Biohazard2020/2021-COVID-19 novel coronavirus (2019-nCoV))病毒: 新型冠状病毒 2019-nCoV

Moorestown, New Jersey, United States

7322321334

7322321334

  • biotecMAX
    • BioHazard2020-3
    • BioHazard2020-2
    • BioHazard2020-1
    • BioHazard2020-0
    • 2021-1
    • 2020-6
    • 2020-5
    • 2020-4
    • 2020-3
    • 2020-2
    • 2020-1
    • 2019-12
    • 2019-11
    • 2019-10
    • 2019-9
    • 2019-8
    • 2019-7
    • 2019-4
    • 2019-3
    • biotecNOVA 2
    • BiotecNOVA 1
    • biotecHOPE
    • biotecHEART
    • portfolio
    • BiotecDATA
    • biotechVORTEX 2
    • biotechVORTEX 1
    • biotechSTORM/BiotecWARS
    • blogs
    • about
    • biotecMAX
    • BioHazard2021
      • BioHazard2020-3
      • BioHazard2020-2
      • BioHazard2020-1
      • BioHazard2020-0
    • BiotecMAX2021
      • 2021-1
    • biotecMAX2020
      • 2020-6
      • 2020-5
      • 2020-4
      • 2020-3
      • 2020-2
      • 2020-1
    • BiotecMAX2019
      • 2019-12
      • 2019-11
      • 2019-10
      • 2019-9
      • 2019-8
      • 2019-7
      • 2019-4
      • 2019-3
    • biotecNOVA
      • biotecNOVA 2
      • BiotecNOVA 1
    • BiotecHOPE
      • biotecHOPE
      • biotecHEART
    • biotecAlpha
      • portfolio
      • BiotecDATA
    • BiotechVortex
      • biotechVORTEX 2
      • biotechVORTEX 1
    • BiotecWARS
      • biotechSTORM/BiotecWARS
    • seeking biotech alpha
      • blogs
      • about
  • biotecMAX
seeking biotech alpha

seeking biotech alpha is biotecMAX 生物技术最大 1/24/2021 the heart of biotech

seeking biotech alpha is biotecMAX 生物技术最大 1/24/2021 the heart of biotechseeking biotech alpha is biotecMAX 生物技术最大 1/24/2021 the heart of biotech

seeking biotech alpha August 2019 & November 2018 insight

KEYTRUDA® (pembrolizumab)

Emgality® (galcanezumab-gnlm)

Emgality® (galcanezumab-gnlm)

image661

 Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Compared to Chemotherapy in Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma Whose Tumors Express PD-L1 (CPS ≥10)

Wed November 14, 2018 6:45 AM|Business Wire|About: MRK 

KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA is not chemotherapy or radiation therapy—it is an immunotherapy and it works with your immune system to help fight certain cancers.

Emgality® (galcanezumab-gnlm)

Emgality® (galcanezumab-gnlm)

Emgality® (galcanezumab-gnlm)

image662

  Lilly Announces Positive Results for Emgality® (galcanezumab-gnlm) from the CONQUER Study in Patients who Failed Previous Migraine Preventive Treatments

08/05/2019 

 Failure to respond to migraine preventive treatments is a common occurrence; internationally it is estimated that more than 40% of patients who use migraine preventive medications have a history of failure or switching treatments(1)

INDIANAPOLIS, Aug. 5, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) 

Emgality is a prescription medicine used in adults for: The preventive treatment of migraine. The medicine (120 mg) comes in a prefilled pen or syringe and is taken once a month. The treatment of episodic cluster headache. The medicine (300 mg) comes in three (100 mg) prefilled syringes, which are taken one after the other at the start of a cluster period and then every month until the end of the cluster period.

AZEDRA® (iobenguane I 131)

Emgality® (galcanezumab-gnlm)

AZEDRA® (iobenguane I 131)

image663

CMS Grants New Technology Add-On Payment for Inpatient Use of AZEDRA® (iobenguane I 131)

Tue August 6, 2019 8:30 AM|GlobeNewswire|About: PGNXGlobeNewswire

NEW YORK, Aug. 06, 2019 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (PGNX),


 https://www.progenics.com/product-pipeline/overview/ 


 https://ir.progenics.com/news-releases/news-release-details/cms-grants-new-technology-add-payment-inpatient-use-azedrar 

AZEDRA is a prescription medicine used to treat adult and pediatric patients 12 years and older with cancers known as pheochromocytoma and paraganglioma that are positive for the norepinephrine transporter (as determined by an iobenguane scan), and who require systemic anticancer therapy. Sign Up

V920 (rVSV∆G-ZEBOV-GP)

V920 (rVSV∆G-ZEBOV-GP)

AZEDRA® (iobenguane I 131)

image664

 Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration

Tue November 13, 2018 4:35 PM|Business Wire|About: MRK 

Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration V920 is the Company’s Investigational Vaccine for Ebola Zaire November 13, 2018 04:35 PM Eastern Standard Time KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK

Celgene (CELG)

V920 (rVSV∆G-ZEBOV-GP)

Celgene (CELG)

image665

 Lyfebulb Partners with Celgene to Inspire Patient-Driven Innovation in the Management of Multiple Sclerosis

Wed November 14, 2018 7:58 AM|PR Newswire|About: CELG

NEW YORK, Nov. 14, 2018 /PRNewswire/

Lyfebulb Partners with Celgene to Inspire Patient-Driven Innovation in the Management of Multiple Sclerosis NEW YORK, Nov. 14, 2018 /PRNewswire/

Elagolix

V920 (rVSV∆G-ZEBOV-GP)

Celgene (CELG)

image666

 November 14, 2018 

AbbVie Presents Positive Phase 3 Data Demonstrating Investigational Elagolix Reduces Heavy Menstrual Bleeding in Women with Uterine Fibroids at 2018 AAGL Global Congress

 NORTH CHICAGO, Ill., Nov. 14, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV) 

ORILISSA™ (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.

seeking biotech alpha August 2019 & November 2018 insight

Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab)

Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab)

Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab)

image667

  Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma

Thu August 1, 2019 7:00 AM|PR Newswire|About: BMY, NKTR 

 SAN FRANCISCO, Aug. 1, 2019 /PRNewswire/ -- Nektar Therapeutics (NKTR) and Bristol-Myers Squibb (BMY) 

Bempegaldesleukin* (NKTR-214)

Triple Combination of VX-659, Tezacaftor and Ivacaftor

Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab)

Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab)

image668

 Two Phase 3 Studies of the Triple Combination of VX-659, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis

Tue November 27, 2018 8:00 AM|Business Wire|About: VRTX 

wo Phase 3 Studies of the Triple Combination of VX-659, Tezacaftor and Ivacaftor Met Primary Endpoint of Improvement in Lung Function (ppFEV1) in People with Cystic Fibrosis November 27, 2018 08:00 AM Eastern Standard Time BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX

CALQUENCE® (acalabrutinib) and LUMOXITI™ (moxetumomab pasudotox-tdfk)

Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab)

CALQUENCE® (acalabrutinib) and LUMOXITI™ (moxetumomab pasudotox-tdfk)

image669

 AstraZeneca Presents Clinical Research Advances for Blood Cancer Patients at 2018 American Society of Hematology Annual Meeting

Tue November 27, 2018 7:00 AM|Business Wire|About: AZN 


 

CALQUENCE® (acalabrutinib) Granted US Breakthrough Therapy Designation for Chronic Lymphocytic Leukemia

Wed August 14, 2019 8:00 AM|Business Wire|About: AZN

Designation based on positive results from two Phase III trials

WILMINGTON, Del.--(BUSINESS WIRE)

 https://seekingalpha.com/pr/17603088-calquence-acalabrutinib-granted-us-breakthrough-therapy-designation-chronic-lymphocytic 

AstraZeneca Presents Clinical Research Advances for Blood Cancer Patients at 2018 American Society of Hematology Annual Meeting 27 scientific presentations, including long-term data from CALQUENCE in mantle cell lymphoma and updated early-phase trial results in chronic lymphocytic leukemia November 27, 2018 07:00 AM Eastern Standard Time WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca, together with Acerta Pharma

LYRICA® (pregabalin)

generic version of EpiPen®1 (epinephrine injection, USP) Auto-Injector, 0.3 mg

CALQUENCE® (acalabrutinib) and LUMOXITI™ (moxetumomab pasudotox-tdfk)

image670

 Pfizer Receives Six Months Pediatric Exclusivity for LYRICA® (pregabalin)

Tue November 27, 2018 3:01 PM|Business Wire|About: PFE 

LYRICA is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain, and pain after shingles. LYRICA (pregabalin) is also indicated to treat partial onset seizures in adults with epilepsy who take 1 or more drugs for seizures. LYRICA can help relieve diabetic nerve pain, pain after shingles, fibromyalgia pain, and spinal cord injury nerve pain.*

Jivi (PEGylated recombinant Factor VIII)

generic version of EpiPen®1 (epinephrine injection, USP) Auto-Injector, 0.3 mg

generic version of EpiPen®1 (epinephrine injection, USP) Auto-Injector, 0.3 mg

image671

 Bayer's hemophilia A treatment Jivi OK'd in Europe

Nov. 27, 2018 11:15 AM ET|About: Bayer A.G. ADR (BAYRY)|By: Douglas W. House, SA News Editor 

Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).

generic version of EpiPen®1 (epinephrine injection, USP) Auto-Injector, 0.3 mg

generic version of EpiPen®1 (epinephrine injection, USP) Auto-Injector, 0.3 mg

generic version of EpiPen®1 (epinephrine injection, USP) Auto-Injector, 0.3 mg

image672

 

Teva’s Generic Version of EpiPen® (Epinephrine Injection, USP) Auto-Injector 0.3 mg Now Available in Limited Quantity in the United States

Tue November 27, 2018 10:06 AM|Business Wire|About: TEVA

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceutical Industries (TEVA) 

Teva’s Generic Version of EpiPen® (Epinephrine Injection, USP) Auto-Injector 0.3 mg Now Available in Limited Quantity in the United States November 27, 2018 10:06 AM Eastern Standard Time PARSIPPANY, N.J.--(BUSINESS WIRE)--Teva Pharmaceutical Industries (NYSE and TASE: TEVA)

seeking biotech alpha August 2019 & November 2018 insight

Valiant Navion thoracic stent graft system

(GILD) antiviral Remdesivir and 3 monoclonal antibody: ZMapp, mAb 114 and (REGN) 3470-3471-3479

Swedish Orphan Biovitrum AB (OTCPK:BIOVF) (Sobi)

image673

 Medtronic's Valiant Navion stent CE Mark'd

Nov. 13, 2018 10:23 AM ET|About: Medtronic plc (MDT)|By: Douglas W. House, SA News Editor  

Valiant Navion™ thoracic stent graft system for your thoracic endovascular aortic repair (TEVAR) procedures.

