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April 29, 2024
by Jason Scott

Recon: Ono set to buy Deciphera for $2.4B; FDA approves X4’s ultra-rare immunodeficiency disease therapy

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

In Focus: US
  • Biden administration boosts some Medicaid payments to match commercial rates (STAT)
  • House bill aimed at Chinese biotechs is advancing (STAT)
  • Drugmaker AbbVie expects Humira volume erosion to worsen (Reuters)
  • Priority Review Vouchers: Tropical Disease Candidates Wait Years For FDA Action On Qualifying List (Pink Sheet)
  • FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications (FDA Law Blog)
In Focus: International
  • Doctors Without Borders challenges pharma by releasing costs for a key clinical trial (STAT)
  • WuXi wants to regain client confidence amid claims of IP transfer to Chinese authorities (Endpoints)
  • 4P-Pharma raises €15M; Oncotelic Therapeutics sells rights to cancer assets (Endpoints)
  • MHRA Needs ‘Rebuilding’ After Post-Brexit Loss Of Capacity & Industry Investment (Pink Sheet)
  • EU & South Korea Sign Deal On Exchange Of Confidential Information (Pink Sheet)
  • EU Parliament OKs New Rules On Use Of Patient Data In Research (Pink Sheet)
  • Merck KGaA, Huma collab bears fruit with launch of bladder cancer patient support app (Fierce Pharma)
Pharma & Biotech
  • New, serious safety risk related to MorphoSys’ cancer drug complicates, potentially threatens, Novartis acquisition (STAT)
  • Ono Pharmaceutical to acquire Deciphera Pharma, maker of cancer drugs, for $2.4 billion (STAT)
  • FDA approves X4 Pharmaceuticals' pill for ultra-rare immunodeficiency disease (Endpoints)
  • AstraZeneca, Daiichi Sankyo’s Enhertu claims another Phase 3 victory in HER2-low breast cancer (Endpoints)
  • Prime Medicine receives FDA clearance to run first prime editing clinical trial (Endpoints)
  • Lead drug from J&J and Addex's 20-year collaboration flunks Phase 2 in epilepsy (Endpoints)
  • Bristol Myers buys into Repertoire's autoimmune vaccines, giving new life to Flagship startup (Endpoints)
  • Bristol Myers eyes major cuts; That $1B AI startup; Pharma reacts to China bill; Q1 earnings highlights; and more (Endpoints)
  • UCB makes major management changes; Bristol Myers’ ADC partner tops list of new CEOs (Endpoints)
  • US FDA approves Pfizer's gene therapy for rare bleeding disorder (Reuters)
  • With sales still stagnant, BioMarin adds divestiture to list of options for gene therapy Roctavian (Fierce Pharma)
Medtech
  • Generative AI is supposed to save doctors from burnout. New data show it needs more training (STAT)
  • Philips will pay $1.1 billion to resolve U.S. lawsuits over breathing machines that expel debris (STAT)
  • Philips shares surge on US recall settlement news (Reuters)
  • US FDA tightens scrutiny of lab-developed tests with new rule (Reuters)
  • Livanova says patient data obtained in 2023 cyberattack (MedTech Dive)
  • Fresenius Medical Care recalls 2M dialysis devices over toxin exposure risk (MedTech Dive)
  • Edwards gets Q1 boost as Pascal valve repair sales ramp up (MedTech Dive)
  • Infutronix infusion pump recall linked to 6 injuries, 1 death (MedTech Dive)
Government, Regulatory & Legal
  • AI is becoming the exclusive province of academic medicine. A new initiative aims to change that (STAT)
  • Philip Morris faces key test with US heated tobacco push (Reuters)
  • Ex-McKinsey partner sues firm, claims he was made opioids 'scapegoat' (Reuters)
  • Mismatch Between Growing Vaccine Pipeline and CDC’s ACIP Capacity (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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