Recon: FDA’s increased use of clinical holds; BioNTech buys AI startup InstaDeep for up to $682M

ReconRecon | 10 January 2023 |  By 

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

In Focus: US
  • U.S. experts recommend weight-loss drugs for obese children (Reuters)
  • Abbvie raises sales outlook of two immunology drugs to more than $17.5 bln in 2025 (Reuters)
  • Sen. Sanders asks Moderna not to hike COVID vaccine price (Reuters) (STAT)
  • FDA’s Califf says congressional report on Aduhelm controversy contained “no surprises” (STAT)
  • FDA Increasingly Halting Human Trials as Companies Pursue Risky, Cutting-Edge Drugs (WSJ)
  • An FDA pathway to clear medical devices is putting patients at risk, research suggests (STAT)
  • Illumina, the DNA sequencing giant, gives Wall Street bad news (STAT)
  • Most Alzheimer’s patients would pay up to $26,500 per year for new treatment Leqembi (CNBC)
In Focus: International
  • Germany's BioNTech buys British AI startup InstaDeep (Reuters) (FT)
  • Illumina challenges EU order to keep Grail separate (Reuters)
  • Bayer flags new blood thinner as $5 bln-plus opportunity (Reuters)
  • Pfizer CEO rules out generic COVID drug Paxlovid for China (Reuters)
  • Free access to Zolgensma curbed, says Novartis (PharmaPhorum)
Pharma & Biotech
  • Private equity acquires a taste for drug development (Reuters)
  • People hate drug ads on TV. Here’s what they complain about most (STAT)
  • FDA commissioner calls for more onshoring of clinical trials (Endpoints)
  • US Funding Law Could Speed Approval Of Drugs And Biologics Manufactured In Advanced Ways (Pink Sheet)
  • US FDA’s Use Of CRLs Hit A High Note In 2022: One-Third Of Novel Agent Decisions Were Not Approvals (Pink Sheet)
  • CVS Is Exploring a $10 Billion-Plus Acquisition of Oak Street Health (Bloomberg)
  • Shenzhen Kangtai Biological sees 2022 net loss on weaker COVID shot demand (Reuters)
  • Novotech's latest acquisitions grow its US presence and plant a European foothold (Endpoints)
  • Alto’s hopes for brain biomarker strategy rise on phase 2 antidepressant data (Fierce)
  • Fierce Biotech Layoff Tracker 2023: Editas edits workforce, plus more (Fierce)
  • JPM23: Mirati's post-Krazati pipeline restock to focus on 'highest opportunity for capital' (Fierce)
  • Voyager goes big, securing multi-billion dollar gene therapy development deal with Neurocrine (Endpoints)
  • Ionis sells partial stake in royalties from Spinraza and Novartis cardio drug to Royalty Pharma for $500M upfront (Endpoints)
  • AbbVie, following in footsteps of Lilly and Takeda, pays Anima $42M to go after undruggable targets (Fierce)
  • Jasper scraps pivotal plans but adds a new indication as more biotechs revise pipelines (Endpoints)
  • 4D Molecular pauses enrollment in Fabry trials after kidney problems in three patients (Endpoints)
  • Sutro shells out latest update on ovarian cancer treatment, plans for pivotal trial (Endpoints)
Medtech
  • GE HealthCare expects 5%-7% organic revenue growth in 2023 on strong demand (Reuters)
  • Medtronic CEO Martha: No more divestitures planned for 2023, but review continues (MedtechDive)
  • UK To Fund ‘Artificial Pancreas’ Technology, But Only For Companies That Cut Prices (MedtechInsight)
  • ResMed responds to ‘humanitarian emergency’ over demand for CPAP devices with new factory (MedtechDive)
  • Beta Bionics hires Harvard diabetes expert as CMO ahead of artificial pancreas launch (MedtechDive)
  • JPM23: 'What has the pandemic done for us?' Freenome and other diagnostics developers on making tests more accessible (Fierce)
Government, Regulatory & Legal
  • Still fuming over the federal Covid response, Republicans redirect the House coronavirus committee (STAT)
  • Teva's opioid settlement moves forward with participation from 48 states (Endpoints)
  • U.S. appeals court won't revive Zofran birth defect cases against GSK (Reuters)
  • Jet Medical and Related Companies Agree to Pay More Than $700,000 to Resolve Medical Device Allegations (FDA)
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.

 

© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

5;6;11;14;16;18;20;25;31;