In late August, when Dynavax Technologies Corp. heard that the FDA nixed an advisory panel to consider the BLA for HBV vaccine Heplisav-B, a few holdouts speculated that the news might bode well – it could mean that regulators had decided the panel wasn’t necessary and only a few details remained to be worked out before approval.
After encouraging word from Europe, PTC Therapeutics Inc.’s “first strategy is to continue to try and push forward [in FDA discussions] with the data that we’ve got,” Chief Financial Officer Shane Kovacs told BioWorld Today. “Why should the kids wait another three years?”
Despite sliding past an interim futility analysis in February 2015, Anthera Pharmaceuticals Inc.'s blisibimod couldn't hit the phase III endpoint against systemic lupus erythematosus (SLE) in the trial called CHABLIS-SC1 – an "obviously disappointing" outcome that the firm's chief medical officer (CMO), William Shanahan, blamed on the high placebo response.
Arrowhead Pharmaceuticals Inc. “should receive a letter from the [FDA] within 30 days that spells out what they want,” President and CEO Christopher Anzalone told BioWorld Today.
Analysts already were asking Exelixis Inc. about the possibility of "decelerated" growth of Cabometyx (cabozantinib) as the company rolled out third-quarter results that show it doing well with the launch of the tablets, approved in April for advanced renal cell carcinoma patients who have received prior anti-angiogenic therapy.
The day before news broke of the lawsuit against Valeant Pharmaceuticals International Inc. – lodged by former shareholders of Sprout Pharmaceuticals Inc. over Valeant’s non-promotion of Addyi (flibanserin) for female sexual dysfunction – officials of Palatin Technologies Inc. groused to me about that very topic. “It’s just there, doing nothing,” he said of Addyi, a non-hormone agonist at the 5-HT1A receptor and an antagonist at the 5-HT2A receptor. Palatin hoped that Valeant’s $1 billion buyout last year of Sprout in order to get its hands on then just-approved Addyi would mean a big push for greater awareness of the drug...
The world had to wait for them about a month longer than expected, but Palatin Technologies Inc.'s positive phase III data with bremelanotide in premenopausal women diagnosed with hypoactive sexual desire disorder (HSDD) should turn up the heat on already busy partnering talks.
It was hardly rocket science that Jupiter moon-named Ganymed Pharmaceuticals AG's claudin 18.2-targeting antibody – the one that created so much buzz at this year's American Society of Clinical Oncology (ASCO) meeting – would draw big pharma's top cancer players to the table. And Tokyo-based winner Astellas Pharma Inc.'s potential $1.4 billion takeover, with €422 million (US$461.3 million) up front plus another €860 million if progress milestones are met, gets not only the IMAB362 antibody but also Claudetect 18.2, an in vitro diagnostic for the biomarkers in patients most likely to be helped.
Durect Corp. CEO James Brown told BioWorld Today that, although phase Ib results proved encouraging with the endogenous, oral small-molecule DUR-928 in patients with nonalcoholic steatohepatitis (NASH), the phase II trial planned for next year will test the drug in acute kidney damage, an indication where today “the only thing they can do is give you fluids and pray.”
Debate over whether amyloid beta represents the most worthy target in the casualty-fraught Alzheimer's disease space hasn't stopped big pharma with biotech partners from hoping that work with BACE inhibitors might yield a modifying therapy.
