seeking biotech alpha January 2019 insight

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

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 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/ -

Lilly Announces Agreement To Acquire Loxo Oncology Jan 07, 2019, 06:30 ET INDIANAPOLIS and STAMFORD, Conn., Jan. 7, 2019 /PRNewswire/ --

Abiomed, Inc. (ABMD)

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 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)

Abiomed Announces Preliminary Q3 FY 2019 Revenue of $201 Million, Up 30% Over Prior Year and Increases Full Year Guidance January 07, 2019 07:00 AM Eastern Standard Time DANVERS, Mass. & SAN FRANCISCO--(BUSINESS WIRE)--Abiomed, Inc. (NASDAQ: ABMD)

Bimatoprost SR

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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 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 - These initial data show the potential for the vast majority of patients to remain treatment free for at least 1 year - DUBLIN, Jan. 7, 2019 /PRNewswire/ -- Allergan plc, (NYSE: AGN)

Allergan (AGN)

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 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),

Advancing the Pipeline Key programs in development that derive from our Open Science pipeline

seeking biotech alpha January 2019 insight

oral JAK3 inhibitor, PF-06651600

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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)

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 January 03, 2019 08:30 AM Eastern Standard Time NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE)

VYZULTA™ (latanoprostene Bunod Ophthalmic Solution, 0.024%)

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 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) 

VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, is used to lower intraocular (eye) pressure in patients with open-angle glaucoma or ocular hypertension.

IQcast(TM)

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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 

American Diabetes Association Issues Hypoglycemia Position Statement

Rapastinel

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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)

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 Preclinical research demonstrated rapastinel positively modulates the NMDA receptor DUBLIN, Jan. 3, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN)

TYSABRI®, natalizumab 300 mg

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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 

TYSABRI® (natalizumab) is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) to slow the worsening of symptoms common in people with MS and to decrease the number of flare-ups (relapses). TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML)

seeking biotech alpha January 2019 insight

novel frozen formulation of Bria-IMT™

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 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")  

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 2, 2019 BERKELEY, Calif., and VANCOUVER, British Columbia, January 2, 2019 – BriaCell Therapeutics Corp. (TSX-V:BCT) (OTCQB:BCTXF) (“BriaCell” or the “Company”),

Cinacalcet is a calcium-sensing receptor agonist

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 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)

Teva and Amgen Resolve Ongoing Dispute Over Teva’s Generic Cinacalet HCl Product January 02, 2019 08:28 PM Eastern Standard Time PARSIPPANY, N.J.--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA)

Bristol-Myers Squibb to Acquire Celgene

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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) 

Bristol-Myers Squibb to Acquire Celgene to Create a Premier Innovative Biopharma Company January 03, 2019 06:58 AM Eastern Standard Time NEW YORK & SUMMIT, N.J.,--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (NASDAQ:CELG) today announced that they have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion.

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

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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)

Merck Exercises Option for NGM Bio’s Investigational Insulin Sensitizer, NGM313, for the Treatment of NASH and Type 2 Diabetes January 03, 2019 06:30 AM Eastern Standard Time KENILWORTH, N.J. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Merck (NYSE:MRK)

seeking biotech alpha December 2018 insight

SPINRAZA™ (nusinersen)

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 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 

SPINRAZA is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.

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

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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 

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) GERMANTOWN, Md., Dec. 21, 2018 /PRNewswire/ -- Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON)

Ruxolitinib Cream

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 Incyte Announces First Patient Treated in Phase 3 Clinical Trial Program for Ruxolitinib Cream in Atopic Dermatitis

Thu December 20, 2018 4:30 PM|Business Wire|About: INCY 

Incyte Announces First Patient Treated in Phase 3 Clinical Trial Program for Ruxolitinib Cream in Atopic Dermatitis December 20, 2018 04:30 PM Eastern Standard Time WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY)

seeking biotech alpha December 2018 insight

Upadacitinib (ABT-494)

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 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 

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 NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV)

XTANDI® (enzalutamide)

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 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 

Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer TOKYO and NEW YORK, Dec. 20, 2018 /PRNewswire/

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 and Agenus Enter Into Collaboration to Develop Immuno-Oncology Therapies

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

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 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 

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

KEYTRUDA® (pembrolizumab)

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 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 

Merck Provides Update on KEYTRUDA® (pembrolizumab) Supplemental Biologics License Application (sBLA) for KEYNOTE-042 Trial December 20, 2018 04:15 PM Eastern Standard Time KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada

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 

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

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

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 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 

Intrexon and Merck KGaA, Darmstadt, Germany, Announce Agreement Realizing Precigen's Vision for Full Developmental Autonomy of its CAR-T Program - Merck KGaA, Darmstadt, Germany, to assign its Chimeric A GERMANTOWN, Md., Dec. 20, 2018 /PRNewswire/ -- Intrexon Corporation (NASDAQ: XON)

KEYTRUDA® (pembrolizumab)

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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

LYNPARZA® (olaparib) approved by US FDA for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer 19 December 2018 AstraZeneca and Merck’s LYNPARZA reduced the risk of disease progression or death by 70% compared to placebo following response to platinum-based chemotherapy First PARP inhibitor approved in 1st-line maintenance for BRCAm advanced ovarian cancer

Nplate® (romiplostim)

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

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

Nplate® is a prescription medicine used to treat low blood platelet counts (thrombocytopenia) in: adults with chronic immune thrombocytopenia (ITP) when certain medicines or surgery to remove your spleen have not worked well enough.

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

Our growing portfolio of medicines includes treatments in the areas of oncology, cardiovascular, diabetes, critical care, neuroscience, men’s health and musculoskeletal fields.