Swedish Orphan Biovitrum AB (OTCPK:BIOVF) (Sobi)

(GILD) antiviral Remdesivir and 3 monoclonal antibody: ZMapp, mAb 114 and (REGN) 3470-3471-3479

Swedish Orphan Biovitrum AB (OTCPK:BIOVF) (Sobi)

image674

 Sobi to acquire U.S. rights to AstraZeneca's Synagis and half interest in MEDI8897 for $1.5B

Nov. 13, 2018 8:34 AM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor  

AstraZeneca has agreed to sell US rights to Synagis (palivizumab) used for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) to Swedish Orphan Biovitrum AB (publ) (Sobi). 13 November 2018 07:00 GMT

(GILD) antiviral Remdesivir and 3 monoclonal antibody: ZMapp, mAb 114 and (REGN) 3470-3471-3479

(GILD) antiviral Remdesivir and 3 monoclonal antibody: ZMapp, mAb 114 and (REGN) 3470-3471-3479

(GILD) antiviral Remdesivir and 3 monoclonal antibody: ZMapp, mAb 114 and (REGN) 3470-3471-3479

image675

 Ebola clinical trial to begin in DRC

Nov. 13, 2018 4:49 AM ET|By: Yoel Minkoff, SA News Editor  

 
Helen Branswell 

A pivotal day in world’s response to Ebola nears: the launch of a clinical trial By HELEN BRANSWELL @HelenBranswell NOVEMBER 12, 2018 Helen Branswell

MAVYRET™ (glecaprevir/pibrentasvir)

MAVYRET™ (glecaprevir/pibrentasvir)

(GILD) antiviral Remdesivir and 3 monoclonal antibody: ZMapp, mAb 114 and (REGN) 3470-3471-3479

image676

 Enanta’s HCV Collaboration Partner AbbVie receives Approval by the European Commission for MAVIRET™ (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve HCV Patients with Compensated Cirrhosis

Fri August 2, 2019 8:51 AM|Business Wire|About: ENTA 

 WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (ENTA) 

MAVYRET™ (glecaprevir and pibrentasvir) tablets are a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.

NovoCure (NVCR)

MAVYRET™ (glecaprevir/pibrentasvir)

Eliquis® (apixaban)

image677

 Novocure Announces More than 70 Presentations on Tumor Treating Fields at 23rd Annual Meeting of the Society for Neuro-Oncology

Tue November 13, 2018 8:24 AM|Business Wire|About: NVCR

 ST. HELIER, Jersey--(BUSINESS 

WIRE)-- Novocure (NVCR)  


The science of Tumor Treating Fields has the potential to extend beyond glioblastoma. Tumor Treating Fields has shown a consistent anti-mitotic effect in our preclinical and clinical research over the last 18 years.

Eliquis® (apixaban)

MAVYRET™ (glecaprevir/pibrentasvir)

Eliquis® (apixaban)

image678

 Real-World Evidence on Patients Aged 80 and Older Presented From ARISTOPHANES, the Largest Real-World Data Study Evaluating Oral Anticoagulants Among Patients with Non-Valvular Atrial Fibrillation

Eliquis® (apixaban) was associated with lower rates of stroke or systemic embolism and major bleeding in elderly patient populations when compared to rivaroxaban and dabigatran

 (PRINCETON, N.J. & NEW YORK) November 11, 2018 – The Bristol-Myers Squibb-Pfizer Alliance  

ELIQUIS (apixaban) is a prescription medicine used to reduce the risk of stroke and blood clots in people who have atrial fibrillation, a type of irregular heartbeat, not caused by a heart valve problem. ELIQUIS is a prescription medicine used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), and reduce the risk of them occurring again. ELIQUIS is a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.

seeking biotech alpha August 2019 & November 2018 insight

LENVIMA® (lenvatinib), in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab)

LENVIMA® (lenvatinib), in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab)

LENVIMA® (lenvatinib), in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab)

image679

 New Data from Investigational Study of LENVIMA® (lenvatinib) and KEYTRUDA® (pembrolizumab) Combination in Three Different Tumor Types Presented at the Society for Immunotherapy of Cancer’s 33rd Annual Meeting

Fri November 9, 2018 6:45 AM|Business Wire|About: MRK 

 TOKYO & KENILWORTH, N.J.--(BUSINESS WIRE)-- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck (MRK), known as MSD outside the United States and Canada,  

LENVIMA is indicated: For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC) In combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)

FARXIGA (dapagliflozin)

LENVIMA® (lenvatinib), in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab)

LENVIMA® (lenvatinib), in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab)

image680

 FARXIGA Significantly Reduced Hospitalization for Heart Failure or CV Death in a Broad Patient Population with Type 2 Diabetes in the Landmark DECLARE-TIMI 58 Trial

Sat November 10, 2018 4:45 PM|Business Wire|About: AZN 

FARXIGA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).

LYNPARZA® (olaparib)

LENVIMA® (lenvatinib), in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab)

Repatha® (Evolocumab)

image681

Lynparza Phase III PROfound trial in HRR* mutation-selected metastatic castration-resistant prostate cancer met primary endpoint

PUBLISHED7 August 2019 


 7 August 2019 07:00 BST

AstraZeneca and MSD’s Lynparza met the primary endpoint of significantly increasing the time patients selected for BRCA1/2 or ATM mutations live without radiographic disease progression vs. standard of care treatment

Only PARP inhibitor with positive Phase III results in four different cancer types (ovarian, breast, pancreatic and prostate)

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc


 AstraZeneca and Merck's Lynparza shows treatment benefit in late-stage prostate cancer study

Aug. 7, 2019 7:04 AM ET|About: AstraZeneca PLC (AZN)|By: Douglas W. House, SA News Editor 


 https://seekingalpha.com/news/3488293-astrazeneca-mercks-lynparza-shows-treatment-benefit-late-stage-prostate-cancer-study 


 Lynparza Phase III PAOLA-1 trial met primary endpoint as 1st-line maintenance treatment with bevacizumab for advanced ovarian cancer 

 

14 August 2019 07:00 BST

AstraZeneca and MSD’s Lynparza, when added to standard-of-care bevacizumab, significantly increased the time women lived without disease progression

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada)

 https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-phase-iii-paola-1-trial-met-primary-endpoint-as-1st-line-maintenance-treatment-with-bevacizumab-for-advanced-ovarian-cancer-14082019.html 

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

Repatha® (Evolocumab)

Mirati Therapeutics' (MRTX) mocetinostat, (HDAC) inhibitor, with (AZN) Imfinzi (durvalumab)

Repatha® (Evolocumab)

image682

 Amgen Presents Results Highlighting The Long-Term Safety And Efficacy Of Repatha® (Evolocumab) In The Longest Duration Study Of A PCSK9 Inhibitor To Date At AHA Scientific Sessions 2018

Mon November 12, 2018 4:00 PM|PR Newswire|About: AMGN 

 THOUSAND OAKS, Calif., Nov. 12, 2018 /PRNewswire/ -- Amgen (AMGN)  

Repatha® is a groundbreaking treatment that reduces your risk of having a heart attack or stroke for real. Repatha® is proven to: Dramatically lower your LDL bad cholesterol Significantly drop your risk of having a devastating heart attack or stroke Reduce the need for a stent or open-heart bypass surgery

Mirati Therapeutics' (MRTX) mocetinostat, (HDAC) inhibitor, with (AZN) Imfinzi (durvalumab)

Mirati Therapeutics' (MRTX) mocetinostat, (HDAC) inhibitor, with (AZN) Imfinzi (durvalumab)

Mirati Therapeutics' (MRTX) mocetinostat, (HDAC) inhibitor, with (AZN) Imfinzi (durvalumab)

image683

 Mirati's mocetinostat + AstraZeneca's Imfinzi show positive effect in mid-stage lung cancer study

Nov. 9, 2018 9:30 AM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor  

IMFINZI® (durvalumab) is a prescription medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.

Praluent® (alirocumab)

Mirati Therapeutics' (MRTX) mocetinostat, (HDAC) inhibitor, with (AZN) Imfinzi (durvalumab)

Mirati Therapeutics' (MRTX) mocetinostat, (HDAC) inhibitor, with (AZN) Imfinzi (durvalumab)

image684

 ODYSSEY OUTCOMES Investigators Highlight at AHA that Praluent® (alirocumab) Injection Was Associated with Fewer Deaths from Any Cause

Sun November 11, 2018 8:14 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, Nov. 11, 2018 /PRNewswire/ --

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

seeking biotech alpha Sept/Aug 2019 & Nov 2018 insight

Repatha® (Evolocumab)

Selpercatinib (LOXO-292)

Selpercatinib (LOXO-292)

image685

 Amgen Announces Presentation Of Research Reinforcing The Long-Term Safety And Efficacy Of Repatha® (Evolocumab) In High-Risk Patients At AHA Scientific Sessions 2018

Mon November 5, 2018 4:00 PM|PR Newswire|About: AMGN 

Repatha® is a groundbreaking treatment that reduces your risk of having a heart attack or stroke for real. Repatha® is proven to: Dramatically lower your LDL bad cholesterol Significantly drop your risk of having a devastating heart attack or stroke Reduce the need for a stent or open-heart bypass surgery

Selpercatinib (LOXO-292)

Selpercatinib (LOXO-292)

Selpercatinib (LOXO-292)

image686

 

Lilly Announces Positive Results for Selpercatinib (LOXO-292), Demonstrating a 68 Percent Objective Response Rate and Sustained Durability in Heavily Pretreated RET Fusion-Positive Non-Small Cell Lung Cancer

Mon September 9, 2019 3:20 AM|PR Newswire|About: LLY 

 PR Newswire

INDIANAPOLIS, Sept. 9, 2019 /PRNewswire/ -- Eli Lilly and Company (LLY) 


 https://www.prnewswire.com/news-releases/lilly-announces-positive-results-for-selpercatinib-loxo-292-demonstrating-a-68-percent-objective-response-rate-and-sustained-durability-in-heavily-pretreated-ret-fusion-positive-non-small-cell-lung-cancer-300913590.html 

Lilly Announces Positive Results for Selpercatinib (LOXO-292), Demonstrating a 68 Percent Objective Response Rate and Sustained Durability in Heavily Pretreated RET Fusion-Positive Non-Small Cell Lung Cancer

Dupixent® (dupilumab)

Selpercatinib (LOXO-292)

Icosapent Ethyl Recognized as Only Non-LDL-Cholesterol Lipid Management Treatment with Cardiovascula

image687

 Dupixent® (dupilumab) Showed Positive Topline Results in Phase 3 Trial of Children Aged 6 to 11 Years with Severe Atopic Dermatitis

Tue August 6, 2019 1:04 AM|PR Newswire|About: REGN

TARRYTOWN, N.Y. and PARIS, Aug. 6, 2019 /PRNewswire/ --

U.S. FDA submission for children planned for 4Q 2019

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi 


 https://www.prnewswire.com/news-releases/dupixent-dupilumab-approved-by-european-commission-for-adolescents-with-moderate-to-severe-atopic-dermatitis-300896737.html 

DUPIXENT is a prescription medicine used: to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 12 years of age. with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems.

