Recon: Biogen's Alzheimer's drug gets negative trend vote from EMA panel; EMA says Novavax authorization could come 'within weeks'
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA Plans to Authorize Pfizer Boosters for All Adults This Week (NYTimes)
- Watchdog group calls on FDA to disqualify Hennepin Healthcare doctors, review board from clinical research (StarTribune)
- U.S. plans to invest billions in manufacturing COVID-19 vaccine (Reuters) (Politico)
- Pfizer CFO D'Amelio to retire after 15 years at company (Reuters)
- U.S. secures GSK-Vir COVID-19 antibody therapy doses worth $1 bln (Reuters)
- MCIT breakthrough device payment pathway included in Cures 2.0 bill (MedtechDive)
- Cardinal Health to Test Drone Delivery to Pharmacies (WSJ)
- Legal battle over Biden Covid vaccine mandate heads to federal appeals court with GOP-appointed majority (CNBC)
- Vials labeled 'smallpox' found at vaccine research facility in Pennsylvania, CDC says (CNN) (Endpoints)
- EU decision on Novavax COVID-19 shot could come 'within weeks' (Reuters)
- EU watchdog to announce view on vaccine for children next week- Austria (Reuters)
- Biogen's Alzheimer's drug gets negative European panel vote (Reuters) (FT) (STAT) (Press)
- Roche walks away from Atea partnership to develop COVID-19 pill (Reuters)
- Ahead of expected EU objections, Illumina defends Grail acquisition (Endpoints)
- Factbox: Front runners in development of antibody drugs against COVID-19 (Reuters)
- Russia's Sputnik V vaccine shows 96.3% COVID-19 efficacy in Belarus – RDIF (Reuters)
- Trump gave an agency $100 million to fight Covid. Here’s what happened. (NBC)
- U.S. drug overdose deaths top 100,000 annually – CDC (Reuters)
- Pfizer on the hunt for a new CFO as Frank D'Amelio retires after nearly 15 years (Endpoints)
- OCE 2.0? US FDA Leadership Change May Present Opportunity To Grant Full Review Authority (Pink Sheet)
- ‘Where’s my prescription?’: California wants to revoke an OptumRx pharmacy license for prescribing lapses (STAT)
- First Alzheimer’s vaccine human trial set to begin at Boston hospital (NBC)
- Epizyme rolls out rare blood cancer effort with patients' stories and friendly digital coach (Endpoints)
- Cassava's problems just got much worse as SEC launches probe into data manipulation claims — report (Endpoints)
- Atlas, Newpath throw $125M behind a new approach to gene editing from the field’s biggest names (Endpoints)
- FDA grants first approval for a VR system to treat chronic lower back pain (Fierce) (FDA)
- Globus in takeover talks with NuVasive to boost spine portfolio: reports (MedtechDive)
- Accelus sizes up $482M SPAC deal to take its minimally invasive spinal surgery tech public (Fierce)
- Siemens Healthineers projects revenue jump fueled by Varian double-digit sales growth (MedtechDive)
- Don’t Call Them Inspections: EUA Holders Shouldn’t Be Surprised If FDA Shows Up To Investigate (MedtechInsight)
- Fed. Circ. Clears Alkem In Horizon Painkiller IP Row (Law360)
- Pfizer Must Face Trimmed Robitussin Labeling Suit (Law360)
- Former Generic Industry Exec Who Went Undercover For DOJ No Longer Debarred (Pink Sheet)
- Merck, Glenmark Want Jury To Decide Zetia Antitrust Market (Law360)
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