Sun Pharmaceuticals continues to dominate the Indian pharmaceutical space while its R&D costs are set to rise.

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

Vanda says FDA improperly requires it to disprove all alleged deficiencies in its Hetlioz application for jet lag. Contentious approach to notice of opportunity for hearing contrasts with that of Intarcia and Lexicon, which also seek hearings over FDA’s proposal to refuse their applications.

During Q3, biopharma merger and acquisition value reached $15.4bn and drew in $37.6bn in potential deal value from alliances. Device company M&A values reached $550m, while in vitro diagnostic firms and research tools players completed M&A activity that totaled $1.9bn.