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Q&A: Cell and gene therapy value assessments need a rework to allow access
With the boom of cell and gene therapy development in recent decades, several regulators have scrambled to adapt their regulations …
AskBio’s AB-1002 gene therapy receives FDA fast-track status
The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy …
API biologics (protein and peptide) companies in contract manufacturing
API peptides and protein-based drugs are promising therapeutics for the treatment of a variety of metabolic and oncological disorders. More …
Evotec and Variant Bio forge antifibrotic drug discovery partnership
Evotec has entered a partnership agreement with Variant Bio aimed at detecting a treatment for ailments caused by fibrosis. The alliance …
Clinical trial packaging services in contract manufacturing for the pharmaceutical industry
Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of …
JS-006 by Shanghai Junshi Biosciences for Hepatocellular Carcinoma: Likelihood of Approval
JS-006 is under clinical development by Shanghai Junshi Biosciences and currently in Phase II for Hepatocellular Carcinoma. According to GlobalData, …
Rhenium (186Re) obisbemeda by Plus Therapeutics for Head And Neck Cancer: Likelihood of Approval
Rhenium (186Re) obisbemeda is under clinical development by Plus Therapeutics and currently in Phase II for Head And Neck Cancer. …
Alvotech moves to bring its Humira biosimilar to US market
Hot on the heels of a US Food and Drug Administration (FDA) approval for Alvotech and Teva Pharmaceuticals’ Simlandi (adalimumab-ryvk), …
XH-001 by NeoCura Bio-Medical Technology for Solid Tumor: Likelihood of Approval
XH-001 is under clinical development by NeoCura Bio-Medical Technology and currently in Phase II for Solid Tumor. According to GlobalData, …
FHND-71 by Protheragen for Solid Tumor: Likelihood of Approval
FHND-71 is under clinical development by Protheragen and currently in Phase I for Solid Tumor. According to GlobalData, Phase I …
DM-5167 by Dime Bio for Solid Tumor: Likelihood of Approval
DM-5167 is under clinical development by Dime Bio and currently in Phase I for Solid Tumor. According to GlobalData, Phase …
Rigosertib sodium by Traws Pharma for Metastatic Melanoma: Likelihood of Approval
Rigosertib sodium is under clinical development by Traws Pharma and currently in Phase II for Metastatic Melanoma. According to GlobalData, …
Vertex’s pain drug suzetrigine advances in FDA approval process
Vertex Pharmaceuticals’ suzetrigine, previously named VX-548, is steadily advancing along its rolling submission approval pathway okayed by the US Food …
Roche wins second FDA label expansion for Alecensa in NSCLC
The US Food and Drug Administration (FDA) has granted a label expansion to Roche’s Alecensa (alectinib) as an adjuvant therapy …
Inhibikase sees “opportunity” in cardiopulmonary disease for IkT-001Pro
Inhibikase Therapeutics is eying pulmonary arterial hypertension (PAH) as a potential indication for its imatinib alternative IkT-001Pro. In an 18 April …