Idea or Concept
Orexo’s Opioid Overdose Nasal Spray Fails FDA Review for Second Time
Orexo, OX124, FDA, Nasal Spray, Opioid Overdose, Naloxone, Human Factors Study, Technical Data
NGM Bio Secures $122 Million in Funding After Going Private
NGM Bio, funding, private, Column Group, pipeline, orphan diseases
VC Firm Oversees NGM Bio’s $122M Series A Funding After Taking it Private
NGM Bio, The Column Group, Venture Capital, Biotech, Series A Funding
AstraZeneca Appeals IRA Loss, Reiterates Constitutional Challenge to Drug Price Negotiations
AstraZeneca, IRA, Medicare, Drug Price Negotiation, Constitutional Challenge, Appeal
Almirall’s Ebglyss Gains NICE Recommendation for Atopic Dermatitis Treatment
Ebglyss, lebrikizumab, atopic dermatitis, NICE recommendation, Almirall, NHS England, biological therapy, moderate to severe atopic dermatitis
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).
Annovis Bio Reports Promising Phase III Study Results for Buntanetap in Parkinson’s Disease Treatment
Annovis Bio, Buntanetap, Parkinson’s Disease, Phase III Study, Neurodegenerative Disorders, Cognitive Function, Motor Functions, Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)
FDA Rejects Rocket Pharmaceuticals’ Gene Therapy for Ultra-Rare Immune Disease, Requests Additional Manufacturing Information
FDA, Rocket Pharmaceuticals, Gene Therapy, Leukocyte Adhesion Deficiency-I (LAD-I), Manufacturing Information, Complete Response Letter