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.