Proqr Therapeutics NV sealed a deal for genetic disorders in the liver and nervous system with Eli Lilly and Co., collecting $50 million in the form of an up-front payment ($20 million) and an equity investment ($30 million), with the prospect of about $1.25 billion more if the arrangement hits research, development and commercialization goals. “The milestones are pretty evenly spread out,” said Smital Shah, Proqr’s chief business and financial officer, though details weren’t provided. Read More
Initial efforts at Humanigen Inc. to win an FDA emergency use authorization (EUA) for treating hospitalized COVID-19 patients with its monoclonal antibody, lenzilumab, have failed to gain the regulator's buy-in, sending company shares (NASDAQ:HGEN) down 47.3% to $7.97 on Sept. 9 after touching a 52-week low during the session, a reaction part of a volatile arc that has seen shares climb as high as $29.20 during the same time span. Read More
If there is one thing that potently illustrates the hope and despair of the COVID-19 pandemic, it is the zigzag of BioWorld’s Infectious Disease Index. Up by nearly 64%, it is towering over both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are up 12.4% and 15.5%, respectively, but it has experienced several downward swings this year as well. Read More
Astrazeneca plc is eyeing an addition to its respiratory diseases portfolio after a potential first-in-class “rescue” asthma inhaler, PT-027, met its goals in two phase III trials. Read More
Monoclonal antibodies are a triumph of modern medicine. They are also too expensive to be a standard therapy in all but the wealthiest countries. “Having 10% or 15% of your population on antibodies is not sustainable even in wealthy countries,” Rachel Liberatore told BioWorld. Liberatore is director of research and development at Renbio Inc., which is testing the intramuscular delivery of antibody-encoding DNA to prevent and treat infections, including SARS-CoV-2 and HIV. Read More
The COVID-19 pandemic has exerted a significant effect on enforcement in the U.S., but Ethan Davis of King & Spalding (K&S) said federal prosecutors have made use of several novel approaches to prosecution in the past year. Read More
China’s Personal Information Protection Law (PIPL) will take effect on Nov. 1, 2021, making it harder for tech firms, including health care companies, to access and use consumers’ personal information. The PIPL was officially passed by the National People’s Congress on Aug. 20. Read More
New hires and promotions in the biopharma industry, including: Algernon, Apexigen, Aytu, Benevolentai, Berkeley Lights, Biophytis, Giiant, Jcyte, Neoleukin, Nimble, Orchard, Rani. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim Immunotech, Albireo, Ascendis, Azurrx, Benitec, Biocryst, Boehringer, Clover, Decibel, Eli Lilly, Eloxx, Freeline, GNT, Hibercell, Humanigen, Inflarx, Myovant, Nabriva, Pfizer, Phathom, Sigilon, Sinovac, Sinovant, Soin, Soligenix, Tearclear, Viewpoint, Vor. Read More
