Intellectual Product – Page 24

FDA Issues Warning Letter to Indian CDMO Brassica for Data Falsification and Poor Hygiene Practices

10 months ago talkbio0Tagged Asian Indian, Cautionary Warning, CDMO, Cyclic GMP, Data Falsification, Indian, Letter [Publication Type], Pharma, United States Food and Drug Administration, Violations

FDA, Warning Letter, Brassica Pharma, Data Falsification, Poor Hygiene, Indian CDMO, CGMP Violations

Agilent Technologies Acquires Biovectra for $925 Million to Enhance Biologics and CRISPR Capabilities

10 months ago talkbio0Tagged Acquisition (action), Agilent Technologies, Biological Factors, Biovectra, CDMO, Clustered Regularly Interspaced Short Palindromic Repeats, Contract agreement, Manufacturing Organization

Agilent Technologies, Biovectra, Acquisition, Biologics, CRISPR, Contract Development and Manufacturing Organization (CDMO)

Tonix Pharmaceuticals Secures $34 Million Contract with US Defense Department for Antiviral Development

10 months ago talkbio0Tagged Antiviral Development, Contract agreement, Department of Defense, Tonix

Tonix Pharmaceuticals, US Defense Department, Antiviral Development, $34 Million Contract

Congress Must Reauthorize FDA Program for Pediatric Rare Diseases to Save Lives

10 months ago talkbio0Tagged Creating Hope Act, Pediatric Rare Diseases, Priority Review, Programs - Publication Format, Reauthorization, United States Food and Drug Administration

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

10 months ago talkbio0Tagged AMT-130, cUHDRS, Disease Progression, gene therapy, Huntington 's disease, Huntington 's Disease Rating Scale, Identifier, neurofilament protein L, NfL, Phase I/II trials, Regenerative Medicine, RMAT, Unified - Type of Agreement, UniQure

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

10 months ago talkbio0Tagged BIOSECURE, Chinese Language, Contract agreement, federal, Health care facility, House Speaker Mike Johnson, National Security

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

10 months ago talkbio0Tagged AMT-130, Clinical Trials, Composite, cUHDRS, Disease Progression, gene therapy, Huntington 's disease, Huntington 's Disease Rating Scale, Identifier, NEFL gene, Neurodegenerative Disorders, NfL, Phase, RMAT, Unified - Type of Agreement, UniQure, United States Food and Drug Administration

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).