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Halozyme Announces First Clinical Dosing Of Adalimumab (Humira) Using ENHANZE(TM) Technology

Thu, 01/21/2016 - 17:05
SAN DIEGO, Jan. 21, 2016 -- (Healthcare Sales & Marketing Network) -- Halozyme Therapeutics, Inc. (HALO) today announced that AbbVie has dosed the first subject in a clinical trial evaluating the safety and pharmacokinetics of adalimumab with Halozyme's p...
Biopharmaceuticals, Drug Delivery, Licensing
Halozyme, ENHANZE, hyaluronidase, subcutaneous

Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for DALVANCE(R) (dalbavancin)

Thu, 01/21/2016 - 13:28
Single-Dose Option Approved for Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) DUBLIN, Jan. 21, 2016 -- (Healthcare Sales & Marketing Network) -- Allergan plc (AGN), a leading global pharmaceutical company, today announ...
Biopharmaceuticals, FDA
Allergan, DALVANCE, dalbavancin, ABSSSI

VIBERZI(TM) (eluxadoline) Phase III Trial Results Published in The New England Journal of Medicine

Thu, 01/21/2016 - 13:20
VIBERZI has been approved for use in the United States in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D) VIBERZI demonstrated effective and sustained relief of abdominal pain and diarrhea IBS-D can be debilitating, affecti...
Biopharmaceuticals, Gastroenterology
Allergan, VIBERZI, irritable bowel syndrome, IBS-D

AcelRx Pharmaceuticals Announces Presentation of Phase 3 Sufentanil Sublingual 30 mcg Tablet (ARX-04) Data at the European Congress of Ambulatory Surgery

Thu, 01/21/2016 - 13:10
Phase 3 Clinical Data Highlights Safety and Efficacy of Sublingual Sufentanil in Outpatient Abdominal Surgery Populations REDWOOD CITY, Calif., Jan. 21, 2016 -- (Healthcare Sales & Marketing Network) -- AcelRx Pharmaceuticals, Inc. (ACRX) today announc...
Biopharmaceuticals, Drug Delivery
AcelRx Pharmaceuticals, sublingual, sufentanil, SAP301, Zalviso

vasopharm Announces EUR 20 Million Fundraising to Progress Treatment for Traumatic Brain Injury

Thu, 01/21/2016 - 12:55
Phase III registration study of VAS203 to commence in H1 2016 WÜRZBURG, Germany, January 21, 2016 -- (Healthcare Sales & Marketing Network) -- vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatm...
Biopharmaceuticals, Neurology, Venture Capital
vasopharm GmbH, Traumatic Brain Injury, VAS203

SI-BONE, Inc. Announces European Expansion with Formation of SI-BONE UK Ltd and Key Additions to Management Team

Wed, 01/20/2016 - 19:53
Appoints Richard Moss, General Manager, UK & Ireland and Silvio Tarantino, Finance Director, EMEA SAN JOSE, Calif., Jan. 20, 2016 -- (Healthcare Sales & Marketing Network) -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse I...
Devices, Orthopaedic, Neurosurgery, Personnel
SI-BONE, iFuse Implant System, sacroiliac

Orphan Medicine Designation and European Medicines Agency Public Opinion Summary Published by EMA Regarding Alferon N Injection(R) as a Treatment of Middle East Respiratory Syndrome (MERS)

Wed, 01/20/2016 - 19:50
PHILADELPHIA, Jan. 20, 2016 -- (Healthcare Sales & Marketing Network) -- Hemispherx Biopharma, Inc. (HEB) (the “Company” or “Hemispherx”) announces that the European Medicines Agency (EMA) on January 6, 2016 has forwarded to Hemispherx both its Public Summ...
Biopharmaceuticals, Regulatory
Hemispherx Biopharma, Alferon N Injection, interferon alfa-n3

Monaghan Medical Introduces Manometer Adapter to Measure Treatment With Aerobika(R) OPEP Device

Wed, 01/20/2016 - 19:42
New Adapter Tracks Airway Pressure Visually Ensuring Therapeutic Effectiveness of Respiratory Treatment PLATTSBURGH, NY--(Healthcare Sales & Marketing Network) - Monaghan Medical Corporation (MMC) (www.monaghanmed.com), a leader in the development, manu...
Devices, Product Launch
Monaghan Medical, Aerobika, Positive Expiratory Pressure

AbbVie's Venetoclax Receives Breakthrough Therapy Designation from FDA in Combination with Rituximab for the Treatment of Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

Wed, 01/20/2016 - 15:32
Marks the second Breakthrough Therapy Designation for venetoclax An application is currently under review for single agent venetoclax treatment of patients with relapsed/refractory chronic lymphocytic leukemia, including patients with the 17p deletion g...
Biopharmaceuticals, Oncology, FDA
AbbVie, venetoclax, chronic lymphocytic leukemia

Allan L. Shaw Joins Syndax Pharmaceuticals As Chief Financial Officer

Wed, 01/20/2016 - 15:28
WALTHAM, Mass., Jan. 20, 2016 -- (Healthcare Sales & Marketing Network) -- Syndax Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing entinostat in multiple cancer indications, announced today that the Company has appoi...
Biopharmaceuticals, Oncology, Personnel
Syndax Pharmaceuticals, Entinostat

