Intellectual Product
Congress Must Reauthorize FDA Program for Pediatric Rare Diseases to Save Lives
Pediatric Rare Diseases, FDA Program, Reauthorization, Creating Hope Act, Priority Review Voucher Program
uniQure Announces Positive Interim Data Update Demonstrating Slowing of Disease Progression in Phase I/II Trials of AMT-130 for Huntington’s Disease
uniQure, Huntington’s disease, AMT-130, gene therapy, Phase I/II trials, disease progression, neurofilament light protein (NfL), Unified Huntington’s Disease Rating Scale (cUHDRS), Regenerative Medicine Advanced Therapy (RMAT) designation
US Speaker Promises Vote on BIOSECURE Act to Halt Federal Contracts with Chinese Biotech Companies
BIOSECURE Act, House Speaker Mike Johnson, Chinese biotech companies, federal contracts, healthcare data, national security
UniQure Wins First FDA RMAT in Huntington’s Disease After Strong Phase I/II Data
UniQure, Huntington’s disease, gene therapy, AMT-130, FDA, RMAT designation, Phase I/II clinical trials, neurodegenerative disorder, neurofilament light (NfL), disease progression, composite Unified Huntington’s Disease Rating Scale (cUHDRS).
US Government Appeals Jury Decision in High-Stakes HIV PrEP Patent Battle Against Gilead
HIV, PrEP, Patent Battle, Gilead, Truvada, Descovy, US Government, Patent Litigation
Supreme Court Overturns Chevron Doctrine, Limiting FDA’s Regulatory Authority
Chevron doctrine, FDA, regulatory authority, Supreme Court, administrative law, agency interpretations, statutory ambiguity
Daiichi Sankyo Secures $47 Million Victory in ADC Patent Arbitration Against AstraZeneca
Daiichi Sankyo, AstraZeneca, ADC Patent Arbitration, $47 Million Settlement
AbbVie’s Duopa Successor in Parkinson’s Rejected Again Due to Third-Party Manufacturer Issues
AbbVie, Duopa, Parkinson’s disease, FDA rejection, third-party manufacturer, ABBV-951, carbidopa, levodopa, subcutaneous pump device
AbbVie’s Parkinson’s Disease Therapy Rejected by FDA Due to Third-Party Manufacturer Issues
AbbVie, Parkinson’s disease, FDA, ABBV-951, foscarbidopa, foslevodopa, third-party manufacturer, regulatory issues
Pfizer Secures Major Contract Over GSK for RSV Vaccine Supply in the UK
Pfizer, GSK, RSV vaccine, UK contract, Abrysvo, Arexvy