Current medical news and unique business news for anyone that cares about the healthcare industry.
Safety slows FDA drug approvals. The U.S. Food and Drug Administration’s 21 approvals last year were fewer than in 2009 (25) or 2008 (24), though far from the 18 in 2007. Dendreon’s cancer prostate drug, Novartis’ and Acorda Therapeutics’ multiple sclerosis drugs, and Watson Therapeutics’ emergency contraceptive all won FDA approvals this year. But diabetes and weight-loss drugs were not approved.
Few, including Pharmalot’s Ed Silverman, were stunned by the FDA approvals decline: “Given the ongoing talk at the FDA about placing greater emphasis on safety, no one should be shocked that the pace of drug approvals remains modest.”
When Investment Rhymes with Canada
Canada has a proud history of achievement in the areas of science and technology, and the field of biomanufacturing and life sciences is no exception.
BSX pays down debt. Boston Scientific finalized its neurovascular deal with Stryker and paid off $600 million in senior notes.
Medical tourism… remains a trickle (for now). Medical tourism companies each send about 285 American patients overseas a year. Favorite ports of call: India, Costa Rica and Thailand.
Drug developments (or lackthereof). A promising cystic fibrosis drug from Inspire Pharmaceuticals “failed to significantly improve breathing.” Meanwhile, Repros Therapeutics will commence with a Phase IIb study of its treatment for low testosterone in men.
GSK responds to 60 Minutes report. GlaxoSmithKline says the 60 Minutes piece was unfair: “The FDA; the US Department of Justice; and Neil Getnick, Cheryl Eckard’s attorney, all stated there was no indication that patients were harmed as a result of the production issues at Cidra. Massachusetts U.S. Attorney Carmen Ortiz herself stated: ‘We did not uncover any evidence that patients were harmed from these adulterated batches.’ ”
The latest US healthcare reform lawsuit… will come from Wisconsin.
Dealflow and more. Vivo Ventures is raising a seventh fund worth $350 million; cardiac stem cell therapy company Capricor raised $2 million; Healthcare Trust of America paid $28 million for the Medical Park of Cary in North Carolina; cancer therapy company Genesis Biopharma raised $845,000; age-related macular degeneration company PanOpitca raises $30 million to develop a topical treatment; vaccine startup Genocea Biosciences has raised $35 million; cancer medical device company Augmenix has raised $3 million; sleep tracking company Zeo raised $12.3 million; and drug developer Compugen raised $5 million.
There’s a Viagra-like gene therapy in here somewhere. An overheated media goes bonkers over evidence of a gene variant whose owners were likely to have “uncommitted sex, including one-night stands and acts of infidelity.”
