Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amolyt, Aquestive, Bioheng, Heron, Inflarx, Moderna, TC, Tetra.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akston, Beyondspring, Biolexis, Centogene, G1, Janssen, Moderna, Oppilotech, Protagonist, Prothena, Q Biomed, Respirex, Saerum, Werewolf.
Despite global drops in COVID-19 infections and because variants never rest, Eiger Biopharmaceuticals Inc. is taking its strong top-line phase III data of pegylated interferon lambda to global regulatory agencies for approval. The type III interferon that stimulates immune responses significantly reduced the risk of COVID-19-related hospitalizations or emergency room visits longer than six hours by 50% and death by 60%. The results prompted Eiger to say it would submit the data to the FDA for an emergency use authorization – and also to the EMA and Asian agencies – as soon as it could.
Alnylam Pharmaceuticals Inc. has filed suits against both Pfizer Inc. and Moderna Inc. over alleged infringements of its patent on biodegradable cationic lipids that it said "are foundational to the success of the mRNA COVID-19 vaccines."
With the World Health Organization’s COVAX facility having more COVID-19 vaccine doses available than have been requested by the countries it was designed to help, industry groups are pushing back against the proposed TRIPS (Trade-Related Aspects of Intellectual Property Rights) waiver for COVID-19 vaccines that has been agreed to by the EU, India, South Africa and the U.S.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amicus, Apellis, Biocorrx, Biogen, Boehringer, Eli Lilly, Grifols, Junshi, NLS, Ocuphire, Oramed, Palisade, Roche.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adagene, Aim Immunotech, Biontech, Brii, Iovance, Kaléo, Ossium Health, Pfizer, Shionogi, Sonnet, The AIDS Clinical Trials Group.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medicine, Minute Molecular Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cellcarta, Cruinn, Eurofins, Healthy.io, Jogo Health, Medica, Physiq, Rivaara, Sense Biodetection, Sirona Dx, Sphingotec, Ultivue.
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