In two phase III studies, Merck & Co. Inc.’s oral, once monthly proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor produced statistically significant and clinically meaningful cuts in low-density lipoprotein cholesterol levels. The PCSK9 inhibitor is looking to fit into a crowded market that already has well-established therapies from other big pharmas and a potential competitor in development to treat another indication. Read More
One of the big questions going into the phase I readout for Metsera Inc.’s amylin analogue, MET-233i, was whether findings would support once-monthly dosing for the potential obesity candidate. They did. Results also indicated solid and dose-dependent weight loss activity, and Metsera was able to identify well-tolerated starting doses for subsequent studies, said Steve Marso, chief medical officer. “So we exceeded expectations on all three scientific objectives.” Read More
Researchers at the Massachusetts Institute of Technology and Recursion Pharmaceuticals Inc. have released an open-source AI model that can predict the binding strength of small molecules as well as structures of proteins and biomolecular complexes. The model, which is called Boltz-2 and was released by the research team on the developer platform Github on June 6, addresses a major bottleneck in drug discovery with its improved ability to predict binding strengths. Read More
Corestemchemon Inc. is planning to file a BLA for Neuronata-R (lenzumestrocel) by the end of 2025 to gain accelerated approval from the U.S. FDA, company officials confirmed to BioWorld during a June 2 interview. Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy that first gained approval in South Korea in 2014 to delay the progression of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disorder also known as Lou Gehrig’s disease. Read More
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued its first official guidance on how to develop bacteriophages as licensed medicinal products. This covers personalized phage therapies designed for specific patients – at present the only form in which they are available – but also is relevant to the development of off-the-shelf products for treating common infections. Read More
Absent extraordinary circumstances, the Patent Trial and Appeal Board “should never cancel claims it has not determined to be unpatentable as a sanction” for misconduct during a board proceeding, according to the acting director of the U.S. Patent and Trademark Office (USPTO). Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Fabre-Kramer, Obi, Pharmadrug, Tegmine. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arvinas, Astrazeneca, Hemispherian, OS Therapies, Pfizer. Read More
