BioPharm News

Dec 20, 2017
By BioPharm International Editors
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
Dec 20, 2017
By BioPharm International Editors
FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.
Dec 20, 2017
New tax legislation may result in savings for biopharma companies.
Dec 19, 2017
By BioPharm International Editors
The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.
Dec 19, 2017
By BioPharm International Editors
Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, have filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.
Dec 19, 2017
By BioPharm International Editors
BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.
Dec 18, 2017
By BioPharm International Editors
The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.
Dec 14, 2017
By BioPharm International Editors
Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.
Dec 14, 2017
By BioPharm International Editors
Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.
Dec 14, 2017
By BioPharm International Editors
The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.
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