seeking biotech alpha March 2019 insight

BOTOX® (onabotulinumtoxinA)

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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)

Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide)

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 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)

Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide)

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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)

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

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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 

fifth Breakthrough Therapy Designation (BTD) to venetoclax,

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 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 

seeking biotech alpha March 2019 insight

Array BioPharma Inc. (ARRY)

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

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

seeking biotech alpha March 2019 insight

Fedratinib is a highly selective JAK2 inhibitor

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

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

Emgality® (galcanezumab-gnlm)

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 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 

Alinity ci-series

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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 

immune tolerance therapy

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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

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  

KEYTRUDA® (pembrolizumab)

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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

BXCL701, Nektar’s NKTR-214 and avelumab

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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)

seeking biotech alpha March 2019 insight

LORVIQUA® (lorlatinib)

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 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 

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

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 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 

Flector® Patch (diclofenac epolamine topical patch)

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 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 

seeking biotech alpha March 2019 insight

Fiasp® (insulin aspart injection) 100 u/mL

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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 

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

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 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% 

ZynquistaTM* (sotagliflozin)

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

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

Dupixent® (dupilumab)

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

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

seeking biotech alpha February 2019 insight

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

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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

NovoCure (NVCR)

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

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

Sangamo Therapeutics, Inc. (SGMO)

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 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

seeking biotech alpha February 2019 insight

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

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 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 

Tremfya(R)

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 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)

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

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 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 

Age Positively Initiative

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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 

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

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 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/

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

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 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 

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  

seeking biotech alpha February 2019 insight

Agilent Technologies Inc. (A)

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 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%).

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

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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”),

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

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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

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 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

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) 

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

seeking biotech alpha February 2019 insight

ZIRABEV™ (bevacizumab)

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

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

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

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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)

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

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

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

seeking biotech alpha February 2019 insight

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

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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)

seeking biotech alpha February 2019 insight

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

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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 

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

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 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),

YESCARTA™ (Axicabtagene Ciloleucel)

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 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 

Personalized Closed Loop (PCL) insulin pump system

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 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)

seeking biotech alpha February 2019 insight

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

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 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 

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

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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./ 

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 

 



seeking biotech alpha February 2019 insight

darolutamide plus androgen deprivation therapy (ADT)

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 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  

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

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 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 

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

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 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. 

seeking biotech alpha February 2019 insight

AstraZeneca Group plc (AZN)

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 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%).

biotech development in South Carolina

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New federal award to promote biotech development in South Carolina

Leslie Cantu February 06, 2019 

Medtronic and Medical University of South Carolina

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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)

seeking biotech alpha February 2019 insight

HeartWare™ HVAD™ System

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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 

CVS HealthHUB

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 CVS HealthHUB design unveiled in Houston

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

SPRAVATO™ (esketamine)

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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 

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 

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 

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

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 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