Following revelations that a randomized, placebo-controlled study of the Gilead Sciences Inc.’s antiviral, remdesivir, reduced time to recovery for hospitalized patients with "advanced" COVID-19, along with additional data from an open-label phase III trial from its maker, the FDA is "working with Gilead to figure out a mechanism to make this easily available to people who need it," Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said April 29.
Preliminary data from the first part of a phase II/III trial testing the interleukin-6 (IL-6) receptor antibody Kevzara (sarilumab, Regeneron Pharmaceuticals Inc. and Sanofi SA) in patients with severe or critical respiratory illness caused by COVID-19 found that, relative to a placebo, the medicine "had no notable benefit on clinical outcomes" among that combined group.
A once-daily add-on therapy for Parkinson's disease (PD) used in Europe for years has now gained clearance in the U.S. with FDA approval of Ongentys (opicapone). The drug, an improvement upon generics in its class, will be sold by Neurocrine Biosciences Inc. The medicine, a catechol-O-methyltransferase (COMT) inhibitor first approved by the EMA in 2016, extends the half-life of levodopa, increasing doses of which are required to achieve motor control as PD progresses. Portugal-based Bial-Portela & Ca SA, from which Neurocrine licensed North American rights to the drug, will receive a $20 million award from its partner. Shares of San Diego-based Neurocrine (NASDAQ:NBIX), a neuroscience company focused on treating movement disorders, rose 3.5% following the approval, closing at $101.67 on April 27.
With completion of a $120 million series B financing, Affinivax Inc. said it's poised to advance several new vaccine candidates for hospital-associated infections into the clinic even as its partner, Astellas Pharma Inc., carries its lead pneumococcal vaccine candidate, ASP-3772, through an upcoming phase III program.
Supernus Pharmaceuticals Inc. has struck an agreement with privately held Navitor Pharmaceuticals Inc. to run a joint phase II program for Navitor's mTORC1 activator, NV-5138, in treatment-resistant depression (TRD).
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
New pivotal data on Scynexis Inc.'s lead candidate, an antifungal for vulvovaginal candidiasis (VVC), have cleared the path to an NDA filing in the indication later this year and a potential approval in mid-2021.
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
