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April 16, 2024
by Jason Scott

Recon: J&J device sales fall short in Q1; Boehringer Ingelheim plans to launch 25 products by 2030

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

In Focus: US
  • Chuck Schumer’s broken promise on affordable insulin (STAT)
  • Regeneron to defend against DOJ complaint on drug-price manipulation (Reuters)
  • J&J's medical device sales fall short, cancer drugs seen growing (Reuters)
  • Biden administration announces new partnership with 50 countries to stifle future pandemics (STAT)
  • Biohaven’s data delay degrades stock price (STAT)
  • Intra-Cellular reports positive results in depression study aimed at expanding use of antipsychotic medicine (STAT)
  • Thanks to CVS, a biosimilar version of AbbVie’s Humira is grabbing huge market share (STAT)
  • Medicare expects a big spike in spending on Leqembi (STAT)
  • National Drug Stockpiles Create ‘False Sense Of Security’ (Pink Sheet)
  • US FDA warns of harmful reactions to fake Botox injections (Reuters)
In Focus: International
  • Boehringer Ingelheim touts 10-year plan as it eyes overtaking Bayer as Germany’s largest pharma (Endpoints)
  • Boehringer Ingelheim Aims to Bring 25 New Products to Market by 2030 (BioSpace)
  • ‘Unbalanced’ EU HTA Timelines Exacerbated By Rare Disease & Cancer Drugs (Pink Sheet)
  • EMA Releases Guidance On How & When Its RWE Generation Service Can Be Used (Pink Sheet)
  • UK Explains New Rules On Parallel Imports From EU (Pink Sheet)
  • EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency (MedTech Insight)
Pharma & Biotech
  • In latest turn to autoimmune therapies, Cullinan nabs $280M to join lupus space (Endpoints)
  • Takeda’s new deal with Kumquat; IL-2 biotech raises $55M (Endpoints)
  • MarketingRx roundup: Viatris taps former Moderna exec for commercial chief; Merck debuts PAH effort (Endpoints)
  • Maternal mental health startup LunaJoy raises $4.2M (Endpoints)
  • J&J says Darzalex, Carvykti drive Q1 pharma sales growth while medtech looms large (Endpoints)
  • Regeneron enters venture investing with $500M, poaches senior partner from ARCH (Endpoints)
  • On the heels of pulmonary arterial hypertension drug nod, Merck launches 'Outnumber PAH' campaign (Fierce Pharma)
  • The key to #FierceMadness victory for AZ and Ionis' Wainua? Unique sounds and 'phonetic appeal,' per the Brand Institute (Fierce Pharma)
  • Viatris, eyeing a return to growth, taps Moderna, Amgen alum as CCO (Fierce Pharma)
  • Novartis Secures Phase III Fabhalta Win in IgAN as FDA Starts Priority Review (BioSpace)
Medtech
  • Solventum appoints Shirley Edwards to board of directors (MedTech Dive)
  • ‘We think in decades’: J&J’s $30B spending spree may not be over (Endpoints)
  • GE Healthcare imaging CEO to resign (MedTech Dive)
  • Edwards pushes back on Medtronic’s head-to-head TAVR trial (MedTech Dive)
  • Abbott’s latest Heartmate recall tied to 273 injuries, 14 deaths (MedTech Dive)
  • Exact Sciences names Aaron Bloomer CFO (MedTech Dive)
  • Ekso's Exoskeleton Receives Medicare Coverage, Paves Way To Faster Rehabilitation (MedTech Insight)
Government, Regulatory & Legal
  • Grocers are pushing legislation they claim would enhance food safety. Advocates say it would gut FDA rules (STAT)
  • Cerebral to pay $7 million fine and limit health data use for ads under federal order (STAT)
  • Medicare Spending Forecast For Leqembi Reflects CMS Angst About Alzheimer’s Drug Costs (Pink Sheet)
  • Patent Office Issues Proposed Rule For Rarely Successful Director Review Requests (Pink Sheet)
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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