seeking biotech alpha March 2019 insight

BOTOX® (onabotulinumtoxinA)

image1

FDA Accepts Supplemental Biologics License Applications (sBLAs) for BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper and Lower Limb Spasticity

Thu March 7, 2019 8:00 AM|PR Newswire|About: AGNPR Newswire

DUBLIN, March 7, 2019 /PRNewswire/ -- Allergan plc (AGN)

DUBLIN, March 7, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) FDA Accepts Supplemental Biologics License Applications (sBLAs) for BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper and Lower Limb Spasticity Applications Seek to Extend Use of BOTOX® for Patients 2 to 17 Years Old NEWS PROVIDED BY Allergan plc Mar 07, 2019, 08:00 ET

Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide)

image2

 Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance

Wed March 6, 2019 5:30 PM|Business Wire|About: GILD

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

March 06, 2019 Gilead Presents Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) in Virologically Suppressed Adults, Including Those With Pre-Existing NRTI Resistance FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 6, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD)

Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide)

image3

Gilead Presents New Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) and TAF-Based Regimens for the Treatment of HIV-1 in Children, Older Adults and Women

Wed March 6, 2019 5:30 PM|Business Wire|About: GILD

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD)

March 06, 2019 Gilead Presents New Data on Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) and TAF-Based Regimens for the Treatment of HIV-1 in Children, Older Adults and Women FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 6, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD)

human leukocyte antigen or HLA type with Bria-IMT’s cell line

image4

BriaCell Therapeutics Corp. Highlights Recent Clinical and Scientific Achievements in Exclusive Audio Interview with NetworkNewsWire

Thu March 7, 2019 6:30 AM|GlobeNewswire|About: BCTXF, MRK 

BriaCell Therapeutics Corp. Highlights Recent Clinical and Scientific Achievements in Exclusive Audio Interview with NetworkNewsWire POSTED ON MARCH 7, 2019 BY FARRAH DEAN NEW YORK, March 07, 2019 (GLOBE NEWSWIRE) — via NetworkWire

fifth Breakthrough Therapy Designation (BTD) to venetoclax,

image5

 AbbVie Announces Multiple Milestones for Phase 3 CLL14 Venetoclax Study of Fixed Duration Treatment in Previously-Untreated Chronic Lymphocytic Leukemia Patients

Thu March 7, 2019 8:46 AM|PR Newswire|About: ABBV 

March 7, 2019 AbbVie Announces Multiple Milestones for Phase 3 CLL14 Venetoclax Study of Fixed Duration Treatment in Previously-Untreated Chronic Lymphocytic Leukemia Patients

seeking biotech alpha March 2019 insight

Array BioPharma Inc. (ARRY)

image8

Array BioPharma Inc. 2019 Q2 - Results - Earnings Call Slides

Feb. 5, 2019 1:43 PM ET  | About: Array BioPharma Inc. (ARRY) 

OUR PIPELINE

seeking biotech alpha March 2019 insight

Fedratinib is a highly selective JAK2 inhibitor

image11

U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis

Tue March 5, 2019 7:30 AM|Business Wire|About: CELG 

U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis March 05, 2019 SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG)

Emgality® (galcanezumab-gnlm)

image12

 Lilly Receives FDA Priority Review Designation for Emgality® (galcanezumab-gnlm) Injection for the Preventive Treatment of Episodic Cluster Headache in Adults

Tue March 5, 2019 6:45 AM|PR Newswire|About: LLY 

Lilly Receives FDA Priority Review Designation for Emgality® (galcanezumab-gnlm) Injection for the Preventive Treatment of Episodic Cluster Headache in Adults 03/05/2019 INDIANAPOLIS, March 5, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)

Alinity ci-series

image13

Abbott's Latest Diagnostics Technology, Alinity, Selected by Regional Medical Laboratory, Inc. to Deliver Benefits to Hospitals and Patients

Tue March 5, 2019 9:00 AM|PR Newswire|About: ABT 

ALINITY SYSTEMS AND PATIENT CARE How diagnostic tests serve as a compass for healthcare

immune tolerance therapy

image15

AnTolRx Announces Pfizer Exercises Option To License Immune Tolerance Therapy For Potential Treatment Of Type 1 Diabetes

Tue March 5, 2019 10:05 AM|PR Newswire|About: PFE

CAMBRIDGE, Mass., March 5, 2019 /PRNewswire/ -- AnTolRx, Inc., a private biotechnology company and a leader in immune tolerance

