OR WAIT null SECS
May 07, 2018
The data and analytics company reports on the anticipated uptake of Humira (adalimumab) biosimilars in the EU once they are launched in 2018.
May 02, 2018
The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.
April 30, 2018
The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
April 19, 2018
The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.
April 05, 2018
The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.
April 03, 2018
The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.
The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.
March 29, 2018
Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
March 23, 2018
The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.