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Latest From Anju Ghangurde
Indian firms have been making extensive efforts to improve their compliance record, including getting on board top-notch global talent. Cipla, which recently appointed a new head of respiratory manufacturing, has tapped an ex-FDA investigator as its audit and compliance director.
Boehringer seeks tweaks in the surveillance plan for nintedanib in India amid disinclination among some physicians to participate in the study. Some experts though believe that the Indian regulatory apparatus should, in general, specify “strict guidance” on all protocol review requests.
China’s Fosun group isn’t backing off from its $1bn-plus buyout of Gland Pharma and will now pursue a tweaked version of the original deal that technically qualifies for automatic approval under Indian rules. Whether that means smooth sailing hereon remains unclear.
Lupin is reorienting its R&D priorities with a thrust on more definitive, near and mid-term opportunities while rationalizing its discovery program and trimming its headcount. The firm’s biosimilars program though remains on track with a filing anticipated in Europe and Japan this fiscal.
Merck has launched Keytruda at an “India-specific” price but some experts say that the immuno-oncology therapy will likely still be beyond the reach of a majority of patients. Merck though also expects to offer a patient access program for those who can’t afford the therapy.
Indian firms must transition from “plain-vanilla” generics to more complex products, including biosimilars, if they want to continue growing. However, returns from the sector’s so-called Third Wave will be some time coming, warns Lupin’s managing director Nilesh Gupta.