Acceleron Pharma Inc., a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair, today announced it will participate in the following upcoming investor conferences. Live audio webcasts for the Cowen and BioCentury events will be...
WASHINGTON- Actavis plc announced the U.S. Food and Drug Administration has approved AVYCAZ. AVYCAZ is part of Actavis' leading portfolio of infectious disease products that address some of the most dangerous pathogens. AVYCAZ was granted priority review and approval as a Qualified Infectious Disease Product in accordance with the Generating Antibi
THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Feb. 26, 2015/ PRNewswire/ Amgen and its subsidiary Onyx Pharmaceuticals, Inc., today announced that the European Medicines Agency has accepted the Marketing Authorization Application of Kyprolis for Injection for the treatment of patients with relapsed multiple myeloma who have received a
Vitae Pharmaceuticals, Inc., a clinical-stage biotechnology company, today announced that its partner Boehringer Ingelheim has voluntarily placed BI 1181181 on a temporary clinical hold, and has notified regulatory agencies of its decision. Richard Gregg, Chief Scientific Officer of Vitae. According to the Centers for Disease Control, Alzheimer's
Biosimilars have emerged as one of the most promising segment of the European pharmaceutical industry in recent years. The biosimilars segment has been experiencing a steady growth driven by patent expiration of blockbuster drugs, amenable regulatory framework, economic incentives along with favorable pricing and reimbursement policies adopted...
Technological progress is continuously increasing allowing pharmaceutical companies to develop newer products with higher pharmacological benefits. Transdermal patches are extension of their continuous efforts due to which several patients have been able to improve quality of life. US is one of the largest transdermal patch market across the globe.
Biota Pharmaceuticals announced today that it has entered into a definitive agreement to acquire Anaconda Pharma, a privately-held biotechnology company based in Paris, France. Joseph Patti, president and chief executive officer of Biota. Marta Blumenfeld, chief executive officer of Anaconda Pharma.
On February 25, 2015, Biota Pharmaceuticals, Inc., each of the shareholders of Anaconda Pharma party thereto, and the Holder Representative thereunder entered into a Stock Purchase Agreement, pursuant to which the Company has agreed to acquire all of Anaconda's outstanding shares for an aggregate purchase price consisting of the issuance of 3.5 mil
Celator Pharmaceuticals, Inc., a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, today announced that Scott Jackson, Chief Executive Officer, will present an overview of the company at the 27 th Annual Roth Conference on Monday, March 9, 2015 at 11:30
-Cipher Pharmaceuticals Inc. today announced it has strengthened its product pipeline by acquiring the worldwide rights to three products from Astion Pharma, a Denmark- based specialty pharmaceutical company. The product was approved in the European Union in 2014 as a Class III medical device for the treatment of seborrheic dermatitis, an inflammat
The report, released at a meeting of the nonpartisan economic policy forum in Anchorage, said the budget includes $52.7 million in wage increases this year and health insurance plans, including one dubbed the "economy plan," in which the state picks up all the cost for certain workers after employees meet a $500 deductible for an individual and a $
Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, announced it has received U.S. Food and Drug Administration emergency use authorization of its ReEBOV? Antigen Rapid Test. The Corgenix Ebola rapid test is the first rapid diagnostic test and the first immunoassay authorized for emergency use by the FDA for
This Annual Report on Form 10- K including this Management's Discussion and Analysis of Financial Condition and Results of Operations contains statements that are forward-looking statements within the meaning of the federal securities laws. These statements involve substantial known and unknown risks and uncertainties that could cause our actual...
Clients of Diamond Pharma Services, Inc. will have access to product development and regulatory affairs expertise for the American market. "We are excited to realise a long time ambition to expand our services into the USA," said Dr Maureen Graham, Managing Director of Diamond BioPharm Ltd. "The new US company will allow us to continue to deliver
The discussions set forth in this Annual Report on Form 10- K contain statements concerning potential future events. In addition, management may make forward-looking statements orally or in other writings, including, but not limited to, in press releases, in the Annual Report and in the Company's other filings with the Securities and Exchange Commi
EmblemHealth, one of New York s leading health benefits and wellness companies, has entered into a two-year partnership with Healthways, Inc., the recognized leader in well-being improvement solutions, to help high-risk commercial, Medicare and Medicaid members effectively manage their chronic conditions. As part of the EmblemHealth Disease Mana
Mr. Bernard has more than 20 years of experience as a senior executive and company officer leading sales and marketing teams to build biopharma and translational research partnerships and commercialize IVD platforms. At Epic, Mr. Bernard will oversee the expansion of Epic's technology in clinical studies as part of collaborations with pharmaceutica
Eytan Alpern, MD, Founder and Chief Operating Officer of Advanced Medical Reviews, one of the country's leading Independent Review and Utilization Management Organizations, will be a featured speaker at the 20th Annual PBMI Conference in San Antonio, Texas, on March 2, 2015. In his session, "The Importance of Revisiting Medication Regimens and a Lo
Pfizer reported that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Rapamune for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. "If approved, Rapamune would be the first FDA approved treatment option for pa
Cytori Therapeutics, Inc. announced today that it received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. Steven Kesten, Chief Medical Officer of Cytori Therapeutics. There are only about 35 specialized scleroderma centers in the U.S. and this decision to expand the trial si
Eagle Pharmaceuticals confirmed that the U.S. Food and Drug Administration has granted seven years of market exclusivity in the U.S. to Ryanodex for Injectable Suspension for the treatment of malignant hyperthermia. According to a release from the company, Ryanodex was designated an orphan drug in August 2013 and was approved by the FDA in July 201
WASHINGTON, Feb. 26 The U.S. Department of Health& Human Services published the following rule in the Federal Register from the Food& Drug Administration:. A Rule by the Food and Drug Administration on 02/26/2015. The classification was applicable June 6, 2014.
Whether a manufacturers needs to convince the FDA to accept a predicate device in a simple 510 filing or implement UDI across a family of high-risk implantable devices, there's one thing all regulatory professionals need. The most up-to-date, latest FDA regulations available. Discover the changes and best practices regarding:? Determining substan
-Otsuka Pharmaceutical Co., Ltd. and its affiliate Otsuka Canada Pharmaceutical Inc. announce that Health Canada has approved JINARC? as the first pharmaceutical agent for the treatment of autosomal dominant polycystic kidney disease. The Health Canada approval of JINARC? is based on the results of the pivotal Phase 3 randomized, double-blind a
Flex Pharma, Inc., a biotechnology company that is developing innovative and proprietary treatments for nocturnal leg cramps and spasms associated with severe neuromuscular conditions, today announced that it will present a corporate overview at the following upcoming investor conferences in March:. Please log on to the Flex Pharma website...