Britain’s National Institute for Health and Care Excellence (NICE), a key gatekeeper on the path to the U.K. market, is backing away from five COVID-19 treatments. No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. The agency said evidence shows the treatments are ineffective against the omicron variant of SARS-CoV-2. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc. because they were not found to be cost effective. The treatments are currently used by Britain’s National Health Service for COVID patients. NICE did not commit to a date for final guidance on the treatments.
APOE4 allele reduces myelination in Alzheimer’s disease
Carrying the apolipoprotein E4 allele (APOE4), and not the APOE3 variant, is the strongest risk factor for developing Alzheimer’s disease. But the underlying mechanism has remained elusive.
Reistone reports positive phase III results for ivarmacitinib in atopic dermatitis
Reistone Biopharma Co. Ltd. said both doses of the JAK1 inhibitor ivarmacitinib, tested against moderate to severe atopic dermatitis (AD) in a multinational phase III trial, met the study’s co-primary endpoints, delivering significant improvements on a common measure of disease severity vs. placebo. It’s the first National Class A new drug for AD that is designed and developed in China, according to the company.
Biotheus out-licenses preclinical EGFR/MET bispecific antibody to Hansoh
Biotheus Inc. out-licensed Chinese rights to its preclinical EGFR/MET bispecific antibody, PM-1080, to Hansoh Pharmaceutical Group Co. Ltd. for ¥50 million (US$359,150) up front and up to ¥1.42 billion in future development, regulatory and commercialization milestones, plus tiered sales-based royalties. Under the terms of the agreement, Hansoh will be responsible for the development, regulatory approval, manufacture and commercialization of the molecule in China. Biotheus retained rights outside of China.
Junshi steps up efforts in Europe by filing for the NDA of toripalimab
Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.
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Acrivon, Alexion, Alphyn, Alvotech, Amarin, Antengene, Arcutis, Astrazeneca, Beckley Psytech, Biomind, Calliditas, Cognition, Daiichi Sankyo, Endevica, Enlivex, Excellthera, Grey Wolf, Horizon, Immunogen, Inmed, Innovent, Junshi, Kineta, Kriya, Legochem, Logicbio, Lumos, Medigene, Nanobiotix, Neurosense, Newamsterdam, Nextcure, Nouscom, Radiomedix, Redpin, Regeneron, Reistone, Sunshine, Trevena, Tricida, Vect-Horus, Zielbio, Zynerba, Zyus