The FDA Friday gave a faster-than-expected nod to Takeda Pharmaceutical Co. Ltd.'s Ninlaro (ixazomib), an oral proteasome inhibitor expected to eventually replace blockbuster Velcade (bortezomib), which is set to lose patent protection later this decade.
Citing insufficient data, a too-small study and a patient population that was not clearly defined, an FDA advisory panel recommended the FDA reject the biologics license application (BLA) for Telesta Therapeutics Inc.'s bladder cancer drug, MCNA.
As expected, Neos Therapeutics Inc. received a complete response letter (CRL) for Cotempla XR-ODT, its orally disintegrating tablet (ODT) version of methylphenidate, delaying its commercial foray into the attention deficit hyperactivity (ADHD) space, though the Dallas-based firm is hoping to offset that delay with an earlier-than-expected introduction of an ODT version of Adderall XR (d-amphetamine).
The needs of the many outweighing the needs of the one might seem the acme of logic, at least for a Vulcan. For humans, it's not so simple, and it's only one of several thorny problems industry, government and society must resolve to establish clear guidance to provide dying patients with compassionate use access to experimental drugs.
The FDA added another drug to the asthma armamentarium, with the approval of Glaxosmithkline plc's Nucala (mepolizumab) as an add-on maintenance therapy for patients who have a history of severe asthma attacks despite being on treatment and who have an eosinophilic phenotype.
Last week's unexpected FDA complete response letter (CRL) for multiple myeloma drug Evomela (melphalan) hasn't disrupted Spectrum Pharmaceuticals Inc.'s plan for bladder cancer candidate apaziquone.
Viventia Bio Inc., which recently launched a phase III study testing lead candidate Vicinium in bladder cancer, is looking to raise up to $86.25 million in an IPO and gain a listing on Nasdaq under the ticker VITA.
Biogen Inc.’s third quarter earnings brought a much-needed – if somewhat superficial – rebound, as revenues for the three months ending Sept. 30 beat consensus estimates and executives outlined a strategy for getting the company back on track after a dismal first half of the year.
For two days, industry observers watched as shares of Zafgen Inc. plummeted for no apparent reason, losing more than half their value and driving analysts to speculate that disappointing data lay ahead for the company's lead candidate, beloranib.
Incyte Corp.'s decision to buy into the costly phase III development of baricitinib in rheumatoid arthritis (RA) looked even smarter Wednesday, upon release of top-line data showing the oral JAK1/2 inhibitor superior to top-selling drug Humira (adalimumab), potentially positioning it for a larger share of the crowded RA market than previously predicted.
