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March 13, 2025
by Jason Scott

Recon: White House pulls CDC director nomination; Endo, Mallinckrodt to merge in $6.7B M deal

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

In Focus: US
  • White House pulls nomination of Dave Weldon as CDC director hours before hearing (STAT)
  • Updated: Endo and Mallinckrodt to merge in $6.7B deal (Endpoints) (Reuters)
  • Trump’s picks to run FDA and NIH win approval from Senate’s health committee (STAT)
  • In the Boston area, biotech’s hub, a slump is being acutely felt (STAT)
  • US FDA's top lawyer Hilary Perkins resigns two days into role (Reuters)
  • More FDA Transitions: CDRH Deputy Director Out, New Chief of Staff And General Counsel In (MedTech Insight)
In Focus: International                                                                                                       
  • Roche secures Zealand obesity drug candidate for up to $5.3 billion (Reuters)
  • Kenya HIV patients live in fear as US aid freeze strands drugs in warehouse (Reuters)
  • Canada pitches in to Entos' facility build; Vetter expands in Germany (Endpoints)
  • Altered EU-US Medtech Trade Dynamics Could Endanger Patient Health (MedTech Insight)
  • European measles cases doubled in 2024 after vaccinaton levels fell post-COVID (Reuters)
  • WHO welcomes end of Marburg virus outbreak in Tanzania (Reuters)
Pharma & Biotech
  • Soleno Therapeutics’ ‘life-changing’ drug nears approval decision (STAT)
  • Biotech raising $35 million to take a second stab at cancer drug from Bert Vogelstein’s lab (STAT)
  • Lilly, J&J boosted spending on executive security after UnitedHealth shooting (Reuters)
  • The new CEO of GoodRx wants to lean into brand names and speed up the drug discount company's growth (Endpoints)
  • Montara Therapeutics adds $20M to seed fundraise for neurology pipeline (Endpoints)
  • Amgen reports more Uplizna data in myasthenia gravis ahead of FDA filing (Endpoints)
  • NFL signs Novartis as first pharmaceutical partner-source (Reuters)
  • How a Novo Nordisk Foundation-funded project sparked ultra-processed food fight (Reuters)
Medtech
  • New Flagship startup aims to trailblaze ‘AI science factories’ (Endpoints)
  • Telehealth platforms in senators’ crosshairs over relationship with Eli Lilly, Pfizer (STAT)
  • Should health care providers tell patients they are using AI? (STAT)
  • Inside NYC’s waitlist-only health tech club, where young professionals find both friends and jobs (Endpoints)
  • Libre 3 Sensors: With Second Plant Online, Abbott Aims For Under-Penetrated ‘Intensive Insulin’ Segment (MedTech Insight)
  • Labcorp to buy Opko unit’s cancer test assets for up to $225M (MedTech Dive)
  • Amplitude Acquisition Marks Global Medtech Entry With High Potential In India For Zydus (MedTech Insight)
  • Dexcom Eyes US FDA Clearance For 15-Day CGM, But Insurance Coverage Remains Uncertain (MedTech Insight)
Government, Regulatory & Legal
  • ‘Deliberate trauma’: SAMHSA employees detail a federal agency in shambles (STAT)
  • UnitedHealth continues making stealthy deals, pushing deeper into medical care as scrutiny mounts (STAT)
  • HIV self-testing is easy, effective — and underutilized (STAT)
  • CDC’s reported study on vaccines and autism could test RFK Jr.’s pledges to a key senator (STAT)
  • Top addiction researcher Nora Volkow on NIH cuts, optimism and the limits of RFK Jr.’s 12-step experience (STAT)
  • Federal research instability risks postdoc careers, American leadership (STAT)
  • Why health experts fear the West Texas measles outbreak may be much larger than reported (STAT)
  • Warren asks HHS watchdog to investigate GSK over its asthma inhaler maneuvers (STAT)
  • Researchers make case against Gilead in HIV product hopping fight (Endpoints)
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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