The FDA’s Center for Drug Evaluation and Research (CDER) is ramping up efforts to make certain that clinical trials include wide enough breadths of patient populations, and don’t unnecessarily keep out subjects with multiple chronic conditions (MCCs) who could turn up important data that would otherwise be missed.

Vanda Pharmaceuticals Inc.’s sales force for Hetlioz (tasimelteon) is “intact and in launch mode,” said CEO Mihael Polymeropoulos, after Friday’s approval of the selective melatonin receptor agonist for non-24-hour wake-sleep disorder (non-24).

Metastatic, castration-resistant prostate cancer as a therapeutic space is heating up still more with the disclosure by Medivation Inc. and partner Astellas Pharma Inc. of powerful data with Xtandi (enzalutamide) from the Phase III study known as PREVAIL.

Qualms about gastrointestinal safety and lack of data in older age groups did not deter the FDA’s Allergenic Products Advisory Committee from giving its nod to recommend approval of Ragwitek, the sublingual ragweed allergy therapy for adults from Merck & Co. Inc. and Alk-Abello A/S.

The drug-development standard that a pill is always better than a shot may not pull as much weight when it comes to treating allergies, and this could be true even when multiple injections are involved.

Briefing papers for the meeting next week of the FDA’s Allergenic Products Advisory Committee suggest that the panel will green-light the sublingual ragweed allergy therapy from Alk-Abello A/S and Merck and Co. Inc., just as the grass-pollen allergy tablet sailed through last month.

Squaring off against anemia leader Amgen Inc., with help from high-powered partner Celgene Corp., Acceleron Pharma Inc. expects to raise $120 million through the sale of 2.4 million shares at $50 each.

The delayed PDUFA date and lack of labeling talks with the FDA presaged unhappy news for Amag Pharmaceuticals Inc. regarding its supplemental new drug application (sNDA) for intravenous Feraheme (ferumoxytol), and a complete response letter (CRL) came next.

“Disappointed but not surprised” by the FDA’s refusal to go back on its surprise withdrawal of the special protocol assessment (SPA) deal for the trial known as ANCHOR, Amarin Corp. plc is moving to the next step in seeking a broader label on the triglyceride-lowering therapy Vascepa (icosapent ethyl), said CEO John Thero.

Emotional intelligence. The importance of face-to-face meetings. How to craft a deal by making friends first, and finding common ground. Such are often the topics of talk when the J.P. Morgan Healthcare Conference (JPM) comes up.