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May 7, 2024
by Jason Scott

Recon: FDA schedules June adcomm to review Lilly Alzheimer’s drug; Medtronic cleared to sell renal denervation device in China

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

In Focus: US
  • UnitedHealth CEO downplays his company’s control over physicians (STAT)
  • The world is relying on the United States to get value-based drug pricing right (STAT)
  • Lilly gets June adcomm for Alzheimer's drug donanemab, following earlier delay (Endpoints)
  • Vertex starts gene therapy Casgevy in five patients (STAT)
  • ‘Remarkable interest’: Madrigal touts early launch progress for first MASH drug Rezdiffra despite VA hurdle (Fierce Pharma)
  • Sharp looks to cut into sterile injectable market growth with expansion of Pennsylvania packaging plant (Fierce Pharma)
  • US FDA panel to discuss first psychedelic-assisted PTSD treatment next month (Reuters)
In Focus: International
  • WHO’s top scientist learned a hard lesson about H5N1 two decades ago: Stopping it takes more than biology (STAT)
  • Exclusive: Feng Zhang CRISPR startup gathers patents, locking up rights to family of editing tech (Endpoints)
  • Medtronic wins approval to sell renal denervation device in China (MedTech Dive)
  • KKR to buy India's Healthium Medtech at $839 mln valuation, sources say (Reuters)
  • Pandemic Treaty Talks Go Up To The Wire (Pink Sheet)
Pharma & Biotech
  • LabCentral helped create 6,300 jobs and 19 IPOs. Amid a slump, demand for lab space has slowed (Endpoints)
  • Tylenol maker Kenvue to cut 4% jobs, beats quarterly profit estimates (Reuters)
  • Lykos’ MDMA therapy to go before FDA committee; GSK expands work with BioVersys (Endpoints)
  • Lonnie Moulder's Zenas closes a $200M Series C to broaden lead drug's autoimmune potential (Endpoints)
  • Flagship commits $50M to new startup that scours viral proteins for new drugs (Endpoints)
  • Memo Therapeutics refuels with $22M to expand trial for infection-fighting antibody in kidney transplant recipients (Endpoints)
  • Kenvue maps out hundreds of layoffs as service pact with J&J winds down (Fierce Pharma)
  • Shah Capital urges Novavax shareholders to vote against three directors (Reuters)
Medtech
  • Virtual first is flaming out. A virtual-second model can refresh telehealth (STAT)
  • As digital health unicorns are pressured to do more with less, Transcarent gets a fresh $126M (Endpoints)
  • Fresenius Medical beats earnings expectations, keeps outlook; shares sink (Reuters)
  • CMR Surgical names new CFO (MedTech Dive)
  • Masimo’s at-home baby monitor cleared for use without prescription (MedTech Dive)
  • Robotic-Assisted Treatment For Enlarged Prostate Shows Promising Results (MedTech Insight)
  • GE HealthCare’s New Investigational MRI Promises Advancements On Neurological Disease Research (MedTech Insight)
  • Can a Device Be Found Not Substantially Equivalent Because of Cybersecurity Risks? A Review of FDA’s Draft Guidance on Cybersecurity in Medical Devices (FDA Law Blog)
Government, Regulatory & Legal
  • As livestock move around the country, so does H5N1. The U.S. needs real-time tracking of livestock movements (STAT)
  • At Milken Institute conference, CDC director Mandy Cohen talks public health preparedness (STAT)
  • ‘Dark Money’ Casts Shadow As Industry, Legislators Push For Litigation-Funding Transparency (MedTech Insight)
  • Expert Proposes AI Device Reimbursement Model ‘Like Netflix’ (MedTech Insight)
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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