Latest Expanded access Stories

2014-06-24 12:28:44

RIDGEFIELD, Conn., June 24, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the company has initiated an open-label, U.S. multi-center expanded access program (EAP) for its investigational compound nintedanib, for people diagnosed with idiopathic pulmonary fibrosis (IPF) and who meet certain eligibility criteria. Nintedanib is an investigational therapy and has not been approved by the U.S. Food and Drug Administration (FDA). The safety and efficacy of...

2014-05-16 08:26:34

BRISBANE, Calif., May 16, 2014 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced it will provide compassionate use of pirfenidone through a multi-center Expanded Access Program (EAP) in the United States to be conducted under InterMune's U.S. IND. Pirfenidone is an investigational therapy in the U.S. and has not been approved by the U.S. Food and Drug Administration (FDA). Expanded access programs provide a mechanism for early access to an investigational drug in the...

2014-05-05 08:28:08

SHANGHAI and TAIPEI, May 5, 2014 /PRNewswire/ -- WuXi PharmaTech (NYSE: WX) and TaiMed Biologics today announced that the FDA has approved the first batch of the ibalizumab (TMB-355) drug substance and sterile drug product manufactured at WuXi's biologics facilities for ongoing treatment of patients under investigator-sponsored IND's. This is the first reported FDA approval of a sterile biologics product manufactured in China for use under a U.S. IND, which marks an important...

2014-02-11 08:28:09

NEW YORK, Feb. 11, 2014 /PRNewswire/ -- PHARMACEUTICAL EXECUTIVE, the biopharmaceutical industry's premier publication, spoke with leaders in a resurgent patient movement about matters of life and death: compassionate use access to new drugs, clinical trial participation policy, and the individual unmet needs of patients suffering from dementia and cancer. Pleas for compassionate use access are on the increase, and Change.org is giving patients an audience. In THE ACTIVE PATIENT:...

2013-09-26 23:31:37

MarketResearchReports.Biz announces addition of new report “Orphan Drugs Market in Europe: Pricing, Reimbursement, Funding and Market Access Issues, 2013” to its database. Visit: http://www.marketresearchreports.biz/analysis-details/orphan-drugs-in-europe-pricing-reimbursement-funding-and-market-access-issues-2013-edition Albany, NY (PRWEB) September 26, 2013 The cost of treating rare diseases in an age when austerity measures are hitting a total health care funding across Europe is a...

2011-07-12 06:00:00

PITTSBURGH and HYDERABAD, India, July 12, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced an expanded licensing agreement between Gilead Sciences Inc. and Mylan's Matrix Laboratories Limited. Matrix has licensed the rights to produce and market generic versions of three Gilead HIV/AIDS therapies, if and when they receive regulatory approval. The Gilead products, which are currently in late-stage clinical development, include: Elvitegravir, an investigational integrase...

Word of the Day
  • A cloth or covering, more or less ornamented, laid over the saddle or furniture of a horse, especially of a sumpter-horse or horse of state.
  • Clothing, especially sumptuous clothing; equipment; outfit.
  • To cover with a caparison, as a horse.
  • To dress sumptuously; adorn with rich dress.
This word ultimately comes from the Medieval Latin 'cappa,' cloak.