Recon: FDA approves Journey’s rosacea drug; EU to decide on Novo’s Catalent acquisition by 6 December
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- What really happens to drug prices when patents expire (STAT)
- Health care execs mostly donate to Democrats, but avoid Trump and Harris (STAT)
- How RFK Jr. might influence the FDA; Pharma's Q3 highlights; AbbVie's latest neuro buyout; and more (Endpoints)
- Americans hungry for weight-loss drugs grapple with supply and insurance hurdles (Reuters)
- US FDA approves Journey Medical's drug for long-term skin condition (Reuters)
- US FDA warns against California facility making compounded weight-loss drugs (Reuters)
- EU antitrust regulators to rule on Novo's Catalent buy by Dec. 6 (Reuters)
- Probe of AstraZeneca executive in China raises questions about company’s tactics (STAT)
- Unforeseen’ Variations & ‘Super-Grouping’ Addressed In New EU Guidance (Pink Sheet)
- Lytenava: England Becomes First to Fund Ophthalmic Bevacizumab For Wet AMD (Pink Sheet)
- Medtechs Applaud UK Life Sciences Fund But Seek Lowering Of £8M Project Threshold (MedTech Insight)
- EU posts guidance on ethylene oxide in device sterilization (MedTech Dive)
- India's Gland Pharma posts Q2 profit drop hurt by Europe business (Reuters)
- Novartis CEO 'very confident' on sales target, doesn't fear patent cliff – newspaper (Reuters)
- GSK acquires autoimmune drug candidate (STAT)
- Is there room for MASH drugs in a GLP-1 world? (Endpoints)
- AstraZeneca says experimental obesity pill safe in early-stage trial (Reuters) (Endpoints)
- Viking slips as manufacturing concerns cloud promising oral obesity drug data (Reuters)
- BioNTech says VEGF bispecific’s PD-L1 target, combo plans will be its edge (Endpoints)
- BioNTech lowers full-year revenue outlook on COVID-19 seasonality, inventory write-downs (Reuters)
- Novo, Ascendis to work on monthly GLP-1; KalVista makes a royalty deal (Endpoints)
- Novo adds to Wegovy’s cardio strength with hospital admissions analysis (Endpoints)
- CinRx touts positive early-stage data from two obesity candidates (Endpoints)
- AstraZeneca backs American Lung Association campaign to improve lives of COPD patients (Fierce Pharma)
- Nektar pads wallet with $90M manufacturing plant sale to Ampersand (Fierce Pharma)
- Medicare finalized coverage for some mental health apps. Now what? (STAT)
- Boston Scientific continues M&A run with Cortex buy (MedTech Dive)
- Medtronic settles pulse oximetry lawsuit alleging inaccuracies (MedTech Dive)
- Zimmer licenses NeuroOne brain ablation system (MedTech Dive)
- These 7 watchdogs scour scientific papers for problems — and often find them (STAT)
- Key senators propose using ‘site-neutral’ pay to boost rural hospitals (STAT)
- BMS, J&J and AstraZeneca plea with appeals court to overturn drug price negotiations (Endpoints)
- US FDA’s New Rare Disease Hub Director Rick Brings Advocacy Experience (Pink Sheet)
- Practical Matters: Rare Disease Advocates Want Help From US FDA Hub To Make Data Useful (Pink Sheet)
- As Jurisprudence Under Loper Bright Develops, Early Scorecard is Mixed (FDA Law Blog)
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