Recon: US buys 1.25M more doses of Regeneron COVID antibody drug; Sinovac defends vaccine after latest Brazilian data

• FDA fights for independence in Trump administration's final days (Politico)
• Johnson & Johnson Expects Vaccine Results Soon but Lags in Production (NYTimes)
• Supreme Court Revives Abortion-Pill Restriction (NYTimes)
• Operation Warp Speed chief resigns at Biden team’s request, will stay through transition, sources say (CNBC)
• US to buy 1.25M additional doses of Regeneron's COVID-19 antibody cocktail (Reuters)
• Biden’s Covid-19 team reconsiders pandemic plan in light of more infectious variants (STAT)
• 27.7M doses of COVID-19 vaccines distributed, 9.3M administered: CDC (Reuters)
• Flawed vaccine rollout will create political stars — and has-beens (Politico)
• Sana Biotechnology, filing for IPO, aims for astronomical valuation (STAT)

• Pharma lobby warns against extending Covid jab times (FT) (Statement)
• J&J likely to seek EU approval for COVID-19 vaccine in February (Reuters)
• MEP Canfin to Commission: We need more details on CureVac vaccine contract (Politico)
• AstraZeneca says to release 2 million vaccine doses a week to UK by mid-February (Reuters)
• English health official says have been extracting extra doses of AstraZeneca vaccine (Reuters)
• Baxter Germany to start production of BioNTech/Pfizer vaccine by early March (Reuters)
• China's Sinovac defends COVID-19 vaccine after disappointing Brazil data (Reuters) (FT)
• India wants Pfizer to do local study before approval (Reuters)
• Mexico aims to fast track Russian Sputnik vaccine authorization after seeing data (Reuters)
• Brazil to decide Sunday on emergency use of Chinese and British COVID-19 vaccines (Reuters)
• Australian scientists suggest delaying AstraZeneca vaccine as infections fall (Reuters) (FT)
• Australia's chief medical officer defends AstraZeneca's Covid vaccine amid efficacy concerns (The Guardian)
• Turkey grants emergency authorization to Sinovac's CoronaVac: Anadolu (Reuters)

• Second year of pandemic 'could even be tougher': WHO's Ryan (Reuters)
• Facing New Outbreaks, China Places Over 22 Million on Lockdown (NYTimes)
• Opinion: The World Is Desperate for More Covid Vaccines (NYTimes)
• Adolescent Recruitment For COVID-19 Vaccine Trials Is Worry For Operation Warp Speed (Pink Sheet)
• US to Require Negative Virus Tests From International Air Passengers (NYTimes)
• Doctor’s Death After Covid Vaccine Is Being Investigated (NYTimes)
• CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts (FDA)

• US FDA To Lose Another COVID-19 Response Leader With Anand Shah’s Resignation (Pink Sheet)
• New Bayer drugs will not bridge revenue gap, says pharma head (FT)
• What can a 157-year-old pharma giant bring to the table of cell and gene therapies? Quite a bit, Bayer says (Endpoints)
• Bayer wins priority review for CKD program finerenone after PhIII data showed a delay in disease progression (Endpoints)
• JPM21: Gene editing for heart disease, a new date to watch in Alzheimer's and Pfizer's deep pockets (BioPharmaDive)
• US FDA Actions On Rx Drug Promos Covered New Territory Last Year (Pink Sheet)
• FDA Defers Decision on Bevacizumab Biosimilar (Big Molecule Watch)
• ViiV gets EU approval for children's HIV treatment (Pharmafile)
• IO Biotech raises $155M to trial IDO and PD-L1 cancer vaccines (Fierce)
• What if a pill could lower cholesterol like pricey injectables? Esperion intends to find out (STAT)
• With KRAS breakthrough on the horizon, Amgen's David Reese reflects on sotorasib's looming review date and murky future (Endpoints)
• Amgen ponies up $240M for Michigan discovery outfit's dendritic cell-based molecules for autoimmune disorders (Endpoints)
• Pfizer's investment fund is making waves in VC — including a $25M bet on IBD player Vedanta Biosciences (Endpoints)
• #JPM21: Albert Bourla prepares Pfizer to settle in to next phase post-Upjohn, but that doesn't mean he's ruling out deals (Endpoints)
• A longtime Pfizer chief's ultra-quiet biotech re-emerges with new cash and plans for the clinic (Endpoints)
• Flagship christens the latest startup to join the drug discovery fleet, this time focused on the lessons of cell death (Endpoints)
• Takeda eyes pathway to natural killer therapies, teeing up $100M to partner with KSQ for its CRISPR-screened molecules (Endpoints)
• News briefing: Merck picks up SHP2 option from Taiho-Astex deal; Taysha expands partnership with UT Southwestern (Endpoints)
• IDO on the rebound? Danish outfit IO Biotech hopes so with oversubscribed Series B one month after BTD in melanoma (Endpoints)
• Adaptimmune 'ready for primetime' as it prepares to launch T cell therapy for sarcoma, CEO Adrian Rawcliffe says (Endpoints)
• Acorda offloads manufacturing operations to Catalent for $70M amid latest restructuring to keep the ship afloat (Endpoints)

• Essential IVD Document Delays Add To Concerns Over 2022 Deadline (MedtechInsight)
• CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic (MedtechDive)
• Allergan Aesthetics Enters Into Option to Acquire Cypris Medical (Press)
• Illumina Launching Pan-Cancer IVD Test, Cloud-Based Bioinformatics Platform (GEN)
• Cognito Therapeutics nets FDA breakthrough label for light, sound therapy for Alzheimer's disease (Fierce)
• JPM: Teladoc to pilot CGMs in Type 2 diabetes as Dexcom eyes new growth market (Fierce)
• JPM: Steris snaps up infection prevention gear provider Cantel Medical for $4.6B (Fierce)
• Big Changes Kicking In Under Australia’s Personalized Medical Devices Rules (MedtechInsight)

• Endocrinologists urge federal lawmakers to act to lower insulin costs (STAT)
• Mexico publishes medicinal cannabis regulation, creating new market (Reuters)
• Opinion: Federal Circuit Should Restore Generics ‘Skinny Label’ Process (Bloomberg)
• PTAB Judge Skeptical Allergan's Juvederm Patents Are Valid (Law360)
• Feds Want Jury Told Of Ex-Theranos CEO's 'Lavish Lifestyle' (Law360) (WSJ)
• Pfizer Sues Over Generic For Arthritis Drug Xeljanz (Law360)