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