Recon: Lilly says antibody drug prevented COVID in nursing home study; Biden to invoke Defense Production Act

• Biden leaves top FDA job open amid vaccine push (Politico)
• Lilly Antibody Drug Prevents Covid-19 in Nursing Homes, Study Finds (WSJ) (STAT)
• U.S., staying in WHO, to join COVID vaccine push for poor nations: Fauci (Reuters)
• California resumes Moderna COVID-19 vaccine usage after pause (Reuters)
• Biden dissolves Covid-19 panel that advised his transition (STAT)
• Biden to sign 10 executive orders and invoke DPA to combat Covid pandemic (CNBC) (FT)
• States’ new vaccine worry: Not enough doses (Politico)
• McKesson to replace some Moderna COVID-19 vaccines due to low temperature (Reuters)
• Amazon offers to help US with vaccine efforts in letter to President Biden (Reuters)
• How much? Hospitals mark up some medicines by 250% on average (STAT)
• How Many Vaccine Shots Go to Waste? Several States Aren’t Counting (ProPublica)

• EU leaders convene amid vaccine delays, virus variant fears (Reuters)
• Boris Johnson says UK ready to deploy tweaked vaccines (FT)
• Oxford scientists preparing vaccine versions to combat emerging virus variants (Reuters)
• Sinovac COVID-19 vaccine unit struggles to add new hires as holiday nears (Reuters)
• Welsh AstraZeneca vaccine facilities not disrupted by flooding, Wockhardt UK says (Reuters)
• Hungary gives initial approval for AstraZeneca and Sputnik V vaccines (Reuters)
• Conflicting COVID-19 results for Roche arthritis drug show more trials needed (Reuters)
• Moderna's COVID-19 given to first Japanese volunteer as Takeda starts trial (Reuters)
• Japan, Pfizer Finalize COVID-19 Vaccine Deal, Agree on Supply of 144 Million Doses (PharmaJapan)
• UK health minister says data on Pfizer vaccine supports shift to 12-week dosing schedule (Reuters)
• COVAX says to supply 1.8 billion COVID vaccine doses to poor in '21, warns of uncertainties (Reuters)

• Emerging Coronavirus Variants May Pose Challenges to Vaccines (NYTimes)
• The 10 Biden officials to watch on the Covid-19 response (STAT)
• Biden will order masks on planes and trains, increase disaster funds to fight coronavirus (Reuters)
• How Defense Production Act May Affect Vaccine Supply Chain (Law360)
• UK researchers say lateral flow tests detect the most infectious COVID cases (Reuters)
• South Korea expects first batch of COVID-19 vaccine from COVAX within weeks (Reuters)
• Russia plans to produce COVID-19 vaccine storable at fridge temperatures – minister (Reuters)
• Indian PM Modi to get COVID-19 vaccine in 2nd phase of inoculation drive: NDTV (Reuters)
• Thai regulator approves AstraZenca vaccine for emergency use: sources (Reuters)
• UAE approves Russia's Sputnik V COVID-19 vaccine for emergency use (Reuters)
• Pakistan: China to gift half million doses of Sinopharm vaccine (Reuters)
• India's Bharat Biotech seeks Bangladesh trial for COVID vaccine approved at home (Reuters)
• Russian vaccine could be fully produced in Brazil by April - company executive (Reuters)
• Bosnia to order Russian, Chinese vaccines ahead of COVAX, EU deliveries (Reuters)
• Ecuador says first batch of 18 million contracted doses of COVID-19 vaccine arrive (Reuters)

• Global Regulators Seek Unified Approach To Remote Inspections (Pink Sheet)
• US FDA Still “Actively” Drafting Proposed Licensing Rule For Wholesalers and 3PLs (Pink Sheet)
• The CEO of Mark Cuban’s generics company talks drug prices, manufacturing, and his famous boss (STAT)
• NICE approves lipid disorder drug Myalepta for NHS use (Pharmafile)
• NICE recommends rheumatoid arthritis drug Jyseleca for NHS use (Pharmafile)
• Japan Regulators Kept On Track Despite Pandemic (Pink Sheet)
• Sentinel Could Be Used For Pregnancy Safety Studies Under PDUFA VII (Pink Sheet)
• Novo Nordisk, following in Lilly's Trulicity footsteps, files higher Ozempic dose for diabetes (Fierce)
• Veru touts novel breast cancer treatment strategy as drug nears phase 3 (Fierce)
• Once laser-focused on liver, MiNA takes swing at neurology with Servier's backing (Endpoints)
• With patent concerns looming, Roche gets a new priority review on blockbuster IPF drug (Endpoints)
• BIO looks to restructure, laying off staff amid challenge to the trade org's normal face-to-face style (Endpoints)
• Plexium adds industry vet Mike Grey to the brain trust with new investor cash funding its protein degradation play (Endpoints)
• Northway Biotech sets up shop in Boston hub, looking to court more customers with biologics-focused plant (Endpoints)
• Deval Patrick joins Cerevel board, further intertwining company with Bain Capital (Endpoints)
• Months after a major rebranding around CAR-NKT cells, Kuur Therapeutics is offering a peek at early results (Endpoints)
• News briefing: Five public biotechs, over 2 days, raise $883M from fresh offerings; Belgian biotech expands Series B funding (Endpoints)

• CMS expands transcatheter mitral coverage, boosting Abbott's MitraClip device (MedtechDive)
• FDA breakthrough nods go to Alzheimer's devices, cardiovascular products (MedtechDive)
• Haemonetics to buy bloodstopper medtech Cardiva Medical in $510M deal (Fierce)
• In vitro test maker Ortho Clinical Diagnostics files $1.5B Nasdaq IPO (Fierce)
• Hillrom makes cardiac monitoring play with $375M BardyDx buy (MedtechDive)

• Two-Tier Specialty Drug Policy: Part D Plans Gain Formulary Flexibility But Impact May Be Limited (Pink Sheet)
• Illumina Rival Infringed DNA Sequencing IP, UK Court Rules (Law360)
• Mylan Wants Out Of Investor Suit Over FDA Inspections (Law360)