Market engineering can give clues to growth
This article was originally published in Clinica
Around 90% of all medical device companies are targeting growth above the industry market growth rate of 7%. Statistically, therefore, there will be losers as well as winners.
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The regulatory agency also urges qualified persons at drug companies to let the agency know as soon as possible if they are finding that the new measures are not flexible enough to deal with the current logistical challenges quickly.
The Swiss biotech's focal-onset seizure therapy, which is licensed from South Korea's SK and is already approved in the US, could have potential in indications beyond epilepsy, Arvelle's CEO tells Scrip.
Biocon has reported FDA clearance for its Malaysian insulin facility, while Lupin and Xellia have also received plant approvals. Meanwhile, Alembic has seen mixed fortunes, receiving both Form 483 observations and an EIR.