Recon: Pharma supply chain vulnerable during COVID; OIG takes aim at pharma speaker program

• Pfizer, Moderna Discussing When To Drop Controls In COVID Vaccine Trials With US Government (Pink Sheet)
• When will COVID-19 vaccines be widely available? Feds lay out an ambitious timeline (Fierce Pharma)
• FDA and FTC issue more warning letters citing products and services making illegal COVID claims (Science-Based Medicine)
• House OKs Bill To Join Global Health Org. Funding Vaccines (Law360)
• COVID Vaccines Getting Parallel Review: ACIP To Begin Process Before FDA Decisions (Pink Sheet)
• Experts say more funding, staffing needed to effectively roll out COVID-19 vaccine (US PIRG)
• Biden adviser says scientists, not political appointees, should lead public communications on Covid-19 (STAT)

• EU Prepares To Reveal Pharma Strategy (Pink Sheet)
• Five Chinese coronavirus vaccines in overseas clinical trials (Pharmafile)
• Samsung Biologics, AstraZeneca to dissolve biosimilar JV, scrap Rituxan copy program: report (Fierce Pharma)
• Virtual G-20 Meeting Not Expected To Result In Unified Approach To COVID-19 (KFF News)
• Covid vaccines must be ‘a global, public good,’ WHO says (CNBC)
• First doses of China's CoronaVac COVID-19 vaccine arrive in Brazil (Reuters)
• Russia resumes COVID-19 vaccine trial after pause - medical staff (Reuters)
• India’s drugmakers will be ‘essential’ in Covid-19 therapy production, says public health expert (CNBC)

• The Lancet: Phase 2 trial of Oxford COVID-19 vaccine in healthy older adults finds it is safe and provokes immune response (AAAS) (Reuters)
• Oxford trial chief says its Covid vaccine could still be ready at a similar time to others (CNBC)
• The COVID Cold Chain: How a Vaccine Will Get to You (SciAm)
• EDQM releases new guidelines for COVID-19 vaccine quality testing (EPM)
• Fever, aches from Pfizer, Moderna jabs aren’t dangerous but may be intense for some (Science)
• A big week for mRNA COVID-19 vaccines: Five key developments (BioPharma-Reporter)
• Roche's Actemra helps the sickest COVID-19 patients, study shows (Reuters)
• Take It From an Expert: Fauci’s Hierarchy of Safety During COVID (NYT)
• COVID-19 vaccines that could report Phase III data before Moderna, Pfizer-BioNTech products become broadly available (Biocentury)

• Investors Launch $750 Million African Biopharmaceutical Platform (FDANews)
• HHS launches pilot program in five states using rapid Covid test deployed by NBA (CNBC)
• Renegotiate the $6B CVR deal Bristol Myers made for the Celgene buyout? Caforio says that’s not happening (Endpoints)
• Sanofi Draws Complete Response Letter for Hemolysis Treatment Candidate (FDANews)
• Alkermes Hit With Complete Response Letter Over Schizophrenia, Bipolar Disorder Drug Candidate (FDANews)
• Pharma supply chain still highly vulnerable to COVID-19 pandemic, says research (EPR)
• Study of 'exceptional responders' yields clues to cancer and potential treatments (NIH/NCI)
• Biotech
• Gene therapy hemophilia B ‘cure’ approach heats up as uniQure/CSL, rivalling Pfizer, shows promise (Fierce Biotech)
• Elevation Raises $65 Million to Advance Treatment for Genomically Defined Tumors (Global Genes)

• Short CO2 supply may complicate COVID-19 vaccine rollout (C&EN)
• Olive Union creates dual-purpose hearing aids and wireless Bluetooth earbuds (MobiHealthNews)
• Regulation of Over-the-Counter Hearing Aids — Deafening Silence from the FDA (NEJM)
• Healthineers’ COVID-19 antibody test launches in EU (PMLive)
• Hydrogel adult heart printed to scale at unprecedented detail (C&EN)
• Bayer looks to digital partnerships to expand efforts in cardiometabolic care, oncology and women's health (MobiHealthNews)

• GAO Critiques Transparency of FDA’s Emergency Use Authorizations (FDANews)
• Bankruptcy Judge Partially Approves Purdue Pharma Opioid Settlement (FDANews)
• Feds Urge Court Not To Ax $300M Teva Kickback Case (Law360)
• Assessing the Magnitude of the Administration’s Drug Pricing Rule (American Action Forum)
• Surprise Federal Drug Rule Directs Insurers to Reveal What They Pay for Prescription Drugs (KHN)
• Amid scrutiny of exec stock sales, SEC chairman echoes calls for 'cooling-off period' in trading plans (Endpoints)
• House passes a bill to close a loophole in a law that gives drug makers ‘unfair’ monopolies (STAT)
• OIG Fires Another Warning Shot at Drug and Device Companies’ In-Person Speaker Programs (FDA Law Blog)