Regulatory

Dec 28, 2017
By BioPharm International Editors
The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.
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 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 14, 2017
By BioPharm International Editors
The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.
Dec 14, 2017
By BioPharm International Editors
FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.
Dec 13, 2017
By BioPharm International Editors
The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.
Dec 11, 2017
By BioPharm International Editors
FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.
Dec 05, 2017
By BioPharm International Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Dec 04, 2017
By BioPharm International Editors
FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.
Dec 01, 2017
By BioPharm International Editors
In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.
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