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Latest From Anju Ghangurde
Data integrity concerns continue to cloud outlook for India’s contract research sector. The European Medicines Agency’s latest action against Micro Therapeutic Research Labs suspends more than 300 products in the EU over “unreliable” data and the firm tells Pink Sheet this will result in a “considerable dent” in its operations.
India has outlined measures to fast track the regulatory process for certain combination products for HIV and hepatitis, and thereby facilitate early access to these treatments.
Bristol-Myers Squibb expanded its collaboration with CytomX for $200m up front and up to $3.6bn in milestone fees. Also, Takeda spun out eight non-core molecules into a new joint venture and X-Chem executed two deals with Japanese partners, among other recent deals.
South East Asia is gearing for additional momentum in the fight against TB, a disease that caused nearly 800,000 deaths in the region in 2015. Increased budgetary outlays, a regional “Innovation to Implementation” fund and the need for high impact interventions were among the key issues brought up at a recent ministerial meeting in India.
A US FDA ban on Sun Pharma’s Mohali site, a legacy Ranbaxy facility, is set to be lifted, marking a significant uptick in Sun’s compliance efforts and raising hopes of momentum at the Indian firm’s other tainted facilities.
Mylan has handed pink slips to around 50 personnel at its Indian R&D unit as it pursues a global revamp aimed at streamlining operations and reining in costs following multiple acquisitions over the past few years.