AstraZeneca's COVID-19 therapy hits goal in phase 3, but efficacy falls short of rivals Sponsored: Purify DNA, RNA, proteins, and cells for many applications Merck makes beeline to FDA, seeking approval for COVID-19 antiviral 10 days after reporting data Protagonist's story gets a happy ending as FDA's hold swiftly lifted on rusfertide program Sponsored: Partnership to unlock the full potential of data to advance the science and practice of healthcare: Q&A with Syntropy and the University of California, Irvine Idorsia's Fabry med did what executives were expecting—it just didn’t relieve the disease's hallmark burning pain He led Bayer's $1B Parkinson's bet. Now, Nuwaysir will helm Takeda-partnered Ensoma Senate to cull Biden's biomedical research agency from social care bill: Report Protalix reaches agreement with FDA on Fabry data package, but resubmission of PRX–102 could be years out Brain atlas unveils dozens of cell types that control movement and could inspire targets in neurological disease Biden doubles down on vaccine mandates, pointing to increased uptake and limited resignations GlaxoSmithKline to leave landmark global HQ after split-up as consumer health business plots £120M new home Deep Lens pens cancer trial matchmaking pact with Pacific Cancer Care Mount Sinai unveils first-of-its-kind department to develop AI tools for healthcare Featured Story | By Nick Paul Taylor AstraZeneca has chalked up another win for its anti-SARS-CoV-2 antibody combination, revealing the prospect cut the rate of severe COVID-19 or death in patients recently infected with the coronavirus. But with AstraZeneca arriving late to the market with efficacy results that fall short of its rivals, the commercial prospects of AZD7442 in the treatment of COVID-19 are uncertain. read more |
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Top Stories Sponsored by: Thermo Fisher Scientific Discover ways your Thermo Scientific™ KingFisher™ system can empower your research beyond SARS-CoV-2. read more By Nick Paul Taylor Merck isn’t hanging around. Ten days after reporting data on its oral COVID-19 antiviral molnupiravir, Merck has filed for emergency use authorization from the FDA as part of a rapid global push to get the drug to patients. read more By Ben Adams A month ago, Protagonist Therapeutics saw its shares more than halved on an FDA clinical hold of its blood cancer drug after worrying preclinical safety signals. read more Sponsored by: Syntropy Q&A with Syntropy and UCI on their collaboration to work across their enterprise and with external partners to advance health research and patient care. read more By Annalee Armstrong Idorsia’s Fabry disease therapy “did exactly what we were expecting,” according to one executive—except relieve neuropathic pain. That means lucerastat failed in a phase 3 clinical trial in adult patients with Fabry disease, a rare metabolic disorder that causes episodes of severe burning pain and can eventually lead to kidney failure or cardiac disease. read more By Kyle LaHucik Emile Nuwaysir led the $1 billion bet that Bayer placed on Parkinson's via its BlueRock Therapeutics subsidiary. Now, the chairman of the Alliance for Regenerative Medicine will take the reigns at Ensoma, a gene therapy biotech that launched with $70 million and a Takeda partnership in February. read more By Ben Adams President Joe Biden’s $3 billion Advanced Research Projects Agency for Health is in jeopardy as the Senate is set to cut the agency from its social care spending bill. read more By Annalee Armstrong Protalix BioTherapeutics sees a path forward for resubmitting an application for a Fabry disease medicine with the FDA; it’s just going to take a while. The Israeli biotech received a complete response letter from the FDA for PRX–102, or pegunigalsidase alfa, in April. read more By Arlene Weintraub A Berkeley-led team discovered that the primary motor cortex in the brain, which controls movement, houses up to 116 distinct cells—five times more than had been identified in previous research. The research is part of the National Institutes of Health's BRAIN Initiative, a massive research effort aimed at the world’s understanding of the human neurological system. read more By Dave Muoio In a speech and new report, the U.S. president pointed to data indicating major increases in employee vaccination rates and relatively few resignations following vaccination requirements. About 40% of all U.S. hospitals have publicly announced a vaccination requirement for their workforce. read more By Angus Liu GSK will leave its iconic glass-façade corporate headquarters in London, known as the GSK House, after 2023 at the earliest. The outgoing consumer health business will invest £120 million to build its own campus in Weybridge, U.K. read more By Ben Adams Deep Lens is looking to help the right cancer patients get into the right trials and is teaming up with Pacific Cancer Care to help in its mission. read more By Andrea Park Many hospitals and health systems talk a big game about integrating artificial intelligence into nearly every aspect of clinical care, but Mount Sinai, for one, is actually putting its money where its mouth is. read more Resources Sponsored By: Unlearn AI Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes. Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. 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