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.
Ambys Medicines Inc. interim CEO Jeff Tong said the firm's unusual combination of the $60 million series A financing with a deal enlisting Takeda Pharmaceutical Co. Ltd. to the tune of $80 million up front came about because venture backer Third Rock, where Tong is a partner, "wanted to make sure that by doing the deal we weren't going to hamper the growth of the company."
Pressed for details about timing of next steps with gemcabene in dyslipidemia – still on partial clinical hold by the FDA – Gemphire Therapeutics Inc. CEO Steve Gullans said the regulators' demand for more toxicology data is "very recent news, so we haven't had time, working with all the third-party vendors that will be involved, to figure out the exact timeline. We would love to get the 13-week study up and running immediately, but these PPAR alpha knockout mice require some work to get a breeding colony up and rolling. That's why we're targeting the end of the year, beginning of next year. Right now, it's the best estimate we're operating from. That's in keeping with what we've seen in prior work we've done around breeding colonies. Roughly speaking, we would see a nine to 12-month delay over where we were before" the agency made known its decree.
Not all investors caught the drift of Ovid Therapeutics Inc.'s phase II data with OV-101 (gaboxadol) in Angelman syndrome (AS), but CEO Jeremy Levin told BioWorld that insiders rejoiced and the company is moving ahead with the delta-selective GABAA receptor agonist.
