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William D. Waddill, Calithera CFO, Elected to Protagonist Therapeutics Board

Fri, 07/08/2016 - 15:03
MILPITAS, Calif., July 8, 2016 -- (Healthcare Sales & Marketing Network) -- Protagonist Therapeutics, Inc. today announced the election of William D. Waddill, Senior Vice President and Chief Financial Officer of Calithera Biosciences, to the Protagonist B...
Biopharmaceuticals, Personnel
Protagonist Therapeutics, inflammatory bowel disease, Crohn's disease

Teligent, Inc. Receives Two FDA Approvals for Topical Prescription Portfolio

Fri, 07/08/2016 - 15:01
Represent the Fifth and Sixth FDA Approvals of the Year, Launches Planned for This Quarter BUENA, N.J., July 8, 2016 -- (Healthcare Sales & Marketing Network) -- Teligent, Inc. (TLGT), a New Jersey-based specialty generic pharmaceutical company, announ...
Biopharmaceuticals, Generics, FDA
Teligent, Triamcinolone Acetonide

Essential Medical Inc. Announces FDA Approval to Begin a U.S. Clinical Trial for the MANTA(TM) Large Bore Vascular Closure Device

Fri, 07/08/2016 - 14:59
MALVERN, Pennsylvania, July 8, 2016 -- (Healthcare Sales & Marketing Network) -- Essential Medical, Inc., a privately held medical device company addressing the rapidly growing large bore vascular closure market, announced today that it has received Inves...
Devices, Interventional, FDA
Essential Medical, MANTA, Vascular Closure

NEPHROCHECK(R) Test Predicts Acute Kidney Injury Risk In Sepsis Patients Including Those With Other Organ Failures

Fri, 07/08/2016 - 14:55
Rapid Identification of Septic Patients at High Risk for Developing AKI Could Substantially Improve the Therapeutic Approach SAN DIEGO, July 8, 2016 -- (Healthcare Sales & Marketing Network) -- Astute Medical, Inc., developer of biomarkers for better h...
Diagnostics
Astute Medical, NEPHROCHECK, kidney injury, sepsis

Pernix Therapeutics Announces Restructuring of Sales Force and Operations

Thu, 07/07/2016 - 13:29
Reorganization Expected to Drive Long-Term Revenue Growth, Improve Profitability and Result in Annualized Cost Savings of Approximately $10 Million MORRISTOWN, N.J. , July 07, 2016 -- (Healthcare Sales & Marketing Network) -- Pernix Therapeutics Holding...
Biopharmaceuticals, Personnel
Pernix Therapeutics

QT Vascular Receives CE Mark Clearance for Chocolate Heart(TM), a Novel Drug-Coated Coronary Balloon

Thu, 07/07/2016 - 13:24
Chocolate Heart™ drug-coated PTCA balloon approved for use in coronary interventions Chocolate Heart™ may offer a new paradigm for the treatment of certain patients with coronary artery disease First-in-Human ("FIH") study of Chocolate Hear...
Devices, Interventional, Cardiology, Regulatory
QT Vascular, Chocolate Heart, PTCA balloon, nitinol

Shire Receives Extension of Market Authorization in Europe for Revestive(R) (Teduglutide) for the Treatment of Paediatric Patients with Short Bowel Syndrome (SBS)

Thu, 07/07/2016 - 13:14
This press release is intended for a global audience. First therapy indicated in the EU for use in patients aged one year and above with SBS, a rare gastrointestinal condition ZUG, Switzerland, July 7, 2016 -- (Healthcare Sales & Marketing Network) ...
Biopharmaceuticals, Regulatory
Shire plc, Revestive, teduglutide, Short Bowel Syndrome

NeuroDerm Announces Additions to Management Team

Wed, 07/06/2016 - 16:29
REHOVOT, Israel, July 06, 2016 -- (Healthcare Sales & Marketing Network) -- NeuroDerm Ltd. (NDRM), a clinical stage pharmaceutical company developing drugs for central nervous system (CNS) disorders, today announced the appointments of Tami Yardeni as Chie...
Biopharmaceuticals, Devices, Neurology, Personnel
NeuroDerm, ND0612H, Parkinson’s disease, Levodopa, Carbidopa

FDA Grants Merrimack Fast Track Designation for Seribantumab (MM-121) in Non-small Cell Lung Cancer

Wed, 07/06/2016 - 16:24
CAMBRIDGE, Mass., July 6, 2016 -- (Healthcare Sales & Marketing Network) -- Merrimack Pharmaceuticals, Inc. (MACK) today announced that the U.S. Food and Drug Administration (FDA) has granted seribantumab, also known as MM-121, Fast Track designation for ...
Biopharmaceuticals, Oncology, FDA
Merrimack Pharmaceuticals, seribantumab, non-small cell lung cancer

Knight and Ember Expand Distribution Partnership

Wed, 07/06/2016 - 15:27
MONTREAL and NEW YORK, July 06, 2016 -- (Healthcare Sales & Marketing Network) -- Knight Therapeutics Inc. (GUD.TO) ("Knight"), a leading Canadian specialty pharmaceutical company, and Ember Therapeutics, Inc. (EMBT) ("Ember"), a New Yo...
Biopharmaceuticals, Distribution
Ember Therapeutics, Knight Therapeutics, Bone Morphogenetic Protein, Migralex

