Recon: Senate confirms Becerra as HHS secretary; NICE rejects Keytruda for advanced bladder cancer

| 18 March 2021 | By Michael Mezher 

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)
  • 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 Sheetv)
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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