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20th February 2025
by Jason Scott

Recon: US CDC postpones February vaccine advisory meeting; AstraZeneca acquires FibroGen’s China unit

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

In Focus: US
  • How much weight loss is too much? Pharma is pushing the limit with new obesity drugs (STAT)
  • Pharma lobbies Trump as 25% tariff on imports looms (Pharmaphorum)
  • Dr. Oz plans to sell insurance, hospital, and pharma stocks, step down from supplement company if confirmed (STAT)
  • FDA sets June date for Gilead's twice-yearly HIV PrEP (Pharmaphorum)
  • Exclusive: FDA staffers told that 'woman,' 'disabled' among banned words; White House says it’s an error (Reuters)
  • Meeting of key CDC vaccine advisory panel, under scrutiny by RFK Jr., is postponed (STAT) (Reuters)
  • FTC retains stricter merger guidelines under Trump (MedTech Dive)
In Focus: International                                                                                                       
  • South African scientists were testing a promising HIV vaccine. Then came Trump’s aid cuts (Reuters)
  • NICE changes its mind on BMS' lymphoma cell therapy (Pharmaphorum)
  • How Keymed steered the China-to-US NewCo model in biotech (Endpoints)
  • Drug packaging manufacturers brace for impact as EU chemical ban looms (Endpoints)
  • AstraZeneca buys FibroGen’s China unit for local control of anemia drug (Endpoints)
  • Paris startup collects €27M in Series B to advance overactive bladder treatment (Endpoints)
  • Canada purchases 500,000 doses of GSK's vaccine for bird flu (Reuters)
  • Philips expects sales struggles in China to continue in 2025 (MedTech Dive)
  • First Spanish Organization Designated Under The IVD Regulation Has Wide Remit (MedTech Insight)
  • Time For EU To Become Full Member Of Global Single Audit Program (MedTech Insight)
Pharma & Biotech
  • Why biotech’s future is threatened by zombies (STAT)
  • Boehringer eyes third quarter FDA verdict for oral HER2 drug (Pharmaphorum)
  • SMA treatment with Evrysdi 'could start prenatally' (Pharmaphorum)
  • UCB's non-cannabis drug for severe epilepsy gets NHS okay (Pharmaphorum)
  • In single case, spinal muscular atrophy drug given before birth spared baby of genetic disease symptoms (Endpoints)
  • BridgeBio’s heart disease drug Attruby sails past prescription estimates (Endpoints)
  • Charles River’s $1B revenue; Theratechnologies restarts HIV drug supply (Endpoints)
Medtech
  • Years after an Apple study, its tech has birthed an asthma management tool (STAT)
  • Illumina to lay off about 100 people; Incyte’s new AI partnership (Endpoints)
  • Baxter forecasts 2025 profit above estimates on medical device demand; shares rise (Reuters)
  • Advamed CEO warns FDA job cuts put patients, industry at risk (MedTech Dive)
  • Vicarious Surgical COO John Mazzola to retire (MedTech Dive)
  • Device industry scrambles as FDA job cuts cause delays (MedTech Dive)
  • Hologic Upgrades Aptima SARS-Cov-2 Assay Authorization To Full FDA Approval (MedTech Insight)
Government, Regulatory & Legal
  • The lasting human impact of Trump funding freeze: An 86-year-old’s ride to dialysis now feels tenuous (STAT)
  • Graduate student admissions paused and cut back as universities react to Trump orders on research (STAT)
  • The health policy cult’s misplaced faith in government (STAT)
  • Why UnitedHealth Group is offering 30,000 voluntary buyouts to its employees (Endpoints)
  • New York sues vape distributors for fueling teen epidemic (Reuters)
  • Law firm Venable hit with $10 mln lawsuit by ex-client in FDA fight (Reuters)
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.