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December 7, 2023
by Jason Scott

Recon: Biden administration exercises authority to seize certain drug patents; Abbvie buys neuro developer Cerevel for $8.7B

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
  • Targeting costly meds, Biden admin asserts authority to seize certain drug patents (POLITICO)
  • Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls (Fierce Pharma)
  • Eli Lilly’s latest $1.4 billion deal might come unglued (STAT)
  • FDA endorses Novartis’ ‘pipeline in a pill,’ granting first nod for potential blockbuster Fabhalta (Fierce Pharma)
  • AbbVie purchases neuroscience developer Cerevel for $8.7 billion (STAT)
  • New England Journal of Medicine reckons with its racist past and complicity in slavery (STAT)
  • ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices (STAT)
  • Biden Rx Pricing Plan Includes Antitrust Scrutiny, Patent ‘March-In’ Actions (Pink Sheet)
 
In Focus: International
  • What is the EU AI Act and when will regulation come into effect? (Reuters)
  • EU’s Talks on AI Rules Stall After Nearly 24 Hours of Debate (Bloomberg)
  • Denmark Introduces Early Dialogue With Procurement Agency For Expensive Medicines (Pink Sheet)
  • HIV vaccine trial in Africa halted after disappointing data (Reuters)
  • EU Lists Its First Reference Laboratories For High-Risk IVDs Falling Into Class D (MedTech Insight)
  • EU Critical Medicines List To Be Ready ‘Within Days’ (Pink Sheet)
  • What To Expect From India’s Proposed National Pharmaceutical Policy (Pink Sheet)
  • Japan Law Revisions Allow Medical Cannabis But Tighten Other Restrictions (Pink Sheet)
 
Pharma & Biotech
  • Pfizer plans to depart BIO (STAT)
  • New gene therapies confront many sickle cell patients with an impossible choice: a cure or fertility (STAT)
  • Merck's lung cancer drug combo fails trial in setback for new therapy class (Reuters)
  • Sanfilippo Syndrome Patients, Drug Developers At Odds With US FDA Guidance (Pink Sheet)
  • Sanofi to boost drug development spend by 700 mln euros in 2024 (Reuters)
  • Sanofi says it has 12 blockbusters in its back pocket. Will investors believe it? (STAT)
 
Medtech
  • US FDA clears Becton's less-invasive blood collection device (Reuters)
  • 5 takeaways from J&J’s investor day (MedTech Dive)
  • US hospitals forecast 9% capex growth to support elective procedure backlog: survey (MedTech Dive)
  • Mosie Baby First To Win FDA Clearance For At-Home DYI Artificial Insemination Kit (MedTech Insight)
  • MDR Changes Aren’t A ‘Catalyst’ For Medtech Investments In Ireland (MedTech Insight)
  • “We’re A Pain-Management Company.” Nevro Adds SI Joint Surgery To SCS Business (MedTech Insight)
  • eSTAR Now Open For PMA Submissions (MedTech Insight)
  • FDA Evaluating Safety Of Plastic Syringes From China, May Prevent Their Import To The US (MedTech Insight)
 
Government, Regulatory & Legal
  • Daiichi Sankyo scores $182M from Novartis settlement in long-running patent case (Fierce Pharma)
  • HP&M Files Comments Opposing FDA’s Proposed LDT Rule (FDA Law Blog)
  • As Biopharma Seeks Broader IRA Orphan Exclusion, Study Urges Boosting Savings By Eliminating It (Pink Sheet)
  • The History Behind The Drug-Device Combos Targeted By FTC (Pink Sheet)
 
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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