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.
It's a busy time to be a bioethicist, thanks to the passage of right-to-try bills in several states, the introduction of federal right-to-try legislation and the onslaught of social media campaigns seeking patient access to experimental drugs.
Since the middle of 2014, Insys Therapeutics Inc.'s pharmaceutical cannabidiol (CBD), a synthetic version of the plant-derived cannabinoid, has been awarded FDA orphan status in a total of six indications – most recently for infantile spasms – and the company looks to accelerate its research. But there's a hitch: The schedule I designation of synthetic CBD by the Drug Enforcement Agency (DEA) continues to drag the drug development process.
With multiple midstage trials ongoing of apatorsen in several cancer types, Oncogenex Pharmaceuticals Inc. is unlikely to spend too much time ruminating on the failure of the phase II Ranier trial testing the drug, formerly known as OGX-427, in pancreatic cancer, an arguably long-shot indication from the start.
After making the jump from drug discovery to drug development and quietly ramping up a clinical-stage oncology pipeline, Deciphera Pharmaceuticals LLC found a new backer in New Leaf Venture Partners, which led a $75 million series B round aimed at getting its lead switch control kinase inhibitor candidates through proof of concept and moving others into human testing.
