- FDA issues guidance to expedite drug development
The FDA has released a draft guidance document designed to help drug companies speed development. The 42-page guidance outlines "enrichment strategies" meant to improve the efficiency of drug trials such as excluding patients unlikely to demonstrate clinical benefit. "These are potentially powerful strategies for the pharmaceutical industry because appropriate use of enrichment could result in smaller studies, shortened drug development times, and lower development costs," wrote Dr. Bob Temple of the FDA. MedPage Today (free registration) (12/26)        | Manage your business with the help of a dedicated partner:
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  | Health Care & Policy |  |  | | - Japan clears Bristol-Pfizer blood thinner Eliquis
Pfizer and Bristol-Myers Squibb obtained approval from Japanese regulators to market the anticoagulant Eliquis, or apixaban, for ischemic stroke and systemic embolism prevention in patients with nonvalvular atrial fibrillation. The approval was based on positive results of the late-stage ARISTOTLE trial. Eliquis has also been approved in Europe and Canada. Pharmaceutical Business Review Online (12/27) - AMAG seeks expanded FDA approval for anemia drug Feraheme
AMAG Pharmaceuticals filed a supplemental new drug application with the FDA seeking approval to market injectable Feraheme, or ferumoxytol, to patients with iron deficiency anemia who don't respond to or can't take oral iron therapy. The filing was based on the results of an international, late-stage program, which had more than 1,400 participants. RTT News (12/24) | Company & Financial News | | | | - Fast Forward and EMD Serono announce $1.4M in grants
ACADIA Pharmaceuticals and the University of California at Los Angeles will receive $545,380; Vicore Pharma, Uppsala University and Charité-Universitätsmedizin Berlin will receive $531,300; and Axxam will receive $402,000 for research on therapies to reverse, treat or prevent nervous system damage due to multiple sclerosis. The grants are through the Accelerating Commercial Development Program funded by the National Multiple Sclerosis Society's Fast Forward subsidiary and Merck KGaA division EMD Serono. Genetic Engineering & Biotechnology News (12/21) | Industry Deals | | | | - Sarepta, NIAID collaborate on trial of flu drug candidate
The National Institute of Allergy and Infectious Diseases and Sarepta Therapeutics entered into a clinical trial agreement centered on the latter's AVI-7100, an investigational drug for influenza viruses. NIAID will conduct an early-stage trial to assess the drug's safety, tolerability and pharmacokinetics in healthy volunteers. Sarepta will use the trial data to support the development of AVI-7100. Pharmaceutical Business Review Online (12/24) | Food & Agriculture | | | | - Medication-friendly grapefruit hybrid is developed in Fla.
Researchers at the University of Florida developed a grapefruit-pomelo hybrid with very low levels of furanocoumarins, compounds that can interact with enzymes and cause problems for people taking certain drugs. A single gene in the parent pomelo was the key to the hybrid's success. Researchers plan to conduct clinical trials to test the hybrid's safety after lab tests showed little interaction with enzymes. The Packer (Lenexa, Kan.) (12/26) | Industrial & Environmental | | | | - Chemtex shows blueprint of planned biofuels plant in N.C.
Chemtex International recently showed officials in Clinton, N.C., the blueprint of the company's $200 million biofuels refinery plant, which will be built in Sampson County and is scheduled to begin production by early 2015. The company says the plant will create about 350 jobs and, if annexed, contribute more than $1 million in annual tax revenue to the city. Paolo Carollo, executive vice president at Chemtex, said the plant could be the first of many in North America. "We are going to be starting with smaller facilities and probably evolving into 40 or 50 million gallons," he said. "We need to have a good handle on the logistics before we can think about expanding the capacity." The Sampson Independent (Clinton, N.C.) (12/23) | News from BIO | | | | - Are you taking full advantage of your membership?
BIO's cost-savings program, BIO Business Solutions, is helping 2,700 companies nationwide save on the cost of essential products and services. Members of BIO and 43 state and regional biotech associations are eligible to receive preferential pricing and other benefits at no additional cost beyond their membership dues. VWR International, FedEx, Office Depot and Business Wire are just a few of the industry leading providers that offer special pricing through this members-only program. Learn more or enroll here.
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