Recon: Eli Lilly seeks EUA for COVID antibody drug; BMS reports positive results for Opdivo plus chemo in NSCLC

• Trump Says FDA Pulled ‘Political Hit Job’ With Vaccine Rules (Bloomberg)
• FDA Will Force Vaccine-Safety Disclosures If Makers Don’t (Bloomberg)
• Eli Lilly Asks FDA to Authorize Covid-19 Antibody Drug (WSJ) (STAT) (Reuters)
• FDA Redactions Upheld in FOIA Suit for Drug Approval Documents (Bloomberg)
• Bristol Myers' Opdivo succeeds in late-stage lung cancer trial (Reuters)
• Race for Covid-19 vaccine slows as regulators, top Warp Speed official tap the brakes (STAT)
• OxyContin maker Purdue nears guilty plea agreement in US criminal probe (Reuters)
• AstraZeneca expects update on halted US vaccine trial in next few weeks: brokerage (Reuters)
• House panel investigates political interference by White House over coronavirus at CDC and FDA (CNBC)

• Pipeline is bare: more funding needed to develop new COVID-19 drugs – Wellcome (Reuters)
• China's experimental COVID-19 vaccine appears safe – study (Reuters)
• UK's COVID testing system hit by Roche supply chain glitch (Reuters)
• Roche supply problems have little or no impact on COVID testing, says UK PM's spokesman (Reuters)
• Drugmaker halts plan to pull bipolar treatment after competition probe (FT)
• EU buys more Remdesivir to treat 3,400 patients amid shortages (Reuters)
• Hungary's Richter has manufactured Remdesivir for 3,000 COVID-19 patients (Reuters)
• Majority of generic drug ingredients produced in Asia (Reuters)
• Merck KGaA out-licenses osteoarthritis programme to Novartis (PharmaTimes) (Endpoints)

• Q&A: Where are we in the COVID-19 vaccine race? (Reuters)
• Fauci: There could be 300,000 to 400,000 Covid deaths unless precautions taken (Politico)
• Why Doctors Aren’t So Sure Trump Is Feeling Better From Covid-19 (NYTimes)
• HHS whistleblower Rick Bright resigns from government (Politico) (STAT)
• House Democrats seek to block funds for 'defeat despair' Covid ads (Politico)
• How Much Would Trump’s Coronavirus Treatment Cost Most Americans? (NYTimes)
• GSK tells UK staff: turn off Covid test-and-trace app while at work (The Guardian)
• UK inks deal with Abingdon Health for rapid COVID-19 antibody tests (PharmaTimes)
• Distrusting Trump, States Plan to Vet COVID Vaccines Themselves. Bad Idea, Say Experts. (KHN)
• Abbott says new data shows rapid COVID-19 test used at White House is highly accurate (Reuters)
• The White House Bet on Abbott’s Rapid Tests. It Didn’t Work Out. (NYTimes)

• Nobel Prize in Chemistry Is Awarded for Crispr Gene-Editing Technology (WSJ) (Science)
• US FDA Has Soured On Abuse Deterrent Labeling Even Outside Of Opioids, Stimulant Docs Suggest (Pink Sheet)
• Roche targets cystic fibrosis with deal for TMEM16A potentiator (Fierce)
• Company veteran Belén Garijo named as Merck KGaA's first-ever female CEO (Pharmafile)
• EMA Reviews Samsung Bioepis’ Lucentis Biosimilar For Eye Diseases (Big Molecule Watch) (PharmaTimes)
• Nonfinancial conflicts of interest can threaten public health: the case of FDA antidepressant warnings and youth suicides (STAT)
• Roche joins AbbVie in stepping on Vertex's turf, betting $96M on an alternative CF approach (Endpoints)
• News briefing: Pfizer on track to early '22 pivotal readout on hemophilia A; Codiak scales back IPO expectations (Endpoints)
• Medicxi splashes more funding into Janpix's STAT protein degrader program (Endpoints)
• Venrock takes the wrap off its first microbiome startup, armed with $50M, a CEO from 23andMe and two founders from Stanford (Endpoints)
• A2 Biotherapeutics nabs $71M-plus Series B for selective cell therapy pipeline (Endpoints)

• Shuren: FDA Making ‘Pre-Cert Simulator’ To ‘Test Drive’ Regulatory Frameworks For Digital Health Tech (MedtechInsight)
• FDA Launches Pilot eCopy Program To Eliminate Mailing CDs, DVDs, Flash Drives (MedtechInsight)
• Steris inks $850M deal for Key Surgical amid medtech M&A wave (MedtechDive)
• Why Many MDD Certificates Will Be Invalid Before Their MDR Replacements Can Be Issued (MedtechInsight)
• Medical Alley, GI docs push to ease CMS device pass-through payments (MedtechDive)
• US FDA publishes trio of final guidances for Accreditation Scheme for Conformity Assessment (ASCA) program (Emergo)
• US FDA ASCA Program: How the new Accreditation Scheme for Conformity Assessment pilot will work for medical device premarket reviews (Emergo)

• PTAB Grants Broad Motion No. 4 for Priority Benefit to U.S. Provisional Application No. 61/736,527 (Patent Docs)
• Mylan Says 3rd Circ. Ruling Can't Boost EpiPen Antitrust Suit (Law360)
• Humira Buyers Ask 7th Circ. To Revive 'Patent Thicket' Case (Law360)