AnTolRx Announces Pfizer Exercises Option To License Immune Tolerance Therapy For Potential Treatment Of Type 1 Diabetes CAMBRIDGE, Mass., March 5, 2019 /PRNewswire/ -- AnTolRx, Inc., a private biotechnology company and a leader in immune tolerance, today announced that Pfizer Inc. (NYSE: PFE)

seeking biotech alpha March 2019 insight

Cosentyx® 300mg (secukinumab)

 Novartis' Cosentyx shows positive effect in Chinese psoriasis patients

Mar. 4, 2019 7:27 AM ET|About: Novartis AG (NVS)|By: , SA News Editor  

Novartis data confirm rapid response and high efficacy of Cosentyx® in psoriasis patients for first time in China Mar 04, 2019 Basel, March 4, 2019

KEYTRUDA® (pembrolizumab)

image18

European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) for Six-Week Dosing Schedule Across All Current Monotherapy Indications

Mon March 4, 2019 6:45 AM|Business Wire|About: MRK

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

European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) for Six-Week Dosing Schedule Across All Current Monotherapy Indications March 04, 2019 06:45 AM Eastern Standard Time KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK),

BXCL701, Nektar’s NKTR-214 and avelumab

image21

BioXcel Therapeutics Announces Addition of Merck KGaA, Darmstadt, Germany, and Pfizer to Clinical Collaboration with Nektar for Development of Triple-combination Therapy in Pancreatic Cancer

Mon March 4, 2019 8:00 AM|GlobeNewswire|About: BTAI, NKTR, PFE

Clinical partnership to evaluate triple combination of BioXcel Therapeutics’ BXCL701, Nektar’s NKTR-214 and avelumab (Merck KGaA, Darmstadt, Germany and Pfizer (PFE)) in pancreatic cancer

Merck KGaA, Darmstadt, Germany and Pfizer to supply checkpoint inhibitor immunotherapy, avelumab

NEW HAVEN, Conn., March 04, 2019 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI”) (Nasdaq: BTAI)

PIPELINE We are leveraging our artificial intelligence and big data capabilites to develop a pipeline of product candidates with a high probability of success in immuno-oncology, neurosciences, and rare diseases. List of development programs of our portfolio companies.

seeking biotech alpha March 2019 insight

LORVIQUA® (lorlatinib)

image24

 Pfizer Receives Positive CHMP Opinion for LORVIQUA® (lorlatinib) for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer

Fri March 1, 2019 8:35 AM|Business Wire|About: PFE 

PFIZER RECEIVES POSITIVE CHMP OPINION FOR LORVIQUA® (LORLATINIB) FOR CERTAIN ADULT PATIENTS WITH PREVIOUSLY-TREATED ALK-POSITIVE ADVANCED NON-SMALL CELL LUNG CANCER Friday, March 1, 2019 - 8:35am EST

NKTR-262, (TLR) 7/8 agonist, in combination w/ bempegaldesleukin* (NKTR-214 or bempeg),

image25

 Nektar Therapeutics Presents Preliminary Immune Activation, Safety and Clinical Activity Data from the Ongoing Dose-Escalation Stage of the REVEAL Study at 2019 ASCO-SITC Meeting

Fri March 1, 2019 4:40 PM|PR Newswire|About: NKTR 

Nektar Therapeutics Presents Preliminary Immune Activation, Safety and Clinical Activity Data from the Ongoing Dose-Escalation Stage of the REVEAL Study at 2019 ASCO-SITC Meeting SAN FRANCISCO, March 1, 2019 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR)

Flector® Patch (diclofenac epolamine topical patch)

image27

 Teva Announces Launch of an Authorized Generic of Flector® Patch (diclofenac epolamine topical patch) in the United States

Fri March 1, 2019 4:08 PM|Business Wire|About: TEVA 

Teva Announces Launch of an Authorized Generic of Flector® Patch (diclofenac epolamine topical patch) in the United States March 01, 2019 04:08 PM Eastern Standard Time JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA

seeking biotech alpha March 2019 insight

Fiasp® (insulin aspart injection) 100 u/mL

image29

Novo Nordisk files for a label update for Fiasp® to the EMA and the FDA seeking approval for use in children and adolescents

