After working through a complete response letter (CRL) brought about by COVID-19 from the U.S. FDA in June 2021, Mediwound Ltd. has received the agency’s approval for Nexobrid (anacaulase-bcdb) to treat severe burns in adults. Read More
Citing an "atypical FDA review process and corporate greed" ahead of the controversial approval of Biogen Inc.'s Aduhelm (aducanumab), Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) called for "corrective actions" at the agency to "re-earn the trust of the American people." Pallone's comments prefaced a report drawn from 18 months of investigation around the regulatory review and approval process for the Alzheimer's disease drug, as well as Biogen’s pricing strategy. Read More
Boan Biotechnology Co. Ltd. raised HK$152.8 million (US$19.6 million) from a Hong Kong IPO, capital the company will use to speed up product development, expand marketing and ramp up manufacturing. Read More
The proportion of clinical data focused on COVID-19 therapeutics and vaccines has dropped from 21.3% in 2020 at the height of the pandemic to only 7.7% for 2022. Read More
Metabolic health is at an odd juncture. With the advent of glucagon-like peptide (GLP-1) agonists, pharmacologically induced weight loss has matured into a viable therapeutic option at long last. And research into the drug class is continuing apace. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bluebird, Carisma, Cellectis, Cipla, Connect, Ethris, Gemini, Primera, Sesen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB, Beigene, Calliditas, Everest, Mediwound, Merck & Co. Read More
