A little over one year after European regulators gave their nod, regulators in the U.S. cleared for marketing Milan-based Dompé farmaceutici SpA's Oxervate (cenegermin) eye drops for neurotrophic keratitis.
Ahead of June's American Society of Clinical Oncology (ASCO) meeting in Chicago, an abstract related to the data to be unveiled by Jounce Therapeutics Inc. so alarmed Wall Street that the company's shares lost 35 percent of their value, and the situation worsened when the data rolled out. But there may be cause to maintain hope for JTX-2011, the agonist of inducible T-cell co-stimulator (ICOS), a protein on the surface of certain T cells that Jounce believes can stimulate an immune response against solid tumors.
Chemocentryx Inc. recently hit an important milestone with the finish of enrollment in the Advocate phase III trial testing avacopan in anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), and that's where many investor eyes are focused.
Even with continued jostling inside the larger immuno-oncology space, the oncolytic virus (OV) approach may be more firmly staking its claim to drug-developer interest. Already this year, Johnson & Johnson inked a potentially massive deal to take over Benevir Biopharm Inc. The arrangement disclosed in early May brought the latter $140 million up front and up to $900 million in milestone payments. Rockville, Md.-based Benevir boasts a platform called T-Stealth, designed to engineer OVs to infect and destroy cancer cells.
U.S. regulators cleared the first generic version of Epipen and Epipen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are anaphylactic, in adults and pediatric patients who weigh more than 33 pounds.
Regeneron Pharmaceuticals Inc.'s bid to get ahead of competitor Novartis AG in wet age-related macular degeneration (AMD) hit a blip as the FDA delivered a complete response letter (CRL) with regard to the supplemental BLA seeking a modified, 12-week dosing schedule for Eylea (aflibercept).
Like popcorn in a pan, data with late-stage drugs for nonalcoholic steatohepatitis (NASH) will burst forth from a series of drug developers, and Wall Street is hard pressed to figure out which treatment – or combination thereof – might work best. But that hasn't stopped them from trying.
Gemphire Therapeutics Inc.'s gemcabene has been given to about 1,200 adult patients in 25 phase I and phase II trials for up to 12 weeks without any drug-related severe adverse events, but that winning safety streak came to an abrupt and puzzling end as the data and safety monitoring board (DSMB) overseeing a phase IIa study in pediatric subjects recommended the study be stopped because patients apparently were getting sicker.
Like popcorn in a pan, data with late-stage drugs for nonalcoholic steatohepatitis (NASH) will burst forth from a series of drug developers, and Wall Street is hard pressed to figure out which treatment – or combination thereof – might work best. But that hasn't stopped them from trying.
