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January 2, 2024
by Joanne S. Eglovitch

Recon: Infant formula recalled for potential contamination risks; Bristol Myers to acquire cancer startup RayzeBio for $4.1B

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Reckitt's Mead Johnson Nutrition recalls baby formula powder from US (Reuters) (CBSnews) (FDA)
  • Zealand drug hit with CRL for ultra-rare disease amid manufacturing concerns, plans to resubmit in 2024 (Endpoints)
  • FDA declines to grant Amgen’s Lumakras full approval in lung cancer after negative advisory committee vote (Endpoints)
  • Following FDA inquiry into CAR-T safety, agency adds warning on secondary cancers for Carvykti (Endpoints)
  • Iovance’s registrational lung cancer trial on hold after patient death (Endpoints)
  • FDA seizes thousands of counterfeit Ozempic units, warns consumers not to use (Endpoints)
  • Big Totals And Big Margins: US FDA Approved 72 Novel Agents In 2023 – And Acted On 90+ (Pink Sheet)
  • The Long Learning Curve For Artificially Intelligent Drug Manufacturing Begins Now (Pink Sheet)
  • Drug-Drug Interactions: Future FDA Guidance Will Focus On Specific Modalities; Patient Website To Come (Pink Sheet)
  • Exclusive: Drugmakers set to raise US prices on at least 500 drugs in January (Reuters)
  • MiMedx Falls on FDA Warning Letter For Axiofill Classification (Bloomberg)
 
In Focus: International
  • AstraZeneca, Sanofi RSV infant shots approved in China (Reuters)
  • UK’s New International Recognition Procedure A ‘Win-Win’ For Stakeholders (Pink Sheet)
  • New Canadian Drug Agency To Focus On Drug Access & Affordability (Pink Sheet)
  • EMA Homes In On Bacteriophages In Fight Against AMR (Pink Sheet)
  • EU CHMP Opinions And MAA Updates (Pink Sheet)
  • Brazil Aims For Top 10 Spot In Clinical Research (Pink Sheet)
 
Pharma & Biotech
  • Bristol Myers will pay $4.1 billion for cancer startup RayzeBio (STAT)
  • Novartis Inks Potential $1.3B Gene Therapy Deal with Voyager to Target Neuro (Biospace)
  • AstraZeneca makes $1B deal for Gracell and its cell therapies, adding to China ties (Endpoints)
  • ImmunityBio Snags $320M Royalty Deal Ahead of FDA Decision in April (Biospace)
  • Regeneron scores Eylea patent win against Mylan, keeping biosimilar at bay (Endpoints)
  • Cytokinetics heart drug aficamten succeeds in pivotal study (STAT
Medtech
  • Shunned by insurers, digital therapeutics startups look for other ways to get paid (Endpoints)
  • Roche to buy part of LumiraDx diagnostics platform for $295 million (Reuters)
  • Apple Watches Are Back On The US Market (MedTech Dive
  • Philips pays $2.4 million for allegedly giving kickbacks to sleep labs (STAT)
  • Former Stimwave CEO Charged With Securities Fraud (MedTech Insight) 
Government, Regulatory & Legal
  • US judge allows FTC to temporarily block IQVIA acquisition of DeepIntent (Reuters)
  • LumiraDx Appoints Administrators, Sells Platform to Roche (Bloomberg)
  • McKinsey to pay $78 million in US opioid settlement with health plans (Reuters)
  • LumiraDx Appoints Administrators, Sells Platform to Roche (Bloomberg)
  • Abortion, Guns, Jan. 6 Highlight Top Supreme Court Cases in 2024 (Bloomberg)
 
 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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