Recon: AstraZeneca’s flu vaccine to get FDA review; EU medtech industry “speechless” over plan to delay Eudamed database
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA accepts AstraZeneca's self-administered flu vaccine for review (Reuters)
- Verve Gets FDA Go-Ahead for First In-Human Base Editing Study in US (BioSpace)
- FDA Approves BioMarin’s Voxzogo for Young Children with Dwarfism (BioSpace)
- CDC recommends rationing of RSV shot due to shortages (STAT)
- Roche settles US patent lawsuit against Biogen over blockbuster arthritis drug (Reuters)
- EU Asks for Details on Anesthesia Risks for Weight-Loss Drugs (Bloomberg)
- EU sets up new mechanisms to stave off medicine shortages (Reuters)
- Pharmaceutical industry close to deal with UK on drug pricing, says Novartis (Financial Times)
- ‘Missed opportunities’: Why a U.K. government plan to disclose financial ties between pharma and docs may fall short (STAT)
- Commission fines pharma companies €13,4 million in antitrust cartel settlement (European Commission)
- Insulin is increasingly affordable in the U.S. What about the rest of the world? (STAT)
- Suspected fake Ozempic puts several in hospital in Austria (Reuters)
- Belgium plans temporary ban on use of Ozempic for weight loss (Reuters)
- Why AstraZeneca’s CEO is accusing British tabloids of ‘fake news’ (STAT)
- Roivant’s CEO is a star, but even a blockbuster deal can’t escape biotech’s black hole (STAT)
- With an old approach but new energy, ADCs take center stage as promising cancer treatments (STAT)
- Startup launches with $245 million for twice yearly asthma treatment (STAT)
- OrbiMed raises $4.3B across three funds to invest in biotech companies, as well as royalty deals and China startups (Endpoints)
- Heard at #ESMO23: Novartis and BeiGene fallout; Now I know my ADCs; and a standing ovation (Endpoints)
- Bristol Myers pays $350M upfront for rights to heart drug Camzyos in Asia (Endpoints)
- BrainStorm to lay off workers; Lilly inks a subcutaneous deal (Endpoints)
- Immutep touts mid-stage data for LAG-3 drug in first-line NSCLC, finalizing plans for PhIII test: #ESMO23 (Endpoints)
- Updated: Novartis 'on track' to complete restructuring post Sandoz spin, pushes back Pluvicto filing (Endpoints)
- Idorsia lays off up to 300 people, plans for pipeline prioritization in effort to extend cash runway (Endpoints)
- Rampart Bioscience raises $125M for non-viral gene therapies (Endpoints)
- Aiolos Bio launches with $245M Series A, chasing one of asthma’s hottest targets (Endpoints)
- Danaher Q3 revenue declines as demand challenges continue (MedTech Dive)
- EU Medtech Sector "Stunned" And "Speechless" At Further Proposals For Delays To Eudamed Database (MedTech Insight)
- UK Regulator Assesses International Recognition Options As It Pursues ‘Joined-Up’ System
- (MedTech Insight)
- For Parkinson’s disease, advances spurred by Apple Watch offer a glimmer of hope (STAT)
- A hacker leaked millions of 23andMe users' data, potentially putting sensitive health information in jeopardy (Endpoints)
- J&J MedTech Chairman Ashley McEvoy to step down (MedTech Dive)
- Icahn sues to remove Illumina board members, asks for at least $476M in damages (MedTech Dive)
- Intuitive Surgical Stock Remains Suppressed, Despite Procedure Growth (MedTech Insight)
- Planned Parenthood must face trial over Texas Medicaid fraud claims (Reuters)
- From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information (FDA Law Blog)
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.
