Regulatory Focus™ > News Articles > 2021 > 1 > Recon: Trump admin eyes term limits on top health jobs; Pfizer temporarily reduces vaccine shipments

Recon: Trump admin eyes term limits on top health jobs; Pfizer temporarily reduces vaccine shipments

Posted 15 January 2021 | By Michael Mezher 

Recon: Trump admin eyes term limits on top health jobs; Pfizer temporarily reduces vaccine shipments

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Vaccine reserve was already exhausted when Trum administration vowed to release it (Washington Post)
  • Trump admin races to enact term limits for top health scientists (Politico)
  • Trump wants billions cut from global Covid vaccine distributor (Politico)
  • Former FDA commissioner: "Reliable drug supply is absolutely critical" (Axios)
  • Biden taps D.C. veteran David Kessler to head Warp Speed (Politico) (STAT) (NYTimes)
  • Researchers test common drugs in quest for treatments for early COVID-19 (Boston Globe)
  • Moderna looks to test Covid-19 booster shots a year after initial vaccination (CNBC)
  • Moderna struggles to find 3,000 adolescent volunteers needed for COVID-19 vaccine trial (USA Today)
  • Trump administration will let nearly all doctors prescribe addiction medicine buprenorphine (STAT)
  • 'We Cannot Afford Inaction': Biden Unveils $1.9 Trillion COVID-19 Relief Plan (NPR)
  • Biden to unveil coronavirus vaccine distribution plan as cases soar (Reuters)
  • U.S. health officials push hospitals to administer unused Covid antibody drugs (CNBC)
In Focus: International
  • World is in a race with a coronavirus trying to mutate, WHO says (Reuters)
  • WHO stops short of advising proof of COVID shots for travel (Reuters)
  • Pfizer to Cut Vaccine Shipments as Belgian Factory Renovated (Bloomberg) (Reuters 1, 2, 3) (FT)
  • Pfizer has told EU it can still make vaccine deliveries in 1st qtr, Von der Leyen says (Reuters)
  • Pfizer vaccine delay comes as Canada battles surge in COVID-19 (Reuters)
  • EMA chief hopes J&J will seek COVID-19 vaccine approval next month (Reuters)
  • Brazil regulator says documents still missing for fast-track COVID-19 vaccine approval (Reuters 1, 2)
  • China's Sinopharm COVID-19 vaccine safe for children, teenagers: state media (Reuters)
  • International COVID-19 vaccine poll shows higher mistrust of Russia, China shots (Reuters)
  • AstraZeneca lung cancer drug gets nod for new dosing regimen in EU, UK (Reuters)
Coronavirus Pandemic
  • China allows entry to WHO COVID-19 probe member after negative test (Reuters)
  • CVS and Walgreens Under Fire for Slow Pace of Vaccination in Nursing Homes (KHN)
  • UK regulator refuses to approve mass COVID-19 testing at England schools - The Guardian (Reuters)
  • New coronavirus variant could become dominant strain in March, CDC warns (STAT)
  • Some big U.S. pharmacies will not check ID before administering COVID-19 vaccines (Reuters)
  • Biden requests $415 billion from Congress to ramp up the country’s Covid-19 response (STAT)
  • Paraguay approves emergency use of Sputnik vaccine, Russian sovereign wealth fund says (Reuters)
  • Azerbaijan to begin vaccinations next week, to use Chinese shot: govt (Reuters)
Pharma & Biotech
  • Biopharma dealmaking in 2020 (Nature)
  • 2020 FDA approvals: momentum kept despite COVID-19, but value falls (Nature)
  • FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (FDA)
  • Janet Woodcock is in the running for FDA commissioner — what does that mean for the agency's future? (Endpoints)
  • Aurinia in ‘show-me phase’ as FDA nears approval decision on autoimmune kidney disease drug (STAT)
  • Gilead partner Arcus earns analysts' plaudits for early pancreatic cancer data that 'exceeded expectations' (Endpoints)
  • Peter Thiel-backed psychedelics start-up targets schizophrenia ahead of IPO (CNBC)
  • Cognate doubles manufacturing capacities in Memphis, Europe, as demand for cell and gene therapies skyrockets (Endpoints)
  • Amgen strikes $240m autoimmune deal with Evoq Therapeutics (PMLive)
  • Looking to build in red-hot viral vector space, Thermo Fisher inks $878M deal for Belgian manufacturer's 2 plants (Endpoints)
  • NICE recommends GSK's ZEJULA for advanced ovarian cancer (Pharmafile)
  • Landos Biopharma guns for a $100 million IPO to boost AI autoimmune R&D work (Fierce)
  • Fujifilm continues CMDO expansion spree with $76M in funding for new Boston site (Fierce)
  • JPM: Jazz eyes a 'dramatic' shift to new-drug revenue by 2022, CEO says (Fierce)
  • JPM: Established relationships were key to pandemic drug launches, Incyte CEO says (Fierce)
  • CEVEC Inks AAV Manufacturing Deal with Biogen (GEN)
  • Recipharm Signs Manufacturing Agreement with Sweden’s Enzymatica (GEN)
  • Cytiva Delivers Modular Biologics Factory to Lonza (GEN)
  • Genmab Set for Stand-Alone Drug Development, Biz in Japan (PharmaJapan)
  • MHLW Initiates Discussions on Amendment of Clinical Research Law (PharmaJapan)
Medtech
  • Abbott, Quidel tout big COVID-19 testing year despite vaccine rollout: JPM21 (MedtechDive)
  • Remote monitoring, wearable companies look to capitalize on virtual care boom: JPM21 (MedtechDive)
  • UK Medtechs Determined To Exploit Digital Health Opportunity Born From The Pandemic (MedtechInsight)
Government, Regulatory & Legal
  • Insulin Report Revives Senate Finance Committee Push On Drug Pricing Legislation (Pink Sheet) (Law360)
  • Medicaid: Data Completeness and Accuracy Have Improved, Though Not All Standards Have Been Met (GAO)
  • Medicare Part D spent twice what the VA paid for the same drugs (STAT)
  • 6th Circ. Won't Stop Ex-FDA Chief's Opioid MDL Testimony (Law360)
  • Mallinckrodt Ch. 11 Talks Stalled Amid Fee Row, Judge Told (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.

Tags: US, worldwide

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