Fri March 1, 2019 7:00 AM|PR Newswire|About: NVO 

Novo Nordisk files for a label update for Fiasp® to the EMA and the FDA seeking approval for use in children and adolescents PLAINSBORO, N.J., March 1, 2019 /PRNewswire/ -- Novo Nordisk

SKYRIZI™ (risankizumab), an investigational interleukin-23 (IL-23) inhibitor

image30

 March 1, 2019

AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI™) for the Treatment of Moderate to Severe Plaque Psoriasis

 NORTH CHICAGO, Ill., March 1, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV) 


 NORTH CHICAGO, Ill., March 1, 2019 /PRNewswire/ -- AbbVie 

ABBV, -0.21% 

AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI™) for the Treatment of Moderate to Severe Plaque Psoriasis Published: Mar 1, 2019 7:00 a.m. ET NORTH CHICAGO, Ill., March 1, 2019 /PRNewswire/ -- AbbVie ABBV,

ZynquistaTM* (sotagliflozin)

image31

 Sanofi : CHMP recommends ZynquistaTM (sotagliflozin) for the treatment of adults with type 1 diabetes

Fri March 1, 2019 8:01 AM|GlobeNewswire|About: SNY 

Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY) CHMP recommends ZynquistaTM (sotagliflozin) for the treatment of adults with type 1 diabetes PARIS and THE WOODLANDS, TX – March 1, 2019

Dupixent® (dupilumab)

image32

 Sanofi: CHMP recommends approval of Dupixent® (dupilumab) for asthma indication

Fri March 1, 2019 8:14 AM|GlobeNewswire|About: SNY 

Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY) CHMP recommends approval of Dupixent® (dupilumab) for asthma indication PARIS and TARRYTOWN, NY – March 1, 2019 -

seeking biotech alpha February 2019 insight

immuno-oncology candidates, bempegaldesleukin* (NKTR-214), a CD122-preferential IL-2 pathway agonist

image36

Nektar Therapeutics Announces Several Preclinical Data Presentations for its Immuno-oncology Pipeline Candidates at the American Association for Cancer Research (AACR) Annual Meeting 2019

Wed February 27, 2019 4:35 PM|PR Newswire|About: NKTR

SAN FRANCISCO, Feb. 27, 2019 /PRNewswire/ -- Nektar Therapeutics (NKTR

Nektar Therapeutics Announces Several Preclinical Data Presentations for its Immuno-oncology Pipeline Candidates at the American Association for Cancer Research (AACR) Annual Meeting 2019 SAN FRANCISCO, Feb. 27, 2019 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR)

NovoCure (NVCR)

image37

NovoCure's (NVCR) CEO Asaf Danziger on Q4 2018 Results - Earnings Call Transcript

Feb. 28, 2019 1:32 PM ET  | About: NovoCure (NVCR) 

NovoCure 2018 Q4 - Results - Earnings Call Slides Feb. 28, 2019 10:37 AM ET | About: NovoCure (NVCR)

Sangamo Therapeutics, Inc. (SGMO)

image38

 Sangamo Q4 top line up 105%

Feb. 28, 2019 4:09 PM ET|About: Sangamo Therapeutics, ... (SGMO)|By: , SA News Editor 

Sangamo Therapeutics (NASDAQ:SGMO) Q4 results ($M): Revenues: 26.8 (+104.6%); Collaborations: 26.7 (+107.0%).


Sangamo Therapeutics Reports Fourth Quarter And Full Year 2018 Financial Results

Thu February 28, 2019 4:01 PM|PR Newswire|About: SGMO 

https://seekingalpha.com/pr/17429195-sangamo-therapeutics-reports-fourth-quarter-full-year-2018-financial-results

Sangamo Therapeutics, Inc. 2018 Q4 - Results - Earnings Call Slides Feb. 28, 2019 5:12 PM ET | About: Sangamo Therapeutics, Inc. (SGMO)

seeking biotech alpha February 2019 insight

MYO-101 Gene Therapy Trial to Treat Limb-Girdle Muscular Dystrophy Type 2E, / Beta-Sarcoglycanopathy

image39

 Sarepta Therapeutics Announces Positive and Robust Expression and Biomarker Data from the First Three-Patient Cohort Dosed in the MYO-101 Gene Therapy Trial to Treat Limb-Girdle Muscular Dystrophy Type 2E, or Beta-Sarcoglycanopathy

