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September 29, 2025
by Jason Scott

Recon: PhRMA launches direct-to-consumer drug site; Shutdown would prompt HHS to furlough 41% of staff

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

In Focus: US
  • US lobby group PhRMA plans website to boost access to cheaper drugs (Reuters) (Bloomberg)
  • White House's 'most favored nation' deadline spurs flurry of pharma concessions (Endpoints)
  • US government shutdown to furlough 41% of health agency workers (Reuters)
  • Trump to Face Off With Democrats Ahead of Shutdown Deadline (Bloomberg)
  • Kala Bio plunges after scrapping development of lead drug (Reuters)
In Focus: International
  • AstraZeneca to list shares in New York while keeping London listing (STAT)
  • AbbVie to launch ovarian cancer drug in UK at US price (Reuters)
  • Germany assumes 15% U.S. tariff rate will apply to pharma, heavy trucks (Reuters)
  • Bavarian Nordic Bidders Extend Offer Deadline, Maintain Price (Bloomberg)
  • Egypt Flexes Export Muscle With Surging Dietary Supplement Trade (Bloomberg)
  • MedTech Europe pressures EU to make regulatory changes by early 2026 (MedTech Dive)
Pharma & Biotech
  • Perimenopause is the new buzzword in the business of women’s health (STAT)
  • As investor for AHA, ‘Venture Valkyrie’ argues ‘good medicine is good business’ (STAT)
  • Genmab to buy Merus in $8B deal (STAT)
  • Lilly executives: How the FDA’s new PreCheck program can unleash the future of U.S. medicine manufacturing (STAT)
  • MoonLake can’t spin away this disastrous autoimmune drug failure (STAT)
  • GSK CEO Walmsley to step down, be succeeded by company’s commercial lead (STAT)
  • Enanta's RSV treatment misses main goal in mid-stage study (Reuters)
  • Larimar's update on Friedreich's ataxia drug derailed by allergic reactions (Endpoints)
  • Tourmaline attracted small bidding war before $1.4B sale to Novartis (Endpoints)
  • IO Biotech to run another study for cancer vaccine; Boehringer ends mid-stage IPF trial (Endpoints)
Medtech
  • Exclusive: Once a mental health chatbot, Wysa acquires physical therapy startup Kins (Endpoints)
  • Prosthetics Firm Ottobock, Owner Seek €702 Million in IPO (Bloomberg)
  • SS Innovations hires new CFO (MedTech Dive)
  • Biolinq gets FDA de novo nod for intradermal glucose sensor (MedTech Dive)
  • J&J’s Abiomed Issues Third Recall Of Automated Impella Controllers Since June (MedTech Insight)
Food & Nutrition
  • A matcha shortage is coming for social media’s latest obsession (Food Dive)
  • Recall impacts corn dogs, sausage-on-a-stick products (The Hill)
Government, Regulatory & Legal  
  • Cannabis stocks surge after Trump endorses cannabidiol for senior healthcare (Reuters)
  • Bedside Upgrade: Glooko Pushes Into Hospitals With Monarch EndoTool Deal, Targeting $1Bn Market (MedTech Insight)
  • Section 232 probe reignites tariff uncertainty for medtech firms (MedTech Dive)
  • OIG Urges Reforms To Medicare Skin Substitute Payments (MedTech Insight)
  • Supply of Birth Control Pills in the US at Risk as Tariffs Kick In (Bloomberg
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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