Recon: FDA rebukes CytoDyn over COVID drug claims; BMS to pay as much as $1.4B for Agenus most cancers drug

Posted on May 18, 2021 | By Michael Mezher

Welcome to Regulatory Reconnaissance, your daily regulatory news and information.

In focus: USA

  • The FDA blames CytoDyn for allegations about the Covid-19 drug (STAT) (Endpoints) (FDA).
  • Biden pledges to export millions of FDA-approved vaccines (Bloomberg) (Reuters) (Politico)
  • Bristol Pays up to $ 1.38 billion to develop and sell Agenus cancer therapy (Reuters) (Endpoints) (Press)
  • Roche COVID test gets the green light for asymptomatic people in the US (Reuters)
  • US Supreme Court rejects Novartis appeal against arthritis drug Enbrel (Reuters) (Endpoints)
  • The US Supreme Court denies J & J’s appeal on Risperdal drug (Reuters) (Law 360).
  • CDC’s deputy Anne Schuchat resigns (Politico) (STAT)
  • The government is calling on drug manufacturers to give discounts or fines to hospitals with safety nets (STAT).
  • The House Committee reveals how the price of Humira increased 470% as AbbVie executes redeemed bonuses related to Endpoints (STAT).

In focus: international

  • G20 snubs’ COVID patent waiver dilutes WHO funding pledge (Reuters)
  • GSK and Medicago Report Positive Data From Covid Vaccine Studies (The Guardian) (Bloomberg) (Press)
  • J&J vaccine shipments to the EU were cut in half this week – EU source (Reuters)
  • India is unlikely to resume its sizeable COVID-19 vaccine exports until October (Reuters)
  • A Spanish study shows the AstraZeneca vaccine followed by the Pfizer dose is safe and effective (Reuters).
  • Japan’s Fujifilm Says It Can Make New Coronavirus Variant Detection Kits In Weeks (Reuters)
  • Singapore Approves Covid Vaccine For Children Ages 12-15 As Case Increase (CNBC)
  • Novartis’ Sandoz Launches € 150M Antibiotic Manufacturing Upgrade in Europe (Fierce) (Press)
  • Northern Ireland faces “huge” rise in generic drug prices (FT)

Coronavirus pandemic

  • How can you make Covid-19 vaccines without the help of J&J, Pfizer, or Moderna? Biolyse sees the difficulties up close (endpoints)
  • India is dropping plasma therapy from Covid-19 Management Guidelines (Economic Times)
  • They are vaccinated and keep their masks, maybe forever (NYTimes)

Pharma & Biotech

  • Cel-Sci’s CEO spoke privately to investors last week and expressed doubts about the long-belated cancer drug (STAT).
  • Effects of COVID-19 on Clinical Trials in Oncology: A 1-Year Analysis (Nature)
  • Charles River is constantly expanding its CDMO arm, grabbing a viral vector player for a whopping $ 350 million (endpoints) (Fierce).
  • Novo Nordisk’s Ziltivekimab Hits Primary Endpoint in CKD Study (PharmaTimes)
  • Advancing the FDA’s mission by targeting key areas for investment and innovation in Regulatory Science (FDA)
  • MHLW proposes lifting the domestic ban on cannabis-derived drugs and moving towards an “ingredient-based” regulation (PharmaJapan)
  • Pharma to Govt: Maintain prices for patented drugs, this is the global standard (PharmaJapan)
  • The start-up focused on the pain relieving effects of cannabis and was performed in London (FT).
  • Johnson & Johnson Donates Ebola Vaccine in New Outbreak; Ji Xing Pledges More than $ 127M for Milestones Fast Heart Rate Nasal Spray (Endpoints)
  • Jim Wilson and Tachi Yamada are back – starting a 2nd generation gene therapy company with risk taking, global vision and $ 200 million to play with (endpoints).
  • Europe’s new investment firm says it is a mission to raise the continent’s “underutilized” science (endpoints).
  • Amgen partner Biotech investigates clinical proof of concept for HER3 drugs and receives US $ 125 million for precision antibodies (endpoints).
  • The Impact of Generic Entry on Antibiotic Prescribing in the US (Natural)


  • Device manufacturers in the joint FDA / MDIC pilot project close CAPAs faster, agency reports (MedtechInsight)
  • Bayer sees a jump in Essure reports of adverse events originating from social media (MedtechDive).
  • Swiss consultation on the local IVDR The EU-MRA was waiting until July (MedtechInsight)
  • European Commission launches specific helpdesk focusing on UDI for Medtech (MedtechInsight)
  • Laboratory Developed Tests: Members of Congress Ask FDA to Do Their Work for Them (FDA Law Blog)
  • Edwards tricuspid valve replacement reduced leakage in 98% of early trial participants (MedtechDive).

Government, Regulation & Law

  • Kodak Says NY Threatened to File Insider Trade Lawsuit (Law360)
  • Shkreli Cos. ‘Ability to Pay Penalties Irrelevant, Says FTC (Law360)
  • FTC Continues to Tackle CBD Vendors’ Panacea Claims (Law 360)

Regulatory Recon is our daily intelligence briefing for the area of ​​regulatory affairs and offers you the most important news from all over the world in the areas of regulatory, biopharma and medtech.

Inclusion of a story in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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