Reflecting the evolving scientific understanding of Alzheimer’s disease, the U.S. FDA revised its 2018 draft guidance on developing drugs to treat early Alzheimer’s.
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
Shanghai-based Henlius Biotech Inc. and India’s Intas Pharmaceuticals Ltd. agreed upon a potential €185 million (US$195.38 million) licensing deal for Intas to develop and sell Henlius’ China NMPA-approved lung cancer drug, serplulimab, across Europe and India. Serplulimab (HLX-02) is a recombinant humanized PD-1 monoclonal antibody (MAb) injection that first gained approval as Hansizhuang in March 2022.
What was once effective is now a non-starter. Newly updated guidelines from the World Health Organization (WHO) caution against using the COVID-19 treatments sotrovimab, from GSK plc and Vir Biotechnology Inc., and Regen-Cov (casirivimab + imdevimab), from Regeneron Pharmaceuticals Inc. Omicron, the group said, has rendered the monoclonal antibodies ineffective.
Regeneron Pharmaceuticals Inc.’s Inmazeb and Ridgeback Biotherapeutics LP’s Ebanga earned a ringing endorsement from the World Health Organization (WHO) in its first ever guideline on Ebola therapies. In releasing the guideline Aug. 19, WHO officials celebrated the fact that Ebola is no longer “a near certain killer” – provided treatment starts as soon as possible following diagnosis.
Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19.
Genentech Inc. is paying Kiniksa Pharmaceuticals Ltd. $100 million in up-front and near-term payments for the development and commercialization rights to vixarelimab, a fully human monoclonal antibody. Kiniksa also could receive up to approximately $600 million in certain clinical, regulatory and sales-based milestones, as well as royalties on annual net sales.
A phase II/III trial testing Inflarx NV's vilobelimab, a monoclonal antibody the company is developing to control inflammatory response, showed a relative reduction in 28-day all-cause mortality of 23.9% vs. placebo (p=0.094) for mechanically ventilated COVID-19 patients, but missed statistical significance on the measure, the study's primary endpoint.
Adagio Therapeutics Inc. plans to file for emergency use authorization in the second quarter of 2022 for its lead candidate, a monoclonal antibody (MAb) for preventing and treating COVID-19. With plenty of competing vaccines around, the company now thinks it has found the right group to receive it: the immunocompromised.
Following Philip Morris International Inc.’s controversial takeover of respiratory drug firm Vectura plc, British American Tobacco plc (BAT) is also making inroads into medical research with U.K.-based Kbio Holdings Ltd., a biotech focused on plant-based medicine.
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