Recon: Senate confirms Becerra as HHS secretary; NICE rejects Keytruda for advanced bladder cancer
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
How the bitter political fight over painkillers could derail Biden's FDA pick (Politico )
Senate confirms Becerra in tight vote with just one GOP defection (The Hill )
FDA official: US AstraZeneca stockpile not in danger of expiring (The Hill )
Biden administration begins throwing out Medicaid work rules (Politico )
Some Long Covid Patients Feel Much Better After Getting the Vaccine (NYTimes )
Translate Bio suffers a setback with mRNA-based treatment for cystic fibrosis (STAT )
Eli Lilly’s Covid-19 drug bamlanivimab is no longer distributed in 3 states because of a variant, Woodcock says (Endpoints )
In Focus: International
EU threat of tougher vaccine export controls backed by heavyweight governments (Reuters )
EU to send letter to AstraZeneca in possible first step of legal action (Reuters )
Keep using AstraZeneca COVID shots to save lives, WHO tells Europe (Reuters )
Mexico authorities seize fake batch of Russian Sputnik V vaccine: RDIF (Reuters )
Britain says delay in Serum Institute vaccines contributing to supply squeeze (Reuters )
NICE rejects Keytruda for advanced bladder cancer in final guidance (PMLive )
Coronavirus Pandemic
Existing COVID vaccines may protect against Brazilian variant - Oxford study (Reuters )
Biden admin unveils $10B school testing plan for Covid-19 (Politico )
Biden to send Mexico vaccine as US seeks border help: reports (The Hill )
Pfizer says it is on course to deliver UK COVID vaccine supplies (Reuters )
Moderna to deliver first UK COVID-19 vaccines in April, schedules on track (Reuters )
Taiwan clears AstraZeneca vaccines, shots may start next week (Reuters )
Real-World Evidence On COVID 19 Vaccines Coming Into US FDA (Pink Sheet )
COVID-19: New And Updated EUA Templates Focus On Serology Tests (MedtechInsight )
Pharma & Biotech
FY2020 GDUFA Science and Research Report (FDA )
Performance of preclinical models in predicting drug-induced liver injury in humans: a systematic review (Nature )
FDA warning letters detail violations at China, Mexico drugmakers already under import alert (Fierce )
UK Extends Recognition Of EU Batch Testing Pending Review (Pink Sheet )
NICE recommends Daiichi Sankyo's cholesterol-lowering treatments for NHS England use (Pharmafile )
Merck KGaA adds 350 workers at French site to build capacity for 'single-use' tech for Covid-19 vaccines, therapies (Endpoints )
Pfizer ships out two cancer ADCs alongside its tech platform to Pyxis Oncology, and its familiar CEO (Fierce )
Living in its post-Shire world, Takeda continues aggressive licensing push in $2.3B deal with Anima (Endpoints )
Are radiopharmaceuticals ready for the mainstream? Novartis, Bristol Myers Squibb bet yes on MPM's platform take (Endpoints )
NICE backs AstraZeneca’s Calquence for CLL (PharmaTimes )
UK gene therapy hub network awarded £18m in funding (PharmaTimes )
Monitoring Panel to Require MHLW's Periodic Reports on Products Designated for Sakigake Review, Conditional Early Approval (PharmaJapan )
Little Apellis is arming itself for a David and Goliath battle over a blockbuster drug franchise (Endpoints )
AmerisourceBergen say-on-pay proposal squeaks by amid outrage over CEO compensation (STAT )
Top biotech investor Peter Kolchinsky tees up a new SPAC — 3 days after a $300M raise for radiopharmaceuticals play (Endpoints )
CAR-M era begins as Carisma doses first patient (Endpoints )
Gilead, Novo Nordisk push NASH cocktail deeper into the clinic (Fierce )
GSK starts the first phase 3 study with a long-acting anti-IL-5 treatment for patients with severe asthma (Press )
Medtech
Robotics demand held firm as pandemic pummeled electives (MedtechDive )
Birth Control Apps Show The Contradictions In FDA Device Oversight (The Verge )
Government, Regulatory & Legal
Teva Sues BioMarin In UK Over Genetic Disorder Drug Patent (Law360 )
States Push New Bellwether Generic Drug Price-Fixing Case (Law360 )
Pharmacies Rip FDA Bid To End Compound Drugs Reg Case (Law360 )
Calif. Must Share Rx Data With Walgreens In Opioid Row (Law360 )
340B Dispute Resolution Rule Likely Violated Proper Regulatory Procedures – Court (Pink Sheet v)
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.