AAM hopes everyday voices – and Mark Cuban’s – will help policymakers appreciate the contributions that generic drugs make to the healthcare system. ‘We need to create an emotional connection,’ a campaign designer said.
The generics industry has a big problem: companies are providing drugs cheaper than ever, thanks in part to the limited number of wholesalers that distribute their products. But consumers are not seeing as much of those savings, mainly due to a shift in approach by pharmacy benefit managers toward formularies that value product rebates instead of the cost of the pills.
PBMs and other middleman “took $20bn out from our industry over the last six, seven years,” Amneal Pharmaceuticals, Inc....
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.
