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NORTHBROOK, Ill., Sept. 6, 2014 /PRNewswire/ -- Astellas today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomy...
RANDOLPH, N.J., Sept. 5, 2014 /PRNewswire/ -- Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential of no...
Pomerantz LLP has filed a class action lawsuit against STAAR Surgical Company ("STAAR" or the "Company") (NASDAQ: STAA) and certain of its officers. The class action, filed in United States District Court, Central District of California, and docketed under 14-cv-05263, is on behalf of ...
Pomerantz LLP has filed a class action lawsuit against Regado Biosciences, Inc. ("Regado" or the "Company") (NASDAQ: RGDO) and certain of its officers. The class action, filed in United States District Court, District of New Jersey, and docketed under 14-cv-04345-JAP-DEA, is on behalf ...
NEWARK, Calif., Sept. 5, 2014 /PRNewswire/ -- Depomed, Inc. (Nasdaq:DEPO) today announced that Judge Kentaji Brown Jackson of the federal district court for the District of Columbia has granted Depomed's motion for summary judgment in the company's lawsuit against the United States Foo...
SARASOTA, Fla., Sept. 5, 2014 /PRNewswire-iReach/ -- WellSpring Pharmaceutical Corporation today announced its acquisition of BONINE®, an over-the-counter drug for motion sickness, from Prestige Brands Holdings, Inc.
GERMANTOWN, Md., Sept. 5, 2014 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that President and CEO Richard Garr will present at the 16th Annual Rodman & Renshaw Global Investment Conference on Wednesday, September 10, at 2:55 p.m. EST. Garr will provide an overview of...
NEW YORK, September 5, 2014 /PRNewswire/ --
Boston Therapeutics, Inc. (OTCQB: BTHE), developer of complex carbohydrate therapeutics to treat diabetes, announced that David Platt, Ph.D., Chief Executive Officer, is scheduled to speak at the Rodman & Renshaw Annual Global Investment Conference at the New York Palace Hotel, New Yor...
NEW YORK, September 5, 2014 /PRNewswire/ --
Align Technology, Inc. (NASDAQ: ALGN) today announced an agreement with Zimmer Dental, Inc. in which the iTero® Intraoral Scanner will support connectivity with Zimmer Zfx custom abutments for implants. This new digital implant workflow will offer clinicians an expanded menu of digital...
DUBLIN, Sept. 5, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' application for ceftazidime-avibactam, its investigational antibiotic for the treatment of patients with Complicated Urinary T...
MELBOURNE, Australia, Sept. 5, 2014 /PRNewswire/ -- Prana Biotechnology (ASX: PBT) has today announced the US Food and Drug Administration (FDA) has granted Orphan Drug designation to PBT2 for the treatment of Huntington Disease.
PITTSBURGH, Sept. 5, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has launched Ibandronate Sodium Injection, 1 mg (base)/mL, packaged in 3 mg (base)/3 mL pre-filled glass syringes, which is the generic version of Hoffmann-La Roche's Boniva® Injection. Mylan rec...
PRINCETON, N.J., Sept. 5, 2014 /PRNewswire/ -- Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today the acquisition of...
WASHINGTON, Sept. 4, 2014 /PRNewswire-USNewswire/ -- Today the FDA approved Keytruda (pembrolizumab), a new treatment for advanced melanoma, the deadliest form of skin cancer. Melanoma patients have been waiting anxiously for this day, given the promising data that early studies have s...
STAMFORD, Conn., Sept. 4, 2014 /PRNewswire/ -- Purdue Pharma is presenting results from several studies and post-hoc analyses evaluating extended-release, single-entity hydrocodone bitartrate tablets, including the analgesic effectiveness and safety among patients transitioning from im...
WHITEHOUSE STATION, N.J., Sept. 4, 2014 /PRNewswire/ -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment...
NEW YORK, Sept. 4, 2014 /PRNewswire/ -- SELLAS Life Sciences Group (SELLAS), a Swiss-based development-stage biopharmaceutical company today announced that it has signed an exclusive global collaboration and license agreement with Memorial Sloan Kettering Cancer Center (MSK) for the de...
