Recon: AstraZeneca cancer drug disappoints in COVID trial; Lawmakers seek changes to $8.3B Purdue settlement

• Fauci stresses on need for equitable access of COVID-19 vaccines (Reuters)
• How Pfizer Plans to Distribute Its Vaccine (It’s Complicated) (NYTimes)
• Moderna close to revealing first data on whether its vaccine works (Politico) (FT)
• Pfizer says placebo patients will eventually get its Covid-19 vaccine. The question of when is complicated (STAT)
• Lawmakers urge Justice Department to revise $8.3 billion settlement with Purdue (STAT)
• Novavax Posts Coronavirus Vaccine Contract That Government Didn't Disclose (NPR)

• WHO in talks with Russian institute on Sputnik V COVID-19 vaccine (Reuters)
• Medicago to kick off large study of COVID-19 vaccine with GSK booster (Reuters)
• CureVac CEO eyes COVID-19 vaccine approval in third quarter of 2021 (Reuters)
• CureVac says its COVID-19 vaccine is suitable for standard fridge transport (Reuters 1, 2)
• AstraZeneca's cancer drug disappoints as potential COVID-19 treatment (Reuters)
• South Korea in final talks over COVID-19 vaccines, seeks supplies for 60% population (Reuters)
• Japan's Fujitsu, Mizuho, PeptiDream to form joint venture to develop COVID-19 treatments (Reuters)
• French regulator indicted for manslaughter for failing to respond to a drug’s side effects (STAT) (Endpoints)

• After COVID Diagnosis, Nearly 1 In 5 Are Diagnosed With Mental Disorder (NPR)
• Hungary to become first EU state to trial Russian Covid vaccine (FT)
• Johnson & Johnson confident in 1B dose goal for COVID vaccine next year, looking ahead to 2022 (Fierce)
• Generics players join pledge to rapidly scale access to COVID-19 drugs. But will pharma sign on? (Fierce)
• ‘The Gruber Moment’: How CBER Got The Answers It Wanted On COVID Vaccine Guidance (Pink Sheet)
• Russia’s claim of a successful COVID-19 vaccine doesn’t pass the ‘smell test,’ critics say (Science)
• Gates Foundation adds $70 million more funding for COVID vaccines for poor (Reuters)
• India's Serum says made 40 million doses of AstraZeneca's COVID vaccine, to make Novavax shot soon (Reuters)
• Cuba leads race for Latin American coronavirus vaccine (Reuters)
• Major generic makers will partner with Medicines Patent Pool to pursue voluntary licenses for Covid-19 drugs (STAT)

• Gene therapy pioneer develops a new approach to curb the side effects of treatment (STAT)
• FDA Quietly Plots Pilot Program For Virtual Inspections As Pandemic Rages On (MedtechInsight)
• Will Aducanumab Join List Of Drugs Approved By US FDA Over Advisory Committee Opposition? (Pink Sheet)
• Report: Workshop on benefit-risk of medicines used during pregnancy and breastfeeding (EMA)
• UCB inks Handl buyout to boost nascent gene therapy unit (Fierce)
• Bayer powers gene-editing startup Metagenomi to $65M A round (Fierce)
• AZ’s BTK inhibitor Calquence fails in COVID-19 study (PMLive)
• Merck, Eisai’s Keytruda plus Lenvima combo hits the mark in renal cancer (PMLive)
• NICE recommends Sanofi’s Cablivi for ultra-rare acute thrombotic thrombocytopenic purpura (Pharmafile)
• US FDA’s Fastest Approvals Concentrate In Oncology, Infectious Disease (Pink Sheet)
• Santhera Pulls EU Filing For Failed DMD Candidate (Pink Sheet)
• Under a new CEO, German CDMO Vibalogics bets $150M and 110,000 square feet on the gene therapy revolution (Endpoints)
• Small merger to advance anti-aging program; Sanger Institute spinout nabs $50M from Series C (Endpoints)
• Kira Pharmaceuticals emerges from stealth with $46M and new CEO to lead complement therapy mission (Endpoints)
• Targeting receptor complexes: a new dimension in drug discovery (Nature)
• Chasing a 'master modulator' in the endocannabinoid system, biotech upstart promises to shake up neuropsychiatric treatments (Endpoints)
• Neglected tropical diseases: World Health Assembly endorses bold new road map targets for 2030 (WHO)

• UK fleshes out post-Brexit approach to regional medical device marking (MedtechDive)
• Japan’s 1st Therapeutic App OK’ed for Health Coverage, Due for Release on Dec. 1 (PharmaJapan)

• Further Musings about DEA’s “Suspicious Order” Proposed Rule: What Will a Registrant be Required to Report? (FDA Law Blog)
• The Ninth Circuit’s Booker Decision (Drug & Device Law)