Novartis has joined the debate regarding the international nonproprietary names (INNs) of biologics saying some companies are casting unnecessary doubt on biosimilars under a guise of pharmacovigilance.
Biopharmas should stop green lighting safe, mediocre candidates and focus on developing drugs that are genuine scientific breakthroughs to control spiralling R&D costs, according to industry guru Bernard Munos.
With in-house production and manufacturing capacity, as well as a deal with Merck Serono, India-based generics giant Dr. Reddy’s is looking to bring as many as four biosimilars to the EU market by 2019.
“Reports of my death have been greatly exaggerated” said American author Mark Twain, and yesterday Janet Woodcock - another American author, albeit of a number of US drug initiatives - echoed his words denying rumours of her imminent retirement.
Agilent Technologies has officially separated its biopharma service offerings from its electric measurement group to create two separate companies, the life science portion of which is expected to bring in about $3.9B in FY2013.
The updated draft guidance calls for fully validated bioanalytical methods for any pivotal studies used to obtain approval or labelling, though less validation may be sufficient for a sponsor’s internal decision making.
GlaxoSmithKline is gambling $50M on a venture capital fund that will invest in 20 projects that pioneer bioelectric drugs and technologies that aim to target individual nerve fibres or specific brain circuits to treat an array of conditions.
Agilent Technologies is partnering with SomaLogic to expand the dissemination of Soma’s proteomic assay to at least five academic and contract research centers by the end of the year as demand for the tool has skyrocketed among biopharma companies.