Wed February 27, 2019 9:00 AM|GlobeNewswire|About: SRPT 

Sarepta Therapeutics Announces Positive and Robust Expression and Biomarker Data from the First Three-Patient Cohort Dosed in the MYO-101 Gene Therapy Trial to Treat Limb-Girdle Muscular Dystrophy Type 2E, or Beta-Sarcoglycanopathy February 27, 2019 at 9:00 AM EST

Tremfya(R)

image40

 MorphoSys Announces that its Licensee Janssen Has Received U.S. FDA Approval for Tremfya(R) One-Press Patient-Controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis

Wed February 27, 2019 8:45 AM|Accesswire|About: JNJ, MOR

PLANEGG and MUNICH, GERMANY / ACCESSWIRE / February 27, 2019 / MorphoSys AG (MPSYF) (FSE: MOR) (NASDAQ: MOR)

Janssen Announces U.S. FDA Approval of Novel TREMFYA® (guselkumab) One-Press Patient-controlled Injector for Adults with Moderate-to-Severe Plaque Psoriasis Nearly 99 percent of patients using One-Press for the first time completed a successful injection(1)Following three injections of TREMFYA, half of the patients experienced 100 percent clear skin(1) HORSHAM, Pa., Feb. 27, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

Accurian(TM) RF ablation platform, which conducts radio frequency (RF) ablation of nerve tissues.

image41

 Medtronic Announces FDA Clearance and U.S. Launch of the Accurian Radio Frequency System for Nerve Tissue Ablation

Wed February 27, 2019 7:00 AM|InPublic US|About: MDT 

Medtronic Announces FDA Clearance and U.S. Launch of the Accurian Radio Frequency System for Nerve Tissue Ablation Medtronic Expands Pain Portfolio with Minimally Invasive Therapy to Support Patients Throughout the Care Continuum DUBLIN - February 27, 2019 - Medtronic plc (NYSE:MDT)

Age Positively Initiative

image42

Gilead Sciences Launches Age Positively Initiative to Address Unique Challenges of Aging Population Living with HIV

Tue February 26, 2019 4:30 PM|Business Wire|About: GILD 

Gilead HIV Age Positively -Gilead’s Age Positively initiative aims to support programs focused on improving the quality of life and health for those aging.

Soliqua® 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL.

image43

 FDA expands indication for Soliqua® 100/33

Wed February 27, 2019 4:17 PM|PR Newswire|About: SNYPR Newswire

BRIDGEWATER, N.J., Feb. 27, 2019 /PRNewswire/

FDA expands indication for Soliqua® 100/33 * Soliqua 100/33 now approved as an add-on to diet and exercise for adults with type 2 diabetes BRIDGEWATER, N.J., Feb. 27, 2019 /PRNewswire/

Grafton(TM) Demineralized Bone Matrix (DBM) bone grafting product for spine & orthopedic procedures

image44

 Medtronic Announces Approval and Launch of Japan's First DBM Bone Grafting Product for Spine and Orthopedic Procedures

Thu February 28, 2019 7:00 AM|InPublic US|About: MDT 

Medtronic Announces Approval and Launch of Japan's First DBM Bone Grafting Product for Spine and Orthopedic Procedures Medtronic plc Grafton(TM) DBM Product Will Provide More Options for Spine and Orthopedic Surgeons in Japan DUBLIN and TOKYO - February 28, 2019 - Medtronic plc (NYSE:MDT)

seeking biotech alpha February 2019 insight

seeking biotech alpha February 2019 insight

2 (AMGN) patents on Repatha (evolocumab), antibodies on PCSK9 & reduce LDL-C

Amgen prevails in PCSK9 patent dispute with Regeneron and Sanofi

Feb. 25, 2019 8:09 PM ET|About: Amgen Inc. (AMGN)|By: , SA News Editor  

Jury Upholds Amgen's Patents On Repatha® (evolocumab) THOUSAND OAKS, Calif., Feb. 25, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN)

seeking biotech alpha February 2019 insight

Agilent Technologies Inc. (A)

image57

 Feb. 20, 2019 4:24 PM ET|About: Agilent Technologies Inc. (A)A$78.56 1.04 1.34%Agilent Technologies, Inc.Designs, manufactures and markets measurement and monitoring instruments52 Week Range60.42 - 78.80Market Cap.24.95BMore »(45,086 followers)|By: , SA News Editor 

Agilent (NYSE:A) fiscal Q1 results ($M): Revenue: 1,284 (+6.0%).

