Advocacy groups lobbying for the approval of a therapeutic to treat sexual dysfunction in women celebrated victory late Tuesday with the agency's after-hours nod to Sprout Pharmaceuticals Inc.'s Addyi (flibanserin); however, by Wednesday afternoon, the critics were out in force, accusing the FDA of succumbing to public pressure and approving a drug with a less-than-stellar safety profile.
Aveo Oncology Inc. is getting $15 million up front in a potential $326 million deal with Novartis AG that hands over development and commercialization rights to preclinical-stage growth differentiation factor 15 (GDF15)-targeting antibody AV-380.
Shares of Karyopharm Therapeutics Inc. hit a new 52-week low Monday on news that a higher-than-expected rate of sepsis prompted the Newton, Mass.-based firm to reduce the dose in an ongoing phase IIb study testing selinexor in elderly patients with acute myeloid leukemia (AML).
As controversy and coverage issues continue dragging uptake of available human papillomavirus (HPV) vaccines – the Centers for Disease Control and Prevention reported last week only a 3 percent increase since 2013 among the 13-to-17 age group – Antiva Biosciences Inc. is striding ahead with its direct-acting antiviral approach to HPV infections, thanks to $16 million in a series B financing.
As it awaits an October FDA decision on lifitegrast, a dry eye drug acquired via a 2013 buyout of Sarcode Bioscience Inc., Shire plc is bolstering its ophthalmology offerings with another acquisition, snapping up privately held Foresight Biotherapeutics Inc. for $300 million in cash.
A wider-than-expected second quarter loss and plans to halve the sales team for obesity drug Qsymia (phentermine/topiramate) took a bite out of Vivus Inc.’s shares Friday, but more troubling news for the Mountain View, Calif.-based company – and its competitors – may be the excruciatingly slow uptake in the branded obesity drug market as a whole.
In an unexpected move, Allergan plc divested its global generic business to Teva Pharmaceuticals Industries Ltd. for $40.5 billion, continuing its evolution into an innovative pharma firm.
Rana Therapeutics Inc., a young firm quietly building up RNA platform technology, padded its coffers with a $55 million series B round to advance its lead programs toward the clinic and expand its in-house capabilities.
Monday morning brought a double shot of positive phase III data in second-line renal cell carcinoma (RCC) from Exelixis Inc.'s multityrosine kinase inhibitor cabozantinib and Bristol-Myers Squibb Co.'s nivolumab, even as the prospect of combination therapy heralds a changing landscape in RCC treatment.
Celgene Corp.'s aggressive business development activity continued this week with the $7.2 billion offer for Receptos Inc., which would add the highly touted late-stage S1P modulator ozanimod to its immunology and inflammatory franchise and raise the Summit, N.J.-based biotech's 2020 guidance to $21 billion-plus.