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

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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)  


Lilly and Aduro Biotech Announce Research Collaboration and License Agreement to Develop Novel Immunotherapies December 18, 2018 4:15 p.m. ET INDIANAPOLIS and BERKLEY, Calif., Dec. 18, 2018 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE: LLY) and Aduro Biotech, Inc. (NASDAQ: ADRO)

Eli Lilly and Company (LLY)

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 Lilly Announces 15 Percent Dividend Increase

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

Lilly Announces 15 Percent Dividend Increase 12/19/2018 INDIANAPOLIS, Dec. 19, 2018 /PRNewswire/
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 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

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 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. 

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

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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.

The Reuters article is wrong in three key areas: The article ignores that thousands of tests by J&J, regulators, leading independent labs, and academic institutions have repeatedly shown that our talc does not contain asbestos. The article ignores that J&J has cooperated fully and openly with the U.S. FDA and other global regulators, providing them with all the information they requested over decades. We have also made our cosmetic talc mines and processed talc available to regulators for testing. Regulators have tested both, and they have always found our talc to be asbestos-free. The article ignores that J&J has always used the most advanced testing methods available to confirm that our cosmetic talc does not contain asbestos. Every method available to test J&J's talc for asbestos has been used by J&J, regulators, or independent experts, and all of these methods have all found that our cosmetic talc is asbestos-free.

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

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 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 

Amgen Submits Biologics License Application for ABP 710 (Biosimilar Infliximab) To US Food And Drug Administration Filing for ABP 710, a Biosimilar Candidate to Infliximab, Supported by Phase 3 Study in Patients With Moderate-to-Severe Rheumatoid Arthritis THOUSAND OAKS, Calif., Dec. 17, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN)

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

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 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 

Innovent and Incyte Announce Strategic Collaboration and Licensing Agreement for Three Clinical-stage Product Candidates in China WILMINGTON, Del. & SUZHOU, China--(BUSINESS WIRE)--Incyte (NASDAQ:INCY) and Innovent Biologics, Inc. (Innovent) (HKEX: 01801)

tislelizumab

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 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  

Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors

seeking biotech alpha December 2018 insight

InterStim(TM) smart programmer

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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) 

INTERSTIM THERAPY FOR URINARY CONTROL InterStim Therapy for Urinary Control is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

Johnson & Johnson (JNJ)

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 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)

Johnson & Johnson Announces $5 Billion Share Repurchase Program NEW BRUNSWICK, N.J., Dec. 17, 2018 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ)

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

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 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,  

Bristol-Myers Squibb and Boston Medical Center Announce Research Collaboration to Investigate Markers of Immuno-Oncology Response and Resistance December 17, 2018 04:30 PM Eastern Standard Time NEW YORK & BOSTON--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY), and Boston Medical Cen

China is the first country to approve roxadustat

image1136

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

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

Roxadustat approved in China for the treatment of anaemia in chronic kidney disease patients on dialysis AstraZeneca today announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China)

seeking biotech alpha December 2018 insight

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

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 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 

European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy for Adults with Resected Stage III Melanoma December 17, 2018 06:30 AM Eastern Standard Time KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK),

Pyramid Biosciences, Inc. & AZN

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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


Pyramid Biosciences Announces Exclusive Global License of AstraZeneca TRK Program for Dermatology and Inflammatory Diseases WALTHAM, Mass., Dec. 17, 2018 /PRNewswire/ -- Pyramid Biosciences, Inc. (www.pyramidbio.com),

Taltz® (ixekizumab)

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 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 

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 INDIANAPOLIS, Dec. 17, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

Diroximel Fumarate

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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 

Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis DUBLIN and CAMBRIDGE, Mass., Dec. 17, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB)

Sprycel (dasatinib)

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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 

Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Sprycel (dasatinib) for Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia December 17, 2018 06:59 AM Eastern Standard Time PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY)

seeking biotech alpha December 2018 insight

Nplate® (Romiplostim)

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

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

FDA Approves Nplate® (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia Application Granted Priority Review Designation THOUSAND OAKS, Calif., Dec. 14, 2018 /PRNewswire/ -- Amgen (NASDAQ: AMGN)

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

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 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 

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 December 14, 2018 06:31 PM Eastern Standard Time INCHEON, South Korea & JERUSALEM--(BUSINESS WIRE)--Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA

Abbott (ABT)

 Abbott Raises Quarterly Dividend 14%, Increasing Payouts for 47 Straight Years

Fri December 14, 2018 11:08 AM|PR Newswire|About: ABT 

Abbott Raises Quarterly Dividend 14%, Increasing Payouts for 47 Straight Years ABBOTT PARK, Ill., Dec. 14, 2018 /PRNewswire/ -- The board of directors of Abbott (NYSE: ABT)

Pfizer Inc. (PFE)

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PFIZER DECLARES FIRST-QUARTER 2019 DIVIDEND

BOARD OF DIRECTORS APPROVES INCREASE IN QUARTERLY CASH DIVIDEND TO $0.36 PER SHARE AND AUTHORIZES NEW $10 BILLION SHARE REPURCHASE PROGRAM

Friday, December 14, 2018 - 12:10pmEST 

PRODUCT PIPELINE

seeking biotech alpha December 2018 insight

Rubraca®▼ (rucaparib)

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 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

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 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

Tislelizumab (BGB-A317)

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 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 

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

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

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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

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 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

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 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

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 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)

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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)

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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)

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 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

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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)

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 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

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 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

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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),

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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®

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 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)

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 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)

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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)

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 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)

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 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)

image1177

 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

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 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)

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 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)

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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

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 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

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 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®)

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 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®)

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 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

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 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)

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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

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 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

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 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)

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 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,

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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)

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 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)

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 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