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

Posted 19 November 2020 | By Kari Oakes 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US

  • 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)

In Focus: International

  • 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)

Coronavirus Pandemic

  • 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)

Pharma & Biotech

  • 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)

Government & Regulatory

  • 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)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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