Recon: Califf nomination timeline slips after Biden admin misses paperwork deadline; Canada fully approves J&J COVID vaccine
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA nomination slips after Biden admin fails to send papers to Congress (Politico)
- Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies (STAT)
- FDA Approves Takeda's drug for post-transplant CMV infection (Reuters) (FDA)
- CVS, Walgreens and Walmart Fueled Opioid Crisis, Jury Finds (NYTimes)
- Elizabeth Holmes Points Fingers at Others and Says She Was a Believer (NYTimes)
- Elizabeth Holmes admits she added drugmakers’ logos to Theranos reports (CNBC)
- Pfizer says former employee stole trade secrets on megablockbuster COVID-19 vaccine (Fierce)
- A vision for use of real-world evidence in EU medicines regulation (EMA)
- Canada gives full approval to J&J's single-shot COVID-19 vaccine (Reuters)
- South Africa delays COVID vaccine deliveries as inoculations slow (Reuters)
- In major shift, EU says vaccine boosters should be considered for all adults (Reuters)
- WHO on EU booster recommendation: "Focus on the unvaccinated and high-risk groups" (Reuters)
- 'False sense of security' around vaccines as Europe again COVID epicentre – WHO (Reuters)
- German government-to-be eyes retroactive drug price cuts (Reuters)
- EU loosens defence of pharma groups on Covid vaccine patents (FT)
- Swiss strike deal for COVAX to get 1 mln Moderna doses more quickly (Reuters)
- Three OTC COVID-19 Tests Win FDA Clearance After Template Updates (MedtechInsight)
- AstraZeneca to run more clinical trials in people’s homes to improve diversity (The Guardian)
- EMA Moves To Ensure ‘Smooth’ Evaluation Of Drug Approval Dossiers (Pink Sheet)
- The deal for BeiGene's massive new US manufacturing and R&D site is complete, and it plans to pour in 'several hundred million dollars' soon (Endpoints)
- BeiGene gets the ball rolling on its 3rd IPO — and this one is expected to fetch $3B (Endpoints)
- FDA halts phase 1b Kura Oncology trial in acute myeloid leukemia following patient death (Fierce)
- Chasing Regeneron, Pfizer posts data on $250M cardiovascular bet (Fierce)
- NICE approves hormone drug which could prevent 1,200 miscarriages each year (PharmaTimes)
- EC grant Trodelvy marketing authorisation for treatment of breast cancer (PharmaTimes)
- US FDA ‘Quietly Working Hard’ To Develop Advanced Manufacturing Framework (Pink Sheet)
- Dragonfly gets Merck on second TriNKET candidate since 2018 collab; Chinese eye gene therapy developer nabs $60M (Endpoints)
- FDA’s New Inspections Council Whipping Up Policy Around Remote Regulatory Assessments (MedtechInsight)
- Philips debuts AI-equipped MRI machines plus spectral angio-CT combination scanners (Fierce)
- European Council gives the go-ahead to new healthtech assessment rules (MobiHealthNews)
- Medtronic's surgery robot rollout hits supply chain speed bumps (Fierce)
- Comments Invited on European Commission Vision For IVDR EU Reference Laboratories (MedtechInsight)
- Paying for Drugs in Medicare Part D Under Current Law and Under Proposals to Redesign the Program (CBO)
- Sun Pharma loses bid to drop Ranbaxy antitrust case; jury trail set for January (Fierce)
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