06/11/14 - 06:48 AM EDT
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 saidREAD FULL POST
06/10/14 - 12:23 PM EDT
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?READ FULL POST
06/10/14 - 08:36 AM EDT
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.READ FULL POST
06/09/14 - 04:38 PM EDT
The desperate Dendreon debacle just descended into despondency with the abrupt departure of Chairman and CEO John Johnson, citing "personal reasons."READ FULL POST
06/09/14 - 09:22 AM EDT
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.READ FULL POST
06/09/14 - 08:27 AM EDT
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.READ FULL POST
06/05/14 - 01:42 PM EDT
Celgene CELG is once again partnering with billionaire drug executive Patrick Soon-Shiong. Next Tuesday, Celgene will announce a $25 million investment in NantHealth, a healthcare technology company founded Soon-Shiong, TheStreet has learned.READ FULL POST
06/05/14 - 08:30 AM EDT
On Wednesday afternoon during a presentation at an investor conference, Northwest Bio CEO Linda Powers once again offered conflicting language on the timeline for enrollment of 312 glioblastoma patients in the phase III study of the experimental cancer vaccine DC-Vax.READ FULL POST
06/03/14 - 07:39 AM EDT
Prepare now for the most epic, two-day FDA advisory panel sometime in the middle of 2015: Prosensa and Sarepta Therapeutics with their respective and competitive exon 51-skipping therapies against Duchenne muscular dystrophy (DMD).READ FULL POST
06/02/14 - 03:20 PM EDT
We just got our first look at the clinical activity of Incyte's immuno-oncology candidate INCB024360 ('360) dosed at 50 mg and combined with Bristol-Myers Squibb's BMY Yervoy in melanoma patients. The Wall Street scrum around the Incyte poster was insane.READ FULL POST
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