ReconRecon | 09 March 2023 |  By 

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US

  • Baby Food, Formula Safety Get FDA Focus in Biden Budget Request (Bloomberg)
  • US FDA flags shortage of medication used to treat breathing conditions (Reuters) (Fierce)
  • Where are all the generic inhalers for asthma and COPD? Researchers call for patent and FDA reforms (Endpoints)
  • U.S. FDA approves Amphastar Pharma’s nasal spray for opioid overdose (Reuters)
  • FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion (Endpoints)
  • FDA says no adcomm planned for Biogen, Sage's depression drug (Endpoints)
  • Makena: Formal Withdrawal Order Would Provide ‘Greater Certainty,’ Transparency – CDER (Pink Sheet)
  • FDA inspection uncovers cherry-colored antibiotic residue on equipment at Teva's New Jersey site (Endpoints)
  • ‘Truth is losing the battle’: FDA commissioner on grappling with a wave of health misinformation (STAT)
  • Pharmalittle: FDA head wants to get rid of advisory panel votes; premature-birth drug is finally withdrawn (STAT)
  • Short supply of commonly used cancer drugs raises concerns among hospital pharmacists (Endpoints)
  • Francis Collins readies a Biden push to eliminate hepatitis C nationwide (Endpoints)
  • Industry advocates urge Senate health committee leaders to support antimicrobial pricing reform (Endpoints)

In Focus: International

  • India prohibits use of propylene glycol from supplier linked to Uzbekistan deaths (Reuters)
  • Canada Consults On Policy Changes For Registering Drug, Device Trials & Disclosing Results (Pink Sheet)
  • Korea’s Biopharma Regulatory Reform Push To Focus On Innovation, Streamlining (Pink Sheet)
  • China’s CDE Explains Major Issues Around Conditional Approval Scheme (Pink Sheet)
  • China New Government Policies Taking Shape As Two Sessions Underway (Pink Sheet)
  • Malawi’s deadly cholera epidemic hits the poor hardest (Reuters)

Pharma & Biotech

  • Bayer plans to spend $1 bln on US pharma R&D in 2023-US pharma head (Reuters) (BioSpace)
  • QurAlis’ Biomarker-Driven Approach Attracts $88M in Series B (BioSpace) (Reuters)
  • Pfizer ready to launch RSV vaccines for older adults, pregnant women in US. Europe (Reuters)
  • Neeoleukin, old ending: De novo protein player lays off 70% of staff, searches for strategic alternative (Fierce) (Endpoints)
  • Chasing Moderna, Merck pays $50M to join race to develop cancer-preventing vaccine (Fierce)
  • AstraZeneca Notches Back-to-Back Late-Stage Wins in Lung Cancer (BioSpace) (Reuters)
  • Eli Lilly Alzheimer’s Drug Fails to Prevent Disease in Trial (Bloomberg) (Endpoints)
  • All systems go for Mesoblast’s 2nd attempt to secure allogenic cell therapy FDA win (Fierce)
  • Organon doubles down on mission to prevent unplanned pregnancies with $30M investment (Endpoints)
  • Novo Nordisk buys 104 acres in North Carolina, making room for more expansion (Fierce)


  • Commission Publishes Regulations Extending Frequency Of Notified Body Reassessments (MedTech Insight)
  • FDA Updates Mammography Rules With Focus on Tissue Density (Bloomberg)
  • ReWalk paves a new path as FDA greenlights exoskeleton tech for stairs and curbs (Fierce)
  • More woes for breast implants, as FDA links procedure to squamous cell carcinoma (MedTech Dive)
  • J&J lays off 350 people at robotics units, says ‘we have to get better’ with Ottava (MedTech Dive) (Fierce)
  • Resilience And ‘Lessons Learned’ Must Be The COVID Legacy In Germany (MedTech Insight)
  • France’s Snitem Demands Shock Cardiac Devices Reimbursement Decision Be Reversed (MedTech Insight)
  • Working Group Seeks To Improve Medical Device Quality And Efficiency Of US Supply Chain (MedTech Insight)

Government, Regulatory and Legal

  • Oncopeptides exec is arrested in Sweden for allegedly passing insider information (Endpoints)
  • Moderna to Court: Ignore Groups’ Concerns in Covid-Vaccine Clash (Bloomberg)
  • In SCOTUS filing, Amgen claps back at Sanofi and Regeneron in long-running patent feud (Fierce)
  • Former drug firm exec sentenced to more than 2 years for illegal opioid sales (Reuters)

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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