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FDA Grants Priority Review for Genentech’s OCREVUS(TM) (ocrelizumab) Biologics License Application

周二, 06/28/2016 - 13:16
Biologics License Application (BLA) acceptance follows European Medicines Agency’s (EMA’s) validation of the Marketing Authorization Application (MAA) for OCREVUS in relapsing and primary progressive multiple sclerosis (MS) OCREVUS is the first investig...
Biopharmaceuticals, Neurology, FDA
Genentech, OCREVUS, ocrelizumab, multiple sclerosis

Pfizer Advances Biosimilars Leadership with Investment in a New World-Class Global Biotechnology Center in China

周二, 06/28/2016 - 13:11
Pfizer’s state-of-the-art facility will foster the continued development of the biotechnology industry in China, further supporting National healthcare reforms NEW YORK & HANGZHOU, China--(Healthcare Sales & Marketing Network)--Pfizer Inc. today announc...
Biopharmaceuticals
Pfizer, biosimilar

Halt Medical, Inc. Announces The First Acquisition Of Acessa Guidance System

周二, 06/28/2016 - 13:04
BRENTWOOD, Calif., June 27, 2016 -- (Healthcare Sales & Marketing Network) -- Halt Medical, Inc. announced today that Trinity Park Surgery Center, Arlington, TX, is the first facility in the United States to acquire the Acessa® Guidance System1. &q...
Devices
Halt Medical, Acessa Guidance System, uterine fibroids, radiofrequency ablation

GW Pharmaceuticals Announces Positive Phase 3 Pivotal Trial Results for Epidiolex(R) (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome

周一, 06/27/2016 - 14:13
Primary endpoint achieved with high statistical significance (p=0.0135) showing that Epidiolex treatment reduces drop seizures compared to placebo Today’s LGS data follows successful Phase 3 trial in Dravet syndrome announced in March 2016 Company to...
Biopharmaceuticals
GW Pharmaceuticals, Epidiolex, cannabinoid, Lennox-Gastaut

Accuray Receives 510(k) FDA Clearance for the Radixact(TM) Image-Guided Radiation Therapy Platform and Integrated Software

周一, 06/27/2016 - 13:44
Next Generation "Smart" System Enables Clinicians to Provide Highly Precise Treatment, Efficiently, for More Patients, Every Day SUNNYVALE, Calif., June 27, 2016 -- (Healthcare Sales & Marketing Network) -- Accuray Incorporated (ARAY) announc...
Devices, Oncology, FDA
Accuray, Radixact, Accuray Precision, radiotherapy

Merck Receives CHMP Positive Opinion for KEYTRUDA(R) (pembrolizumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

周一, 06/27/2016 - 13:37
Opinion Based on Data from KEYNOTE-010, Which Showed Superior Overall Survival Compared to Chemotherapy in Previously-Treated Patients Whose Tumors Express PD-L1 KENILWORTH, N.J.--(Healthcare Sales & Marketing Network)--Merck (MRK), known as MSD outside...
Biopharmaceuticals, Oncology, Regulatory
Merck, KEYTRUDA, pembrolizumab, anti-PD-1 therapy, NSCLC

Avita Medical Awarded US$7.96M in BARDA Extension Deal

周一, 06/27/2016 - 13:18
Additional non-dilutive funds to accelerate US market approval and product launch Support aims to increase familiarity/acceptance in US Burn Centers, demonstrate economic benefits and increase acceptance of ReCell® in US Burn Centers Funds will b...
Regenerative Medicine, Venture Capital
Avita Medical, ReCell

Medigus’ MUSE(TM) Continues to Gain Clinical Adoption in the U.S.

周五, 06/24/2016 - 14:52
Innovative technology allows physicians to perform transoral fundoplication for effective, long-term treatment of acid reflux and improve patients’ GERD-related quality of life OMER, Israel, June 24, 2016 -- (Healthcare Sales & Marketing Network) -- Med...
Devices, Surgery, Gastroenterology
Medigus, Ultrasonic Surgical Endostapler, transoral fundoplication, GERD

Pfizer Completes Acquisition of Anacor

周五, 06/24/2016 - 14:47
Tender offer for all of the outstanding shares of Anacor common stock expired as scheduled immediately after 11:59 p.m., New York City time, on June 23, 2016 Pfizer and Anacor begin joint operations on June 24, 2016 NEW YORK--(Healthcare Sales & Mar...
Biopharmaceuticals, Mergers & Acquisitions
Pfizer, Anacor Pharmaceuticals

Allergan Announces FDA Approval of Supplemental New Drug Application (sNDA) for AVYCAZ(R) (ceftazidime and avibactam)

周四, 06/23/2016 - 14:24
Label now includes Phase 3 clinical data evaluating the safety and efficacy of AVYCAZ (in combination with metronidazole) in patients with complicated intra-abdominal infections (cIAI) DUBLIN, June 23, 2016 -- (Healthcare Sales & Marketing Network) -- ...
Biopharmaceuticals, FDA
Allergan, AVYCAZ, ceftazidime, avibactam, cIAI

