Recon: Gilead Warns Against Counterfeit HIV Drugs in US; Novavax is slow to seek approval for its COVI

Posted on August 06, 2021 | Through Michel mezher

Welcome to Regulatory Reconnaissance, your daily briefing on regulatory news and intelligence.

Focus: United States

  • FDA’s Covid-19 vaccine recall plan could be ready in weeks (WSJ)
  • Novavax delays US approval request for COVID-19 vaccine again (Reuters)
  • Novavax says US to suspend funding for vaccine production (NYTimes)
  • Medtronic Acquires Intersect ENT in $ 1.1 Billion Agreement Targeting Chronic Rhinosinusitis Market (MedtechDive)
  • Gilead says he is aware of the distribution of HIV drugs in the United States (Reuters)
  • FDA approves new treatment for Pompe disease (FDA)
  • US plans to give additional COVID-19 injections to Americans at risk, Fauci says (Reuters)
  • FDA cuts down on Spectrum’s neutropenia drug, citing manufacturing issues (Endpoints)
  • FDA Med Conference Study Raises Risk of Drug Law Enforcement (Law360)
  • Court ruling pushes FDA to make landmark change and regulate drug products / borderline devices as devices (endpoints)
  • Federal Circuit upholds Teva-GlaxoSmithKline decision, dealing another blow to “skinny” labels (Endpoints) (Law360)

Focus: international

  • Interoperability of traceability systems: key to the protection of public health (EMA)
  • Highlights of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting August 5, 2021 (EMA)
  • EU: Too early to say if COVID recall is needed as Germany and France move forward (Reuters)
  • CanSinoBIO COVID-19 says booster may reverse drop in antibodies (Reuters)
  • J&J calls for green light for emergency use of COVID-19 vaccine in India (Reuters)

Coronavirus pandemic

  • White House pushes back to school for student vaccinations (NYTimes)
  • A giant trial of COVID-19 treatments is restarting. Here are the drugs he bet on (Science)
  • South African study shows high COVID protection from J&J shot (Reuters)
  • Early signs COVID-19 vaccines may not stop Delta transmission, England says (Reuters)
  • SII will not seek special marketing approval from the EU body for vax (Economic Times)
  • DHS watchdog blames data management for rocky PPE distribution: report (The Hill)

Pharma & Biotech

  • Consultation on the Early Access to Medicines Program (EAMS) (MHRA)
  • Biden plan backfires as court tells AstraZeneca: no obligation to provide discounted drugs to pharmacies with unlimited contracts (endpoints)
  • A Texas-based pharmaceutical company brought in Catalent for the manufacture of oral solids; Cytiva Drops Massive Home State Manufacturing Investment (Endpoints)
  • Q&A: BeiGene executive reflects on his path to selecting NJ for a major manufacturing / R&D campus (Endpoints)
  • FDA orders clinical suspension of Aprea’s p53 reactivator as struggling biotech vows to address safety concerns (Endpoints)
  • Drug price disruptor EQRx wins big with $ 1.8 billion PSPC deal and new CEO at the helm (Endpoints)
  • With help from AstraZeneca, Sierra’s rescue team are betting another $ 216 million they can resurrect an old drug Gilead JAK (Endpoints)
  • Dicerna’s RNAi Drug Shows ‘Inconsistent’ Results in Rare Kidney Diseases, Registering Market Share Despite Trial Win (Endpoints)
  • Chinese start-up led by Merck veterinarian acquires rights to nasal spray for eye diseases from Oyster Point (Endpoints)
  • M&A mGx? Moderna Executives Leverage Their Covid Money for Gene Editing and Gene Therapy Agreements (Endpoints)


  • ResMed estimates Philips recall will boost sales by up to $ 350 million as it struggles to meet growing demand (MedtechDive)
  • TriGUARD 3 data fails the rally: FDA experts (MedtechInsight)
  • BD Results Mixed Amid Bullish COVID-19 Testing Outlook (MedtechDive)
  • Huit Medical International Recalls Recirculator 8.0 Disposable Wash Kits Due To Potential Exposure To High Levels Of Aluminum (FDA)
  • Zoll Gets FDA Approval for Updated Sleep Apnea Implant Acquired from Respicardia (Fierce) Buyout
  • Illumina Reports 78% Revenue Growth Due to Cancer and Resume DNA Testing (Fierce)
  • iRhythm does not expect CMS 2022 pricing. “It may take a while. »(Medtech Diving)

Government, Regulation and Legal

  • Federal Court Orders California Company and Owner to Stop Distributing Unapproved, Mislabeled, and Falsified (DOJ) “Poly-MVA” Products
  • Actavis Marketed Off-Label Testosterone Drug, Sick Jury Says (Law360)
  • 8th Circ. Backs 3M In Nixing Suit Over Warming Device (Law360)
  • Teva launches accusations of tough tactics against GM (Law360)

Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you key regulatory, biopharmaceutical and medical news from around the world.

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

© 2021 Society of Regulatory Affairs Professionals.

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