Recon: FDA rejects J&J’s application for injectable lung cancer drug; BD to pay $175M to settle SEC Alaris pump charges
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Truth-teller or reflexive contrarian: Which Marty Makary would run the FDA? (STAT)
- Congress nears deal to rein in PBMs after years of debate (STAT)
- Pharmacy benefits managers should be worried (STAT)
- How a duty to spend wisely on worker benefits could loosen PBMs' grip on drug prices (Endpoints)
- Gene-edited pig kidney transplanted into a third person, moving xenotransplants closer to trials (STAT)
- BD to pay $175M to settle charges of misleading investors on Alaris pump (MedTech Dive)
- Pfizer’s 2025 forecast meets expectations and leaves room for debate (STAT)
- Pfizer CEO says he developed 'good relation' with RFK Jr., highlights Trump's pride in vaccine work (Fierce Pharma)
- Trump's pick for health secretary, RFK Jr, supports polio vaccination, US senator says (Reuters)
- US FDA declines to approve injection form of J&J's lung cancer drug (Reuters)
- Teva, Sanofi say bowel disease drug met primary targets (Reuters) (Endpoints)
- EU Works Towards Phased Implementation Of Electronic Product Information (Pink Sheet)
- New Swiss Paper Outlines Safety Measures For FIH, Early Phase I Studies (Pink Sheet)
- Great Britain Pre-Market Device Regulations Reset For Late 2025 (MedTech Insight)
- Indivior reshuffles board under Oaktree pressure (Reuters)
- Congo's health ministry says unknown disease is severe malaria (Reuters)
- Who stood out as Best Biopharma CEO of 2024? (STAT)
- Chicago’s biotech scene is growing up. What’s fueling it? (Endpoints)
- Affimed’s early lung cancer data disappoint; Indapta's $22M round (Endpoints)
- Obesity giants will begin $80 bln M&A face-off (Reuters)
- Merck winds down TIGIT, LAG-3 programs meant to temper Keytruda erosion (Endpoints)
- Health tech investing during Trump 2.0 (Endpoints)
- UCB, Novartis say a Phase 2a Parkinson's study failed (Endpoints)
- Exclusive: Cell therapy startup Shinobi adds Borges as science chief, Katz as top medical officer (Endpoints)
- Analysts Tell Moderna Investors to Hold After 2024’s Steep Drop (BioSpace)
- Postmarket Studies A Good Fit For Pragmatic And Decentralized Elements (Pink Sheet)
- Boston Scientific recalls Accolade pacemakers tied to 2 deaths (MedTech Dive)
- PFA to surpass radiofrequency ablation in 2025: Citi survey (MedTech Dive)
- Zimmer receives FDA nod for stemless shoulder implant (MedTech Dive)
- FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule (FDA Law Blog)
- Novo Holdings is set to close its $16.5 billion acquisition of Catalent after FTC declines to challenge the deal (STAT)
- Sanofi is the latest drug company to sue HHS over payment terms for 340B hospitals (STAT)
- Trump’s CMS Inherits Medicare Price ‘Facilitator’ System Build Out; Should Pharma Be Worried? (Pink Sheet)
- Sandoz shells out $275M in latest effort to move past 'legacy' price-fixing litigation (Fierce Pharma)
- Doctors weigh in on GLP-1s: The impact of celeb endorsements, the indications they’re hoping for and more (Fierce Pharma)
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