seeking biotech alpha August 2019 & November 2018 insight

KEYTRUDA® (pembrolizumab)

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 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)

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  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.

V920 (rVSV∆G-ZEBOV-GP)

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 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)

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 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

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 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)

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  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

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 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)

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 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

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

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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

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 Medtronic's Valiant Navion stent CE Mark'd

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

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

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

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 Ebola clinical trial to begin in DRC

Nov. 13, 2018 4:49 AM ET|By: , 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)

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 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)

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 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)

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 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)

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 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)

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 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)

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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: , 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)

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 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

Praluent® (alirocumab)

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 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 August 2019 & November 2018 insight

Repatha® (Evolocumab)

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 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

Eli Lilly and Company (LLY)

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 Eli Lilly Q3 revenues up 7%; non-GAAP EPS up 32%; raises revenue and non-GAAP EPS guidance

Nov. 6, 2018 7:15 AM ET|About: Eli Lilly and Company (LLY)|By: , SA News Editor 

Lilly Delivers Solid Third-Quarter 2018 Results, Revises EPS Guidance 11/06/2018

JPOD @ Philadelphia launching in collaboration with the University of Pennsylvania

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 JPOD @ Philadelphia QuickFire Challenge

 Up to $30K + Lab space + Mentorship 

 JPOD @ Philadelphia launching in collaboration with the University of Pennsylvania 

The premier life science incubator empowering and enabling innovators to deliver life-enhancing health and wellness solutions to people around the globe.

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

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 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.

seeking biotech alpha August 2019 & November 2018 insight

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

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 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)

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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)

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 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)

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 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: , 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

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 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

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 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

Tivicay (dolutegravir) + lamivudine

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

Nov. 19, 2018 7:14 AM ET|By: , 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™

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 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)

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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®

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 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)

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

Nov. 19, 2018 7:46 AM ET|By: , 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)

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 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)

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 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)

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 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

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 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®

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 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

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 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

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FDA Approves EYLEA® (aflibercept) Injection Prefilled Syringe

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

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

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 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)

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 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).

DRG Invisible Trial System

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 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

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 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

LUXTURNA® (voretigene neparvovec)

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 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.

Bristol-Myers Squibb (BMY)

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 Bristol-Myers Squibb Awards “Golden Tickets” for LabCentral to ReviveMed, Strand Therapeutics

Mon November 26, 2018 6:59 AM|Business Wire|About: BMY

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (BMY) (NYSE: BMY) and LabCentral

Bristol-Myers Squibb Awards “Golden Tickets” for LabCentral to ReviveMed, Strand Therapeutics

seeking biotech alpha November 2018 insight

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

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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

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

Nov. 28, 2018 4:33 PM ET|By: , 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.

seeking biotech alpha November 2018 insight

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

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 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.

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

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 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: , 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™

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 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)

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 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

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 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

Johnson & Johnson Vision

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 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

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 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.

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 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

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 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)

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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.

ibrutinib (Imbruvica®) & venetoclax (Venclexta®

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 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),

MDT, MZOR, MZRTF

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 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),

seeking biotech alpha August 2019 & November 2018 insight

Impella CP®

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 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

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 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

Illumina (ILMN)

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 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

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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

LORBRENA® (lorlatinib)

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 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)

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

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  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.

Pamiparib (BGB-290)

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 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

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

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 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

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 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)

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 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)

seeking biotech alpha November 2018 insight

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

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 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

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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

Bausch Health Companies Inc. (BHC)

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 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

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

Nov. 12, 2018 2:08 PM ET|About: Akcea Therapeutics (AKCA)|By: , 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)

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 Intuitive Surgical Is Ironman For Doctors

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

  

Intuitive Surgical, Inc. ISRG

seeking biotech alpha November 2018 insight

Trulicity® (dulaglutide)

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 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)

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 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

seeking biotech alpha November 2018 insight

Abiomed, Inc. (ABMD)

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 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

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 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.

FARXIGA

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 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.

umbralisib + ublituximab + Keytruda (pembrolizumab)

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 TG Therapeutics up 7% on positive umbralisib + ublituximab data

Nov. 1, 2018 11:04 AM ET|By: , 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.