Four weeks after its launch, 2,000 patients were taking obesity drug Qsymia (phentermine/topiramate), from Vivus Inc., with new patient starts slowing from an initial four- or fivefold increase to a 27 percent to 33 percent increase from week three to week four, according to IMS and Wolters Kluwer weekly prescription data.
Vivus Inc. will appeal a negative opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The committee recommended against approval of Qsiva (phentermine/topiramate) based on concerns about potential cardiovascular and central nervous system effects over long term use, and other safety issues.
BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., will acquire Presidio Pharmaceuticals Inc., of San Francisco, in an all-stock transaction valued at about $101 million, creating a new company centered on hepatitis C virus (HCV) and rare disease hereditary angioedema (HAE).
Cebix Inc., of La Jolla, Calif., closed a $30.9 million Series B investment to support development of its investigational drug for peripheral neuropathy, Ersatta. It also reported new results from a Phase I/II trial showing the drug had efficacy in patients with Type I diabetes dosed once weekly for 12 weeks.
The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) voted unanimously Tuesday that the benefits of NPS Pharmaceuticals Inc.'s Gattex (teduglutide) for short bowel syndrome (SBS) outweighed its risks, and that the drug should be approved.
Briefing documents that were released ahead of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting for short bowel drug Gattex (teduglutide) held "no surprises" according the drugmaker, NPS Pharmaceuticals Inc.
Intercept Pharmaceuticals Inc. and Kythera Biopharmaceuticals Inc. each priced initial public offerings (IPO) at the top of their ranges Thursday, and both companies' stock surged, selling several dollars above even that top price.
It was compassion that moved Yutaka Niihara to start Emmaus Medical Inc. more than 10 years ago. The hematologist and University of California Los Angeles (UCLA), professor would have been content to continue with his medical practice and teaching, had it not been his passion for research and his desire to find a treatment for the intense pain crises his sickle cell patients suffered.
According to the Biotechnology Industry Organization (BIO), the upcoming lame duck session of Congress is unlikely to have time to consider the High Technology Small Business Research Incentive Act sponsored by Sens. Olympia Snow (R-ME) and Robert Menendez (D-NJ) and Reps. Jim Gerlach (R-PA) and Richard Neal (D-MA), leaving it for the 113th Congress in the new year.
President Obama has signed into law the SAFE DOSES Act, a law that will increase penalties for prescription drug crimes like robbing pharmacies and medical product cargo. Medical cargo theft has increased as organized crime networks target and sell those products on the black market.