US FDA pathway opens to SCENESSE(R) following Fast Track designation for treatment of EPP

Wed, 07/06/2016 - 15:24
FDA awards Fast Track Designation¹ to expedite review of SCENESSE® in EPP NDA filing allowed on a rolling basis FDA hosting a Scientific Workshop² on EPP to learn more about disease and drug treatment MELBOURNE, Australia and NEW YOR...
Biopharmaceuticals, FDA
Clinuvel Pharmaceuticals, SCENESSE, afamelanotide, erythropoietic protoporphyria

Mylan Launches Generic Fenoglide(R) Tablets

Wed, 07/06/2016 - 15:21
HERTFORDSHIRE, England and PITTSBURGH, July 6, 2016 -- (Healthcare Sales & Marketing Network) -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Fenofibrate Tablets USP, 40 mg and 120 mg, which is a generic version of Santarus's Fenoglid...
Biopharmaceuticals, Generics, FDA, Product Launch
Mylan, Fenofibrate, Fenoglide, hypercholesterolemia

SI-BONE, Inc. Appoints Tony Recupero Chief Commercial Officer

Tue, 07/05/2016 - 14:47
SAN JOSE, Calif., July 5, 2016 -- (Healthcare Sales & Marketing Network) -- SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for...
Devices, Orthopaedic, Neurosurgery, Personnel
SI-BONE, iFuse , sacroiliac fusion, degenerative sacroiliitis

Recro Pharma Appoints Michael Celano as Chief Financial Officer

Tue, 07/05/2016 - 14:45
MALVERN, Pa., July 05, 2016 -- (Healthcare Sales & Marketing Network) -- Recro Pharma, Inc. (REPH), a revenue generating specialty pharmaceutical company developing multiple non-opioid therapeutics for the treatment of pain, today announced the appointment...
Biopharmaceuticals, Personnel
Recro Pharma, Meloxicam, dexmedetomidine

Eagle Pharmaceuticals Announces Changes to Its Board of Directors; Director, Michael Graves Appointed Chairman

Tue, 07/05/2016 - 14:43
Douglas L. Braunstein and Robert Glenning join the board Hudson Executive Capital LP acquires 6.1% equity interest in Eagle WOODCLIFF LAKE, N.J.--(Healthcare Sales & Marketing Network)--Eagle Pharmaceuticals, Inc. (EGRX) (“Eagle” or the “Company”) ...
Biopharmaceuticals, Personnel
Eagle Pharmaceuticals

Bristol-Myers Squibb Acquires Cormorant Pharmaceuticals

Tue, 07/05/2016 - 13:39
Gains full-rights to Cormorant’s HuMax-IL8 antibody program and lead asset HuMax-IL8 in Phase 1/2 Development Broadens Bristol-Myers Squibb’s oncology pipeline focus on the tumor microenvironment and combination therapy NEW YORK & STOCKHOLM--(Health...
Biopharmaceuticals, Mergers & Acquisitions
Bristol-Myers Squibb, Cormorant Pharmaceuticals, HuMax-IL8

Insys Therapeutics Announces FDA Approval of Syndros(TM)

Tue, 07/05/2016 - 13:32
PHOENIX, July 05, 2016 -- (Healthcare Sales & Marketing Network) -- Insys Therapeutics, Inc. (“Insys” or “the Company”) (INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an oral...
Biopharmaceuticals, FDA
Insys Therapeutics, Syndros, dronabinol, cannabinoid

Takeda and TiGenix Enter into Licensing Agreement for Ex-U.S. Rights to Cx601 for the Treatment of Complex Perianal Fistulas in Patients with Crohn's Disease

Tue, 07/05/2016 - 13:24
OSAKA, Japan and LEUVEN, Belgium, July 5, 2016 -- (Healthcare Sales & Marketing Network) -- Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") and TiGenix NV (Euronext Brussels: TIG) ("TiGenix") today announced that the compa...
Biopharmaceuticals, Regenerative Medicine, Licensing
Takeda Pharmaceutical, TiGenix, Crohn's disease

NightBalance Closes EUR 12.5 Million Series B Financing to Support Commercial Rollout in Europe and Enter the U.S. Market with Its Innovative Sleep Apnea Device

Tue, 07/05/2016 - 13:16
Industry veteran Jan Keltjens to be appointed Chairman of the Board of Directors Geoffrey Waters, former President of Respironics International Group, Dirk Kersten of Inkef Capital, and Pieter van der Meer of Gilde Healthcare Partners to join Board of D...
Devices, Venture Capital, Personnel
NightBalance, obstructive sleep apnea, Sleep Position Trainer

Regeneron and Sanofi Announce Approval of Praluent(R) (alirocumab) for the Treatment of Hypercholesterolemia in Japan

Tue, 07/05/2016 - 13:08
TARRYTOWN, N.Y. and PARIS, July 5, 2016 -- (Healthcare Sales & Marketing Network) -- Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi today announced that the Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing authoriz...
Biopharmaceuticals, Cardiology, Regulatory
Regeneron Pharmaceuticals, Sanofi, Praluent, alirocumab

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