Icosapent Ethyl Recognized as Only Non-LDL-Cholesterol Lipid Management Treatment with Cardiovascula

Icosapent Ethyl Recognized as Only Non-LDL-Cholesterol Lipid Management Treatment with Cardiovascula

Icosapent Ethyl Recognized as Only Non-LDL-Cholesterol Lipid Management Treatment with Cardiovascula

image688

  

National Lipid Association’s New Position Statement on Use of Icosapent Ethyl in High and Very-High-Risk Patients Recognizes Importance of Addressing Residual Cardiovascular Risk in Patients on Statins

Mon September 16, 2019 6:00 AM|GlobeNewswire|About: AMRN

Millions of Patients on Statins with Elevated Triglycerides Are at Risk of Cardiovascular Events, Such as Heart Attack, Stroke or Death

Icosapent Ethyl Recognized as Only Non-LDL-Cholesterol Lipid Management Treatment with Cardiovascular Risk Reduction Outcomes Results

DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 16, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN)

https://www.vascepa.com/ Vascepa TV Commercial, 'Lowers High Triglycerides'

Eli Lilly and Company (LLY) and NextCure, Inc.

Icosapent Ethyl Recognized as Only Non-LDL-Cholesterol Lipid Management Treatment with Cardiovascula

Eli Lilly and Company (LLY) and NextCure, Inc.

image689

 Lilly and NextCure Announce Collaboration to Discover and Develop Novel Immuno-Oncology Medicines

Mon November 5, 2018 4:30 PM|PR Newswire|About: LLY 

Lilly and NextCure Announce Collaboration to Discover and Develop Novel Immuno-Oncology Medicines INDIANAPOLIS and BELTSVILLE, Md., Nov. 5, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and NextCure, Inc.

REGN-EB3 THERAPY

Icosapent Ethyl Recognized as Only Non-LDL-Cholesterol Lipid Management Treatment with Cardiovascula

Eli Lilly and Company (LLY) and NextCure, Inc.

image690

  August 12, 2019 at 10:01 AM EDT

PALM EBOLA CLINICAL TRIAL STOPPED EARLY AS REGENERON'S REGN-EB3 THERAPY SHOWS SUPERIORITY TO ZMAPP IN PREVENTING EBOLA DEATHS

TARRYTOWN, N.Y., Aug. 12, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

May 31, 2018 at 4:05 PM EDT REGENERON'S INVESTIGATIONAL EBOLA TREATMENT SHIPPING TO DEMOCRATIC REPUBLIC OF THE CONGO FOR USE IN CURRENT OUTBREAK TARRYTOWN, New York, May 31, 2018 /PRNewswire/ -- Regeneron working with World Health Organization, U.S. Food and Drug Administration and Democratic Republic of the Congo authorities to ensure appropriate and timely access Data published today in Journal of Infectious Diseases show promising efficacy of REGN-EB3 (REGN3470-3471-3479) in animal models; Phase 1 results have demonstrated safety in healthy human volunteers Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)

seeking biotech alpha August 2019 & November 2018 insight

Illumina, Inc. (ILMN) and Pacific Biosciences (PACB)

Illumina, Inc. (ILMN) and Pacific Biosciences (PACB)

Illumina, Inc. (ILMN) and Pacific Biosciences (PACB)

image691

 Illumina to Acquire Pacific Biosciences for Approximately $1.2 Billion, Broadening Access to Long-Read Sequencing and Accelerating Scientific Discovery

Thu November 1, 2018 4:02 PM|Business Wire|About: ILMN, PACB 

Illumina to Acquire Pacific Biosciences for Approximately $1.2 Billion, Broadening Access to Long-Read Sequencing and Accelerating Scientific Discovery SAN DIEGO & MENLO PARK, Calif.--(BUSINESS WIRE)--Nov. 1, 2018-- Illumina, Inc. (NASDAQ: ILMN) and Pacific Biosciences (NASDAQ:PACB)

Amgen (AMGN)

Illumina, Inc. (ILMN) and Pacific Biosciences (PACB)

Illumina, Inc. (ILMN) and Pacific Biosciences (PACB)

image692

  

Amgen Wins Patent Case On Enbrel® (etanercept)

Fri August 9, 2019 4:05 PM|PR Newswire|About: AMGN

Preliminary Injunction to Remain in Place

PR Newswire

THOUSAND OAKS, Calif., Aug. 9, 2019 /PRNewswire/ -- Amgen (AMGN)


 https://www.enbrel.com/ 

Amgen Wins Patent Case On Enbrel® (etanercept) Court Upholds Validity of Patent Claims Directed to Enbrel Preliminary Injunction to Remain in Place THOUSAND OAKS, Calif., Aug. 9, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN

Tecentriq® (ATEZOLIZUMAB)

Illumina, Inc. (ILMN) and Pacific Biosciences (PACB)

Bavarian Nordic A/S's (BVNKF) CV301, combined with (AZN) PD-L1 inhibitor IMFINZI (durvalumab)

image693

 Genentech’s Tecentriq® (ATEZOLIZUMAB) Plus Platinum-based Chemotherapy Reduced the Risk of Disease Worsening or Death in People With Previously Untreated Advanced Bladder Cancer

Mon August 5, 2019 1:00 AM|Business Wire|About: RHHBY

– IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer –

– Data will be shared with health authorities globally, including the U.S. Food and Drug Administration (FDA) –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

 https://www.businesswire.com/news/home/20190804005062/en/ 

TECENTRIQ is a prescription medicine used to treat adults with: A type of bladder and urinary tract cancer called urothelial carcinoma. A type of lung cancer called non-small cell lung cancer (NSCLC). A type of breast cancer called triple-negative breast cancer (TNBC). A type of lung cancer called small cell lung cancer (SCLC).

Bavarian Nordic A/S's (BVNKF) CV301, combined with (AZN) PD-L1 inhibitor IMFINZI (durvalumab)

Bavarian Nordic A/S's (BVNKF) CV301, combined with (AZN) PD-L1 inhibitor IMFINZI (durvalumab)

Bavarian Nordic A/S's (BVNKF) CV301, combined with (AZN) PD-L1 inhibitor IMFINZI (durvalumab)

image694

 Bavarian Nordic launches Phase 1/2 study of prime/boost vaccine CV301 in colorectal and pancreatic cancers

Nov. 2, 2018 11:47 AM ET|By: Douglas W. House, SA News Editor  

to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose disease is stable on, or responding to 1st line therapy for metastatic disease.

Elagolix

Bavarian Nordic A/S's (BVNKF) CV301, combined with (AZN) PD-L1 inhibitor IMFINZI (durvalumab)

BioArctic and AbbVie - BAN0805

image695

 AbbVie Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women

Mon August 5, 2019 8:30 AM|PR Newswire|About: ABBV, NBIX 


 PR Newswire

NORTH CHICAGO, Ill., Aug. 5, 2019 /PRNewswire/ -- AbbVie (ABBV)

.


 https://www.prnewswire.com/news-releases/abbvie-submits-new-drug-application-to-us-fda-for-investigational-elagolix-for-management-of-heavy-menstrual-bleeding-associated-with-uterine-fibroids-in-women-300896046.html 

ORILISSATM (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.

BioArctic and AbbVie - BAN0805

Bavarian Nordic A/S's (BVNKF) CV301, combined with (AZN) PD-L1 inhibitor IMFINZI (durvalumab)

BioArctic and AbbVie - BAN0805

image696

 BioArctic's Partner AbbVie Exercises its Option to License the Alpha-synuclein Antibody Portfolio for Parkinson's  Disease

 Thu November 1, 2018 11:09 PM|PR Newswire|About: ABBV, B, BIOA

STOCKHOLM, Oct. 2, 2018 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B)

BioArctic's Partner AbbVie Exercises its Option to License the Alpha-synuclein Antibody Portfolio for Parkinson's Disease STOCKHOLM, Oct. 2, 2018 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B)

seeking biotech alpha August 2019 November 2018 insight

PROMACTA (eltrombopag)

Tivicay (dolutegravir) + lamivudine

Tivicay (dolutegravir) + lamivudine

image697

 FDA OKs expanded use for Novartis' Promacta

Nov. 16, 2018 4:43 PM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor 

PROMACTA is a thrombopoietin receptor agonist indicated for the treatment of: thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

Tivicay (dolutegravir) + lamivudine

Tivicay (dolutegravir) + lamivudine

Tivicay (dolutegravir) + lamivudine

image698

 European advisory group backs ViiV Healthcare's Tivicay + lamivudine in HIV-1

Nov. 19, 2018 7:14 AM ET|By: Douglas W. House, SA News Editor  

TRIUMEQ is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 40 kg.

Descovy for PrEP™

Tivicay (dolutegravir) + lamivudine

TAGRISSO® (OSIMERTINIB)

image699

 August 08, 2019

Gilead Sciences Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™

FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 7, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD


 https://seekingalpha.com/pr/17597519-gilead-sciences-statement-u-s-food-drug-administration-advisory-committee-s-recommendation 

DESCOVY® is a prescription medicine that is used together with other HIV-1 medicines to treat HIV-1 in people who weigh at least 77 lbs (35kg).

