Recon: FDA puts Bellicum cancer trial on hold; Biden makes first health picks

• Biden picks Xavier Becerra to lead HHS, coronavirus response (AP) (Reuters) (NYTimes) (NPR)
• Biden transition, US coronavirus vaccine teams to meet amid surge, distribution questions (Reuters)
• Palantir Wins FDA Contract to Power Drug Review, Inspections (Bloomberg)
• FDA places clinical hold on Bellicum's cancer therapy (Reuters)
• Moderna CEO confident of producing 500 million COVID-19 vaccine doses in 2021 (Reuters)
• Doctors Are Skeptical of Pricey Drug Given Emergency Approval for Covid (NYTimes)
• A payoff for taxpayers? CDC may have claims on remdesivir patents held by Gilead (STAT)
• States defer to health providers on who gets first vaccines (Politico)
• FDA approves Novo Nordisk's Saxenda for adolescent obesity (Pharmafile) (FDA)

• Britain gets ready for rollout of Pfizer's COVID-19 vaccine this week (Reuters)
• UK regulator who approved COVID jab says 'we are ready' for no-deal Brexit (Reuters)
• WHO does not envisage COVID-19 vaccines being made mandatory (Reuters)
• WHO hopes to have 500M vaccine doses via COVAX scheme in Q1 2021 (Reuters)
• Scandal Dogs AstraZeneca’s Vaccine Partner in China (NYTimes)
• Bayer accelerates cell and gene therapy drive with Atara deal (Reuters)
• Sinovac secures $515 million funding to boost COVID-19 vaccine production (Reuters) (FT)
• PMDA to Continue Remote GCP/Compliance Inspections through June Next Year (PharmaJapan)
• Pfizer has sought emergency approval for COVID-19 vaccine in India - government adviser (Reuters) (Economic Times)

• As Virus Spreads, C.D.C. Draws Up an Urgent Battle Plan (NYTimes)
• ‘Natural Immunity’ From Covid Is Not Safer Than a Vaccine (NYTimes)
• U.S. AstraZeneca vaccine trial will clear confusion on how well it works - U.S. scientist (Reuters)
• Biotech company seeking FDA approval to test nasal spray as short-term coronavirus protection (The Hill)
• Canada doubles Moderna vaccine order, daily COVID-19 cases could top 10,000 by January (Reuters)
• Canada set to receive first doses of Pfizer's COVID-19 vaccine before end of year (Reuters)
• Pfizer's COVID-19 shots could be shipped within 24 hours after Canadian approval (Reuters)
• Swiss say Pfizer/Biontech will deliver three million doses of vaccine (Reuters)
• Some 3,000 to 5,000 Hungarians could participate in trials of Russian vaccine (Reuters)
• Russia approves clinical trials for Chinese COVID-19 vaccine Ad5-Ncov: Ifax (Reuters)
• TimesCovid vaccines will be available for private purchase in India (FT)
• Indonesia receives first COVID vaccine from China's Sinovac (Reuters)
• Quest gets first FDA nod for at-home collection COVID-flu combo test (MedtechDive)

• FTC says the number of pay-to-delay cases remains low, but vows to keep watch (STAT) (Law360)
• Janssen seeks EU approval for twice-yearly schizophrenia treatment (PharmaTimes)
• With new data and a storied history, Eli Lilly’s blood cancer pill is looking stronger (STAT)
• J&J’s CAR-T drug maintains strong efficacy in myeloma, shaded by neurotoxicity (STAT)
• ASH: Incyte, Novartis eye Jakafi approval after chronic graft vs. host win (Fierce)
• J&J study finds multiple myeloma cell therapy to be strongly effective (Fierce)
• ASH: AstraZeneca's Calquence, BeiGene's Brukinsa turn heads with new data, putting Imbruvica on notice (Fierce)
• ASH: Allogene's off-the-shelf CAR-T posts 60% response rate in fiercely competitive BCMA field (Fierce)
• Preliminary but ‘nothing short of great.’ New data on CRISPR treatment for blood diseases suggest cure is possible (STAT) (NEJM)
• Innovative universal flu vaccine shows promises in first clinical test (Science)
• Roivant gets $200M for major push into protein degradation (Fierce)
• Constellation’s blood cancer drug shows greater benefit, easing concerns about its future (STAT)
• Genetically targeted drug from Kura Oncology induces remissions in adult leukemia patients (STAT)
• C&EN’s Year in Pharma 2020 (C&EN)
• Clinical Study Shows Benefits of Using Pharmacogenetics among Statin Users (GEN)
• Why don't patients love pharma apps? Because most are just mediocre, advocacy network says (Fierce)
• Endo eliminating 560 positions as its prepares to launch cellulite treatment (Bizjournals)
• New studies show diabetes drug not proven to improve blood sugar control in pediatric patients (FDA)
• Generic Drug User Fee Projections Complicated By Shifting Personnel Costs (Pink Sheet)
• EU Makes Only Limited Use Of Remote Clinical Trial Monitoring (Pink Sheet)

• Olympus to pay $300M to buy Veran for lung navigation system (MedtechDive)
• CBT digital therapeutic for IBS patients receives FDA De Novo clearance (mobihealthnews)
• The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems (FDA)

• The Future of EUAs: What Happens Post-Crisis (FDA Law Blog)
• U.S. Supreme Court takes up Trump bid to revive Medicaid work requirements (Reuters)
• Broken Promises — How Medicare Part D Has Failed to Deliver Savings to Older Adults (NEJM)
• Sens. Back PTAB Denial Rules, Drug Pricing Activists Balk (Law360)
• Ind. Panel Affirms Medtronic's $112M Loss In IP Contract Row (Law360)
• Regeneron Can't Escape Feds' Medicare Kickback Case (Law360)
• 'Lifesaving' Claim Barred In Hernia Mesh Bellwether Trial (Law360)
• Vectura Ltd. v. GlaxoSmithKline LLC (Fed. Cir. 2020) (Patent Docs)