Net income: 504 (+257.5%); non-GAAP net income: 244 (+13.0%); EPS: 1.57 (+258.6%); non-GAAP EPS: 0.76 (+15.2%).

Agilent Technologies Reports First-Quarter Fiscal Year 2019 Financial Results Strong Start to Year as First-Quarter Revenue and EPS Exceed Guidance; Raising Full Year Guidance SANTA CLARA, Calif., February 20, 2019

sacituzumab govitecan in patients with metastatic triple-negative breast cancer (mTNBC)

image58

Immunomedics Announces Publication of Triple-Negative Breast Cancer Data With Sacituzumab Govitecan in the New England Journal of Medicine

Wed February 20, 2019 5:05 PM|GlobeNewswire|About: IMMUGlobeNewswire

MORRIS PLAINS, N.J., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (IMMU), (NASDAQ: IMMU) (“Immunomedics” or the “Company”),

Immunomedics Announces Publication of Triple-Negative Breast Cancer Data with Sacituzumab Govitecan in the New England Journal Of Medicine Publication Highlights Safety and Efficacy Profile of Sacituzumab Govitecan Addressing High Unmet Need in Metastatic Triple-Negative Breast Cancer Morris Plains, N.J., February 20, 2019 — Immunomedics, Inc., (NASDAQ: IMMU)

U.S. healthcare spending to rise 5.5% per annum over next decade

image60

U.S. healthcare spending to rise 5.5% per annum over next decade

Feb. 21, 2019 7:14 AM ET|About: AbbVie Inc. (ABBV)|By: , SA News Editor 

FreeStyle® Libre flash glucose monitoring system

image61

 New Real-World Evidence Analysis of Nearly Half a Million FreeStyle® Libre System Users Shows Higher Rates of Scanning Improves Glucose Control

Thu February 21, 2019 9:40 AM|PR Newswire|About: ABT 


Approach to Using Trend Arrows in the FreeStyle Libre Flash Glucose Monitoring Systems in Adults

 Yogish C Kudva Andrew J Ahmann Richard M Bergenstal James R Gavin, IIIDavida F Kruger L Kurt Midyett Eden Miller Dennis R Harris 

 Journal of the Endocrine Society, Volume 2, Issue 12, 1 December 2018, Pages 1320–1337,https://doi.org/10.1210/js.2018-00294 

https://academic.oup.com/jes/article/2/12/1320/5181247

New Real-World Evidence Analysis of Nearly Half a Million FreeStyle® Libre System Users Shows Higher Rates of Scanning Improves Glucose Control - Data presented at ATTD confirms previous analyses that higher rates of scanning with the FreeStyle Libre system are strongly associated with improved glucose control - Prolonged hypoglycemia reduced by up to 56 percent if users scan a second time within an hour of low glucose readings - Trend arrow readings before meals can help identify glucose levels that can potentially be used to adjust treatment and address after meal hyperglycemia BERLIN, Feb. 21, 2019 /PRNewswire/ -- Abbott (NYSE: ABT)

seeking biotech alpha February 2019 insight

Bausch Health Companies Inc. (BHC)

 Bausch Health Companies Inc. 2018 Q4 - Results - Earnings Call Slides

Feb. 20, 2019 10:00 AM ET|28 comments  | About: Bausch Health Companies Inc. (BHC) 

Bausch Health Companies Inc. Announces Fourth-Quarter And Full-Year 2018 Results And Provides 2019 Guidance FEBRUARY 20, 2019 LAVAL, Quebec, Feb. 20, 2019 /PRNewswire/ --

NASH BIOTECHS AN OVERVIEW ON NASH DISEASE AND FUTURE TREATMENTS - G Divry

2019, THE NASH LANDSCAPE

UPDATED the 20 of february 2019

 G Divry 



 Intercept Pharmaceuticals Investors Strap In for a Wild Ride

Top-line data from the Regenerate trial cleared an important hurdle, but the race to launch the first NASH treatment isn't over yet.

