: GILD, SRRK 

KEYTRUDA® (pembrolizumab)

image82

 Merck Provides Update on KEYTRUDA® (pembrolizumab) Supplemental Biologics License Application (sBLA) for KEYNOTE-042 Trial

Thu December 20, 2018 4:15 PM|Business Wire|About: MRK 

seeking biotech alpha December 2018 insight

KEYTRUDA® (pembrolizumab)

 FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Adult and Pediatric Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma, a Rare Form of Skin Cancer

Wed December 19, 2018 4:13 PM|Business Wire|About: MRK 

Merck KGaA, Darmstadt, Germany, will assign its exclusive CAR-T development rights to Intrexon

image84

 Intrexon and Merck KGaA, Darmstadt, Germany, Announce Agreement Realizing Precigen's Vision for Full Developmental Autonomy of its CAR-T Program

Thu December 20, 2018 7:30 AM|PR Newswire|About: XON 

KEYTRUDA® (pembrolizumab)

image85

KEYTRUDA is a prescription medicine used to treat:

  • a kind of skin cancer called melanoma. It may be used when your melanoma has spread or cannot be removed by surgery (advanced melanoma).
  • a kind of lung cancer called non–small cell lung cancer (NSCLC).
    • It may be used with the chemotherapy medicines pemetrexed and a platinum as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called “nonsquamousand your tumor does not have an abnormal “EGFR” or “ALK” gene.
    • It may be used with the chemotherapy medicines carboplatin and either paclitaxel or nab-paclitaxel as your first treatment when your lung cancer has spread (advanced NSCLC) and is a type called “squamous”.
    • It may be used alone as your first treatment when your lung cancer has spread (advanced NSCLC) and tests positive for “PD‑L1and your tumor does not have an abnormal “EGFR” or “ALK” gene.
    • It may also be used alone for advanced NSCLC if you have tried chemotherapy that contains platinum and it did not work or is no longer working and your lung cancer tests positive for “PD‑L1” and, if your tumor has an abnormal “EGFR” or “ALK” gene, you have also received an “EGFR” or “ALK” inhibitor medicine that did not work or is no longer working.
  • a kind of cancer called head and neck squamous cell cancer (HNSCC). It may be used when your HNSCC has returned or spread and you have received chemotherapy that contains platinum and it did not work or is no longer working.
  • a kind of cancer called classical Hodgkin lymphoma (cHL). It may be used for cHL in adults and children when you have tried a treatment and it did not work or when your cHL has returned after you received 3 or more types of treatment.
  • a kind of cancer called primary mediastinal B-cell lymphoma (PMBCL). It may be used for PMBCL in adults and children when you have tried a treatment and it did not work oryour PMBCL has returned after you received 2 or more types of treatment.
  • a kind of bladder and urinary tract cancer called urothelial carcinoma. It may be used when your bladder or urinary tract cancer has spread or cannot be removed by surgery (advanced urothelial cancer) and you are not able to receive chemotherapy that contains a medicine called cisplatin, and your tumor tests positive for PD‑L1, or you are not able to receive a medicine called cisplatin or carboplatin, or you have received chemotherapy that contains platinum, and it did not work or is no longer working.
  • a kind of cancer that is shown by a laboratory test to be a microsatellite instability-high (MSI‑H) or a mismatch repair deficient (dMMR) solid tumor. It may be used in adults and children to treat:
    • cancer that has spread or cannot be removed by surgery (advanced cancer), and
    • has progressed following treatment, and you have no satisfactory treatment options, or
    • you have colon or rectal cancer, and you have received chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan but it did not work or is no longer working.
  • It is not known if KEYTRUDA is safe and effective in children with MSI-H cancers of the brain or spinal cord (central nervous system cancers).
  • a kind of stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that tests positive for “PD‑L1.” It may be used when your stomach cancer:
    • has returned or spread (advanced gastric cancer), and
    • you have received 2 or more types of chemotherapy including fluoropyrimidine and chemotherapy that contains platinum, and it did not work or is no longer working, and
    • if your tumor has an abnormal “HER2/neu” gene, you also received a HER2/neu‑targeted medicine and it did not work or is no longer working.
  • a kind of cancer called cervical cancer that tests positive for “PD-L1.” It may be used when your cervical cancer has returned, or has spread or cannot be removed by surgery (advanced cervical cancer), and you have received chemotherapy, and it did not work or is no longer working.
  • a kind of liver cancer called hepatocellular carcinoma. It may be used after you have received the medicine sorafenib.

