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Latest From Celera Group
As India revealed finer details of two schemes to promote bulk drug production, Mankind Pharma and Aarti Drugs spelled out a preference for chemical synthesis products – they are likely to be joined by more companies reluctant to invest in some that are fermentation-based. Whether a “plug and play” format for bulk drug parks will attract foreign investment remains to be seen.
Sixteen applications are in line for US FDA decisions in August. Ten are novel agents.
Second-quarter earnings results from two of the Big Three – Teva and Mylan – hold much of the intrigue in August, while more competition in the nascent Avastin biosimilar market could materialize in Europe.
US demands for 30,000 subject studies and harmonized protocols mean a robust result could arrive soon – but recruitment could still be a challenge.