TAGRISSO® (OSIMERTINIB)

Bria-IMT™ in combination with pembrolizumab [KEYTRUDA®

TAGRISSO® (OSIMERTINIB)

image700

  

TAGRISSO® (OSIMERTINIB) Significantly Improves Overall Survival in the Phase III FLAURA Trial for 1st-line EGFR-mutated Non-small Cell Lung Cancer

Fri August 9, 2019 7:00 AM|Business Wire|About: AZN

TAGRISSO is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous system metastases lived without disease progression

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca

TAGRISSO is a prescription medicine for non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic). TAGRISSO is used: as a first treatment if tumors have a certain abnormal epidermal growth factor receptor (EGFR) gene(s) or for a certain type of EGFR gene that has been treated with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working

Bria-IMT™ in combination with pembrolizumab [KEYTRUDA®

Bria-IMT™ in combination with pembrolizumab [KEYTRUDA®

Bria-IMT™ in combination with pembrolizumab [KEYTRUDA®

image701

 BriaCell to Present Updated Clinical Data Including Early Safety Data in KEYTRUDA® Combination Study and Positive Phase IIa Monotherapy Efficacy Data at 2018 San Antonio Breast Cancer Symposium

Mon November 19, 2018 6:30 AM|GlobeNewswire|About: BCTXF, MRK 

Bria-IMT™ has demonstrated positive proof-of-concept in advanced breast cancer, and we will delve into these data in San Antonio. We have firm grounds to believe the anti-tumor effects of Bria-IMT™ can be greatly improved by combination with KEYTRUDA®,” stated Dr. Bill Williams, BriaCell’s President & CEO.

Nucala (mepolizumab)

Bria-IMT™ in combination with pembrolizumab [KEYTRUDA®

Bria-IMT™ in combination with pembrolizumab [KEYTRUDA®

image702

Glaxo files U.S. marketing application for expanded use of Nucala

Nov. 19, 2018 7:46 AM ET|By: Douglas W. House, SA News Editor 

NUCALA is an add-on, prescription maintenance treatment for patients 12 and older with severe eosinophilic asthma. NUCALA is not used to treat sudden breathing problems.

seeking biotech alpha August 2019 & November 2018 insight

DAURISMO™ (glasdegib)

VENCLEXTA® (venetoclax)

VENCLEXTA® (venetoclax)

image703

 U.S. FDA Approves DAURISMO™ (glasdegib) for Adult Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML) for Whom Intensive Chemotherapy is Not an Option

Wed November 21, 2018 1:40 PM|Business Wire|About: PFE 

U.S. FDA Approves DAURISMO™ (glasdegib) for Adult Patients with Newly-Diagnosed Acute Myeloid Leukemia (AML) for Whom Intensive Chemotherapy is Not an Option DAURISMO is the first and only Hedgehog pathway inhibitor approved for the treatment of AML November 21, 2018 01:40 PM Eastern Standard Time NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE)

VENCLEXTA® (venetoclax)

VENCLEXTA® (venetoclax)

VENCLEXTA® (venetoclax)

image704

 AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy

Wed November 21, 2018 2:14 PM|PR Newswire|About: ABBV 

VENCLEXTA is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior treatment.

SIRTURO® (bedaquiline)

VENCLEXTA® (venetoclax)

SIRTURO® (bedaquiline)

image705

 Janssen Announces U.S. FDA Accelerated Approval for SIRTURO® (bedaquiline) as Part of Combination Therapy to Treat Adolescents with Pulmonary Multidrug-Resistant Tuberculosis

Label expansion marks important milestone in Johnson & Johnson’s pediatric research and development program for bedaquiline

TITUSVILLE, NJ, August 9, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson

SIRTURO® (bedaquiline) is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adults (≥18 years) with pulmonary multi drug resistant tuberculosis (MDR TB). Reserve SIRTURO® for use when an effective treatment regimen cannot otherwise be provided. Administer SIRTURO® by directly observed therapy (DOT). This indication is approved under accelerated approval based on time to sputum culture conversion. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

BeiGene BGNE

Bria-IMT™ with KEYTRUDA®

SIRTURO® (bedaquiline)

image706

 Analysts Take Action on Health Care Stocks

JPMorgan initiates coverage of BeiGene, Brookline Capital Markets starts covering Celsion and Cellectar Biosciences 

November 21, 2018 

 Alberto Abaterusso 

 BGNE CLSN CLRB 

BeiGene Pipeline

Bria-IMT™ with KEYTRUDA®

Bria-IMT™ with KEYTRUDA®

Bria-IMT™ with KEYTRUDA®

image707

 UPDATE - BriaCell to Present Updated Clinical Data Including Early Safety Data in KEYTRUDA® Combination Study and Positive Phase IIa Monotherapy Efficacy Data at 2018 San Antonio Breast Cancer Symposium

November 20, 2018 | About: BCTXF +0% MRK +0%

Note: This Press Release contains amendments to the press release previously issued on Nov. 19, 2018

Positive proof of concept data with Bria-IMT™ Monotherapy will highlight potent anti-tumor activity and an excellent safety profile for Bria-IMT™ in advanced breast cancer. · Patient dosing is ongoing in a combination study of Bria-IMT™ with KEYTRUDA® (by Merck & Co., Inc.) in advanced breast cancer.

BRACAnalysis CDx

Bria-IMT™ with KEYTRUDA®

Bria-IMT™ with KEYTRUDA®

image708

 Myriad Will Seek FDA Approval of BRACAnalysis CDx® As a Companion Diagnostic for Lynparza® (olaparib) In Men with Metastatic Castrate-Resistant Prostate Cancer

Wed August 7, 2019 7:05 AM|GlobeNewswire|About: AZN, MYGN

SALT LAKE CITY, Aug. 07, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics (MYGN), Inc. (NASDAQ: MYGN)

BRACAnalysis CDx® is an FDA-approved laboratory developed test for BRCA1 and BRCA2 intended to inform patient management related to the PARP inhibitors, Lynparza® (olaparib) and Zejula® (niraparib). 1,2,3

seeking biotech alpha August 2019 & November 2018 insight

EYLEA® (aflibercept) Injection Prefilled Syringe

EYLEA® (aflibercept) Injection Prefilled Syringe

EYLEA® (aflibercept) Injection Prefilled Syringe

image709

  

FDA Approves EYLEA® (aflibercept) Injection Prefilled Syringe

Tue August 13, 2019 7:00 AM|PR Newswire|About: REGNQ2: 08-06-19 Earnings Summary

  • Transcript

EPS of $6.02 beats by $0.60 Revenue of $1.93B (20.25% Y/Y) beats by $131.71M

TARRYTOWN, N.Y., Aug. 13, 2019 /PRNewswire/ -


 https://www.prnewswire.com/news-releases/fda-approves-eylea-aflibercept-injection-prefilled-syringe-300900436.html 

EYLEA® (aflibercept) Injection 2 mg (0.05 mL) is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).

Zanubrutinib and Tislelizumab

EYLEA® (aflibercept) Injection Prefilled Syringe

EYLEA® (aflibercept) Injection Prefilled Syringe

image710

 Priority Review Granted to BeiGene’s New Drug Applications for Zanubrutinib and Tislelizumab in China

Thu November 15, 2018 7:00 AM|GlobeNewswire|About: BGNE 

Priority Review Granted to BeiGene’s New Drug Applications for Zanubrutinib and Tislelizumab in China CAMBRIDGE, Mass., and BEIJING, China, Nov. 15, 2018 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160)

CABOMETYX® (cabozantinib)

EYLEA® (aflibercept) Injection Prefilled Syringe

ADCETRIS® (Brentuximab Vedotin)

image711

 Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) Tablets for the Treatment of Hepatocellular Carcinoma in Adults Previously Treated with Sorafenib

Thu November 15, 2018 1:32 AM|Business Wire|About: EXEL 

CABOMETYX is a prescription medicine used to treat people with advanced kidney cancer (renal cell carcinoma).

ADCETRIS® (Brentuximab Vedotin)

ADCETRIS® (Brentuximab Vedotin)

ADCETRIS® (Brentuximab Vedotin)

image712

 FDA Grants Breakthrough Therapy Designation to ADCETRIS® (Brentuximab Vedotin) for Frontline Peripheral T-Cell Lymphomas

Thu November 15, 2018 8:00 AM|Business Wire|About: SGEN 

ADCETRIS® (brentuximab vedotin) is approved for the treatment of: Previously untreated Stage 3 or 4 classical Hodgkin lymphoma (cHL): Adult patients with newly diagnosed Stage 3 or 4 cHL in combination with chemotherapy Consolidation therapy in cHL: Adult patients with cHL at high risk of coming back or becoming worse after a stem cell transplant (SCT) Relapsed cHL: Adult patients with cHL after an SCT fails or after at least 2 combination chemotherapy treatments fail and SCT is not an option Relapsed systemic anaplastic large cell lymphoma (sALCL): Adult patients with sALCL after at least 1 combination chemotherapy treatment fails

DRG Invisible Trial System

ADCETRIS® (Brentuximab Vedotin)

DRG Invisible Trial System

image713

 New Approvals Allow Chronic Pain Sufferers to Try Abbott's Non-Opioid Pain Therapy Before Getting Device Implant

Thu November 15, 2018 9:00 AM|PR Newswire|About: ABT 

Dorsal root ganglion (DRG) therapy is a new type of neurostimulation therapy designed to manage difficult-to-treat chronic pain in specific areas of the lower body, such as the foot, knee, hip or groin.

CVS

ADCETRIS® (Brentuximab Vedotin)

DRG Invisible Trial System

image714

 CVS Health Teams Up with Philadelphia Job Corps, Philadelphia Works and Philadelphia Youth Network to Open New Mock Pharmacy for Aspiring Pharmacy Technicians

Thu November 15, 2018 8:00 AM|PR Newswire|About: CVS 

 PHILADELPHIA, Nov. 15, 2018 /PRNewswire/  

CVS Health Teams Up with Philadelphia Job Corps, Philadelphia Works and Philadelphia Youth Network to Open New Mock Pharmacy for Aspiring Pharmacy Technicians PHILADELPHIA, Nov. 15, 2018 /PRNewswire/

seeking biotech alpha August 2019 & November 2018 insight

oral semaglutide

LUXTURNA® (voretigene neparvovec)

LUXTURNA® (voretigene neparvovec)

image715

 Novo Nordisk's PIONEER 9 trial successfully meets primary endpoints

Nov. 23, 2018 7:40 AM ET|About: Novo Nordisk A/S (NVO)|By: Mamta Mayani, SA News Editor 

Ozempic® (semaglutide) injection 0.5 mg or 1 mg is an injectable prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

LUXTURNA® (voretigene neparvovec)

LUXTURNA® (voretigene neparvovec)

LUXTURNA® (voretigene neparvovec)

image716

 European Commission Approves Spark Therapeutics’ LUXTURNA® (voretigene neparvovec), a One-time Gene Therapy for Inherited Retinal Disease Caused by Confirmed Biallelic RPE65 Mutations

Fri November 23, 2018 1:15 AM|GlobeNewswire 

 

Spark Therapeutics (ONCE) will manufacture and supply LUXTURNA for Novartis, while Novartis has exclusive rights to pursue development, registration and commercialization in all other countries outside the U.S.