St. Jude Medical Expands Its Heart Failure Portfolio with SyncAV CRT Technology, Providing Physicians Another Option for Managing Patients Not Responsive to Other Therapies

周四, 06/23/2016 - 14:14
Adding SyncAV™ CRT technology to the company’s comprehensive heart failure offerings provides further advantages to the St. Jude Medical portfolio to support physicians seeking new treatment options for heart failure patients ST. PAUL, Minn.--(Healthcar...
Devices, Cardiology, Regulatory, Product Launch
St. Jude Medical, SyncAV CRT, MultiPoint Pacing, cardiac resynchronization

HeartFlow Introduces Next Generation Platform

周四, 06/23/2016 - 14:05
REDWOOD CITY, Calif.--(Healthcare Sales & Marketing Network)--HeartFlow, Inc., a personalized medical technology company seeking to transform the way cardiovascular disease is diagnosed and treated, announced today that it is launching its next generation ...
Devices, Personalized Medicine, Cardiology, Product Launch
HeartFlow, FFRct

Centinel Spine(TM) Granted Australian Clearance for STALIF L(TM) Minimally-Invasive, Lateral Integrated Interbody(TM) System

周四, 06/23/2016 - 12:54
NEW YORK, June 22, 2016 -- (Healthcare Sales & Marketing Network) -- Centinel Spine, Inc., (Centinel Spine), the pioneer of the No-Profile, Integrated Interbody™ fusion device market, is granted clearance for STALIF L™ No-Profile, Lateral Lumbar Integrate...
Devices, Orthopaedic, Neurosurgery, Regulatory
Centinel Spine, Interbody, STALIF L, spine surgery

AirXpanders' AeroForm(R) Tissue Expander Technology Showcased at Three International Surgery Conferences

周三, 06/22/2016 - 13:30
Company continues to build momentum around its innovative breast reconstruction technology with leaders in breast and plastic surgery PALO ALTO, Calif., June 22, 2016 -- (Healthcare Sales & Marketing Network) -- AirXpanders, Inc., a company developing ...
Devices, Surgery, Oncology
AirXpanders, AeroForm, tissue expander

Life Spine Announces Initial Cases and Multiple Surgeries for LONGBOW(TM) Expandable Lateral Spacer System

周三, 06/22/2016 - 13:22
HUNTLEY, Ill.--(Healthcare Sales & Marketing Network)--Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the company has successfully complete...
Devices, Orthopaedic, Neurosurgery
Life Spine, LONGBOW, Lateral Spacer, interbody, spine surgery

Digital Health Company, Reflexion Health, Secures $18 Million for Its Series B Financing

周三, 06/22/2016 - 13:15
SAN DIEGO, CA--(Healthcare Sales & Marketing Network) - Reflexion Health, a digital health company dedicated to bringing personalized rehabilitation healthcare into patients' homes, today announced that it has received $18 million in an insider-led, series...
Devices, Venture Capital
Reflexion Health, digital medicine, rehabilitation

IFM Therapeutics Raises $27 Million Series A Financing Led by Atlas Venture and Abingworth

周三, 06/22/2016 - 13:05
First-in-class immune-modulators for cancer and inflammatory diseases CAMBRIDGE, Mass.--(Healthcare Sales & Marketing Network)--IFM Therapeutics, a biopharmaceutical company developing a portfolio of first-in-class small molecules targeting the innate i...
Biopharmaceuticals, Venture Capital
IFM Therapeutics

Lumos Pharma Appoints Carol A. Dutch As Senior Director, Patient Engagement

周二, 06/21/2016 - 15:47
AUSTIN, Texas, June 21, 2016 -- (Healthcare Sales & Marketing Network) -- Lumos Pharma, Inc. has further expanded its management team with the appointment of Carol A. Dutch as Senior Director, Patient Engagement. Ms. Dutch will create and lead global pati...
Biopharmaceuticals, Personnel
Lumos Pharma, Creatine Transporter Deficiency

Neurotrope Appoints Paula T. Trzepacz, M.D. as Executive Vice President and Chief Medical Officer

周二, 06/21/2016 - 15:42
NEWARK, N.J., June 21, 2016 -- (Healthcare Sales & Marketing Network) -- Neurotrope, Inc. (NTRP): today announced that Paula T. Trzepacz, M.D., has joined Neurotrope BioScience, Inc., the Company's wholly owned operating subsidiary, as its Executive Vice...
Biopharmaceuticals, Neurology, Personnel
Neurotrope, Alzheimer's disease

Perrigo Announces FDA Clearance And Launch Of Non-GMO* Infant Formulas For The U.S. Store Brand Market

周二, 06/21/2016 - 15:39
DUBLIN, June 21, 2016 -- (Healthcare Sales & Marketing Network) -- Perrigo Company plc (NYSE: PRGO; TASE), today announced it has received final U.S. Food and Drug Administration ("FDA") clearance for three milk-based, store brand non-GMO infant...
Biopharmaceuticals, FDA, Product Launch
Perrigo, Infant Formula

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