PD‑L1 = programmed death ligand 1;
EGFR = epidermal growth factor receptor;
ALK = anaplastic lymphoma kinase;
HER2/neu = human epidermal growth factor receptor 2.


LYNPARZA® (olaparib)

 LYNPARZA is a prescription medicine used to treat adults who have:

  • advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
  • ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
  • advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

Nplate® (romiplostim)

image86

 Amgen Submits Supplemental Biologics License Application For Nplate® (romiplostim)

Wed December 19, 2018 4:00 PM|PR Newswire|About: AMGN 

seeking biotech alpha December 2018 insight

Eli Lilly and Company (LLY)

Lilly Announces Financial Guidance, Reviews Commercial Performance, and Highlights Promising Pipeline Opportunities at Investment Community Meeting

12/19/2018 

 INDIANAPOLIS, Dec. 19, 2018 /PRNewswire/ -

2019 revenue is expected to be between $25.3 billion and $25.8 billion

Eli Lilly and Company (NYSE: LLY) and Aduro Biotech, Inc. (NASDAQ: ADRO)

image87

Lilly and Aduro Biotech Announce Research Collaboration and License Agreement to Develop Novel Immunotherapies

12/18/2018 

 INDIANAPOLIS and BERKLEY, Calif., Dec. 18, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Aduro Biotech, Inc. (NASDAQ: ADRO)  


Eli Lilly and Company (LLY)

image88

 Lilly Announces 15 Percent Dividend Increase

Wed December 19, 2018 6:25 AM|PR Newswire|About: LLY 

image89

 STING is known to be a central mediator of innate immunity. When stimulated, STING induces the expression of type I interferon, cytokines and T cell recruitment factors that result in the activation of macrophages and dendritic cells, innate effector cells such as natural killer (NK) cells, and priming of tumor-specific T cells. 

STING Pathway Activator technology

image90

 Aduro’s STING Pathway Activator platform is based on the activation of the cytoplasmic STING (Stimulator of Interferon Genes) receptor to lead to a tumor-specific immune response. 

image91

 

Natural STING Pathway Activators are small molecules expressed by bacteria and immune cells. Aduro has established pioneering expertise in STING Pathway Activator technology and, working in collaboration with academic leaders in the field, has developed synthetic STING Pathway Activators with significantly higher activity than the natural STING ligands produced by bacteria and mammalian cells. These synthetic STING Pathway Activators are being developed for direct injection into tumors to stimulate an immune response against antigens present in the tumor. The process is expected to use the tumor itself as a “vaccine,” enabling the induction of a tumor-specific immune response that is unique to the treated individual; an off-the-shelf small molecule approach to personalized immunotherapy.


seeking biotech alpha December 2018 insight

www.factsabouttalc.com.

image92

 

NEW BRUNSWICK, N.J., Dec. 14, 2018 /PRNewswire/ -- Johnson & Johnson (JNJ) today issued the following statement regarding speculation about the safety of our products.

The Reuters article is one-sided, false, and inflammatory. Johnson & Johnson's baby powder is safe and asbestos-free. Studies of more than 100,000 men and women show that talc does not cause cancer or asbestos-related disease. Thousands of independent tests by regulators and the world's leading labs prove our baby powder has never contained asbestos. Johnson & Johnson will continue to defend the safety of our product. For the truth and facts about talc, please go to www.factsabouttalc.com.

ABP 710, a biosimilar candidate to REMICADE® (infliximab).

image93

 Amgen Submits Biologics License Application for ABP 710 (Biosimilar Infliximab) To US Food And Drug Administration

Mon December 17, 2018 9:00 AM|PR Newswire|About: AMGN 

Incyte (NASDAQ:INCY) and Innovent Biologics, Inc. (Innovent) (HKEX: 01801)

image94

 Innovent and Incyte Announce Strategic Collaboration and Licensing Agreement for Three Clinical-stage Product Candidates in China

Sun December 16, 2018 5:40 PM|Business Wire|About: INCY 

tislelizumab

image95

 BeiGene's tislelizumab shows positive action in early-stage cancer study

Dec. 17, 2018 12:09 PM ET|About: BeiGene (BGNE)|By: , SA News Editor  

seeking biotech alpha December 2018 insight

InterStim(TM) smart programmer

image100

FDA Approves Smart Programmer for the InterStim System

(GLOBE NEWSWIRE via COMTEX) --Intuitive and Discreet Device Provides Sacral Neuromodulation Therapy for Overactive Bladder and Bowel Incontinence

