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July 18, 2024
by Jason Scott

Recon: Merck pushes DC federal court for swift IRA decision; GoodRx unveils discount for Boehringer’s Humira biosimilar

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

In Focus: US
  • Q&A: The new CEO of biotech’s top trade group on China, vaccines, and Trump (STAT)
  • Ardelyx sues US health department over kidney disease drug (Reuters)
  • IRBs fail to assess trials’ scientific merit, putting participants at risk (STAT)
  • FDA thwarts Agenus' accelerated approval plans for CTLA-4/PD-1 combo in 'disappointing' move (Endpoints)
  • US FDA declines to approve Orexo's opioid overdose drug (Reuters)
  • Merck asks DC federal court for IRA decision 'as soon as practicable' (Endpoints)
  • Boehringer-GoodRx partner to offer Humira rival at 92% discount (Reuters) (Endpoints)
  • Argenx posts J&J-rivaling Sjögren's data, massively upscales Vyvgart patient population at R&D day (Fierce Pharma)
  • Umpteenth time’s a charm? Lawmakers try to block DTC drug ad tax deductions yet again (Fierce Pharma)
In Focus: International
  • Sanofi seeks deeper roots in India with €400M hub expansion (Endpoints)
  • Novartis lifts profit forecast for second time on Cosentyx, Entresto (Reuters)
  • AstraZeneca skewered by marketing watchdog over repeat offense (Fierce Pharma)
  • Danaher setting up labs to support companion diagnostic development (MedTech Dive)
  • EU Confidence In China Market Still On Downward Trend (MedTech Insight)
  • China suspends imports of Daewoong Bio's antibiotic over law violation (Reuters)
Pharma & Biotech
  • Roche looks to have a competitive GLP-1 drug (STAT)
  • J&J beats Wall St estimates on strong drug sales ahead of Stelara competition (Reuters)
  • Gilead’s chief medical officer to leave as R&D efforts stall (STAT)
  • Startup Q Bio raises $27 million to build its own full-body scanner (STAT)
  • KRAS cancer drug eased symptoms of rare and serious blood vessel condition in two patients, new study shows (Endpoints)
  • Novartis settles in to new normal two years after big reorg, even as fine-tuning continues (Endpoints)
  • J&J ditches epilepsy collaboration with Addex, blindsiding 20-year partner (Endpoints)
  • Phathom wins label expansion on heartburn drug to include non-erosive patients (Endpoints)
  • Roche touts Phase 3 Susvimo data in diabetes-related ophthalmic diseases (Endpoints)
  • Exclusive: TMRW Life Sciences raises $28M Series D to upgrade storage for egg freezing (Endpoints)
  • Caribou to slash preclinical allogeneic CAR-NK work, lay off 12% of staff (Endpoints)
  • Thyme Care scores $480M valuation in new funding round (Endpoints)
  • Grünenthal designates $87M to update plants in Ecuador and Chile (Fierce Pharma)
  • Novo Nordisk explores a family tree to explain genetic roots of obesity in new social media clip (Fierce Pharma)
  • American Clinical Research Services rebrands as Elixia following acquisition (Fierce Pharma)
Medtech
  • Abbott raises profit forecast on strong medical device sales (Reuters)
  • Broad Institute, facing end of Microsoft cloud contract, shuffles data science leadership (STAT)
  • Real-time vital signs data: a hidden source of value in medical AI (STAT)
  • American Lung Association plans to ‘BEAT’ lung cancer with biomarker test-boosting campaign (Fierce Pharma)
  • J&J medtech fails to meet growth expectations (MedTech Dive)
  • Quest closing Pennsylvania lab, laying off 121 people (MedTech Dive)
  • DeepWell DTx Brings Mental Health To Meta Store (MedTech Insight)
Government, Regulatory & Legal
  • Vaccination slashes risk of long Covid, says large study tracing cases through Delta and Omicron variants (STAT)
  • PhRMA doubles down on pricing attack, targeting shared ownership of insurers and PBMs in new ad (Fierce Pharma
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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