Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US

• FDA Takes Key Action by Approving Second COVID-19 Vaccine (FDA) (The Hill)
• Biden’s FDA pick makes major ethics pledges to win over Elizabeth Warren (Politico)
• Merck's COVID pill is last choice for U.S. patients, global use varies (Reuters)
• Roche looks to compete against a blockbuster with its newly approved vision drug (STAT) (Scrip)
• Regeneron and Sanofi pull Libtayo app in cervical cancer, citing post-market study disagreement with FDA (Endpoints)
• JAK woes continue as Eli Lilly warns of possible Olumiant CRL for atopic dermatitis and reports PhIII fail in lupus (Endpoints)
• White House frustrations grow over health chief Becerra’s handling of pandemic (Washington Post)
• Exclusive: U.S. diabetes deaths top 100,000 for second straight year (Reuters)

 
In Focus: International

• Massive $1.5B investment in manufacturing widens Eli Lilly's footprint in Ireland and North Carolina (Endpoints)
• BMS’ Cell Therapy For Lymphoma On Track For EU-Wide Approval (Pink Sheet)
• EU OKs Continued Use Of Etifoxine For Anxiety Despite Toxicity Concerns (Pink Sheet)
• WHO official under fire after allegations of racism, leaking sensitive data — report (Endpoints)
• UK biotechs smash 2020 investment records, surpassing San Diego in VC and IPO raises (Endpoints)

 
Coronavirus Pandemic

• Early data indicate vaccines still protect against Omicron’s sister variant, BA.2 (STAT)

• The Covid-19 vaccine IP waiver is back at the WTO, with a new deadline. Can it muster enough support? (Endpoints)
• American Indians, Other Medicare Minorities Disproportionately Affected By COVID-19: CMS (MedTech Insights)
• Federal vaccine mandate for health-care workers starts to take effect (Washington Post)
• Russia reports fresh record of daily COVID cases (Reuters)

 
Pharma & Biotech

• Waking up from some big blockbuster dreams, Pfizer scraps a $250M drug deal as data sour, safety fears rise (Endpoints)
• Merck enlists HPV-related cancer survivors and physicians in social and digital ‘Story’ campaign (Endpoints)
• Madrigal drug for fatty liver disease clears safety hurdle in first of two late-stage studies (STAT)
• Biosimilars Forum’s New Executive Director Faces Down Challenge Of Interchangeability Confusion (Pink Sheet)
• Flagship startup brings out the budget ax, chops staff and clinical plans as share price flounders (Endpoints)
• Illumina’s embrace of long-read technology signals a shift in the DNA-sequencing market (STAT)
• As pockets fill with cash, Maravai spends $240M to ensure pure mRNA production (Endpoints)
• In the heart of the booming biotech industry, workers are in short supply (STAT)
• Cryo-EM focused biotech from longtime NIH veteran secures $40M backing from Bayer in Series A (Endpoints)

 
Medtech

• MDCG 2022-2 - Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) (MDCG)
• IVDR Clinical Evidence: EU Guidance Document Spells Out What Is Required (MedTech Insights)
• FDA must improve medical device interoperability through data standards: JAMA (MedTech Dive)

Government, Regulatory & Legal

• Purdue's Appeal on Ch. 11 Releases Fast-Tracked By 2nd Circ. (Law360)
• Nurses made $1.5 million selling fake vaccination cards, prosecutors say (Washington Post)
• Lack of Medicare coverage for at-home coronavirus tests sparks outcry (Washington Post)