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Latest From Anju Ghangurde
Eisai India chief Dr. Sanjit Singh Lamba outlines the competitive edge that the Japanese group’s Indian site offers under the deal with Nichi-Iko; the site has also never “depended” on active pharmaceutical ingredients from China. In a wide-ranging interview with Scrip, Lamba also discusses recent quality compliance initiatives in India.
Cipla expands on its in-licensing strategy in India with Lilly’s insulin glargine product, while Aptose signs second agreement with CrystalGenomics to add Chinese rights for leukemia candidate CG-806, and Yakult gains Japanese rights to Verastem's duvelisib.
The advisory committee route for approving a first biosimilar to a reference product is no longer necessarily the norm, going by FDA's recent approval of Mylan/Biocon's pegfilgrastim-jmdb, which references Amgen’s Neulasta; agency’s view that a meeting was not needed should encourage other biosimilar aspirants.
Sun's Halol manufacturing facility is over the compliance hump, receiving an EIR [Establishment Inspection Report] from the US FDA. The site, seen as core to India's top ranked firm's promising filings, including injectables, is also expected to lift the prospects of Sun's spin-off R&D arm, SPARC.
Sanofi has sought to block an alleged infringer's attempt to ride on its trademarks, trade name and logo in India; the French multinational views these activities as intended to cause confusion among consumers.
Cipla has outlined its intent to incubate disruptive ideas in the healthcare space, along the lines of similar initiatives to accelerate innovation from US/European big pharma. It hopes that this "culture" will expand in India.