Recon: US orders 1.5M Novavax COVID vaccine doses as Japan cancels order; EMA committee starts safety review of pseudoephedrine
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Bernie Sanders Has a New Role. It Could Be His Final Act in Washington. (NYTimes)
- U.S. government to buy 1.5 mln more Novavax COVID vaccine doses (Reuters)
- Elon Musk’s Neuralink is under investigation for possible unsafe transport of contaminated hardware (CNBC)
- Big Pharma divided? Pfizer, AZ, Lilly and more support Sanofi in high-profile Amgen patent fight (Fierce)
- Biden’s moonshot examined: Researchers say cancer cure is a long ways off (Politico)
- G1 Therapeutics to halt drug trial in colon cancer, shares plunge (Reuters)
- U.S. states, others weigh in on court battle over abortion pill (Reuters)
- U.S. FDA puts partial hold on Blueprint Medicines' cancer drug trial (Reuters)
- Nestle's $6,000 Peanut Allergy Pill Has Been a Dud (Bloomberg)
- Alcon to pay Johnson & Johnson $199 mln to settle eye-laser cases (Reuters)
- Analysis: Biotech IPOs to bloom with spotlight on startups with human trial data (Reuters)
- EMA's safety committee starts review of cold medicines (Reuters)
- Novo Nordisk apologises for not disclosing sponsorship of anti-obesity training (FT)
- Sanofi’s R&D head John Reed to step down (BioPharmaDive) (Endpoints) (STAT)
- The success of NHS England’s Innovative Medicines Fund will depend on its operational details (Nature Medicine)
- Japan cancels 140M dose order for Novavax Covid vaccine amid 'lower than expected' demand (Endpoints)
- Amid bankruptcy, Clovis reveals more regulatory troubles for Rubraca (Fierce)
- GSK Defends Against US FDA Doubts About Jemperli Confirmatory Trial Feasibility (Pink Sheet)
- 3 years after rejecting $1B buyout, Sorrento files for bankruptcy amid legal battles (Fierce)
- Frequency to cut jobs after clinical trial setback (BioPharmaDive)
- ‘It is a balance’: Scientists grapple with ethics of cutting-edge stem cell research (STAT)
- Sun Pharma recalls at least 34,000 bottles of generic drug (Pharmafile)
- Sandoz files biosimilar of Amgen osteoporosis drug in US (Pharmaphorum)
- Radioligand therapy, a ‘game-changer’ for cancer treatment, forces manufacturers to race against a ticking clock (CNBC)
- Genentech to start construction on a new manufacturing facility in California (Endpoints)
- Bristol Myers, 2seventy roll out full Abecma data in earlier-stage cancer (Endpoints)
- Incyte says under-the-radar JAK inhibitor clears a high bar for skin disorder (Endpoints)
- G1 Therapeutics abandons PhIII colorectal cancer trial after disappointing overall response rates (Endpoints)
- Baxter, Abbott, Thermo Fisher among medtech firms cutting jobs on supply issues, slide in testing (MedtechDive)
- Insulet bulks up automated insulin delivery tech with $25M purchase of Bigfoot patents (Fierce)
- Medtronic ordered by jury to pay $106.5M to Colibri over TAVR patent infringement (MedtechDive)
- Report Finds Most FDA-Approved AI Devices Are Used For Imaging (MedtechInsight)
- Could a swallowable, quarter-sized device make diagnosing GI diseases less unpleasant? (STAT)
- Teva Slams Lilly's 'Scorched-Earth' Tactics In Migraine Battle (Law360)
- Martin Shkreli: I'm not in contempt over drug industry ban (Reuters)
- Hugh Auchincloss was Anthony Fauci’s longtime deputy. Now he’s taking his job as House Republicans probe the pandemic (STAT)
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