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 No longer recommended in a draft guidance were Ronapreve (casirivimab + imdevimab) from Roche Holding AG, Xevudy (sotrovimab) from GSK plc, and Evusheld (tixagevimab + cilgavimab) from Astrazeneca plc. NICE also recommended discontinuing use of Lagevrio (molnupiravir) from Merck and Co. Inc. and Veklury (remdesivir) from Gilead Sciences Inc. Read More
Carrying the apolipoprotein E4 allele (APOE4), and not the APOE3 variant, is the strongest risk factor for developing Alzheimer’s disease (AD). But the underlying mechanism has remained elusive. Now, researchers at MIT and Mount Sinai have found that in brains carrying the APOE4 allele, lipid and cholesterol processes were dysregulated in oligodendrocytes and that this effect reduced myelination. Read More
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. Read More
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. Read More
Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alphyn, Antengene, Arcutis, Beckley Psytech, Daiichi Sankyo, Endevica, Enlivex, Excellthera, Innovent, Nanobiotix, Nouscom, Reistone, Vect-horus, Zyua. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Compugen, Frazier Lifesciences Acquisition, Grey Wolf, Horizon, Inmd, Kriya, Legochem, Logicbio, Medigene, Newamsterdam Pharma, Nextcure, Redpin, Regeneron. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Biomind Everest, Immunogen, Junshi, Kineta, Neurosense, Zielbio, Zynerba. Read More
