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.
China’s NMPA has approved 12 antigen self-test kits between March 12 and 16 amid COVID-19 outbreaks in many parts of the country. The regulator claims that there will soon be more test kits approved. The number of COVID-19 infectious cases in China surged rapidly over the first half of March.
With global COVID-19 cases on the rise once again, the World Trade Organization (WTO) said it reached consensus among four WTO members – the U.S., European Union, India and South Africa – for an IP waiver regarding vaccines, a proposal to which biopharma reiterated its objections. Meanwhile, in the U.S., the White House appealed to Congress to provide adequate funding to continue the country’s pandemic response, and Pfizer Inc. and Biontech SE submitted an application to the FDA seeking emergency use authorization for a fourth shot of its COVID-19 vaccine.
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