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November 4, 2024
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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
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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