Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
Ascletis Pharma Inc. announces that the company has filed an IND application with the FDA for ASC-10, an oral antiviral drug candidate targeting viral polymerase of monkeypox virus.
Innocare Pharma Ltd. has received IND approval from China's National Medical Products Administration (NMPA) to begin clinical trials of its B-cell lymphoma-2 (BCL2) inhibitor ICP-248.
The EMA's Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion on Sensorion SA's application seeking orphan drug designation for OTOF-GT, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss.
China's National Medical Products Administration (NMPA) has cleared CSPC Pharmaceutical Group Limited to conduct clinical trials of TG-103 injection for the treatment of Alzheimer's disease and for the treatment of nonalcoholic steatohepatitis (NASH).
Tenaya Therapeutics Inc. has received FDA clearance of its IND application to begin clinical testing of TN-301, a highly selective small-molecule inhibitor of histone deacetylase 6 (HDAC6) initially being developed for heart failure with preserved ejection fraction (HFpEF).
Monte Rosa Therapeutics Inc. has received FDA clearance of its IND application for MRT-2359, a potent and selective GSPT1-directed molecular glue degrader (MGD).
Immuneering Corp. has submitted an IND application to the FDA to support a phase I/IIa trial of IMM-1-104, an oral once-daily small molecule in development for the treatment of advanced RAS-mutant solid tumors.
Stemcyte Inc. has received IND approval from the FDA for a phase II trial using umbilical cord blood stem cell therapy for post-COVID syndrome, or long COVID.
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