Recon: Lilly, UnitedHealth launch COVID antibody trial; Bahrain authorizes Pfizer-BioNTech vaccine

• FDA chief had 'robust discussion' with White House about vaccine timelines (Reuters)
• How key decisions slowed FDA’s review of Covid-19 vaccine — but also gave it important data (STAT)
• Pfizer Shares Gain Amid Pushback on COVID Vaccine Rollout Headlines (The Street) (Fierce)
• Pfizer Slashed Its Original Covid-19 Vaccine Rollout Target After Supply-Chain Obstacles (WSJ) (Reuters)
• Analysis: First US delivery of COVID-19 vaccine will leave out many high-risk workers (Reuters)
• Lilly and UnitedHealth launch trial of COVID-19 antibody (Reuters)
• CDC approves expert panel recommendations on COVID-19 vaccine distribution (Reuters)
• Biden says he'll publicly get a COVID-19 vaccine, keep Fauci (Reuters)
• Zients, Murthy tapped to head up Biden’s Covid-19 response (Politico)
• Rhode Island Gov. Raimondo says she won't be Biden's HHS secretary (The Hill)
• BIO to file lawsuit today to block Trump international drug pricing policy (STAT)

• UK hopes for millions of Pfizer/BioNTech vaccine doses this year: minister (Reuters)
• Fauci apologises for saying UK 'rushed' vaccine (BBC) (FT) (CNBC)
• Britain to cover COVID-19 vaccine side-effects under damages scheme (Reuters)
• China could have 600m vaccine doses ‘ready’ this month (FT)
• France says COVID-19 vaccine will be free for all (Reuters)
• WHO hopes to have half a billion vaccine doses through COVAX facility in first quarter of 2021: chief scientist (Reuters)
• Bahrain approves Pfizer/BioNTech COVID-19 vaccine (Reuters)
• Russia to vaccinate two million against COVID-19 in December - RDIF head to BBC (Reuters)
• China's Clover says its COVID-19 vaccines trigger 'strong immune responses' in early trial (Reuters)

• Access Consortium statement on COVID-19 vaccines evidence (Health Canada)
• CBER Will Need About A Week To Complete COVID Vaccine Assessment Following Advisory Cmte., Marks Says (Pink Sheet)
• Could a Blood Test Show if a Covid-19 Vaccine Works? (NYTimes)
• First-of-its-kind African trial tests common drugs to prevent severe COVID-19 (Science)
• Vaccine production in focus as Moderna, Pfizer await FDA decision (BioPharmaDive)
• Dry Ice Demand Swells as Covid-19 Vaccines Prepare for Deployment (WSJ)
• Siemens COVID-19 test gets high marks on FDA sensitivity list, beating Abbott, BD and Roche (MedtechDive)
• COVID-19 Vaccines: AstraZeneca’s UK Study Not Good Enough For US FDA Authorization, Slaoui Says (Pink Sheet)
• Norway to use three vaccines to stop COVID-19 from early 2021 (Reuters)
• Costa Rica signs COVID-19 vaccine deal with Pfizer and BioNTech (Reuters)
• Brazil gets Chinese COVID-19 vaccine doses, Senate OK's British vaccine funding (Reuters)
• Moderna to supply four million more doses of COVID-19 vaccine to Israel (Reuters)
• Dutch PM Rutte: expects one million doses of Pfizer, 400,000 doses of Moderna vaccines (Reuters)

• BioCryst wins approval for HAE pill and charges half-a-million dollars, but will anyone take it? (Endpoints)
• Drug companies’ payments and gifts affect physicians’ prescribing. It’s time to turn off the spigot (STAT)
• As COVID-19 demand surges, BD blueprints $1.2B expansion to jack up prefilled syringe output by 50% (Fierce)
• A new RNA partnership hunts rare epilepsies; AbbVie and I-Mab tackle CD47 (Endpoints)
• Ziopharm's activist drama continues as another board member member resigns. Is the end in sight? (Endpoints)
• GSK vet Antony Blanc signs on to become CureVac's CBO and CCO; Chris Cabell out, Paul Streck in as Arena Pharmaceuticals CMO (Endpoints)
• A decade after it first failed, a Shire-developed Takeda antiviral appears successful in Phase III (Endpoints)
• J&J guns for quick drug OK in lung cancer niche, taking the first step challenging AstraZeneca in EGFR (Endpoints)
• Four biotechs hit Wall Street with upsized IPOs, each raising more than $20M over their goals (Endpoints)
• Sutro's continued PhI data readouts indicate improving response in ovarian cancer. What's next? (Endpoints)
• FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection (FDA)

• CMS Final Medicare Outpatient Rule Gives Patients More Surgical Site Choices, At Lower Costs (MedtechInsight)
• CMS adds hip replacements, other surgeries to ASC list in final rule (MedtechDive)
• LivaNova to exit heart valve business via €60M carve-out deal (Fierce)
• Public Health Threat For EU Patients If IVDR Implementation Issues Remain Unaddressed (MedtechInsight)

• Congress takes up historic bill to decriminalize cannabis (NBC)
• With growing usage and few generics, Medicare spending on inhalers is climbing (STAT)
• W.Va. Opioid Bellwether Delayed By Virus Concerns (Law360)
• Vivus Cleared For Amended Ch. 11 Plan With Drug Royalties (Law360)