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August 26, 2024
by Jason Scott

Recon: Siemens Healthineers seeks takeover of Novartis’ molecular imaging business; FDA expands probe into Lykos MDMA drug studies

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

In Focus: US
  • Biden administration’s $3.2 billion antiviral pandemic plan is fizzling out (STAT)
  • U.S. agency slaps down a J&J plan to switch payments for 340B hospitals (STAT)
  • FDA Widens Probe of Ecstasy-Based Drug Studies (WSJ) (Reuters)
  • Mpox vaccine collab; $11M oncology seed; Gates backs RSV vaccine; Kyowa Kirin slims portfolio (Endpoints)
  • US Presidential Elections: Are Prescription Drug Pricing Reforms Losing Political Luster? (Pink Sheet)
  • McKesson to buy controlling stake in Florida Cancer Specialists' unit for about $2.5 billion (Reuters)
  • Cigna to remove AbbVie's Humira from some drug reimbursement lists next year (Reuters)
In Focus: International                                                                                                       
  • Regeneron wins EU approval for lymphoma bispecific following FDA rejection (Endpoints)
  • Belgium's UCB to sell China neurology, allergy business for $680 mln (Reuters) (Endpoints)
  • Progress Or Hype? Looking At A Decade Of Cell Therapy In Japan (Pink Sheet)
  • WHO To Finalize Preferred & Critical Characteristics Of New Mpox Human Vaccines (Pink Sheet)
  • Regulatory tracker: Merck's blockbuster-to-be PAH drug Winrevair wins EC nod (Fierce Pharma)
  • Bayer to Lay Off 150 in Basel, Switzerland (BioSpace)
  • Missed Warnings, $100 Vaccines and Red Tape — Why Mpox Was an Avoidable Emergency (Bloomberg)
  • LinkedIn post lands Vertex in hot water with MHRA over breach of UK ad regulations (Fierce Pharma)
  • Novartis receives binding offer from Siemens Healthineers for molecular imaging business (Reuters)
Pharma & Biotech
  • A Galapagos investor signals impatience with its turnaround efforts (STAT)
  • Tome Biosciences files notice to lay off virtually entire staff (STAT)
  • Once one of immuno-oncology's next great hopes, CD47 faces final shots on goal (Endpoints)
  • GSK’s Bexsero Dangles No More: Meningococcal B Vaccine Converts To Regular Approval (Pink Sheet)
  • With new focus, Kyowa Kirin pulls decades-old breast cancer drug Fareston from US market (Fierce Pharma)
Medtech
  • Dexcom launches over-the-counter continuous glucose sensors in the US (Reuters          )
  • Continuous glucose monitoring for the masses is here. Are we ready for it? (STAT)
  • Defibtech recalls chest compression device linked to patient death (MedTech Dive)
  • Getinge to buy Paragonix organ-preserving tech for up to $477M (MedTech Dive)
  • Stryker to add back pain treatment with Vertos Medical buy (MedTech Dive)
  • Quest inks deal for University Hospitals’ outreach lab services (MedTech Dive)
  • Getinge To Acquire Paragonix Technologies For About $477M (MedTech Insight)
  • Diagnostics firm Labcorp weighs ramping up mpox testing capacity (Reuters)
Government, Regulatory & Legal
  • Better Coverage For Cancer Screening Tests On Horizon (MedTech Insight)
  • Would Trump Repeal the Inflation Reduction Act if Elected? (BioSpace)
  • HHS kicks off vaccine awareness campaign to reduce risk of COVID, flu and RSV (Fierce Pharma)
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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