It was a grueling year for life sciences companies trying to raise money and keep afloat. Despite the industry’s front-line position in fighting COVID-19, sparking an overzealous enthusiasm, the soaring financings and rising stock prices of 2020 took an about-face beginning in 2021 and dropping even further in 2022. Share prices plummeted amid economic turmoil that included rising inflation, geopolitical pressures, and budgetary threats. Investors closed their wallets just as burn rates increased and funds diminished. Partnering fell to pre-pandemic levels and mergers and acquisitions hit a five-year low. Without capital, the uncertainty led companies to the only other option, workforce reductions and restructurings, pushing aside promising candidates at the expense of patients. Read More
After posting positive top-line data in August from its phase III ENHANCE-2 study of ensifentrine for treating chronic obstructive pulmonary disease (COPD), Verona Pharma plc now has positive results from the companion phase III study. The ENHANCE-1 trial of ensifentrine as a COPD maintenance treatment hit its primary and key secondary endpoints, prompting the company to say it plans to submit an NDA for the treatment to the U.S. FDA sometime in the first half of 2023. Read More
Pfizer Inc. has acquired rights to respiratory syncytial virus (RSV) drug candidate sisunatovir from Lianbio Co. Ltd. in a deal worth up to $155 million covering development and commercialization rights in mainland China, Hong Kong, Macau and Singapore. With this agreement, Pfizer now holds global development and commercialization rights to the candidate, an orally administered fusion inhibitor is designed to block RSV replication by inhibiting F-mediated fusion with the host cell. Read More
Magenta Therapeutics Inc., the developer of an antibody-drug conjugate intended to help prep certain relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome patients for stem cell transplant or gene therapy, has stopped dosing the drug in part of an ongoing trial after observing two cases of serious adverse events (SAEs) possibly related to the candidate. Read More
New hires and promotions in the biopharma industry, including: Arca, Cassava, Cyxone, Geovax, Ikena, Mestag, Moderna, New Amsterdam, Paratek. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Angiocrine, Arrowhead, Carrick, Catalyst, Eisai, Menarini, Merck, Paratek, Pfizer, Royalty. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Albireo, Arcutis, Ardelyx, Astrazeneca, Biocytogen, Bluebird, Daiichi Sankyo, Eagle, Eqrx, F2G, Ferring, HRA, Hutchmed, Neurophth, On Target, TG Immunopharma, Perrigo, Recbio. Read More