LONDON – Morphosys AG finally has some heft to put behind its U.S. commercialization ambitions following FDA approval for its long-nurtured anti-CD19 antibody, Monjuvi (tafasitamab-cxix) in relapsed or refractory diffuse large B-cell lymphoma (r/rDLBCL). Read More
Since more than 40% of U.S. coronavirus deaths have links to U.S. long-term care facilities, Eli Lilly and Co. is getting on the road with a clinical trial design that takes researchers directly to outbreaks. Read More
The share prices of blue-chip biopharmaceutical companies continued on their lackluster trajectory, which started in June and collectively lost ground last month, with the BioWorld Biopharmaceutical index slipping about 1.3% as investors took a break in order to digest the deluge of COVID-19 vaccine data released during the period and the impact on the bottom lines that the pandemic has exerted among those companies that have reported their second-quarter results. Read More
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong. Read More
Shares of Cymabay Therapeutics Inc. (NASAQ:CBAY) shot 37% higher on Monday after top-line data showed 78.2% of people with primary biliary cholangitis (PBC) in the company's disrupted phase III test of seladelpar achieved the primary composite outcome after just three months on a 10-mg dose of the drug vs. 12.5% in the trial’s placebo arm. Read More
Universities in China’s Greater Bay Area have developed a recombinant receptor-binding domain (RBD) protein vaccine candidate that has shown promise against COVID-19, researchers said Monday at a press conference in Hong Kong. The vaccine can induce neutralizing activity after seven days with one dose, but more animal studies are now underway to test its durability. Read More
New hires and promotions in the biopharma industry, including: Aditx, ANI, Aslan, Axoprotego, Cybrexa, Disc Medicine, Humanigen, Melinta, Oxurion, Valo, Velosbio, Yumanity, Zealand. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Biocryst, Calidi, Cerecor, GW, Janssen, Morphosys, Novartis, Polypid, Roche, Sonoran, Tyme, Vanda. Read More
