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February 09, 2016
There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.
February 04, 2016
In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.
February 02, 2016
Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.
January 28, 2016
Novartis announced the companies plan to boost growth at Alcon, the company’s vision care division.
NICE announces plans to back biosimilar alternatives to Merck’s Remicade.
January 22, 2016
FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.
January 21, 2016
More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.
January 19, 2016
Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.
January 15, 2016
The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.
January 12, 2016
The British Standards Institution (BSI) and the Alliance for Clinical Research Excellence and Safety (ACRES) announced a collaboration to develop global standards of excellence for clinical research sites.