Recon: Pfizer working on COVID vaccine booster; J&J expects data on its COVID vaccine next week

• Biden sets sights on 1.5 million vaccinations a day (Politico)
• Pfizer working on booster shot to protect against COVID-19 variants: Bloomberg (Reuters)
• Pfizer to Deliver US Vaccine Doses Faster Than Expected (Bloomberg)
• Johnson & Johnson expects details on COVID-19 vaccine trial next week (Reuters) (CNBC)
• FTC sues drug makers over allegedly illegal deal over an opioid painkiller (STAT) (Reuters)
• US goal to squeeze more COVID shots from Pfizer vials hampered by syringe production (Reuters)
• Regeneron says monoclonal antibodies prevent Covid-19 in study (STAT) (Reuters)
• Lilly antibody combo cuts risk of death due to COVID-19 by 70% -study (Reuters)
• Moderna says on track to deliver 100 million COVID-19 vaccine doses by first quarter (Reuters)
• Democrats may move forward on coronavirus aid without Republicans: Schumer (Reuters)
• Judge orders Merck documents on anti-baldness drug Propecia unsealed (Reuters)

• Keep your supply promises, EU tells vaccine makers as deliveries wobble (Reuters 1, 2)
• Britain says it will work with EU to avoid vaccine disruption (Reuters)
• Astra offers small concession, EU pleads for UK-made shots amid vaccine row -sources (Reuters)
• EU to monitor vaccine exports, but says it's not a ban (Reuters)
• No data suggesting lower efficacy of AstraZeneca vaccine: German health ministry (Reuters 1, 2)
• WHO expected to review AstraZeneca COVID-19 vaccine on February 8: expert (Reuters)
• WHO working with Moderna on emergency use listing for its COVID shot (Reuters)
• Sweden wants clarity on vaccine doses before paying Pfizer (Reuters)
• WHO issues new clinical advice on treating COVID-19 patients (Reuters)
• GAVI seeks political support for COVAX as bilateral vaccine deals grow (Reuters)
• Japan's Shionogi sells coronavirus drug rights to US biotech BioAge (Reuters)
• PharmaMar says paper in journal Science confirms drug's efficacy (Reuters)

• Why Even Presidential Pressure Might Not Get More Vaccine to Market Faster (KHN)
• EMA says some leaked COVID-19 documents 'taken out of context' (Reuters)
• States taking back Covid shots unused by nursing homes (Politico)
• UK study shows azithromycin, doxycycline ineffective in early COVID-19 (Reuters)
• Israel’s Early Vaccine Data Offers Hope (NYTimes)
• How Israel secured more vaccines than it can use (FT)
• Russia's RDIF: Sputnik V vaccine to be approved by 25 countries within weeks (Reuters)
• Inactivated COVID vaccines can be upgraded for variants in two months: China CDC expert (Reuters)
• Italy sends warning letter to Pfizer over COVID vaccine delays (Reuters)
• France's Veran: sticking with decision to have 21-days gaps between two Pfizer shots (Reuters)
• Taliban backs Afghan vaccine drive after COVAX pledges $112 million (Reuters)
• Malaysia secures 18.4 million doses of Russian, Chinese COVID-19 vaccines (Reuters)
• Ukraine expects 100,000-200,000 vaccines from Pfizer in February – PM (Reuters)
• Saudi Arabia to get three million AstraZeneca shots in about a week from India (Reuters)
• COVID-19: EU Dexamethasone Taw Filing Pulled (Pink Sheet)

• Pharmaceutical giants not ready for next pandemic, report warns (The Guardian)
• Opinion: The Biden-Harris FDA should make friends with independent researchers (STAT)
• Novartis CEO says U.S. approval timeline for Leqvio 'out of our control' (Reuters)
• EDQM Sets 2023 Target For Modernizing ‘Certificates Of Suitability’ (Pink Sheet)
• Year in Review: Biosimilars (Harvard Bill of Health)
• AbbVie's psoriatic arthritis drug gets EU approval (Pharmafile)
• AbbVie's Rinvoq bags two new EU approvals (PharmaTimes)
• Kobayashi Kako Notified of Record Biz Suspension of 110-Plus Days over Drug Mix-Up (PharmaJapan)
• Emergent BioSolutions unveils 7th pandemic CDMO contract, this time for Humanigen's late-stage antibody hopeful (Fierce)
• AstraZeneca, with new data, claims its leukemia drug is safer than Imbruvica (BioPharmaDive)
• Drugmakers 'inching ahead' in increasing access to drugs worldwide, with GlaxoSmithKline leading the pack (Endpoints)
• Nostrum Labs adds another NDMA-tainted metformin lot to its growing recall (Fierce)
• Iterum nabs speedy FDA antibiotic review, but follows in the footsteps of bankrupt biotechs (Fierce)
• After 3 deaths rock the field, gene therapy researchers contemplate AAV's future (Endpoints)
• News briefing: Nestlé whips up research collaboration with newly-unveiled Flagship upstart; Marianne De Backer joins Kronos board (Endpoints)
• Vir's CMO says he's surprised that a low dose of their hepatitis B drug appears promising in early slice of data — shares soar (Endpoints)
• Myovant beefs up data package in NDA #3, boosting its case for longterm dosing of Pfizer-partnered relugolix (Endpoints)
• Looking to win over some skeptical analysts, Rhythm beats the drum on interim data in PhII basket study for additional indications (Endpoints)
• Novartis' Q4 earnings clouded by regulatory setbacks on inclisiran, Zolgensma (Endpoints)

• Philips beats Q4 expectations as COVID-19 boosts connected care, slows procedures (MedtechDive)
• Backed by BD and Siemens, Babson begins clinical testing of its retail pharmacy blood draw device (Fierce)
• Swiss startup Aktiia receives CE mark for continuous blood pressure monitoring system (mobihealthnews)
• Medtronic Looks To Adaptive DBS To Advance Treatment Of Parkinson’s Disease (MedtechInsight)
• Regulatory Science Tools For Phantoms, Lab Methods Added To US FDA Catalog (MedtechInsight)
• FDA To Hold Postponed 3-Day Pediatric Device Workshop In February (MedtechInsight)
• Theranica’s migraine DTx receives FDA clearance for adolescent use (mobihealthnews)

• Biden to reopen online health insurance marketplace, ease Medicaid rules (Reuters)
• Why health care lobbyists saw a windfall in 2020 (STAT)
• New HHS Policy on Buprenorphine for the Treatment of Opioid Use Disorder – Finally, Treatment is More Accessible than Opioids…. UPDATE (FDA Law Blog)
• EpiPen Buyers Want Remote Testimony In Pricing MDL (Law360)
• Drugmakers Must Face Warranty Claims In Valsartan MDL (Law360)
• FTC Says Endo, Impax Cut 2nd Opana ER Pay-For-Delay Deal (Law360)
• Eidos Therapeutics Investor Seeks Docs On BridgeBio Deal (Law360)
• Ex-Indivior Parent Withdraws $1.4B Claim Over Suboxone (Law360)
• J&J's Bid To Ax $15M Mesh Verdict Meets Skeptical NJ Court (Law360)