Recon: Inovio to lay off 18% of its staff; EU signs COVID-19 procurement deal with Gilead

ReconRecon
| 19 July 2022 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • The politics of passing a major FDA funding bill just got complicated (STAT)
  • FDA approves first at-home therapy for skin repigmentation in vitiligo patients (STAT)
  • Biotech employees cash in health care’s largest salaries, while people working at providers sit near the bottom (STAT)
  • Dozens of lawmakers urge HHS to fine drugmakers for curtailing discounts to a federal program (STAT)
  • J&J's cancer drug sales help weather hit from stronger dollar (Reuters)
  • Inovio to cut 18% full-time jobs to conserve cash (Reuters)
  • In another Lynparza flop, AstraZeneca, Merck pull the plug on a colorectal cancer trial (Fierce)
In Focus: International
  • EU signs COVID drug procurement deal with Gilead (Reuters)
  • AstraZeneca's Enhertu gets broader EU approval for breast cancer (Reuters)
  • Novartis expects improved earnings at generics unit Sandoz (Reuters)
  • Japan's Shionogi starts COVID-19 vaccine trial among children (Reuters)
  • Australia provisionally approves Moderna's COVID shot for children under 5 (Reuters)
  • As COVID patent war rages on, pharma group seeks fairer future access (Reuters)
  • India’s patent office refuses BMS’ application for hepatitis C drug (Pharmabiz)
Pharma & Biotech
  • Contract research organization to transfer 4,000 beagles from facility cited for inhumane care (STAT)
  • Spain's Oryzon shares soar after US Cancer Institute agrees to test new drug (Reuters)
  • Personalized cancer therapy biotech PACT Pharma lets go of nearly 100 staffers (Fierce)
  • EU Rejects Calls To Extend Clinical Trial Regulation Transition Period (Pink Sheet)
  • Delfi Diagnostics scoops up $225M from Lilly, Illumina and more for its cancer blood tests (Fierce)
  • Covid-19 vaccines: shape-shifting virus puts agile manufacturers at an advantage (FT)
  • Sanofi/Sobi’s Next-Gen Factor VIII Therapy BLA Heats Up Biotech-Driven Hemophilia Arms Race (Pink Sheet)
  • Local Generics Win Big In China's Latest National Tender (Scrip)
Medtech
  • US FDA Requests Input For New Report On Non-Device Software Functions (MedtechInsight)
  • Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery (MedtechInsight)
  • Very Few Outstanding Items On European Commission’s Shrinking Rolling Plan (MedtechInsight)
  • Diagnostic sector faces a ‘challenging set-up’ amid economic slowdown: analysts (MedtechDive)
  • Roche's Alzheimer's blood test earns breakthrough label from FDA (Fierce)
  • Sci-fi no more: Synchron implants mind-reading device in first U.S. patient in paralysis trial (Fierce)
Government, Regulatory & Legal
  • Federal patent initiatives could cause ‘headwinds’ for drugmakers and their broad filings (STAT)
  • Justices Warned That Biogen's Loss Will End Drug Patents (Law360)
  • Drug Cos., Researchers Back Juno's 'Possession' Petition (Law360)
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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