India’s new draft pharmaceutical policy proposes a raft of radical changes that have left industry jittery and could force a significant realignment in the operations of foreign and local firms. Second brand strategies and widespread licensing-out of manufacturing are no longer favored, and a 'one company – one drug – one brand name – one price' thrust are among the key changes proposed.
India’s draft pharmaceutical policy 2017 appears to have caught pharma off-guard with a range of proposals, which if cleared in the current form, could potentially require significant recalibration of industry’s marketing and manufacturing approach.
Among other proposals, the policy draft seeks to rein in loan licensed manufacturing and also frowns upon strategies such as...
The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.
Private Company Edition: June’s eight $100m-plus venture capital rounds already outpace the seven each raised in March, April and May, including €255m ($274.2m) for ITM and $200m for Upstream, but while there were five $25m or less VC financings during the past week, mid-sized deals were lacking.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
