Recon: US orders 1.5M Novavax COVID vaccine doses as Japan cancels order; EMA committee starts safety review of pseudoephedrine

ReconRecon | 13 February 2023 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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