DUBLIN - December 17, 2018 - Medtronic plc (NYSE:MDT) 

Johnson & Johnson (JNJ)

image101

 Johnson & Johnson Announces $5 Billion Share Repurchase Program

Mon December 17, 2018 4:22 PM|PR Newswire|About: JNJ

NEW BRUNSWICK, N.J., Dec. 17, 2018 /PRNewswire/ -- Johnson & Johnson (JNJ)

Bristol-Myers Squibb Company (BMY), and Boston Medical Center

image102

 Bristol-Myers Squibb and Boston Medical Center Announce Research Collaboration to Investigate Markers of Immuno-Oncology Response and Resistance

Mon December 17, 2018 4:30 PM|Business Wire|About: BMY 

 NEW YORK & BOSTON--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE:BMY), and Boston Medical Center,  

China is the first country to approve roxadustat

image103

 FibroGen's roxadustat OK'd in China for CKD patients on dialysis

Dec. 18, 2018 7:01 AM ET|By: , SA News Editor  

seeking biotech alpha December 2018 insight

First Approval for KEYTRUDA in an Adjuvant Setting in the European Union

image104

 European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Adults with Resected Stage III Melanoma

Mon December 17, 2018 6:30

 AM|Business Wire|About: MRK 

 KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (MRK), known as MSD outside the United States and Canada 

Pyramid Biosciences, Inc. & AZN

image105

Pyramid Biosciences Announces Exclusive Global License of AstraZeneca TRK Program for Dermatology and Inflammatory Diseases

Mon December 17, 2018 7:00 AM|PR Newswire|About: AZN 

 Pyramid Biosciences, Inc. (www.pyramidbio.com


Taltz® (ixekizumab)

image107

 Lilly Announces Positive Top-Line Results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a Head-to-Head (SPIRIT-H2H) Superiority Study in Patients with Active Psoriatic Arthritis

Mon December 17, 2018 6:45 AM|PR Newswire|About: LLY 

Diroximel Fumarate

image108

Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis

Mon December 17, 2018 7:30 AM|PR Newswire|About: ALKS, BIIB 

Sprycel (dasatinib)

image109

Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Sprycel (dasatinib) for Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Mon December 17, 2018 6:59 AM|Business Wire|About: BMY 

seeking biotech alpha December 2018 insight

Baricitinib

image110

 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 

Amgen & Magellan Rx

image112

 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 

Boehringer Ingelheim and Lilly Partner with Duke Clinical Research Institute

image113

 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 

ORKAMBI® (lumacaftor/ivacaftor)

image114

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 

TREMFYA® (guselkumab)

image115

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 

seeking biotech alpha December 2018 insight

Medtronic plc (MDT)

image120

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

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

Entera Bio and Amgen

image121

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) 

seeking biotech alpha December 2018 insight

BIIB067 (IONIS-SOD1RX),

image122

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 

Bria-IMT™, with pembrolizumab [KEYTRUDA®

image123

 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 

Illumina, Inc. (ILMN)

image124

 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 

PI3K inhibitor BYL719 (alpelisib)

image125

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

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

Bausch Health Companies Inc. (BHC)

image126

 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 

Bristol-Myers Squibb Company (BMY)

image127

 Bristol-Myers Squibb Announces Dividend Increase

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

seeking biotech alpha December 2018 insight

Stryker Corporation (SYK)

image128

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

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

IMBRUVICA® (ibrutinib) plus rituximab

image129

 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 

Kadcyla® (ado-trastuzumab emtansine)

image131

 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 

Tecentriq® (atezolizumab)

image132

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 

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 

seeking biotech alpha December 2018 insight

CAR-T therapy JCARH125

image133

 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 

FDA Grants Fast Track Designation for AMG 420

image134

 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)

seeking biotech alpha December 2018 insight

IMBRUVICA® (ibrutinib) plus obinutuzumab (Gazyva®)

image139

 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 

Ruxolitinib (Jakafi®)

image140

 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 

tislelizumab

image141

 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 

Hemlibra® (emicizumab-kxwh)

image142

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 

NCCN Oncology Research

image143

 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 

seeking biotech alpha December 2018 insight

REGN1979

image145

 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/

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

image146

 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 

REFLECTIONS B328-06,

image148

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  

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

image149

 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 

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

image150

 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