Biotech columnist Adam Feuerstein answers readers' questions about health care companies.
EnteroMedics and its VBLOC "fat-zapping" implantable medical device will be the focus of an FDA advisory panel meeting next Tuesday, June 17. If FDA follows historical form, the agency's review of VBLOC's safety and efficacy will be available publicly tomorrow morning.
FDA needs more time to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of heart-safety related outcomes for Contrave, Orexigen said
Inovio Pharmaceuticals CEO Joseph Kim is walking back expectations for the phase II study of its DNA vaccine VGX-3100 in women with high-grade cervical intraepithelial neoplasia (CIN 2/3), also known as cervical pre-cancerous lesions. Results from the VGX-3100 study should be announced any day, but I suspect Inovio already has data in hand. Why else would Kim be laying the foundation for a massive spin job, if not to cushion the vaccine's failure?
Talk about uncanny timing, one day after Achillion Pharmaceuticals rips higher on takeover speculation, the company announces the lifting of an FDA clinical hold on its lead hepatitis C drug candidate and the start of a new study with a second hepatitis C compound.
The desperate Dendreon debacle just descended into despondency with the abrupt departure of Chairman and CEO John Johnson, citing "personal reasons."
Selling weight-loss pills to fat Americans is clearly more difficult than Vivus and Arena envisioned. Orexigen will face the same challenges, but of the three companies, it has the best marketing partner in Takeda because of its metabolic drug expertise.
Johnson & Johnson and Abbvie were both reportedly interesting in buying Idenix but lost out to Merck, reports CNBC. Achillion shares are up almost 30% to $TK Monday as investors bet the losers in the Idenix sweepstakes may move on to the next target.
With Gilead Sciences already marketing the hepatitis C pill Sovaldi and competition from Abbvie-Enanta Pharma and Bristol-Myers Squibb close behind, a lot of investors believed the hepatitis C drug race had transitioned to marketing and away from M&A. But Merck chief scientitist Roger Perlmutter is no dummy, so his decision to spend almost $4 billion on Idenix says the hepatitis C treatment market may have a much longer tail than many believed.
I've been getting so much hate mail and nasty tweets lately, I thought it would be fun to throw them all into a single column for funny Friday read. There's probably something deeper to be said about market psychology and what an uptick in hate mail means for biotech investor sentiment, but I'll leave the interpretations up to you.