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Home » Authors » Catherine Shaffer

Catherine Shaffer

Articles

ARTICLES

Qsymia Uptake Slow, Steady, but Will It Win Obesity Race?

Oct. 23, 2012
By Catherine Shaffer
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.
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Europe's CHMP Bounces Vivus' Weight Loss Drug

Oct. 22, 2012
By Catherine Shaffer
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.
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BioCryst, Presidio in All-Stock Deal; Form HCV Powerhouse

Oct. 19, 2012
By Catherine Shaffer
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).
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Cebix Closes $30.9M Series B, Reports Phase II Ersatta Data

Oct. 18, 2012
By Catherine Shaffer
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.
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FDA Advisory Committee Gives Thumbs Up to Gattex in SBS

Oct. 17, 2012
By Catherine Shaffer
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.
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FDA Pitches Soft Ball with Gattex Briefing Docs in SBS

Oct. 15, 2012
By Catherine Shaffer
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.
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Kythera, Intercept Dazzle with Dueling Initial Public Offerings

Oct. 12, 2012
By Catherine Shaffer
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.
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Emmaus Medical Carried Far by Friends and Family Funding

Oct. 12, 2012
By Catherine Shaffer
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.
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113th Congress to Focus on High-Tech Tax Reform

Oct. 11, 2012
By Catherine Shaffer
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.
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Safe Drugs, User Fees, High Tech Finish Busy Session

Oct. 9, 2012
By Catherine Shaffer
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.
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View All Articles by Catherine Shaffer

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