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
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)
- 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.
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