Recon: J&J completes enrollment for Phase 3 COVID vaccine trial; COVAX scheme in deals for 2B vaccine doses

• FDA advisory panel sets stage for Moderna vaccine authorization (Reuters) (NYTimes)
• Upstart Moderna takes on outsized role in US vaccine effort (Politico)
• FDA chief says 'rapidly' working to issue Moderna vaccine authorization (Reuters)
• Pence says Moderna's COVID-19 vaccine could be approved Friday (Reuters) (Politico)
• Moderna Ditches 400,000 Vaccine Doses But Still Set to Meet Goal (Bloomberg)
• J&J enrolls about 45,000 participants for late-stage COVID-19 vaccine trial (Reuters)
• Walgreens starts administering Pfizer vaccine in nursing homes, care facilities (Reuters)
• The wealthy scramble for COVID-19 vaccines: ‘If I donate $25,000 ... would that help me?’ (LA Times) (Politico)
• Sacklers Face Furious Questions in Rare Testimony on Opioid Epidemic (NYTimes) (STAT) (FT) (Politico)
• Biogen to pay $22M for illegally using charities to pay kickbacks to Medicare patients (STAT) (DoJ)

• Europe purchases 80 million more doses of Moderna's coronavirus vaccine (Reuters)
• Belgian secretary of state accidentally reveals EU vaccine prices (Politico) (Reuters)
• COVAX programme doubles global vaccine supply deals to 2 billion doses (Reuters)
• Trudeau commits Canada to sharing any extra vaccine doses (Reuters)
• Pfizer applies for COVID-19 vaccine approval in Japan (Reuters)
• Vaccines for sale on dark web as criminals target pandemic profits (FT)
• Commission puts forward rules on rapid antigen tests and secures 20 million tests for Member States (EC)
• State of Vaccine Confidence in the EU+UK (EC)
• EMA Management Board: highlights of December 2020 meeting (EMA)

• States Complain of Smaller Vaccine Shipments Than Expected (NYTimes)
• Pence gets COVID vaccine as U.S. deaths top 3,000 for third straight day (Reuters)
• Members of Congress to get COVID-19 vaccine in first round, physician says (Reuters)
• HHS secretary tells staff: My wife is sick with Covid (Politico)
• Mesoblast craters as Novartis-backed COVID-19 drug flunks trial (Fierce)
• After Lilly's failure, NIH tests GSK/Vir and Brii COVID-19 drugs in hospitalized patients (Fierce)
• Placebo-Unblinding Should Be Uniform Across COVID Vaccine Trials, Advisory Committee Says (Pink Sheet)
• China to vaccinate 50 million people for Lunar New Year – SCMP (Reuters)
• Russia trials COVID-19 vaccine for domestic animals, including mink (Reuters)
• Russia signs more deals with India to make 300 million Sputnik V vaccines (Reuters)
• India's Biological E. to start vaccine late-stage trials in April – executive (Reuters)
• Ukraine PM says first COVID-19 vaccines expected in Feb (Reuters)

• Kulkarni victorious in best biopharma CEO vote; Leschly tops worst list (STAT)
• FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients (FDA)
• Fast-Track Loss In EU For Celgene’s CAR-T Cell Therapy (Pink Sheet)
• Google sister Verily sports another impressive raise, hauling in $700M to support its two big platforms (Endpoints)
• Novo Nordisk eyes EU approval for once-weekly semaglutide (PharmaTimes)
• Boehringer Ingelheim Files Citizen Petition Urging FDA to Address “Strength” Definition for Biosimilars, Citing Concerns Over Evergreening (Big molecule watch)
• FDA Approves Amgen's RIABNI™ (rituximab-arrx), A Biosimilar To Rituxan (Press)
• GSK pays $85m upfront for Surface Oncology’s lead cancer drug (PMLive) (FT)
• NICE recommends GSK’s Nucala for more asthma patients (Pharmafile)
• Mereo BioPharma pens $50M Ultragenyx deal for rare bone disease drug (Fierce) (Endpoints)
• Taysha Gene Therapies looks to build on rapid IPO with $85M dev-manufacturing plant in North Carolina (Endpoints)
• John Connolly has a new mission to tack on to his role at the Parker Institute: interim chief of a buzzy biotech backed by a pair of billionaires (Endpoints)
• Janux pairs up with Merck for $1B-plus T-cell engager deal (Fierce)

• At FDA's request, Penumbra recalls catheter device after 14 patient deaths (MedtechDive)
• Fivefold Increase In MDR Notified Body Demand Could Lead EU Into Chaos (MedtechInsight)
• NMPA guidances address real-world data, medical device naming, and IVD technical review (Emergo)
• FTC clears Stryker-Wright Medical deal (MassDevice)
• Philips to acquire Biotelemetry for $2.47B (MassDevice)
• FDA approves Abbott Heartmate 3 label update in pediatric patients (MassDevice)

• 'Cautiously optimistic' on Obamacare lawsuit, Becerra to focus on health disparities at HHS (Politico)
• Former Medical Director of Suboxone Manufacturer Indivior Sentenced in Connection with Drug Safety Claims (DoJ)
• Former J&J exec sues for sexual discrimination and harassment, alleging ‘ruthless pattern of retaliation’ (STAT)
• Gilead Says Overbroad Patent Doesn't Need Justices' Review (Law360)
• Ex-Indivior Exec Dodges Prison In Suboxone Opioid Case (Law360)
• EpiPen Trial Not Feasible Nor Prudent Amid Virus, Judge Says (Law360)
• Fed. Circ. Won't Revive Patent Suit Over Gallbladder Drug (Law360)