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. Read More
Weeks after raising an oversubscribed $60 million series A, Affinia Therapeutics Inc., of Waltham, Mass., is collaborating with Vertex Pharmaceuticals Inc. in a far larger deal, one potentially worth more than $1.6 billion. Read More
Given all the public-private partnerships responding to the need for timely COVID-19 therapies, diagnostics and vaccines, the demands to forgo patents or exclusive licenses for coronavirus products and the clamor that industry shouldn’t “profit” from U.S. taxpayer-supported research are growing louder. Read More
LONDON – Leading genome sequencing groups are launching the first meta-analysis in the hunt for genetic factors that explain why some people have worse COVID-19 symptoms than others, after agreeing to share patient sequence data from around the world. Read More
Blincyto (blinatumomab, Amgen Inc.), the first FDA-approved bispecific antibody, gained regulatory approval in 2014, but the intervening years have been fairly bleak for bispecific antibodies as companies worked through technical challenges. Read More
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. Read More
DUBLIN – Compass Pathways Ltd. raised $80 million in a series B round to continue its development of the psychedelic drug psilocybin in treatment-resistant depression. Read More
New hires and promotions in the biopharma industry, including: ADC, Anika, Arcutis, Cerecor, Galecto, Mycovia, Nkarta, Saniona, Touchlight, Veritas, Xilio. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research’s Virtual Annual Meeting, including: Alligator, Alpine Immune, Aptose, Astrazeneca, Compugen, Iteos, Macrogenics, Merck, Rgenix, Ribon, Sutro, Theratechnologies, Vaccinex, Verastem. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Avadel, Axsome, CTI Biopharma, Harpoon, Hua, Italfarmaco, Myovant, Regeneron, Sanofi, Valo. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Carmell, Carsgen, Cytodyn, Diffusion, Eiger, Green Valley, Halozyme, Janssen, Mateon, Neurocrine, Polyneuron, Takeda. Read More
