Just ahead of the three-day weekend, the FDA granted approval of antibiotic dalbavancin, a drug that ended its long and winding development road by becoming the first qualified infectious disease product (QIDP) to win approval, getting the nod for use in acute bacterial skin and skin structure infections (ABSSSIs) caused by gram-positive microorganisms, including the dreaded methicillin-resistant Staphylococcus aureus.

Agile Therapeutics Inc. updated its S-1 filing this week to propose selling 9.2 million shares at $6 apiece in a $55 million initial public offering (IPO), an amount that, even in the current ticklish market, seems relatively modest for a late-stage firm. But if the current IPO market has shown any trend for biotech, it's that post-pricing stock performance and market cap have little to do with development stage.

Coming as little surprise after an FDA advisory panel backed Entyvio (vedolizumab) for treatment of severe ulcerative colitis and moderate to severe Crohn's disease, Takeda Pharmaceutical Co. Ltd.'s drug gained approval on its May 20 PDUFA date, becoming the first integrin inhibitor to hit the market since Biogen Idec Inc.'s Tysabri (natalizumab).

While death rates for most cancers have decreased over the years, the overall survival rate for pancreatic cancer hasn't budged in four decades, a lamentable statistic due in part to the lack of diagnostic biomarkers or procedures capable of detecting the disease in an early, localized stage and leading to better treatment outcomes.

Even before the American Society of Clinical Oncology (ASCO) freed thousands of abstracts from embargo late Wednesday afternoon, immunotherapy already was emerging as the biggest story at the upcoming meeting in Chicago and big pharma firms as its major stars.

If you've discovered a new therapeutic approach for rare and neurodegenerative diseases stemming from lysosomal biology and need help starting a company, you go to the experts.

Corcept Therapeutics Inc. still has hopes of building a portfolio based on cortisol blocking drug mifepristone, but it looks like psychotic major depression (PMD) is off the table after the monitoring committee reported that an ongoing phase III trial was unlikely to hit its primary endpoint, defined as a rapid and sustained reduction in psychotic symptoms.

Endocyte Inc.'s vintafolide-induced roller coaster ride continued Friday. A month after shares jumped a whopping 92 percent on a positive opinion from European regulators on conditional approval of the drug and its companion imaging agents in ovarian cancer, shares of the West Lafayette, Ind.-based company took a 62 percent tumble on news that the phase III ovarian cancer trial was halted for futility, likely putting the kibosh on that expected EU launch.

SAN FRANCISCO – Discussions on dealmaking, the focus of the recently concluded Allicense 2014 meeting, typically focus on terms, values and trends. But attendees of this year's meeting got a rare peek into the minds of business development (BD) executives whose negotiating prowess helped transform their respective companies and set them on various career tracks.

SAN FRANCISCO – When talking trends in biopharma there’s no shortage of metaphors – Tuesday’s health care debate, for example, went for the timely baseball terms, referencing singles and home runs – or oft-overused industry buzzwords, of which the recent Allicense meeting featured several, among them the apparent new fave, “optionality,” a word not actually found in Webster’s. But during the two-day conference a certain gastronomically charged trend emerged, fitting, I suppose, given San Francisco’s reputation as a destination for foodies. There were appetizers: “When they’re passing out the hors d’oeuvres, use both hands,” said Isaac Ciechanover, CEO of Atara...