Recon: Eli Lilly COVID antibody trial paused; Health Canada to review Moderna COVID vaccine in real time

• FDA faults quality control at Lilly plant making Trump-touted COVID drug (Reuters)
• Eli Lilly’s Antibody Trial Is Paused Over Potential Safety Concern (NYTimes)
• Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern (Reuters)
• FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’ (Politico)
• J&J to contribute up to $5 billion to potential US opioid settlement (Reuters)
• McConnell says US Senate will vote on target COVID relief bill (Reuters)
• Kids may not be recommended for COVID-19 vaccination initially, US CDC says (Reuters)
• Democrats urge watchdog to rush review of Trump drug cards (Politico) (WSJ)
• Will Kids Get A COVID-19 Vaccine? Pfizer To Expand Trial To Ages 12 And Up (NPR)

• Canada to review Moderna's COVID-19 vaccine candidate in real time (Reuters)
• Russia approves second COVID-19 vaccine after preliminary trials (Reuters)
• World Bank board approves $12B for COVID vaccines, treatments in developing countries (Reuters)
• Astrazeneca to provide Indonesia 100M COVID-19 vaccines next year- foreign minister (Reuters)
• South Africa's Biovac in talks to manufacture COVID-19 vaccines (Reuters)
• Pandemic puts global progress against tuberculosis at risk: WHO (Reuters)
• Healthineers launches rapid coronavirus antigen test, sees tight supply (Reuters)
• Air cargo industry not yet ready for COVID-19 vaccine distribution: survey (Reuters)
• AstraZeneca loses first-of-its-kind lawsuit filed by Dutch insurer over patent maneuver (STAT)

• Covid-19 Vaccines Are Chance at Salvation, Financial and Beyond, for Drug Makers (NYTimes)
• Coronavirus Vaccine Makers Are Not Mass-Slaughtering Sharks (NYTimes)
• US government signs deal to make more COVID-19 vaccine components (Reuters)
• New coronavirus rapid diagnostic tests will be game changer - PAHO director (Reuters)
• HHS invests $480 million in Cue Health to boost manufacturing of rapid coronavirus test (CNBC)
• Trial to test if Vitamin D protects against Covid (BBC)
• YouTube bans coronavirus vaccine misinformation (Reuters)
• Facebook Bans Ads Discouraging Vaccines, In Latest Misinformation Crackdown (NPR)
• FDA Warns Supplement Companies Illegally Selling Products Containing Cesium Chloride (FDA)
• Japan supercomputer shows humidity affects aerosol spread of coronavirus (Reuters)
• Vaxart was served a grand jury subpoena in July over its controversial role in OWS-funded preclinical study (Endpoints)
• FDA Grants EUA For Access Bio’s Lateral Flow COVID-19 Antigen Test (MedtechInsight)

• Dr. Hahn's Remarks to the Reagan Udall Foundation Annual Meeting (FDA)
• How To Get Orphan Drug Status In Great Britain From 2021 (Fierce)
• CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual Conference (IPQ)
• FDA puts Voyager study on hold in latest gene therapy speed bump (BioPharmaDive)
• Roche turns to a Harvard upstart out of George Church’s lab to construct AAV 2.0 model vectors — a key part of building the gene therapy pipeline (Endpoints) (BioPharmaDive)
• Gossamer plummets as its lead drug fails 2 studies (BioPharmaDive)
• Big 4 Wholesalers Now Suspected to Have Rigged Drug Prices in 2016 Too (PharmaJapan)
• Antibiotic Action Fund Remains Stop-Gap As Industry Waits For Reimbursement Legislation (Pink Sheet)
• Canaan raises another $800M as it launches its next fund with an emphasis on biotech (Endpoints)
• Third Rock-backed Cedilla reels in $57.6M for small molecule programs to fight cancer (Endpoints)
• Novartis bet $6B on the idea — now Versant, venBio have $45M to birth a platform play for radiopharmaceuticals (Endpoints)
• Months after achieving unicorn status, Orca steers into the fast lane with an RMAT designation for cell therapy candidate (Endpoints)
• Polyphor bags second grant in two years for a new class of antibiotics to fight drug-resistant bacteria (Endpoints)
• Pair of Lancet studies give final word on a promising Shionogi antibiotic that turned out to be 'as good' as the other 'suboptimal' options (Endpoints)
• Cyclerion axes another program as struggles grow for Peter Hecht's Ironwood spinout (Endpoints)
• Is right to try being tried? Using crowdfunding data to better understand usage of nontrial pre-approval access pathways (Future Medicine)
• AI Changing The Skills Balance In Pharmacovigilance Teams (Pink Sheet)

• Swiss referendum leaves MDR mutual recognition agreement question unresolved (Emergo)
• ANVISA publishes list of exempted healthcare products and cybersecurity guide (Emergo)
• Chinese regulators delay medical device UDI implementation (Emergo)

• Did the Federal Circuit Just Kill ANDA “Skinny Labeling”? – GSK v. Teva (FDA Law Blog)
• Supreme Court to Consider Constitutional Propriety of Appointment of PTAB Judges (Patent Docs)
• Theranos Founder Elizabeth Holmes Can't Shake New Charges (Law360)
• Medicare Proposed Part B Payment Policy For 505(b)(2) Drugs Is Illegal, Biopharma Argues (Pink Sheet)
• Patent Law Is Just The Beginning For High Court In Arthrex (Law360)
• Humira Buyers Get Backing Against AbbVie's 'Patent Thicket' (Law360)
• High Court PBM Case Could Be Turning Point In 20-Year Fight (Law360)
• Fed. Circ. Backs Sanofi, Regeneron PTAB Win Over Amgen (Law360)
• Mylan Can't Expedite Novartis Blood Transfusion IP Fight (Law360)