Recon: Inovio will lay off 18% of its staff; EU signs COVID-19 supply agreement with Gilead


| July 19, 2022 | By Michael Mezher


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

In brief: United States

  • The Politics of Passing a Major FDA Funding Bill Just Got Tricky (STAT)
  • FDA approves first home therapy for skin repigmentation in patients with vitiligo (STAT)
  • Biotech employees take the highest salaries in healthcare, while those working in providers sit near the bottom (STAT)
  • Dozens of lawmakers urge HHS to fine drugmakers for cutting rebates to a federal program (STAT)
  • J&J’s cancer drug sales help weather a stronger dollar (Reuters)
  • Inovio to cut 18% of full-time jobs to save money (Reuters)
  • In another Lynparza flop, AstraZeneca, Merck pulls the plug on colorectal cancer trial (Fierce)

Focus: International

  • EU signs COVID drug purchase agreement with Gilead (Reuters)
  • AstraZeneca’s Enhertu wins wider EU approval for breast cancer (Reuters)
  • Novartis expects earnings improvement from Sandoz generics unit (Reuters)
  • Japan’s Shionogi launches COVID-19 vaccine trial in children (Reuters)
  • Australia tentatively approves Moderna’s COVID vaccine for children under 5 (Reuters)
  • As COVID patent war rages, pharma group seeks fairer future access (Reuters)
  • Indian patent office denies BMS application for hepatitis C drug (Pharmabiz)

Pharmaceuticals and biotechnology

  • Contract research organization to transfer 4,000 beagles from facility cited for inhumane care (STAT)
  • Oryzon’s Spanish shares soar after the US Cancer Institute agreed to test a new drug (Reuters)
  • Personalized cancer therapy biotech PACT Pharma lays off nearly 100 employees (Fierce)
  • EU rejects calls to extend clinical trials regulation transition period (pink sheet)
  • Delfi Diagnostics recovers $225 million from Lilly, Illumina and more for its cancer blood tests (Fierce)
  • Covid-19 vaccines: shapeshifting virus gives nimble manufacturers an advantage (FT)
  • BLA, Sanofi/Sobi’s next-generation factor VIII therapy, heats up the biotech-driven hemophilia arms race (pink sheet)
  • Local generics win big in China’s latest national tender (Scrip)

medical technology

  • US FDA seeks feedback for new report on non-device software functions (MedtechInsight)
  • Well done: FDA clears Apollo Endosurgery weight loss suture systems (MedtechInsight)
  • Very few outstanding items on the European Commission’s rolling reduction plan (MedtechInsight)
  • Diagnostics industry faces ‘difficult setup’ amid economic downturn: analysts (MedtechDive)
  • Roche’s Alzheimer’s blood test gets breakthrough label from FDA (Fierce)
  • No more sci-fi: Synchron implants mind-reading device in first US patient in paralysis trial (Fierce)

Government, regulation and legal

  • Federal patent initiatives could cause ‘headwinds’ for drugmakers and their broad filings (STAT)
  • Judges warned loss of Biogen will end drug patents (Law360)
  • Drug Cos., Researchers Support Juno’s ‘Possession’ Petition (Law360)

Regulatory Recon is our daily intelligence briefing for regulatory affairs, bringing you top regulatory, biopharma and medtech news from around the world.

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