Biogen's ALS drug has failed phase 3. Will FDA approve anyway? A single patient is producing insulin after treatment with Vertex's new diabetes cell therapy Valneva soars after its COVID-19 shot tops AstraZeneca's in head-to-head trial Sponsored: Considerations for Laboratory-Related Operational and Patient Burden in Decentralized Clinical Trials. Clinical Lab Testing in Your Home: Fact or Fiction? FDA rejects Omeros transplant drug over difficulties estimating its effect Agenus cell therapy spinoff MiNK inks mark on Wall Street with low-end $40M IPO Natera launches lung DNA test for catching transplant rejections Pfizer, Moderna will rake in a combined $93 billion next year on COVID-19 vaccine sales: report Conflicting federal, state COVID-19 vaccine requirements have hospitals trapped in noncompliance A new target in multiple myeloma? TAK1 blocker boosts chemo's cancer-killing power in preclinical study AI drug discovery startup Quris launches with $9M to predict drug success starting with rare diseases Sensyne teams up with OMNY for 22M patient records for clinical research Featured Story | By Nick Paul Taylor Stop me if you think you've heard this one before. A Biogen neurodegenerative disease prospect has failed a pivotal study, but the Big Biotech has latched onto biomarker data and “trends favoring” the treatment as it heads into talks with the FDA. Will it be enough to get the candidate to market? read more |
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Top Stories By Annalee Armstrong Vertex is providing an initial peek at the first patient to receive a new type of diabetes cell therapy that could prevent the need for organ transplantation. A single patient with type 1 diabetes achieved a “robust” restoration of islet cell function after receiving VX-880. Restoration of these cells could allow patients to regulate insulin or even produce it on their own. read more By Kyle LaHucik Travel vaccine maker Valneva says its COVID-19 vaccine has topped AstraZeneca's in a head-to-head pivotal trial in the U.K. Valneva hopes to win approval in Europe for the vaccine, which is now also being tested in New Zealand. read more Sponsored by: Q2 Solutions Clinical lab testing at home - fact or fiction? Many operational and patient-related considerations must be taken when using a decentralized approach to specimen collection at or near the trial participant's home. read more By Nick Paul Taylor There will be no miraculous escape for Omeros. Weeks after the FDA flagged deficiencies with the filing for approval of a stem cell transplant drug, the agency has issued the complete response letter foreshadowed by its earlier communication. read more By Kyle LaHucik MiNK Therapeutics inked its spot on the Nasdaq with a $40 million initial public offering on Friday to take its lead candidate through phase 1 trials in multiple cancers and infectious diseases. read more By Conor Hale The lung test launch marks Natera's third in as many months for its Prospera DNA test, which recently debuted heart- and kidney-focused diagnostics. read more By Kevin Dunleavy Pfizer-BioNTech COVID-19 vaccine sales will reach $54.5 billion in 2022 and Moderna’s will hit $38.7 billion, says analytics group Airfinity. The organization puts total market sales for COVID vaccines in 2022 at $124 billion. The Airfinity numbers are radically divergent from consensus figures, The Financial Times reports. read more By Dave Muoio Legal experts weigh in on the options for hospitals forced to choose between Biden's executive orders and a number of state-level bans on COVID-19 vaccine mandates. read more By Arlene Weintraub Several new therapies have been approved in recent years to treat multiple myeloma, but drug resistance is a common problem. Now, a team of Norwegian researchers has preliminary evidence that targeting a protein kinase called TAK1 could restore the power of chemotherapy to attack multiple myeloma cells. read more By Kyle LaHucik Quris, a new artificial intelligence startup, thinks it has the tools to predict whether a drug candidate will work safely in humans. The drug discovery company launches with $9 million in angel funding to help reduce risks and costs associated with failed clinical trials. read more By Kyle LaHucik Artificial intelligence company Sensyne Health and real-world data network OMNY Health are teaming up on 22 million patient records to support data analytics for life sciences clients. Sensyne and OMNY will also work on commercial projects for clinical medical research. read more Resources Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific 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. Sponsored By: Bioclinica This whitepaper addresses where AI can make the biggest impact in clinical trials. 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