PHILADELPHIA, Nov. 23, 2018 (GLOBE NEWSWIRE) -- Spark Therapeutics

LUXTURNATM (voretigene neparvovec-rzyl) is a prescription gene therapy product used for the treatment of patients with inherited retinal disease due to mutations in both copies of the RPE65 gene, which can only be confirmed through genetic testing. You must also have enough remaining cells in your retina (the thin layer of tissue in the back of your eyes) as determined by your healthcare professional.

Imbruvica®▼(ibrutinib)

LUXTURNA® (voretigene neparvovec)

Imbruvica®▼(ibrutinib)

image717

  

Janssen Announces European Commission Approval of Imbruvica®▼(ibrutinib) for Expanded Use in Two Indications

Decision represents the fifth European approval in five years

August 13, 2019 07:08 AM Eastern Daylight Time

BEERSE, Belgium--(BUSINESS WIRE)--The Janssen Pharmaceutical Companies of Johnson & Johnson

IMBRUVICA® (ibrutinib) is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL). CLL/SLL with 17p deletion. Waldenström's macroglobulinemia (WM). Marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

Fasenra

Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd)

Imbruvica®▼(ibrutinib)

image718

AstraZeneca's Fasenra an Orphan Drug in U.S. for rare type of blood vessel inflammation

Nov. 26, 2018 6:46 AM ET|About: AstraZeneca Group plc (AZN)|By: Douglas W. House, SA News Editor  

FASENRA is a prescription medicine used with other asthma medicines for the maintenance treatment of asthma in people 12 years and older whose asthma is not controlled with their current asthma medicines. FASENRA helps prevent severe asthma attacks (exacerbations) and may improve your breathing. Medicines such as FASENRA reduce blood eosinophils. Eosinophils are a type of white blood cell that may contribute to your asthma.

Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd)

Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd)

Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd)

image719

 

European Commission Approves Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Tue August 27, 2019 4:16 PM|Business Wire|About: BMY 

EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with the medicines: Revlimid® (lenalidomide) and dexamethasone in adults who have received one to three prior treatments for their multiple myeloma. Pomalyst® (pomalidomide) and dexamethasone in adults who have received at least two prior treatments including Revlimid and a proteasome inhibitor.

JULUCA

Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd)

Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone (EPd)

image720

 ViiV Healthcare's HIV med Juluca OK'd in Japan

Nov. 26, 2018 7:33 AM ET|By: Douglas W. House, SA News Editor 

JULUCA is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults to replace their current anti-HIV-1 medicines when their healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

seeking biotech alpha November 2018 insight

Verzenio® (abemaciclib)

DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate) + once-daily PIFELTRO (doravirine)

DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate) + once-daily PIFELTRO (doravirine)

image721

 Lilly to Present Clinical Data for Verzenio® (abemaciclib) and Real-World Evidence across HR+, HER2- Metastatic Breast Cancer at 2018 SABCS

Thu November 29, 2018 6:45 AM|PR Newswire|About: LLY 

Verzenio is a prescription medicine used to treat a type of breast cancer. It is a medicine you can take if: You have a type of breast cancer called HR+/HER2− (hormone receptor positive/human epidermal growth factor receptor 2 negative) and the cancer has spread to other parts of the body (metastasized) Verzenio is given in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, in combination with fulvestrant in women whose disease has progressed after hormonal therapy, or alone in women whose disease has progressed after hormone therapy and prior chemotherapy

DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate) + once-daily PIFELTRO (doravirine)

DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate) + once-daily PIFELTRO (doravirine)

DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate) + once-daily PIFELTRO (doravirine)

image722

European Commission Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients

 Wednesday, November 28, 2018 4:30 pm EST  KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK) 


European Commission Approves Merck’s DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients Approvals Based on Findings from the Pivotal Phase 3 DRIVE-AHEAD and DRIVE-FORWARD Trials Evaluating the Efficacy and Safety of DELSTRIGO and PIFELTRO Through 96 Weeks November 28, 2018 04:30 PM Eastern Standard Time

Xalatan

DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate) + once-daily PIFELTRO (doravirine)

Amgen Inc. (AMGN)

image723

 Eyenovia's micro-dose latanoprost shows positive effect in mid-stage study

Nov. 28, 2018 4:33 PM ET|By: Douglas W. House, SA News Editor  

XALATAN is a prescription medication for the treatment of high eye pressure/intraocular pressure (IOP) in people with open-angle glaucoma or ocular hypertension.

Amgen Inc. (AMGN)

ALKS 3831 (olanzapine/samidorphan)

Amgen Inc. (AMGN)

image724

 Amgen opts in on second cancer program with Nuevolution

Nov. 29, 2018 6:55 AM ET|About: Amgen Inc. (AMGN)|By: Douglas W. House, SA News Editor  

Nuevolution has developed a proprietary drug discovery platform Chemetics®, a unique, patent protected hybrid of proven wet chemistry and molecular biology, which represents the ultimate drug discovery platform for both identification and optimization of hits to drug candidates. Chemetics® enables DNA encoded synthesis of billions of chemically diverse (different) drug-like small molecule compounds, and the efficient screening and optimization of these, facilitating effective identification of drug candidates at an unprecedented speed and scale.

ALKS 3831 (olanzapine/samidorphan)

ALKS 3831 (olanzapine/samidorphan)

ALKS 3831 (olanzapine/samidorphan)

image725

 Alkermes Announces Positive Topline Results From ENLIGHTEN-2 Phase 3 Study of ALKS 3831 in Patients With Schizophrenia

Thu November 29, 2018 7:01 AM|PR Newswire|About: ALKS 

Alkermes Announces Positive Topline Results From ENLIGHTEN-2 Phase 3 Study of ALKS 3831 in Patients With Schizophrenia -- ALKS 3831 Met Both Co-Primary Endpoints, Demonstrating a Favorable Weight Profile Compared to Olanzapine -- -- Company Plans to Submit New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) in Mid-2019 - DUBLIN, Nov. 29, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS)

Varian (VAR)

ALKS 3831 (olanzapine/samidorphan)

ALKS 3831 (olanzapine/samidorphan)

image726

 Varian Halcyon Treatment System Receives China NMPA Approval

Wed November 28, 2018 4:10 PM|PR Newswire|About: VAR 

Varian hardware, software, and professional services for radiation treatments are widely used on a global basis. There are more than 7,200 linear accelerators, 3,300 treatment planning sites, and 3,000 ARIA® sites in use worldwide. We continue to innovate and offer products and services that integrate into the complete treatment process, so an entire department can come together for the one common goal: treating cancer.

seeking biotech alpha November 2018 insight

ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab)

ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab)

ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab)

image727

 FDA Approves the ACTPen for Genentech’s Actemra, a Single-Dose, Prefilled Autoinjector for the Treatment of Rheumatoid Arthritis, Giant Cell Arteritis and Two Forms of Juvenile Arthritis

Mon November 26, 2018 11:35 AM|Business Wire|About: CHGCY, RHHBY 

ACTEMRA® (tocilizumab) was the first RA treatment to directly block the action of a protein in your body called interleukin-6 (IL-6). This protein is believed to play a part in RA.

EPIDIOLEX (cannabidiol)

ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab)

ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab)

image728

 GW Pharma's Epidiolex successful in second late-stage study in Dravet syndrome

Nov. 26, 2018 7:16 AM ET|About: GW Pharmaceuticals plc (GWPH)|By: Douglas W. House, SA News Editor 

GW Pharmaceuticals Announces Second Positive Phase 3 Pivotal Trial for EPIDIOLEX® (cannabidiol) oral solution CV in Patients with Dravet Syndrome November 26, 2018 LONDON, Nov. 26, 2018 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: “GWP,” “GW,” “the Company” or “the Group”)

NeuVax (nelipepimut-S), combined with Roche's (RHHBY) Herceptin (trastuzumab)

ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab)

NeuVax (nelipepimut-S), combined with Roche's (RHHBY) Herceptin (trastuzumab)

image729

 Opthea completes enrollment in mid-stage study of OPT-302 in wet AMD

Nov. 26, 2018 11:48 AM ET|About: Opthea Limited ADR (CKDXY)|By: Douglas W. House, SA News Editor  

NeuVax (nelipepimut-S) is an investigational immunotherapy being developed by Galena Biopharma to treat human epidermal growth factor 2 (HER2)-associated breast cancers.

Zymeworks’ Azymetric™ and EFECT™

Zymeworks’ Azymetric™ and EFECT™

NeuVax (nelipepimut-S), combined with Roche's (RHHBY) Herceptin (trastuzumab)

image730

 Zymeworks and BeiGene Announce License and Collaboration Agreement for Zymeworks’ HER2-Targeted Therapeutic Candidates, ZW25 and ZW49, in Asia-Pacific and Research and License Agreement for Zymeworks’ Azymetric™ and EFECT™ Platforms Globally

Tue November 27, 2018 6:30 AM|Business Wire|About: BGNE, ZYME 

Zymeworks and BeiGene Announce License and Collaboration Agreement for Zymeworks’ HER2-Targeted Therapeutic Candidates, ZW25 and ZW49, in Asia-Pacific and Research and License Agreement for Zymeworks’ Azymetric™ and EFECT™ Platforms Globally November 27, 2018 06:30 AM Eastern Standard Time VANCOUVER, Canada & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zymeworks Inc. (NYSE/TSX: ZYME) and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160)

Vitrakvi® (larotrectinib)

Zymeworks’ Azymetric™ and EFECT™

Vitrakvi® (larotrectinib)

image731

 FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion(1,2)

Mon November 26, 2018 7:16 PM|GlobeNewswire|About: LOXO 

FDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor, for Patients with Advanced Solid Tumors Harboring an NTRK Gene Fusion(1,2) WHIPPANY, N.J. and STAMFORD, Conn., Nov. 26, 2018 /PRNewswire/

bb2121

Zymeworks’ Azymetric™ and EFECT™

Vitrakvi® (larotrectinib)

image732

 Celgene Corporation and bluebird bio Complete Enrollment of Pivotal KarMMa Study of anti-BCMA Car T Cell Therapy bb2121 in Patients with Relapsed and Refractory Multiple Myeloma

Tue November 27, 2018 7:30 AM|Business Wire|About: BLUE, CELG

SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Celgene Corporation (CELG) and bluebird bio, Inc. (BLUE)

Celgene Corporation and bluebird bio Complete Enrollment of Pivotal KarMMa Study of anti-BCMA Car T Cell Therapy bb2121 in Patients with Relapsed and Refractory Multiple Myeloma November 27, 2018 07:30 AM Eastern Standard Time SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Celgene Corporation (Nasdaq: CELG) and bluebird bio, Inc. (Nasdaq: BLUE)

seeking biotech alpha August 2019 & November 2018 insight

HUMIRA® (adalimumab)

Empliciti (elotuzumab), in combination with Celgene's Pomalyst (pomalidomide) and dexamethason

Empliciti (elotuzumab), in combination with Celgene's Pomalyst (pomalidomide) and dexamethason

image733

 November 6, 2018

AbbVie Announces HUMIRA® (adalimumab) Global Patent License with Momenta

 NORTH CHICAGO, Ill., Nov. 6, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV) 

HUMIRA is a prescription medicine used: To reduce the signs and symptoms of: Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines. Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Ankylosing spondylitis (AS) in adults. Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab. Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.

