Recon: Novo follows Lilly in slashing US insulin prices; FDA staff signal support for Pfizer’s COVID drug in high-risk patients

ReconRecon | 14 March 2023 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • Novo Nordisk to slash US insulin prices, following move by Eli Lilly (Reuters) (STAT) (NYTimes)
  • Amgen is sued for concealing $10.7 billion tax bill from investors (Reuters) (Bloomberg)
  • Pfizer's COVID drug data supports use in high-risk patients - FDA staff (Reuters)
  • With positive combo meningococcal vaccine data, GSK eyes US approval (Reuters)
  • US sues Rite Aid for missing opioid red flags (Reuters) (DoJ)
  • US VA to cover Eisai, Biogen Alzheimer's treatment Leqembi (Reuters) (STAT)
  • McKinsey Consulted VA While Advising Opioid Makers to Target Agency for Sales (WSJ)
In Focus: International
  • Novartis Starts Sale of Some Ophthalmology Assets (Bloomberg)
  • Pholcodine cough medicines withdrawn in UK over allergy fears (The Guardian) (MHRA)
  • China pharma: sector that tested world takes test of its own (FT)
  • Merck asks EMA to reevaluate rejected Covid-19 antiviral (Endpoints)
Pharma & Biotech
  • U.S. FDA places Mersana's cancer drug trial on hold following death (Reuters)
  • National Academies calls for transforming use of racial and ethnic labels in genetics research (STAT)
  • Amylyx’s ALS drug launch starts strong. That could be trouble for the FDA (STAT) (BioPharmaDive)
  • FDA, CMS And Accelerated Approval: Flipping The Script (Pink Sheet)
  • US FDA Open To Cell Therapy ‘Assessment Aid’ That Could Speed Development Of Next-Gen Cancer Drugs (Pink Sheet)
  • Switch Therapeutics launches with $52M to capitalize on RNA medicine ‘era’ (BioPharmaDive)
  • Further shuffling at Leo Pharma as dermatology drugmaker splits R&D (Endpoints)
  • Servier says its next IDH inhibitor has passed PhIII, but no regulatory timeline yet (Endpoints)
  • Bristol Myers passes on two Exscientia oncology candidates, but biotech to move them into clinic next year (Endpoints)
  • Exercise in a pill? That's the focus of Cambrian's new pipeline company (Endpoints)
  • Celltrion teams up with another Korean biopharma in antibody discovery deal (Endpoints)
  • Illumina has been ignoring its investors, but it can’t ignore Carl Icahn (STAT)
  • Philips poaches new connected care business leader from Pear (MedtechDive)
  • PerkinElmer completes $2.45B spinoff to create new diagnostics, life sciences company (Fierce)
  • Insulet tapped to replace SVB on S&P 500 index after bank collapse (Fierce)
  • Baxter Warns Of Low Blood Oxygen Levels From Portable Breathing Device (MedtechInsight)
  • UK’s NHS Launches AI Regulation Service Specifically For Medtech Firms (MedtechInsight)
  • Joint replacement business likely to be busy for the next year or more: BTIG analysts (MedtechDive)
  • Philips finds new head of recall-laden connected care segment in Pear Therapeutics exec (Fierce)
Government, Regulatory & Legal
  • Texas judge sets hearing in case seeking to ban abortion pill nationwide (Reuters)
  • Recent Trends In Multiple First Generic Drug Filings (Law360)
  • Sun Pharma, Taro Pharmaceutical reach $75M settlement agreement in alleged price fixing scheme (Endpoints)
  • CVS Can't Escape FCA Suit Alleging Drugmaker Collusion (Law360)
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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