The first BCMA-targeted CAR T therapy, idecabtagene vicleucel, cleared FDA approval for use in adults with multiple myeloma (MM) who have received four or more prior lines of therapy. Developed by partners Bluebird Bio Inc. and Bristol Myers Squibb Co., the drug, branded Abecma, is also the first CAR T drug indicated for MM. It is designed for use as a one-time infusion, with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. The personalized therapy will be produced at BMS’ cellular manufacturing facility in Summit, N.J. Bluebird developed the lentiviral vector used in Abecma. Read More
Shares of Humanigen Inc. (NASDAQ:HGEN) leapt 54.5% to $21.61 March 29 on news that its monoclonal antibody, lenzilumab, improved the relative likelihood of survival without mechanical ventilation in hospitalized patients with COVID-19, setting the company up to submit an application for emergency use authorization (EUA) in the U.S. "as soon as possible," it said. Separately, a combination of two monoclonal antibodies, the Eli Lilly and Co.-Abcellera Biologics Inc.-developed therapy bamlanivimab and the Vir Biotechnology Inc.-Glaxosmithkline plc candidate VIR-7831, demonstrated a 70% relative reduction in persistently high SARS-CoV-2 viral load at day seven compared to placebo for low-risk adult patients with mild to moderate COVID-19, the companies reported. Read More
Top-line from Orphazyme A/S’ phase II/III trial of arimoclomol for treating inclusion body myositis, a muscle-wasting disease, failed to hit its primary and secondary endpoints. The data caused investors to pull back sharply as shares of Copenhagen-based Orphazyme (NASDAQ:ORPH) had dropped 28.97% on March 29 to close at $8.80 per share. Read More
Inflarx NV has submitted a special protocol assessment (SPA) to the FDA for the phase III trial with vilobelimab against the skin disorder hidradenitis suppurativa (HS), pleasing investors with clarity regarding the path forward for the drug, which is in the works for antineutrophil cytoplasmic antibody-associated vasculitis (AAV) as well – and faces competition on both fronts. Read More
It’s a first for Larry Miller. In his 30 years of working in pharma, he has never run a company that didn’t have a pack of near competitors scrambling to develop a therapy. “Not even close,” he told BioWorld. Miller, the CEO of Apnimed Inc., just saw the company close on a $25 million series B to help drive its lead program, a once-daily, oral obstructive sleep apnea (OSA) therapy, into a phase III registrational trial. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: Time needed to develop immunity with Sputnik V; CRS: Rutledge opens door to more PBM reforms. Read More
New hires and promotions in the biopharma industry, including: Amylyx, Chiesi, DBV, Endsulin, Erasca, Foundation, Melinta, Okyo, PYC, Theratechnologies, Verrica, Xilio. Read More
