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)
- 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)
- 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)
- 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)
- 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)
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