A patient death marred Erasca Inc.’s phase I dose-escalation efforts with pan-RAS molecular glue ERAS-0015 in cancer, and shares (NASDAQ:ERAS) ended April 28 at $9.90, down $9.25. ERAS-0015 is being tested in RAS-mutant solid tumors, specifically non-small-cell lung and pancreatic ductal adenocarcinoma. Read More

New U.K. clinical trials regulations coming into force today, April 28, aim to reduce the time taken to get approval for studies and introduce a category of lower risk trials which will be automatically assessed in 14 days. The key measure to cut timelines is the Combined Review, under which sponsors will be able to submit a single application for regulatory review by the Medicines and Healthcare products Regulatory Agency and ethics review by the Health Research Authority, the body responsible for managing ethics committees. Read More

After a hiatus of more than nine months, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet April 30 to discuss two Astrazeneca plc applications – an NDA for camizestrant used in combination with a CDK4/6 inhibitor to treat HR+HER2- locally advanced or metastatic breast cancer and an sNDA for Truqap (capivasertib) to treat metastatic hormone-sensitive prostate cancer that’s phosphatase and tensin homolog deficient. Read More

Thermo Fisher Scientific Inc. agreed to sell its microbiology business to Astorg, a private equity firm, for approximately $1.075 billion, consisting of cash and a $50 million seller note. The business unit provides antimicrobial susceptibility testing and culture media solutions for clinical, pharmaceutical and food safety testing. Read More

Nervonik Inc. raised $52.5 million in a series B financing round for its peripheral nerve stimulation (PNS) system designed to treat patients with chronic pain and other neurological conditions. The funds will be used to support the continued development Nervonik's PNS system, including enhancements to the system’s sensing capabilities, as well as preparations for commercialization. Read More

Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin said. “That’s why more than 60% of solid tumor patients do not respond to treatment.” Read More

China’s biotech ecosystem has crossed an inflection point, and Chinese biotechs are gaining leverage in dealmaking, executives from multinational companies said during the Chinabio Partnering Forum in Shanghai April 28. Read More

More than two years after signing a $1.7 billion deal with Takeda Pharmaceutical Co. Ltd., Protagonist Therapeutics Inc. has opted out of a 50-50 U.S. profit-and-loss sharing arrangement for its hepcidin mimetic peptide, rusfertide, a priority review drug developed to treat adults with polycythemia vera. Read More

Soligenix Inc. intends to spend the next weeks further analyzing data and reviewing strategic options in the wake of a disappointing interim analysis from a pivotal phase III study testing Hybryte, its synthetic hypericin, in cutaneous T-cell lymphoma. Read More

Alleging “untrue statements” included in the approval application for vasculitis drug Tavneos (avacopan), the U.S. FDA’s Center for Drug Evaluation and Research is proposing to withdraw the NDA for small-molecule C5aR antagonist at the center of Amgen Inc.’s 2022 buyout of Chemocentryx Inc. for $3.7 billion. Read More

An alleged coverup of NIH-funded gain-of-function research at China’s Wuhan Institute of Virology has led to criminal charges against a former career scientist and top aide to Tony Fauci, the head of the National Institute of Allergy and Infectious Diseases in the time of the COVID-19 pandemic. Read More

New hires and promotions in the biopharma and med-tech industries, including: Armata, Avalyn, Circular, Evaxion, Fulcrum, Infinimmune, Nervgen, Paratus, Puretech, Seaport. Read More

Biopharma and med-tech companies raising money in public or private financings, including: Citius, Fathom, Lucid, Plaquetec, Sagimet, Sanofi, Sonoma, Squaremind. Read More

Clinical updates for biopharma and med tech, including data readouts and publications: Abbott, Adagio, Berlin, Brii, Cantargia, Compass, Concept, Cormedix, Implicity, Intellia, Mirum, Neuropace, Orthotrophix, Oruka, Pulse, Relay, Secura, Veradermics. Read More

Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Aluvaris, Amicus, Aoti, Biomarin, Myndtec, Pharmala, Teli, Telomir. Read More

Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Arcutis, Astrazeneca, Compass, Galaxy, GSK, Intellia, Jazz, J&J, Novartis, OSE, Santhera, Terns, Veloxis. Read More