NEW YORK, Sept. 4, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
will highlight topics including the FDA's views on the future of manufacturing, quality and compliance in the pharmaceutical industry, and innovations to address regulatory challenges in R&D and Manufacturing.
PARSIPPANY, N.J., Sept. 4, 2014 /PRNewswire/ -- GlaxoSmithKline (GSK) Consumer Healthcare applauds CVS for its courageous decision to end the sale of tobacco products. This monumental step will go a long way towards improving and protecting public health.
WINNETKA, Calif., Sept. 4, 2014 /PRNewswire/ -- Green Cures & Botanical Distribution Inc. (OTC Pink: GRCU) ("Green Cures") announced today that it is now working with Florida-based Nutritional Products International and InHealth Media for the distribution and marketing of Green Cur...
PARIS, September 4, 2014 /PRNewswire/ --
PARIS, September 4, 2014 /PRNewswire/ --
BuzzeoPDMA, A Cegedim Company, today announced that Shionogi Inc. has selected BuzzeoPDMA’s sample management services to help the company maintain compliance with the FDA’s PDMA regulations. Shionogi Inc., the U.S.-based subsidiary of Shionogi & ...
LONDON, Sept. 4, 2014 /PRNewswire/ -- Reportbuyer.com has added a new market research report:
MARLTON, N.J., Sept. 4, 2014 /PRNewswire/ -- Acsis Inc., the market leader for supply chain visibility, brand protection and serialization solutions, announced the company will be attending two major pharmaceutical industry conferences in September – PDA/FDA Joint Regulatory Conference...
WESTMINSTER, Colo., Sept. 4, 2014 /PRNewswire/ -- Cerapedics, a privately-held orthobiologics company, today announced that the company has filed a Premarket Approval Application (PMA) with the U.S. Food & Drug Administration for i-FACTOR™ Peptide Enhanced Bone Graft. The applicati...
IRVINE, Calif., Sept. 4, 2014 /PRNewswire/ -- ALPHAEON® Corporation, a leader in lifestyle healthcare and subsidiary of Strathspey Crown Holdings LLC, announced today that the U.S. Food and Drug Administration (FDA) accepted the Investigational New Drug (IND) application to conduct cli...
CHICAGO, Sept. 4, 2014 /PRNewswire/ -- Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the Unite...
NEW YORK, September 4, 2014 /PRNewswire/ --
LAWRENCEVILLE, N.J., Sept. 4, 2014 /PRNewswire/ -- September 4, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN) today announced that data from two Phase I studies on ThermoDox® in recurrent chest wall breast cancer were published in the International Journal of Hyperthermia. Th...
Spiracur, the developer of the only mechanically powered advanced wound care solution that delivers the proven efficacy of Negative Pressure Wound Therapy (NPWT), today announced that Health Care Services Corporation (HCSC) has approved reimbursement coverage of the SNaP® Wound Care Sy...
MADISON, Wisc. and WAYNE, Penn., Sept. 4, 2014 /PRNewswire/ -- Propeller Health, the FDA-cleared digital health solution for chronic respiratory disease, today announced that it raised $14.5 million in Series B financing, led by Safeguard Scientifics (NYSE:SFE) with participation from ...
ROCHESTER, N.Y., Sept. 4, 2014 /PRNewswire/ -- Complemar Partners, Inc. (http://www.complemar.com) launched its new web site this week after several months of refining the company's brand and identity. The new web site, both developed and designed entirely in-house in Complemar's Creat...
Vycor Medical, Inc. ("Vycor") (OTCQB: VYCO), a provider of innovative and superior surgical and therapeutic solutions, announced that researchers from the Department of Neurological Surgery at Weill Cornell Medical College will present their recent work on minimally invasive neurosurgi...
Esaote North America announced that its new MyLab Six ultrasound system has received 510(k) clearance from the U.S. Food and Drug Administration and is now available for sale in the United States.
NASHUA, N.H., Sept. 4, 2014 /PRNewswire/ -- iCAD, Inc. (NASDAQ: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that, in addition to Volpara®Density™ volumetri...