Interpace Diagnostics Announces New Medicare Local Coverage Determination for Molecular Testing of Pancreatic Cysts

Wed, 01/20/2016 - 15:23
PARSIPPANY, N.J., Jan. 20, 2016 -- (Healthcare Sales & Marketing Network) -- Interpace Diagnostics Group (IDXG:NASDAQ) announced today that its Medicare administrative carrier (MAC), Novitas Solutions, has issued a new local coverage determination (LCD) f...
Diagnostics, Oncology, Reimbursement
Interpace Diagnostics, PancraGen

Immunotherapy Company PDS Biotechnology Strengthens Senior Management Team, Adds Two Drug Development Executives

Wed, 01/20/2016 - 15:21
NORTH BRUNSWICK, N.J., Jan. 20, 2016 -- (Healthcare Sales & Marketing Network) -- PDS Biotechnology, a clinical-stage biotechnology company developing cancer immunotherapies, is pleased to announce the appointments of Dr. Robert Shepard, M.D., F.A.C.P. as...
Biopharmaceuticals, Oncology, Personnel
PDS Biotechnology, Versamune, immunotherapy

Oncimmune Appoints Greg Stanley as President of Commercial Operations

Wed, 01/20/2016 - 15:18
NOTTINGHAM, England, January 20, 2016 -- (Healthcare Sales & Marketing Network) -- Oncimmune, a leader in early cancer detection, today announced the appointment of Greg Stanley as President of Commercial Operations. Greg Stanley is a senior executive ...
Diagnostics, Oncology, Personnel
Oncimmune, EarlyCDT

Kuros Biosurgery Holding Ltd. Closes Merger With Cytos Biotechnology Ltd. Which is Renamed Kuros Biosciences Ltd.

Wed, 01/20/2016 - 15:16
ZURICH, Switzerland, January 20, 2016 -- (Healthcare Sales & Marketing Network) -- Kuros Biosciences Ltd. (SIX:KURN formerly CYTN) ("Kuros") today announced the closing of the acquisition of Kuros Biosurgery Holding Ltd. and the change of name o...
Devices, Regenerative Medicine, Mergers & Acquisitions
Kuros Biosurgery, Cytos Biotechnology

Thetis Receives Orphan Drug Designation for TP-252 in Familial Adenomatous Polyposis

Tue, 01/19/2016 - 18:35
SOUTHPORT, CT--(Healthcare Sales & Marketing Network) - Thetis Pharmaceuticals LLC (Thetis or the Company), a privately-held biopharmaceutical company focused on gastrointestinal (GI) and cardiometabolic (CM) diseases, announced today that the U.S. Food an...
Biopharmaceuticals, FDA
Thetis Pharmaceuticals, familial adenomatous polyposis

Medical Device Firm Advanced Cooling Therapy Receives 510(k) Clearance from FDA for Second Esophageal Cooling Device to Cool and Warm Patients

Tue, 01/19/2016 - 16:14
CHICAGO--(Healthcare Sales & Marketing Network)--Emerging medical device firm Advanced Cooling Therapy (ACT) has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its second product, the Esophageal Cooling Device (ECD-02), ...
Devices, FDA
Advanced Cooling Therapy, Esophageal Cooling Device

Mylan Launches Generic Felbatol(R) Tablets

Tue, 01/19/2016 - 16:11
HERTFORDSHIRE, England and PITTSBURGH, Jan. 19, 2016 -- (Healthcare Sales & Marketing Network) -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Felbamate Tablets USP, 400 mg and 600 mg, which is the generic version of Meda Pharms' Felb...
Biopharmaceuticals, Generics, Neurology, Product Launch
Mylan, Felbamate, Felbatol, epilepsy

Amylyx Announces Election of Nobel Laureate Walter Gilbert, PhD, to Board of Directors

Tue, 01/19/2016 - 16:09
CAMBRIDGE, Mass.--(Healthcare Sales & Marketing Network)--Amylyx Pharmaceuticals, a privately-held pharmaceutical company focused on disease-modifying treatments for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases, today announced ...
Biopharmaceuticals, Neurology, Personnel
Amylyx Pharmaceuticals, Amyotrophic Lateral Sclerosis

ZipLine(R) Medical Secures $19 Million Financing Led by New Investor, MVM Life Science Partners LLP

Tue, 01/19/2016 - 16:03
Clinical studies continue to show shorter procedure times, fewer wound complications, reduced post-surgical care cost CAMPBELL, Calif.--(Healthcare Sales & Marketing Network)--ZipLine Medical, Inc. announced it has completed a $19 million round of finan...
Devices, Surgery, Venture Capital
ZipLine Medical, Zip Surgical Skin Closure, skin closure

Twist Bioscience Completes $61 Million Series D Financing And $20 Million Debt Facility

Tue, 01/19/2016 - 15:59
Oversubscribed Round Validates Twist Bioscience's Acceleration of Research and Development through Synthetic DNA Proceeds to Support Vertical Integration in Multiple Market Segments SAN FRANCISCO, Jan. 19, 2016 -- (Healthcare Sales & Marketing Network)...
Biopharmaceuticals, Venture Capital
Twist Bioscience, Synthetic DNA

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