Resolution Therapeutics Ltd. has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase I/II study of its lead candidate RTX-001 in patients with decompensated liver cirrhosis.
Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.
In reviving another case involving drug label carveouts, the U.S. Court of Appeals for the Federal Circuit insisted that its June 25 decision in Amarin Pharma Inc. v. Hikma Pharmaceuticals plc will not kill so-called skinny labels that allow generics to come to market when some of the brand’s indications still have patent protection.
Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU.
The problems with devices for low-volume conditions are well known, and regulatory agencies such as the European Union’s Medical Device Coordination Group are working to ease the regulatory hurdles for these products.
Sometimes a court cites long-standing precedent in deciding how to handle a case, but the U.S. Court of Appeals for the Federal Circuit leveraged a decision it rendered only last year in deciding a patent case between Apple Inc., and Omni Medsci Inc.
CSPC Pharmaceutical Group Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China with the first mRNA-lipid nanoparticles (LNP)-based CAR T-cell injection, SYS-6020.
The industry is again raising concerns that new EU health technology assessment rules coming into force on Jan. 12, 2025, will have the opposite of the desired effect and slow down access to innovative therapies.
In May, the U.S. FDA approved 11 new drugs, a significant drop from the 26 approvals in April, which was the sixth-highest monthly total since 2016. This also falls short of March’s record-setting 30 approvals, the highest number recorded by BioWorld.
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.
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