Cory Renauer

 Feb 20, 2019 at 10:18PM
https://www.fool.com/investing/2019/02/20/intercept-pharmaceuticals-investors-strap-in-for-a.aspx

Feb 20, 2019 at 10:18PM Intercept Pharmaceuticals Investors Strap In for a Wild Ride Top-line data from the Regenerate trial cleared an important hurdle, but the race to launch the first NASH treatment isn't over yet. Cory Renauer Cory Renauer owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool has a disclosure policy.

seeking biotech alpha February 2019 insight

ZIRABEV™ (bevacizumab)

image66

Pfizer Receives European Approval for ZIRABEV™ (bevacizumab), a Biosimilar to Avastin®*

Tue February 19, 2019 9:32 AM|Business Wire|About: PFE 

Pfizer Receives European Approval for ZIRABEV™ (bevacizumab), a Biosimilar to Avastin®* February 19, 2019 09:32 AM Eastern Standard Time NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE)

Ion™ endoluminal system to enable minimally invasive biopsy in the peripheral lung.

image67

U. S. FDA Grants Clearance for Ion by Intuitive

February 19, 2019 at 11:18 AM ESTPDF VersionFlexible robotic catheter helps physicians reach nodules in the peripheral lung

SUNNYVALE, Calif., Feb. 19, 2019 (GLOBE NEWSWIRE) -- Intuitive Surgical, Inc. (Nasdaq: ISRG)

Ion by Intuitive A new robotic endoluminal platform for minimally invasive peripheral lung biopsy

Ochsner Health System, Louisiana’s largest non-profit academic healthcare system & Pfizer Inc (PFE)

image68

Ochsner Health System and Pfizer Partner to Develop Innovative Models for Clinical Trials

Tue February 19, 2019 10:30 AM|Business Wire|About: PFE 

chsner Health System and Pfizer Partner to Develop Innovative Models for Clinical Trials As a national leader in healthcare, Ochsner is delivering on its mission to bring the most innovative ideas to our patients. We are relentless about using the latest breakthroughs in science and technology to solve some of the toughest healthcare challenges”

seeking biotech alpha February 2019 insight

polatuzumab vedotin in combination with bendamustine plus Rituxan ® (rituximab)

image76

 

Monday, Feb 18, 2019

FDA Grants Priority Review to Genentech’s Polatuzumab Vedotin in Previously Treated Aggressive Lymphoma

Diffuse large B-cell lymphoma is an aggressive type of blood cancer that typically becomes harder to treat each time it returns
Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease

South San Francisco, CA -- February 18, 2019 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

seeking biotech alpha February 2019 insight

PRODIGY Results: a Study to Identify Patients at High Risk for Opioid-Induced Respiratory Compromise

image78

Medtronic Announces Preliminary PRODIGY Results: a Global Study to Identify Patients at High Risk for Opioid-Induced Respiratory Compromise

Sun February 17, 2019 6:45 PM|InPublic US|About: MDT 

Respiratory depression in low acuity hospital settings–Seeking answers from the PRODIGY trial Author links open overlay panel Ashish K.Khannaa Frank J.Overdykb ChristineGreeningc PaolaDi Stefanod Wolfgang F.Buhree Journal of Critical Care Volume 47, October 2018, Pages 80-87

galectin-3 inhibitor GR-MD-02 in NASH cirrhosis

image79

 November 5, 2018

Data Collected by Exalenz Bioscience in Galectin Therapeutics’ Phase 2 NASH-CX Trial of GR-MD-02 to Be Presented at AASLD Annual Meeting

NORCROSS, Ga., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT),

OUR PIPELINE = Galectin Therapeutics focuses on studying the science of galectin proteins and applying this knowledge in the clinic. Galectins are important therapeutic targets because they are the mediators of fundamental biologic mechanisms in pathological processes.

YESCARTA™ (Axicabtagene Ciloleucel)

image81

 Gilead Receives Approval in Canada for YESCARTA™ (Axicabtagene Ciloleucel) CAR T Therapy for Adults With Relapsed or Refractory Large B-cell Lymphoma After Two or More Lines of Systemic Therapy

Tue February 19, 2019 8:00 AM|Canada Newswire|About: GILD 

YESCARTA is made from your own white blood cells, which have been modified to recognize and attack your lymphoma cells. It is the first CAR T therapy for adults living with certain types of non-Hodgkin lymphoma, who have failed at least 2 other kinds of treatment.

