2. ANDA litigation primarily takes place in Delaware and New Jersey The overwhelming majority of ANDA cases were filed in federal courts in Delaware and New Jersey. Delaware was the forum of ...

Senores Pharmaceuticals through its wholly-owned subsidiary Senores Pharmaceuticals, Inc., USA (SPL) has signed an agreement to acquire the US FDA approved Abbreviated New Drug Application (ANDA) for ...

The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated ...

On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district ...

Eighteen Pakistani security personnel were killed while attempting to stop an armed attack by the Baloch Liberation Army (BLA) in the Kalat district of Balochistan late Friday night, the Pakistan ...

Baker’s apparent ban on NDAs. Fifty-two of the 159 settlements with NDA language happened after the informal ban in 2018. However, DiZoglio said her office could not find any documented evidence ...

Alvotech (ALVO) and Teva Pharmaceuticals (TEVA) announced that the FDA has accepted for review a Biologics License Application, or BLA, for AVT06, Alvotech’s proposed biosimilar to Eylea ...