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 …
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 …
Pharmaceutical compliance management software for the pharmaceutical industry
Pharmaceutical and biotechnology companies must maintain quality and meet stringent regulatory standards throughout their operations. Pharmaceutical compliance management software is …
NIH team develops AI tool to predict cancer drug response
Researchers at the National Cancer Institute, a unit of the National Institutes of Health (NIH) in the US, have developed …
FDA approves Takeda’s ENTYVIO SC for Crohn’s disease
The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy …
The next phase for mRNA: Looking beyond COVID-19
In early 2020, with the world ground to a halt, long-studied messenger RNA (mRNA) technology helped scientists develop COVID-19 vaccines …
SGN-1 by Guangzhou Huajin Pharmaceutical Technology for Peritoneal Cancer: Likelihood of Approval
SGN-1 is under clinical development by Guangzhou Huajin Pharmaceutical Technology and currently in Phase II for Peritoneal Cancer. According to …
SGN-1 by Guangzhou Huajin Pharmaceutical Technology for Solid Tumor: Likelihood of Approval
SGN-1 is under clinical development by Guangzhou Huajin Pharmaceutical Technology and currently in Phase II for Solid Tumor. According to …