China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
After receiving a complete response letter (CRL) in 2023 related to device issues, North Chicago-based Abbvie Inc. received another CRL for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in advanced Parkinson’s disease, this time for issues at a third-party manufacturer.
Suzhou, China-headquartered Ascentage Pharma Group Corp. Ltd. has filed plans for a confidential IPO to the U.S. SEC for a potential dual listing on both the U.S. and Hong Kong stock exchanges. News of the U.S. IPO came just a few days after Ascentage drew a $75 million equity investment from Osaka, Japan-headquartered Takeda Pharmaceutical Co. Ltd. with the issuance of about 24.3 million shares at a purchase price of HK$24.09 (US$3.08) per share.
Even though the U.S. FTC recently claimed a court victory in its campaign to shut down the listing of device patents for drugs in the FDA’s Orange Book, 80% of the listings targeted in the commission’s first round of warning letters remain in place more than seven months later.
Alzheon Inc. has raised $100 million in a series E financing round to push its oral drug candidate for early Alzheimer’s disease (AD), ALZ-801 (valiltramiprosate), through a late-stage, Apolloe4 study.
A nearly two-year-old partial clinical hold has been lifted by the U.S. FDA on PTC Therapeutics Inc.’s pivotal phase II study in Huntington’s disease. The agency had paused enrollment in October 2022, saying it wanted more data on PTC-518, an orally bioavailable small-molecule splicing modifier, before enrollment could continue.
Gilead Sciences Inc. tallied a “clear win,” said Barclays analyst Carter Gould, in the phase III interim analysis showing that the Foster City, Calif.-based company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, yielded 100% efficacy as an HIV blocker for cisgender women.
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
Ionctura SA closed a €80 million (US$86 million) series B round as it prepares to accelerate development of lead asset roginolisib in the treatment of uveal melanoma. That follows publication of phase Ib data showing roginolisib, an orally available allosteric modulator of the delta isoform of PI3K (phosphatidylinositol-4,5-bisphosphate kinase), is distinguished from other drugs in this class, in being well-tolerated over long periods, with patients having been treated for up to 38 months.
Takeda Pharmaceutical Co. Ltd. has signed an option agreement to in-license Ascentage Pharma Group Inc.’s olverembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI). If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.
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