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17th February 2022
by Joanne S. Eglovitch

Recon: Judge dismisses Chantix cancer risk suit; Janssen and Remix agree to $1B licensing deal for RNA reprograming tech

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • A new analyst report spotlights 3 more deaths, ARIA among Alzheimer's patients taking Aduhelm (Endpoints)
  • Lawsuit over Pfizer's disclosures before Chantix recall is dismissed (Reuters)
  • '150 Billion Pills' Gaffe Imperils NY AG's Opioid Win Over Teva (Law360)
  • Generic Firms Likely To Withdraw Drugs If US FDA’s Pursues ‘Disastrous’ PANDA Policy (The Pink Sheet)
  • Biden’s new global vaccine push is running out of funds (Politico)
  • Ex-NIH chief Collins returns as science advisor to Biden weeks into retirement (Fierce)
  • NIH's top vaccine director retires, adding to the exodus of government vaccine expertise (Endpoints)
  • AstraZeneca Wins Bid to Quash HHS’s Drug HHS’s Drug Discount Demand (Bloomberg) (STAT)
  • Lawmakers ask Justice Department to explore criminal charges against Sacklers (STAT)
In Focus: International
  • WHO calls for strengthened role as US proposes new pandemic fund (Reuters)
  • UK to Offer Pfizer’s Covid Shot to All Children Aged 5 to 11 (Bloomberg)
  • Industry Skeptical Of EU Moves To Facilitate Compulsory Licensing (The Pink Sheet)
  • PRIME: How The EU Scheme Is Delivering On Promise Of Faster Drug Approvals (The Pink Sheet)
  • Generic Firms Resign Themselves To A Merger Drought As Regulators Tighten Up (The Pink Sheet)
  • Putting its pivotal failure in the rearview mirror, AstraZeneca scores an EU nod for its lupus drug (Endpoints)
  • EMA might deny Merck's molnupiravir conditional marketing authorization — report (Endpoints) (FT)
  • Bill Gates visits Pakistan, says polio eradication possible in a few years (Reuters)
Coronavirus Pandemic
  • Moderna patent application raises fears for Africa COVID vaccine hub (Reuters)
  • Covid Patients May Have Increased Risk of Developing Mental Health Problems (NYT)
Pharma & Biotech
  • As Omicron fears fade, pandemic restrictions are being dismantled. And that's a big deal for some biopharmas (Endpoints)
  • Remix Therapeutics signs Janssen licensing deal that could top $1B (Fierce)
  • Applying mRNA to healing broken bones (Fierce)
  • Innovent’s phase 3 hits tee it up to challenge Amgen and Sanofi for Chinese PCSK9 market (Fierce)
  • Yumanity's ugly demise continues with plans to axe 60% of staff in search for 'strategic alternatives' (Endpoints)
  • Avalo Therapeutics shuffles leadership team as the flailing biotech searches for a port in the storm (Endpoints)
  • Billionaire’s fund backs Heidelberg to carve out niche in busy BCMA space (Fierce)
  • Innovent claims two PhIII wins for PCSK9 antibody, but non-China strategy remains unclear (Endpoints)
Medtech
  • Inspection-Challenged FDA Defies Odds By Issuing Most Quality-Related Warning Letters Since 2017 (MedTech Insight)
  • How Notified Bodies Must Actively Monitor Legacy Products (MedTech Insight)
  • Baxter begins integrating Hillrom, faces supply chain pressures (MedTech Dive)
  • FDA clears Tandem’s smartphone app for programming insulin doses (Fierce)
  • MindMaze Raises $105M To Advance Mixed-Reality Brain Health Tech (MedTech Insight)
Government, Regulatory & Legal
  • Purdue Pharma Mediator to Provide Settlement Update by Friday (Bloomberg)
  • Drug Price Reporting Rules Foiled by Loopholes in Supply Chain (Bloomberg)
  • OptumTx Wins Exit From Antitrust, RICO Case Over Insulin Prices (Bloomberg)
  • Trump-era Medicare program under increased scrutiny (Politico)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.