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)
- 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)
- 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)
- 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)
- 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)
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