Personalized Closed Loop (PCL) insulin pump system

image82

 Medtronic Receives FDA Breakthrough Designation for Developing Personalized Closed Loop Insulin Pump System for Diabetes Management

(GLOBE NEWSWIRE via COMTEX) --DUBLIN - February 19, 2019 - Medtronic plc (NYSE:MDT)

Medtronic Receives FDA Breakthrough Designation for Developing Personalized Closed Loop Insulin Pump System for Diabetes Management DUBLIN - February 19, 2019 - Medtronic plc (NYSE:MDT),

seeking biotech alpha February 2019 insight

Bempegaldesleukin (NKTR-214) with Nivolumab in Metastatic Urothelial Carcinoma Patients

image84

 Clinical Data Presented from PIVOT-02 Study of Bempegaldesleukin (NKTR-214) with Nivolumab in Metastatic Urothelial Carcinoma Patients at the 2019 ASCO Genitourinary Cancers Symposium

Fri February 15, 2019 3:15 PM|PR Newswire|About: NKTR 

Bempegaldesleukin* (NKTR-214)

NASH Directeur de la Publication : Géry DIVRY -Copyrights - G.Divry - NASHBIOTECHS.COM

image85

Non Alcoholic Steatohepatitis is an emerging disease with high prevalence in the world population ! 

In the coming years, the treatment of the disease will become a big challenge and a huge market . 

 Copyrights  -  G.Divry - NASHBIOTECHS.COM 

http://www.nashbiotechs.com./ 

AN OVERVIEW ON NASH DISEASE AND FUTURE TREATMENTS Directeur de la Publication : Géry DIVRY -http://www.nashbiotechs.com./

Keytruda (pembrolizumab) 17th U.S. indication

FDA OKs expanded use for Merck's Keytruda

Feb. 16, 2019 10:13 AM ET|About: Merck & Co Inc. (MRK)|By: , SA News Editor 

 



KEYTRUDA is a medicine that may treat certain cancers by working with your immune system.

seeking biotech alpha February 2019 insight

darolutamide plus androgen deprivation therapy (ADT)

image89

 Bayer's darolutamide extends survival in late-stage prostate cancer study

Feb. 14, 2019 4:57 PM ET|About: Bayer A.G. ADR (BAYRY)|By: , SA News Editor  

Copyright © 2019 Massachusetts Medical Society Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer February 14, 2019 DOI: 10.1056/NEJMoa1815671

LYS-SAF302, a Gene Therapy for the Treatment of MPS IIIA (Sanfilippo Syndrome Type A)

image91

 Lysogene and Sarepta Therapeutics Announce Dosing of the First Patient in AAVance, a Phase 2/3 Clinical Trial Investigating LYS-SAF302, a Gene Therapy for the Treatment of MPS IIIA (Sanfilippo Syndrome Type A)

Thu February 14, 2019 4:01 PM|GlobeNewswire|About: SRPT 

Lysogene and Sarepta Therapeutics Announce Dosing of the First Patient in AAVance, a Phase 2/3 Clinical Trial Investigating LYS-SAF302, a Gene Therapy for the Treatment of MPS IIIA (Sanfilippo Syndrome Type A) February 14, 2019 at 4:01 PM EST CAMBRIDGE, Mass. and PARIS, Feb. 14, 2019 (GLOBE NEWSWIRE) -- Lysogene (FR0013233475 – LYS), a pioneering biopharmaceutical company specializing in gene therapy targeting central nervous system (CNS) diseases, and Sarepta Therapeutics, Inc. (NASDAQ:SRPT)

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

image92

 FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma

Fri February 15, 2019 6:45 AM|Business Wire|About: MRK 

 The FDA has accepted under Priority Review status Merck's (NYSE:MRK) supplemental marketing application seeking approval for Keytruda (pembrolizumab) plus Pfizer's (NYSE:PFE) Inlyta (axitinib) for the treatment of advanced renal cell carcinoma in a first-line setting. 

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma Application Based on Overall Survival and Progression-Free Survival Data from Phase 3 KEYNOTE-426 Trial February 15, 2019 06:45 AM Eastern Standard Time KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada

seeking biotech alpha February 2019 insight

AstraZeneca Group plc (AZN)

image97

 Feb. 14, 2019 7:13 AM ET|About: 

AstraZeneca Group plc (AZN)AZN

$36.58 -0.62 -1.67%

AstraZeneca PLC Sponsored ADR

Engages in manufacturing of pharmaceutical products

52 Week Range32.69 - 41.77Market Cap.92.70B

By: , SA News Editor 

AstraZeneca (AZN) Q4 results: Revenues: $6,417M (+11.1%); Product Sales: $5,768M (+5.1%); Externalisation Revenue: $649M (+123.8%).

