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Recon: Marks takes over CBER's vaccines office; Pfizer submits data on COVID vaccine for children ages 5-11

Posted 28 September 2021 | By Michael Mezher 

Recon: Marks takes over CBER's vaccines office; Pfizer submits data on COVID vaccine for children ages 5-11

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • A top FDA official moved on Monday to take over the agency’s vaccines office. (NYTimes) (Endpoints)
  • Pfizer begins study of mRNA flu vaccine (Reuters)
  • Pfizer submits data for COVID-19 vaccine use in younger kids (Reuters)
  • Merck Nears Deal to Acquire Acceleron Pharma (NYTimes)
  • Lilly to cut price of Lispro insulin injection by 40% from Jan. 1 (Reuters)
  • Eisai, Biogen start U.S. accelerated approval for new Alzheimer's drug (Reuters) (STAT)
  • Valneva, Pfizer report good Phase 2 results for Lyme disease vaccine candidate (Reuters)
  • Big business lobbies bitterly divided over drug pricing reform (STAT)
  • Pharmacy Owner Pleads Guilty to Federal Charge Involving the Vaccination of Minors Under 12 with the Pfizer-BioNTech Covid-19 Vaccine (DOJ)
In Focus: International
  • WHO plans to eliminate bacterial meningitis epidemics by 2030 (Reuters)
  • Sanofi ditches mRNA COVID-19 vaccine after rivals' success (Reuters) (STAT)
  • GSK to develop longer-acting therapy for HIV with Japan's Shionogi (Reuters) (FT)
  • India allows Serum Institute to enrol 7-11 year olds in Novavax COVID-19 vaccine trial (Reuters)
  • European Health Union: Towards a reform of EU's pharmaceutical legislation (European Commission)
Coronavirus Pandemic
  • COVID-19 pill developers aim to top Merck, Pfizer efforts (Reuters)
  • The fear of Delta, not rewards or mandates, is motivating Americans to get shots, a survey finds. (NYTimes)
  • Facebook groups promoting ivermectin as a Covid-19 treatment continue to flourish. (NYTimes 1, 2)
  • WHO chief expects collaboration of China, others on virus origins follow-up (Reuters)
  • Top CDC official steps aside as head of pandemic task force (Politico)
  • Germany Decides On Added Benefit Of Gilead’s Veklury For COVID-19 (Pink Sheet)
  • NIH spotlights trio of academic teams chasing after 'pan-coronavirus' vaccines (Endpoints)
  • TGA grants provisional determination to Roche Products Pty Ltd COVID-19 treatment tocilizumab (ACTEMRA) (TGA)
Pharma & Biotech
  • Inflation and rebates caused wholesale prices on medicines to drop in second quarter (STAT)
  • Contract research is having a moment right now. Will M&A splashes drive the industry to even greater heights? (Endpoints)
  • Ziopharm lays off half its staff after manufacturing issues force delays (Endpoints)
  • Safety fears force Pfizer to change pivotal DMD gene therapy trial protocol (Endpoints)
  • George Church, his students, and top VCs go nationwide with a biotech training camp (Endpoints)
  • Looking to rewrite the rules of drug licensing, startup Anji is on the hunt for 'dynamic equity' joint ventures (Endpoints)
  • Banking on integrase inhibitors as HIV cornerstone, ViiV bags 3rd-generation compound from Shionogi (Endpoints)
  • On a journey to drastically speed up cell therapy manufacturing, Kytopen lands $30M Series A (Endpoints)
  • Innovent bets $250M+ on Union's PDE4 inhibitor ahead of a PhII readout (Endpoints)
  • As supply chain worries ease up, Big Pharma CEOs have a new top concern: recruiting and keeping employees (Endpoints)
  • MIT cell-engineering spinout nets $30M for mass manufacturing platform (Fierce)
  • US FDA Guidance On B. Cepacia Contamination Coming Soon, CDER Director Cavazzoni Says (Pink Sheet)
  • Picture Is Worth 1,000 Meetings: ‘Snapshots’ Could Support ‘Breakthrough’ Dialogue At US FDA (Pink Sheet)
  • Real-World Evidence Under Consideration For Use In Interchangeable Biosimilars Applications (Pink Sheet)
  • CDRH's 2021 'reset' shunted again as COVID-19 dominates workload (MedtechDive)
  • Vensana Capital redoubles medtech investment efforts with $325M 2nd fund (Fierce)
  • Zebra Medical Vision lands FDA clearance for tool to detect cardiovascular disease (Mobihealthnews)
  • FDA starts review after study finds Boston Scientific's Watchman is riskier in women (MedtechDive)
  • Borderline And Classification Decisions: New Process Means Six-Month Time Limit – Sometimes (MedtechInsight)
Government, Regulatory & Legal
  • FTC Deepens Look At $1B Medtronic-Intersect Deal (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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