China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
As Cardiff Oncology Inc. dosed the first patient in its phase II study of onvansertib (CRDF-004) in a first-line setting to treat RAS-mutated metastatic colorectal cancer (mCRC), the company also revealed positive efficacy data from its discontinued phase II of onvansertib as a second-line treatment of bevacizumab-naïve RAS-mutated mCRC.
Biovie Inc.’s double-barrelled blast of positive data with insulin sensitizer NE-3107 in Alzheimer’s disease (AD) and Parkinson’s disease (PD) launched shares (NASDAQ:BIVI) on a wild ride to close March 1 at $2.23, up 99 cents, or almost 80%, after trading as high as $3.31.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Achieve, Ariceum, Atara, Cytodyn, Indapta, Inhibikase, Intercept, Liscure, SN, Springworks, Valneva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biomind, BMS, Clene, Ironwood, Mithra, Neurobo, Pfizer, Taysha, Viracta, Vivacelle.
In a panel discussion with executives at the 2024 BIO CEO conference this week in New York, the consensus emerged that artificial intelligence is here to stay, despite its occasional moments of hype, as its applications continually grow.
Is the U.S. Inflation Reduction Act with its Medicare drug price negotiation provision the new legislative sacred cow that cannot be tweaked? Debate over whether the orphan drug carveout included in the negotiation provision should be extended to drugs with more than one rare disease indication was the major discord in an otherwise bipartisan discussion the House Energy and Commerce Subcommittee on Health had in a hearing held Feb. 29 in observation of Rare Disease Day.
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