New and updated guidances are good news for ANDA sponsors, but timing – coming the day Sandoz announced a CRL for its Advair copy – underscores challenges that developers of complex generics face.
The US FDA has handed Novartis AG's generics unit Sandoz Inc. a complete response letter for copycat of Advair Diskus (fluticasone propionate and salmeterol), highlighting the broader challenges of replicating complex drugs raised by agency Commissioner Scott Gottlieb.
GlaxoSmithKline PLC's Advair – a combination product for the treatment of asthma and airflow obstruction – has become the...
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.
