Recon: Philips no longer selling sleep apnea devices in US after FDA consent decree; BMS’ Opdivo posts disappointing post-kidney cancer trial results
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Vaccines save lives and generate profits. Why is investment lagging? (STAT)
- Merck, Johnson & Johnson CEOs agree to testify in Congress on high drug prices, avoiding Bernie Sanders’ subpoena (STAT)
- First-ever RNA editing trial in US gets clearance, pitting ‘exon editing’ technology against vision loss (Endpoints)
- Philips' US sales of sleep apnea devices face years-long halt after FDA deal (Reuters)
- Top 10 most anticipated drug launches of 2024 (Fierce Pharma)
- Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month (Fierce Pharma)
- Which country has the best health care? That’s the wrong question (STAT)
- Exclusive: UK biotech raises $33.1M to test CF drug that could work on top of standard of care (Endpoints)
- UK government to ban disposable vapes to prevent use by children (Reuters)
- Britain's disposable vape ban hits stocks, divides experts (Reuters)
- Zimbabwe launches door-to-door cholera vaccination campaign (Reuters)
- Lilly in talks with Germany over weight-loss drug coverage -Spiegel (Reuters)
- WuXi Biologics plays defense after US bill brands certain Chinese biopharmas as security threats (Fierce Pharma)
- Another step toward new drugs for Parkinson’s (STAT)
- Cognito raises $35 million for Alzheimer’s treatment device, touts benefits compared to drugs (STAT)
- Mid-stage CNS biotech Alto Neuroscience plots $89M IPO (Endpoints)
- Roche ends KRAS deal with Hookipa Pharma, as biotech lays off 30% of staff (Endpoints)
- Ascendis spins out ophthalmology company; Gamida Cell eyes strategic options (Endpoints)
- Sanofi partners with Synthekine in immunology race (Endpoints)
- Bristol Myers' Opdivo fails part two of post-kidney cancer surgery test as competitor Merck touts new survival data (Endpoints)
- Fractyl has the GUTS: Obesity and diabetes biotech charts $99M IPO (Endpoints)
- Sanofi's $1.7B rare disease gambit; CAR-T boxed warning saga; New biotechs on Nasdaq; A seller's market for M&A?; and more (Endpoints)
- Less corporate, more human: How Sanofi is using the Olympics to change public perceptions (Fierce Pharma)
- Eli Lilly overtakes Tesla in market value (STAT)
- Decentralized trials company Science 37 to go private in deal with diagnostics startup eMed (Endpoints)
- What to watch for as Stryker, Boston Scientific and BD post earnings this week (MedTech Dive)
- Absolutions receives FDA breakthrough designation for abdominal wall closure device (MedTech Dive)
- Globus lays off Nuvasive employees after merger (MedTech Dive)
- How Masimo forced Apple to redesign its smartwatches (MedTech Dive)
- Cook Medical sells ear, nose and throat devices to C2Dx (MedTech Dive)
- 23andMe breach targeted Chinese, Jewish populations (STAT)
- Pricey sickle cell treatments raise daunting new challenges for Medicaid programs (STAT)
- From a small town in Wales, a scientific sleuth has shaken Dana-Farber — and elevated the issue of research integrity (STAT)
- Bayer shares fall nearly 6% on court order to pay $2.25 bln in damages (Reuters)
- Outlining the Legal Arguments Against FDA’s Proposed Rule Regulating LDTs (FDA Law Blog)
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