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)
- 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)
- 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)
- 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)
- 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)
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