European regulators have accepted for review Sandoz’ marketing applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab). The company is seeking approval for its biosimilars for use in
Tag "Regulation"
Aspen Pharmacare is under investigation by the European Commission over its pricing practices for five cancer medicines. EU antitrust regulators will investigate whether the South African generics firm abused
EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference. In an effort to provide healthcare professionals with information on the science
On 4 May, the in vitro diagnostic medical device industry will gather in Dublin for an All-Ireland IVD Symposium on the new European regulation. Mani Subramani, head of business support,
EU regulators have expanded the scope of Janssen’s Darzalex to include patients with multiple myeloma who have received at least one prior therapy, when given in combination with lenalidomide and
Now that the die has been cast, it’s time for the deal-making process to begin – if indeed a deal is on the cards. It seems that every time a
Xeljanz (tofacitinib citrate) receives marketing authorization in the European Union for the treatment of moderate to severe active rheumatoid arthritis (RA). Pfizer Inc. announced today that the European Commission (EC)
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