On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled glass syringe for injecting a VEGF-antagonist into the eye.  This is the second time the PTAB reviewed Regeneron’s petition to

Last week, Eli Lilly and Company (“Lilly”) announced that galcanezumab met its primary endpoint in a Phase 3 study of patients with episodic cluster headaches. Lilly previously announced that galcanezumab met its primary endpoints in three different Phase 3 studies evaluating its effectiveness in preventing episodic and chronic migraine.

The episodic cluster headache study was

Last week, Novartis and Amgen announced the FDA approved Aimovig™ (erenumab) for the preventive treatment of migraine in adults.  The FDA granted approval to Amgen; however, Amgen and Novartis have entered into a global collaboration to develop and commercialize treatments in the field of migraine. As part of this agreement, the two companies will co-commercialize

Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019)

The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public meeting on Wednesday, July 12, 2017, to consider Novartis’ biologic license application (BLA 125646) for tisagenlecleucel (CTL019), an investigational chimeric antigen receptor T cell (“CAR-T”) therapy.  Novartis is seeking approval of CTL019 for the treatment of patients from