• US ready for ‘immediate mass shipment’ of COVID-19 vaccines: agency (Reuters)
• First US COVID-19 shots could be given 24-to-48 hours after FDA nod: health official (Reuters)
• FDA chief called to West Wing (Axios) (CNN)
• Regeneron, UPenn to use gene therapy tools to deliver a COVID-19 antibody drug (BioPharmaDive)
• White House to host Covid-19 vaccine summit, as Trump seeks to burnish record (STAT)
• AbbVie Faces Revived Fraud Claims Over Humira Ambassador Program (Bloomberg)
• Trump Covid vaccine chief Slaoui says everyone in U.S. could be immunized by June (CNBC)
• Burr, in line to lead Senate Republicans’ health strategy, has a long history of antagonizing the FDA (STAT)

In Focus: International

• COVID R&D Alliance launches trial of Amgen, UCB, Takeda drugs (Reuters)
• COVID-19 vaccine sprint as Pfizer-BioNTech, Moderna seek emergency EU approval (Reuters)
• EMA starts rolling review of J&J’s COVID-19 vaccine candidate (Reuters)
• EU Commission to authorise COVID-19 vaccines days after regulatory approval (Reuters)
• Covid vaccinations in EU unlikely to start before next year (FT)
• Russia tries to import COVID-19 drugs as deaths hit high (Reuters)
• AstraZeneca sells former blockbuster cholesterol drug for $320 million (Reuters)
• Europe Hits Teva With €60M Fine Over Pay-For-Delay Deal (Law360)
• Medicines Patent Pool expands deal for access to key HIV drug to several upper middle-income countries (STAT)

Coronavirus Pandemic

• GAO: ‘Urgent’ actions needed to respond to pandemic (The Hill)
• Scott Atlas, Special Coronavirus Adviser To Trump, Resigns (NPR)
• An EU programme of COVID-19 convalescent plasma collection and transfusion (EC)
• Coronavirus was present in US earlier than initially thought: CDC scientists (The Hill)
• Novavax May Seek COVID-19 Vaccine Emergency Authorization In US Based On UK Data (Pink Sheet)
• AstraZeneca partner sticks with two full dose regimen in COVID trials in India (Reuters)
• India says may not need to vaccinate entire population to control COVID (Reuters)
• China gave COVID-19 vaccine candidate to North Korea’s Kim: US analyst (Reuters)
• Under an EUA, Can Businesses Require Employees and Customers to Get Vaccinated? (Harvard Bill of Health)
• ‘No-swab’ coronavirus test from OptiGene highly sensitive, UK says (Reuters)
• Companies say French regulator gives positive feedback on saliva-based COVID-19 test (Reuters)
• Serbia to make lab tests of Russia’s COVID-19 vaccine: statement (Reuters)

Pharma & Biotech

• Berry-Flavored H.I.V. Medication Is Ready for Babies (NYTimes)
• FDA spikes a drug approval program that inadvertently led to price hikes and shortages (STAT)
• FDA Announces 4 Grant Awards for Projects Exploring the Use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (FDA)
• Revance’s frown-line injection latest to face regulatory delay after FDA can’t hit inspection deadline (Fierce)
• The FDA spells out 4 reasons why it hates Minerva’s NDA ideas — but the biotech is going for it anyway (Endpoints)
• FDA goes beyond the label to educate doctors—and enlighten others—about new cancer drugs (Fierce)
• A top cancer R&D exec at Genentech joins the exodus, jumping to a marquee China biotech as the new oncology chief, dealmaker (Endpoints)
• Legend Biotech believes it is not a target of Chinese investigation, CEO says (STAT)
• Agios returns positive PhIII data in a rare blood disorder as it seeks to move past recent cancer setbacks (Endpoints) (STAT)
• Labeling Changes In Store For Hydroxychloroquine In EU After COVID-19 Experience (Pink Sheet)
• Aducanumab Review: Looking For Precedents – Long Ago And Far Afield (Pink Sheet)
• Arena Pharma’s R&D lead quits 6 months into the job, replaced by Alder CMO (Fierce)
• BridgeBio grabs a second priority review for the portfolio — giving Perceptive startup cause to celebrate (Endpoints)
• Roche shelved these psychiatry drugs. So its former head of neuro cooked up some new plans — and raised $59M for his startup (Endpoints)
• Regeneron teams with gene therapy pioneer James Wilson, adapting its Covid-19 antibody cocktail to an AAV-based nasal spray (Endpoints)
• Merck’s Roger Perlmutter buys his first solid tumor TriNKET from Dragonfly; ViGeneron to expand production of eye gene therapy (Endpoints)
• With eyes on an IPF franchise, Galapagos pushes second candidate into a dose-finding study (Endpoints)
• Piqray – What EU Regulators Saw And What They Wanted (Pink Sheet)

Medtech

• First blood test to help diagnose Alzheimer’s goes on sale (NBC)
• EU Notified Bodies Demand IVDR System Readiness Or Deadline Review By Year End (MedtechInsight)
• Vectorious’ in-heart microcomputer wins FDA breakthrough nod (MassDevice)
• Next-gen MitraClip performs as well as earlier version (MassDevice)
• Zimmer Biomet completes A&E Medical acquisition (MassDevice)

Government, Regulatory & Legal

• HHS Policy Move Means FDA Must Publish More Documentation To Support Rulemaking Decisions (MedtechInsight)
• The Rebate Rule May Not Last, But It Changed The Pricing Debate (Pink Sheet)
• Bayer Hits Generic Co. With Another Hypertension Drug Suit (The Hill)
• Anticipating The Biden Administration’s Health Care Agenda (Law360)
• AbbVie Gets Humira Kickbacks FCA Suit Limited To Florida (Law360)
• Outcomes: Low-negligible risk changes to Permissible Ingredients – 2020-2021 (TGA)

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.
 
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