AstraZeneca Group plc 2018 Q4 - Results - Earnings Call Slides Feb. 14, 2019 5:37 AM ET | About: AstraZeneca Group plc (AZN)

biotech development in South Carolina

image99

New federal award to promote biotech development in South Carolina

Leslie Cantu February 06, 2019 

Heart research gets $4.1 million boost on Valentine’s Day Paul Alongi, College of Engineering, Computing and Applied Sciences February 14, 2019 CLEMSON

Medtronic and Medical University of South Carolina

image100

Medtronic and Medical University of South Carolina Partner to Improve Patient Outcomes

Thu February 14, 2019 8:00 AM|InPublic US|About: MDT 

 

Value-Based Health Care Partnership Will Target
Acute Conditions and Chronic Diseases in South Carolina

DUBLIN and CHARLESTON, S.C. - February 14, 2019 - Medtronic plc (MDT) and the Medical University of South Carolina (MUSC)

The Charleston region offers medtech companies an adaptable workforce with a business-friendly environment. The presence of the Medical University of South Carolina, a tier 1 academic and research institution, our proximity to the Port of Charleston and our ability to attract talent make this an ideal location for medtech companies looking for growth.

seeking biotech alpha February 2019 insight

HeartWare™ HVAD™ System

image101

Medtronic Heart Pump is the First to Receive Health Canada Licence for Less-Invasive Implant Procedure

Wed February 13, 2019 7:30 AM|Canada Newswire|About: MDT 

HEARTWARE HVAD SYSTEM Advanced Heart Failure Management

CVS HealthHUB

image102

 CVS HealthHUB design unveiled in Houston

Feb. 13, 2019 6:20 AM ET|About: CVS Health Corporation (CVS)|By: , SA News Editor 

More health services on your schedule. All in one place.

SPRAVATO™ (esketamine)

image103

FDA Advisory Committee Recommends Approval of SPRAVATOTM (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression

If approved, SPRAVATOTM will offer the first new mechanism of action in 30 years to treat this debilitating disease, continuing Janssen’s 60-plus-year history and commitment to research that make a difference for people living with mental illnesses, including severe mood disorders

TITUSVILLE, N.J., February 12, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson 

FDA Advisory Committee Recommends Approval of SPRAVATO™ (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression If approved, SPRAVATO™ will offer the first new mechanism of action in 30 years to treat this debilitating disease, continuing Janssen's 60-plus-year history and commitment to research that make a difference for people living with mental illnesses, including severe mood disorders TITUSVILLE, N.J., Feb. 12, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

Chinese, US scholars jointly develop AI model to improve diagnosis of sick children

  • Drawing on records of nearly 600,000 paediatric patients, the software diagnosed common childhood diseases with an 85 per cent accuracy rate

 

PUBLISHED : Wednesday, 13 February, 2019, 7:04pm

UPDATED : Wednesday, 13 February, 2019, 7:03pm

 SCMP TODAY: INTL EDITION 

Published: 11 February 2019 Evaluation and accurate diagnoses of pediatric diseases using artificial intelligence Huiying Liang, Brian Y. Tsui, […]Huimin Xia

seeking biotech alpha February 2019 insight

Tangible® Hydra-PEG® Custom Contact Lens Coating Technology

 Bausch + Lomb Receives 510(k) Clearance For Use Of The Tangible® Hydra-PEG® Custom Contact Lens Coating Technology On Several Of Its Boston® Gas Permeable Lens Materials And Zenlens™ Family Of Scleral Lenses

Wed February 13, 2019 8:00 AM|Canada Newswire|About: BHC 

Bausch + Lomb Receives 510(k) Clearance For Use Of The Tangible® Hydra-PEG® Custom Contact Lens Coating Technology On Several Of Its Boston® Gas Permeable Lens Materials And Zenlens™ Family Of Scleral Lenses Coating Technology offers Improved Lens Wettability for Patients with Challenging Vision Needs BRIDGEWATER, N.J., Feb. 13, 2019 /PRNewswire/ -- Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC)

KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib)

image109

 Merck Highlights Breadth of Immuno-Oncology Research Program in Genitourinary Cancers at ASCO GU

Mon February 11, 2019 5:02 PM|Business Wire|About: MRK 

Prescribing Information for KEYTRUDA