Empliciti (elotuzumab), in combination with Celgene's Pomalyst (pomalidomide) and dexamethason

Empliciti (elotuzumab), in combination with Celgene's Pomalyst (pomalidomide) and dexamethason

Empliciti (elotuzumab), in combination with Celgene's Pomalyst (pomalidomide) and dexamethason

image734

 FDA OKs Bristol-Myers Squibb's Empliciti for treatment-resistant myeloma

Nov. 6, 2018 4:51 PM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor 

U.S. Food and Drug Administration Approves Empliciti® (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma TUESDAY, NOVEMBER 6, 2018 4:34 PM EST #FDA approves $BMY therapy for certain previously treated patients with #MultipleMyeloma. PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY)

Johnson & Johnson Vision

Empliciti (elotuzumab), in combination with Celgene's Pomalyst (pomalidomide) and dexamethason

Johnson & Johnson Vision

image735

 Two Studies Measure Performance of ACUVUE OASYS with Transitions Light Intelligent Technology Contact Lenses in Simulated Sunlight, Day and Night Driving Conditions

Tue November 6, 2018 9:19 AM|PR Newswire|About: JNJ 

This year, we are excited to showcase our newest innovation, ACUVUE® OASYS with Transitions™ Light Intelligent Technology™, through interactive experiences in our booth. Stop by to see the newest in contact lens innovation! Try ACUVUE® Brand Contact Lenses

ALKS 4230

anti-CEA CAR-T utilizing a Pressure-Enabled Drug Delivery (PEDD) by TriSalus™ Life Sciences.

Johnson & Johnson Vision

image736

 Alkermes Presents New Data on ALKS 4230 at Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting

Tue November 6, 2018 8:01 AM|PR Newswire|About: ALKS 

Alkermes Presents New Data on ALKS 4230 at Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting -- Initial Clinical Data From Ongoing Monotherapy Dose-Escalation Stage of Phase 1 Study to be Presented --

anti-CEA CAR-T utilizing a Pressure-Enabled Drug Delivery (PEDD) by TriSalus™ Life Sciences.

anti-CEA CAR-T utilizing a Pressure-Enabled Drug Delivery (PEDD) by TriSalus™ Life Sciences.

anti-CEA CAR-T utilizing a Pressure-Enabled Drug Delivery (PEDD) by TriSalus™ Life Sciences.

image737

 Sorrento Therapeutics Anti-CEA CAR-T Demonstrates Significant Therapeutic Activity With Increased Overall Survival in Pancreatic Cancer Patients With Liver Metastases

Tue November 6, 2018 8:01 AM|GlobeNewswire|About: SRNE 

 SAN DIEGO, Nov. 06, 2018 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (SRNE) ("Sorrento") 

Sorrento Therapeutics Anti-CEA CAR-T Demonstrates Significant Therapeutic Activity With Increased Overall Survival in Pancreatic Cancer Patients With Liver Metastases Nov 6, 2018 at 8:01 AM EST

Insulet Corporation’s Omnipod® DASH™ Insulin Management System

anti-CEA CAR-T utilizing a Pressure-Enabled Drug Delivery (PEDD) by TriSalus™ Life Sciences.

anti-CEA CAR-T utilizing a Pressure-Enabled Drug Delivery (PEDD) by TriSalus™ Life Sciences.

image738

 TUV Rheinland OpenSky helps insulin pump by Insulet achieve cybersecurity certification by DTSec

Tue November 6, 2018 11:59 AM|GlobeNewswire|About: PODD 

 COLOGNE, Germany and LITTLETON, Mass., Nov. 06, 2018 (GLOBE NEWSWIRE)  


 

Insulet (PODD) Presents At Canaccord Genuity Growth Conference - Slideshow

Aug. 13, 2019 2:31 PM ET | About: Insulet Corporation (PODD) 

 https://seekingalpha.com/article/4285220-insulet-podd-presents-canaccord-genuity-growth-conference-slideshow 

OMNIPOD® DELIVERY SYSTEM Customizable delivery for complex drug regimens

seeking biotech alpha August 2019 & November 2018 insight

Rozlytrek™ (entrectinib)

ibrutinib (Imbruvica®) & venetoclax (Venclexta®

Rozlytrek™ (entrectinib)

image739

  

FDA Approves Genentech’s Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors

Thu August 15, 2019 4:10 PM|Business Wire|About: RHHBY

– First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer that has spread to the brain –

– Genentech’s first FDA-approved tumor-agnostic medicine –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)


 https://www.gene.com/download/pdf/rozlytrek_prescribing.pdf 

ROZLYTREK™ (ENTRECTINIB) -ROZLYTREK is a prescription medicine used to treat: Adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by an abnormal ROS1 gene. Adults and children 12 years and older with solid tumors (cancer) that: are caused by certain abnormal NTRK genes and have spread or if surgery to remove their cancer is likely to cause severe complications, and there is no satisfactory alternative treatment option or the cancer grew or spread on other treatment.

Medtronic plc (MDT)

ibrutinib (Imbruvica®) & venetoclax (Venclexta®

Rozlytrek™ (entrectinib)

image740

 Medtronic Q2 revenues up 6%; non-GAAP EPS up 14%; raises revenue growth guidance

Nov. 20, 2018 7:10 AM ET|About: Medtronic plc (MDT)|By: Mamta Mayani, SA News Editor  

Medtronic Reports Second Quarter Financial Results Revenue of $7.5 Billion Increased 6.1% Reported; Increased 7.5% Organic GAAP Diluted EPS of $0.82; Non-GAAP Diluted EPS of $1.22 Cash Flow from Operations of $2.9 Billion in First Six Months vs. $1.6 Billion in Prior Year; Free Cash Flow of $2.4 Billion in First Six Months vs. $1.1 Billion in Prior Year Company Increases FY19 Organic Revenue Growth Guidance DUBLIN - November 20, 2018 - Medtronic plc (NYSE: MDT)

ibrutinib (Imbruvica®) & venetoclax (Venclexta®

ibrutinib (Imbruvica®) & venetoclax (Venclexta®

ibrutinib (Imbruvica®) & venetoclax (Venclexta®

image741

 AbbVie to Highlight Breadth of Innovative Science and Ongoing Commitment to Blood Cancer Patients with New Data From Studies of Ibrutinib and Venetoclax at 2018 American Society of Hematology Annual Meeting & Exposition

Tue November 20, 2018 8:32 AM|PR Newswire|About: ABBV 

UPDATED AbbVie to Highlight Breadth of Innovative Science and Ongoing Commitment to Blood Cancer Patients with New Data From Studies of Ibrutinib and Venetoclax at 2018 American Society of Hematology Annual Meeting & Exposition NORTH CHICAGO, Ill., Nov. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV),

AVYCAZ (ceftazidime and avibactam)

AVYCAZ (ceftazidime and avibactam)

ibrutinib (Imbruvica®) & venetoclax (Venclexta®

image742

 FDA accepts Allergan's sNDA for AVYCAZ

Nov. 20, 2018 7:54 AM ET|About: Allergan plc (AGN)|By: Mamta Mayani, SA News Editor  

AVYCAZ® is indicated for the treatment of HABP/VABP, cUTI (including pyelonephritis), and cIAI (in combination with metronidazole) caused by designated susceptible microorganisms.

MDT, MZOR, MZRTF

AVYCAZ (ceftazidime and avibactam)

MDT, MZOR, MZRTF

image743

 Mazor Robotics Shareholders Approve Merger Agreement With Medtronic

Mon November 19, 2018 5:30 PM|PR Newswire|About: MDT, MZOR, MZRTF 

Mazor Robotics Shareholders Approve Merger Agreement With Medtronic CAESAREA, Israel, Nov. 19, 2018 /PRNewswire/ -- Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR),

reSET®

AVYCAZ (ceftazidime and avibactam)

MDT, MZOR, MZRTF

image744

 Sandoz and Pear Therapeutics announce launch of reSET® for treatment of patients with Substance Use Disorder

Mon November 19, 2018 6:46 PM|GlobeNewswire|About: NVS 

Pear Therapeutics THE LEADER IN PRESCRIPTION DIGITAL THERAPEUTICS SANDOZ AND PEAR THERAPEUTICS ANNOUNCE LAUNCH OF RESET® FOR TREATMENT OF PATIENTS WITH SUBSTANCE USE DISORDER reSET® is the first and only FDA-authorized prescription digital therapeutic for Substance Use Disorder (SUD) Adding reSET to outpatient therapy significantly improved abstinence in substances of abuse and treatment retention compared to standard of care alone

seeking biotech alpha August 2019 & November 2018 insight

Entresto (sacubitril/valsartan)

Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI) and (JNJ) Vision

Entresto (sacubitril/valsartan)

image745

 Novartis' Entresto beats enalapril in heart failure study

Nov. 12, 2018 7:46 AM ET|About: Novartis AG (NVS)|By: Douglas W. House, SA News Editor  

ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. ENTRESTO is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.

Impella CP®

Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI) and (JNJ) Vision

Entresto (sacubitril/valsartan)

image746

 FDA Safety Study of Unloading the Left Ventricle for 30 Minutes Prior to Reperfusion in Heart Attack Patients is Safe and Feasible

Abiomed will initiate pivotal randomized controlled trial with FDA

CHICAGO--(BUSINESS WIRE)--Nov. 11, 2018-- Abiomed (NASDAQ: ABMD)

The Impella CP® heart pump pulls blood from the left ventricle through an inlet area near the tip and expels blood from the catheter into the ascending aorta. The increased flow of the Impella CP is delivered on the same platform as the Impella 2.5®.

Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI) and (JNJ) Vision

Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI) and (JNJ) Vision

Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI) and (JNJ) Vision

image747

 Singapore National Eye Centre, Singapore Eye Research Institute And Johnson & Johnson Vision Set Sights On Halting Global Myopia Epidemic

Mon November 12, 2018 1:30 AM|PR Newswire|About: JNJ 

 SINGAPORE, Nov. 12, 2018 /PRNewswire/ 

New US$26.35 Million Collaboration Seeks Prevention and Treatment Solutions to Address Rising Burden of Condition SINGAPORE, Nov. 12, 2018 /PRNewswire/ -- The Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI) and Johnson & Johnson Vision today announced a US$26.35 million (S$36.35 million) research collaboration to tackle myopia, or nearsighted vision, the largest threat to eye health this century

Approval Marks 14th Indication for KEYTRUDA

filgotinib, an investigational, oral, selective JAK1 inhibitor

Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI) and (JNJ) Vision

image748

 FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib

Fri November 9, 2018 4:21 PM|Business Wire|About: MRK 

KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen any time during treatment or even after your treatment has ended.

Illumina (ILMN)

filgotinib, an investigational, oral, selective JAK1 inhibitor

filgotinib, an investigational, oral, selective JAK1 inhibitor

image749

 Illumina’s Growth Shows No Signs of Slowing Down

Illumina's recent acquisition of Pacific Biosciences of California strongly strengthens its product offering and ensures growth for years to come

 Maxwell Koobatian 

 November 12, 2018 | About: ILMN +0% PAC 

Sequencing and array-based solutions for analysis of genetic variation and function, in fields ranging from cancer research to agriculture

filgotinib, an investigational, oral, selective JAK1 inhibitor

filgotinib, an investigational, oral, selective JAK1 inhibitor

filgotinib, an investigational, oral, selective JAK1 inhibitor

image750

 

European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis

Thu August 15, 2019 4:01 PM|Business Wire|About: GILD, GLPG

FOSTER CITY, Calif. & MECHELEN, Belgium--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) and Galapagos NV (GLPGF) (Euronext & NASDAQ: GLPG) 

July 01, 2019 Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 1, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD)

seeking biotech alpha August 2019 & November 2018 insight

DSUVIA™

Kymriah® (tisagenlecleucel)

LORBRENA® (lorlatinib)

image751

AcelRx announces FDA approval of DSUVIA™ 

 REDWOOD CITY, Calif., Nov. 2, 2018 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX),  

  AcelRx Pharmaceuticals... (ACRX) 

DSUVIA (sufentanil sublingual tablet, 30 mcg) is an investigational product candidate consisting of 30 mcg sufentanil in small sublingually absorbed tablets that are delivered via a disposable, pre-filled, single-dose applicator (SDA). AcelRx is developing DSUVIA for the management of moderate-to-severe acute pain in a variety of medically supervised settings, including in emergency medicine, outpatient or ambulatory surgery, non-surgical patients experiencing pain in the hospital, or post-operative patients, following short-stay surgery, who do not require more long-term analgesia.

LORBRENA® (lorlatinib)

Kymriah® (tisagenlecleucel)

LORBRENA® (lorlatinib)

image752

 U.S. FDA Approves LORBRENA® (lorlatinib) for Previously-Treated ALK-Positive Metastatic NSCLC

Fri November 2, 2018 4:42 PM|Business Wire|About: PFE 

LORBRENA® (lorlatinib) U.S. FDA Approves LORBRENA® (lorlatinib) for Previously-Treated ALK-Positive Metastatic NSCLC November 02, 2018 04:42 PM Eastern Daylight Time NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE)

Kymriah® (tisagenlecleucel)

Kymriah® (tisagenlecleucel)

evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody

image753

 Novartis data at ASH and SABCS show strength of pipeline and portfolio in hematology and oncology

Fri November 2, 2018 5:27 PM|PR Newswire|About: NVS 

 EAST HANOVER, N.J., Nov. 2, 2018 /PRNewswire/  

KYMRIAH is made from your own white blood cells and is a prescription cancer treatment used in patients up to 25 years old who have acute lymphoblastic leukemia (ALL) that is either relapsing (went into remission, then came back) or is refractory (did not go into remission after receiving other leukemia treatments). It is also used in patients with non-Hodgkin lymphoma that has relapsed or is refractory after having at least two other kinds of treatment.

evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody

evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody

evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody

image754

  August 14, 2019 at 7:00 AM EDT Back

REGENERON ANNOUNCES POSITIVE TOPLINE RESULTS FROM PHASE 3 TRIAL OF EVINACUMAB IN PATIENTS WITH SEVERE, INHERITED FORM OF HIGH CHOLESTEROL

TARRYTOWN, N.Y., Aug. 14, 2019 /PRNewswire/ --

Adding evinacumab reduced LDL cholesterol by 49% in patients with homozygous familial hypercholesterolemia, compared to lipid-lowering therapies alone

Evinacumab was generally well-tolerated, and all evinacumab patients completed the six-month treatment period

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN

pipeline of investigational product candidates strives to address many serious medical conditions including asthma, pain, cancer and infectious diseases.

SOLIRIS® (eculizumab)

evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody

SOLIRIS® (eculizumab)

image755

 

European Commission Approves SOLIRIS® (eculizumab) For the Treatment of Adults with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Tue August 27, 2019 8:30 AM|Business Wire|About: ALXN

 - SOLIRIS® (eculizumab) is the first and only approved medication for NMOSD in Europe -

- 98% of adult anti-aquaporin-4 (AQP4) antibody-positive patients treated with SOLIRIS were relapse free compared to 63% receiving placebo at 48 weeks -

BOSTON--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (ALXN) 

Soliris® (eculizumab) is the first and only medication approved by the FDA to treat adults with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

Pamiparib (BGB-290)

evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody

SOLIRIS® (eculizumab)

image756

 BeiGene to Present Clinical Data on PARP Inhibitor Pamiparib at Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology

Mon November 5, 2018 7:00 AM|GlobeNewswire|About: BGNE 

Pamiparib (BGB-290) = Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP–DNA complex trapping in preclinical models.

seeking biotech alpha November 2018 insight

BLINCYTO® (Blinatumomab)

Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab)

ADCETRIS® (Brentuximab Vedotin)

image757

 Amgen Receives CHMP Positive Opinion To Expand Use Of BLINCYTO® (Blinatumomab) In Patients With Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia

Fri November 16, 2018 9:00 AM|PR Newswire|About: AMGN 

BLINCYTO® (blinatumomab) is a prescription medicine used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in patients who still have detectable traces of cancer after chemotherapy. The approval of BLINCYTO® in these patients is based on a study that measured response rate and duration of response. There are ongoing studies to confirm clinical benefit. BLINCYTO® (blinatumomab) is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) in adults and children. ALL is a cancer of the blood and bone marrow in which a particular kind of white blood cell is replicating out of control.

ADCETRIS® (Brentuximab Vedotin)

Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab)

ADCETRIS® (Brentuximab Vedotin)

image758

 Seattle Genetics Announces FDA Approval of ADCETRIS® (Brentuximab Vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas

Fri November 16, 2018 10:52 AM|Business Wire|About: SGEN 

ADCETRIS® (brentuximab vedotin) is approved for the treatment of: Previously untreated Stage 3 or 4 classical Hodgkin lymphoma (cHL): Adult patients with newly diagnosed Stage 3 or 4 cHL in combination with chemotherapy Consolidation therapy in cHL: Adult patients with cHL at high risk of coming back or becoming worse after a stem cell transplant (SCT) Relapsed cHL: Adult patients with cHL after an SCT fails or after at least 2 combination chemotherapy treatments fail and SCT is not an option Relapsed systemic anaplastic large cell lymphoma (sALCL): Adult patients with sALCL after at least 1 combination chemotherapy treatment fails Relapsed primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF): Adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy (treatment that reaches and affects the entire body)

Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab)

Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab)

Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab)

image759

 Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab) as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

Thu November 15, 2018 4:30 PM|Business Wire|About: BMY 

Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab) as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma Recommendation based on results from the Phase 3 CheckMate -214 clinical trial November 15, 2018 04:30 PM Eastern Standard Time PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY)

ACUVUE OASYS

PARP inhibitor pamiparib, combined with radiation therapy and/or the chemo agent temozolomide

Opdivo® (nivolumab) Plus Low-Dose Yervoy® (ipilimumab)

image760

 ACUVUE OASYS with Transitions Light Intelligent Technology Named Among TIME's 'Best Inventions of 2018'

Fri November 16, 2018 7:03 AM|PR Newswire|About: JNJ 

 JACKSONVILLE, Fla., Nov. 16, 2018 /PRNewswire/ 

ACUVUE OASYS with Transitions Light Intelligent Technology Named Among TIME's 'Best Inventions of 2018' JACKSONVILLE, Fla., Nov. 16, 2018 /PRNewswire/

Agilent Technologies Inc (A)

PARP inhibitor pamiparib, combined with radiation therapy and/or the chemo agent temozolomide

PARP inhibitor pamiparib, combined with radiation therapy and/or the chemo agent temozolomide

image761

 Agilent Expands Cell Analysis R&D Capabilities in Ireland

Fri November 16, 2018 11:00 AM|Business Wire|About: A 

Agilent Expands Cell Analysis R&D Capabilities in Ireland New facility incorporates recently acquired Luxcel Biosciences SANTA CLARA, Calif., November 16, 2018 Agilent Technologies Inc. (NYSE: A)

PARP inhibitor pamiparib, combined with radiation therapy and/or the chemo agent temozolomide

PARP inhibitor pamiparib, combined with radiation therapy and/or the chemo agent temozolomide

PARP inhibitor pamiparib, combined with radiation therapy and/or the chemo agent temozolomide

image762

 BeiGene's pamiparib shows positive action in Phase 1/2 brain cancer study

Nov. 16, 2018 7:56 AM ET|About: BeiGene (BGNE)|By: Douglas W. House, SA News Editor  

BeiGene Announces Preliminary Clinical Data on PARP Inhibitor Pamiparib Presented at Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology November 16, 2018 07:00 ET | Source: BeiGene, LTD. CAMBRIDGE, Mass., and BEIJING, China, Nov. 16, 2018 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160)

seeking biotech alpha November 2018 insight

Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel])

Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel])

Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel])

image763

 FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Abraxane for the Initial Treatment of People with PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

Tue November 13, 2018 1:06 AM|Business Wire|About: RHHBY 

FDA Grants Priority Review to Genentech’s Tecentriq in Combination with Abraxane for the Initial Treatment of People with PD-L1-Positive, Metastatic Triple-Negative Breast Cancer November 13, 2018 01:06 AM SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group

JPOD @ PHILADELPHIA

Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel])

Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel])

image764

      

JPOD   @ Philadelphia officially launched at Pennovation Works
JPOD @ Philadelphia, the first of its kind in the   nation, is a networking hub that includes a secure telecommunications   conferencing system to connect regional innovators to the J&J Innovation   and JLABS network. It's about leveraging the talent-particularly in the health   sciences-that is rampant and unique to Philadelphia, as well as boosting it.
READ MORE › 

 November 13, 2018

 

Johnson & Johnson Innovation Announces JPOD @ Philadelphia to Accelerate Healthcare Innovation in Philadelphia’s Ecosystem Philadelphia, Pennsylvania, July 18, 2018

GS-9674

Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel])

Bausch Health Companies Inc. (BHC)

image765

 Gilead's GS-9674 shows positive action in mid-stage NASH study

Nov. 9, 2018 8:35 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor  

Gilead Announces Positive Phase 2 Results for GS-9674 in Primary Sclerosing Cholangitis (PSC) at The Liver Meeting® 2018 GS-9674 Granted Orphan Drug Designation by the U.S. Food and Drug Administration – SAN FRANCISCO--(BUSINESS WIRE)--Nov. 9, 2018-- Gilead Sciences, Inc. (Nasdaq: GILD)

Bausch Health Companies Inc. (BHC)

Bausch Health Companies Inc. (BHC)

Bausch Health Companies Inc. (BHC)

image766

 Bausch Health Will Expand Contact Lens Manufacturing Facilities In Rochester, NY And Waterford, Ireland

Tue November 13, 2018 7:00 AM|PR Newswire|About: BHC

LAVAL, Quebec, Nov. 13, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (BHC)

Bausch Health Companies Inc. (BHC) Pipeline Highlights

AKCEA-APO(a)-Lrx

Bausch Health Companies Inc. (BHC)

Intuitive Surgical, Inc. (ISRG)

image767

 Akcea up 3% on positive AKCEA-APO(a)-Lrx data

Nov. 12, 2018 2:08 PM ET|About: Akcea Therapeutics (AKCA)|By: Douglas W. House, SA News Editor  

 collaboration partner Novartis (NVS)  

Phase 2 Study of ISIS 681257 (AKCEA-APO(a)-LRx) in Patients With Hyperlipoproteinemia(a) and Cardiovascular Disease

Intuitive Surgical, Inc. (ISRG)

Bausch Health Companies Inc. (BHC)

Intuitive Surgical, Inc. (ISRG)

image768

 Intuitive Surgical Is Ironman For Doctors

Nov. 12, 2018 9:02 AM ET|8 comments  | About: Intuitive Surgical, Inc. (ISRG) 

 Rob Koyfman 

Intuitive Surgical, Inc. ISRG

seeking biotech alpha November 2018 insight

Opdivo (Nivolumab)

Amgen (AMGN) and Provention Bio, Inc. (PRVB)

Trulicity® (dulaglutide)

image769

 Bristol-Myers Squibb and Infinity Pharmaceuticals Announce a New Clinical Collaboration to Evaluate Opdivo (Nivolumab) in Combination with IPI-549 in Urothelial Cancer

Mon November 5, 2018 6:59 AM|Business Wire|About: BMY, INFI 

OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

Trulicity® (dulaglutide)

Amgen (AMGN) and Provention Bio, Inc. (PRVB)

Trulicity® (dulaglutide)

image770

 Trulicity® (dulaglutide) demonstrates superiority in reduction of cardiovascular events for broad range of people with type 2 diabetes

Mon November 5, 2018 6:45 AM|PR Newswire|About: LLYPR Newswire

INDIANAPOLIS, Nov. 5, 2018 /PRNewswire/ 

Trulicity is a once-weekly injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. It should be used along with diet and exercise

Amgen (AMGN) and Provention Bio, Inc. (PRVB)

Amgen (AMGN) and Provention Bio, Inc. (PRVB)

Amgen (AMGN) and Provention Bio, Inc. (PRVB)

image771

 Amgen And Provention Bio Announce Co-Development Collaboration In Celiac Disease

Mon November 5, 2018 9:00 AM|PR Newswire|About: AMGN, PRVB 

Amgen And Provention Bio Announce Co-Development Collaboration In Celiac Disease Provention to Lead Phase 2b Stage of Development for Anti-IL-15 Antibody AMG 714 Amgen Will Invest $20 Million in Provention Equity

Ocaliva® (obeticholic acid)

ADCETRIS® (Brentuximab Vedotin)

Amgen (AMGN) and Provention Bio, Inc. (PRVB)

image772

 Intercept Announces New OCA Data to be Presented at The Liver Meeting® 2018

Mon November 5, 2018 7:00 AM|GlobeNewswire|About: ICPT 

OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. There are ongoing studies to find out how OCALIVA works over a longer period of time.

JARDIANCE (empagliflozin)

ADCETRIS® (Brentuximab Vedotin)

ADCETRIS® (Brentuximab Vedotin)

image773

 Lilly's Jardiance reduced heart failure hospitalization risk in real-world study

Nov. 5, 2018 7:55 AM ET|By: Douglas W. House, SA News Editor  

JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and also to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

ADCETRIS® (Brentuximab Vedotin)

ADCETRIS® (Brentuximab Vedotin)

ADCETRIS® (Brentuximab Vedotin)

image774

 Seattle Genetics Submits Supplemental Biologics License Application for ADCETRIS® (Brentuximab Vedotin) in Frontline Treatment of CD30-Expressing Peripheral T-Cell Lymphomas

Mon November 5, 2018 8:00 AM|Business Wire|About: SGEN 

ADCETRIS® (brentuximab vedotin) is approved for the treatment of: Previously untreated Stage 3 or 4 classical Hodgkin lymphoma (cHL): Adult patients with newly diagnosed Stage 3 or 4 cHL in combination with chemotherapy Consolidation therapy in cHL: Adult patients with cHL at high risk of coming back or becoming worse after a stem cell transplant (SCT) Relapsed cHL: Adult patients with cHL after an SCT fails or after at least 2 combination chemotherapy treatments fail and SCT is not an option Relapsed systemic anaplastic large cell lymphoma (sALCL): Adult patients with sALCL after at least 1 combination chemotherapy treatment fails Relapsed primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF): Adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy (treatment that reaches and affects the entire body)

seeking biotech alpha November 2018 insight

Abiomed, Inc. (ABMD)

SYMKEVI (tezacaftor/ivacaftor), combined with KALYDECO (ivacaftor)

VENCLYXTO® (venetoclax) Plus Rituximab

image775

 Abiomed Announces Q2 FY 2019 Record Revenue of $182 Million, up 37% Over Prior Year

Thu November 1, 2018 7:00 AM|GlobeNewswire|About: ABMD

DANVERS, Mass., Nov. 01, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (ABMD) 

Nov 01,2018 Abiomed Announces Q2 FY 2019 Record Revenue of $182 Million, up 37% Over Prior Year DANVERS, Mass., Nov. 01, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ: ABMD)

VENCLYXTO® (venetoclax) Plus Rituximab

SYMKEVI (tezacaftor/ivacaftor), combined with KALYDECO (ivacaftor)

VENCLYXTO® (venetoclax) Plus Rituximab

image776

 AbbVie Receives European Commission Approval of VENCLYXTO® (venetoclax) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy

Thu November 1, 2018 12:02 AM|PR Newswire|About: ABBV 

VENCLEXTA is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior treatment.

SYMKEVI (tezacaftor/ivacaftor), combined with KALYDECO (ivacaftor)

SYMKEVI (tezacaftor/ivacaftor), combined with KALYDECO (ivacaftor)

SYMKEVI (tezacaftor/ivacaftor), combined with KALYDECO (ivacaftor)

image777

 Vertex Pharma's Symkevi OK'd in Europe

Nov. 1, 2018 7:05 AM ET|About: Vertex Pharmaceuticals... (VRTX)|By: Douglas W. House, SA News Editor 

SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) is indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence

FARXIGA

umbralisib + ublituximab + Keytruda (pembrolizumab)

SYMKEVI (tezacaftor/ivacaftor), combined with KALYDECO (ivacaftor)

image778

 The Landmark DECLARE-TIMI 58 Cardiovascular Outcomes Trial of FARXIGA in Patients with Type 2 Diabetes to Be Featured at AHA 2018

Thu November 1, 2018 7:00 AM|Business Wire|About: AZN 

 WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca 

FARXIGA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Novo Nordisk A/S (NVO)

umbralisib + ublituximab + Keytruda (pembrolizumab)

umbralisib + ublituximab + Keytruda (pembrolizumab)

image779

 Novo Nordisk Q3 revenues up 4%; 

 Nov. 1, 2018 6:24 AM ET|About: Novo Nordisk A/S (NVO)|By: Mamta Mayani, SA News Editor  

Novo Nordisk's operating profit decreased by 6% in Danish kroner and increased by 2% in local currencies in the first nine months of 2018 Sales decreased by 2% in Danish kroner and increased by 4% in local currencies to USD 13.2 billion.

umbralisib + ublituximab + Keytruda (pembrolizumab)

umbralisib + ublituximab + Keytruda (pembrolizumab)

umbralisib + ublituximab + Keytruda (pembrolizumab)

image780

 TG Therapeutics up 7% on positive umbralisib + ublituximab data

Nov. 1, 2018 11:04 AM ET|By: Douglas W. House, SA News Editor  

 The overall response rate (ORR) was 89% (n=8/9) in BTK-refractory chronic lymphocytic leukemia (CLL) patients receiving the combination of umbralisib + ublituximab + Merck's (MRK +0.1%) Keytruda (pembrolizumab).  

Umbralisib (TGR-1202) is an orally available PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K.

Copyright © 2018 seeking biotech alpha - All Rights Reserved. City Photos from  Pixabay

Powered by GoDaddy Website Builder

  • biotecMAX
  • BioHazard2020-3
  • BioHazard2020-2
  • BioHazard2020-1
  • BioHazard2020-0
  • 2021-1
  • 2020-6
  • 2020-5
  • 2020-4
  • 2020-3
  • 2020-2
  • 2020-1
  • 2019-12
  • 2019-11
  • 2019-10
  • 2019-9
  • 2019-8
  • 2019-7
  • 2019-4
  • 2019-3
  • biotecNOVA 2
  • BiotecNOVA 1
  • biotecHOPE
  • biotecHEART
  • portfolio
  • BiotecDATA
  • biotechVORTEX 2
  • biotechVORTEX 1
  • biotechSTORM/BiotecWARS
  • blogs
  • about

This website uses cookies.

We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.

DeclineAccept