More than 30 years after entering the scene as a first-generation monoclonal antibody pioneer, Morphosys AG is to be acquired by Novartis AG for €2.7 billion (US$2.9 billion). The all-cash deal, announced after Nasdaq closed on Feb. 5, will see Novartis paying €68 per share, a premium of 94% to the average daily price in the month leading up to Jan. 25, when rumors of a takeover started swirling. Read More
Vertex Pharmaceuticals Inc. upped its own ante with pivotal phase III data in its strong suit, cystic fibrosis (CF). Taking on Trikafta, the company’s bestseller, Vertex’s once-daily vanzacaftor/tezacaftor/deutivacaftor (vanza) combo hit all primary and key secondary endpoints in two randomized controlled studies of those ages 12 and older. Read More
A disease-modifying gene therapy for Sanfilippo syndrome type A has demonstrated reductions in heparin sulfate within cerebrospinal fluid, as well as increases in the cognitive function of young patients, arming Ultragenyx Pharmaceutical Inc. with data needed to support an accelerated BLA with the U.S. FDA. Read More
Korean bioventure Curacle Co. Ltd. reported positive top-line findings from its U.S.-based phase IIa study of CU06-1004, an oral drug for diabetic macular edema, spurring plans for a bigger phase IIb study in the second half of 2024. Read More
The BioWorld Cancer Index (BCI) had a stellar performance in 2023, finishing the year with an increase of 76.26%. The rise is a notable spike from the end of the third quarter, when it was up 22.96%. BCI’s performance surpassed both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, and stands in contrast to 2022, when the BCI concluded the year with a decline of 41.98%, and 2021, when the index saw a decrease of 36.34% over the year. Read More
Sangamo Therapeutics Inc.’s gene therapy for Fabry disease, isaralgagene civaparvovec (ST-920), is continuing to show promising efficacy and safety in the phase I/II study, Staar, but further ahead, the company needs to either attract a partner or secure financing to move to a registrational trial. Read More
When the House Energy and Commerce’s Subcommittee on Oversight and Investigations held its last hearing on the U.S. FDA’s foreign drug inspection program in December 2019, there were “reasons for cautious optimism,” subcommittee Chair Morgan Griffith (R-Va.) said in opening a Feb. 6 hearing on the issue. But in the wake of the pandemic, the optimism is gone. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4DMT, Amgen, CSL, Eyepoint, Iregene, Janssen, Ocuphire, Oragenics, Palatin, Pliant, Profoundbio, Rani, Triumvira. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aatec, Ayala, Bayer, Canary Speech, Cognition, Dyadic, FSD, Halia, Immunome, Mithra, Nighthawk, Rallybio, Scorpius, Tetrascience. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acepodia, Anamar, Bridgebio, BMS, Chiesi, Fermion, Napp, Nurexone, Ultimovacs, Vanda. Read More
