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Novartis will appeal to U.S. Court of Appeals to uphold validity of Entresto® combination patent; maintains 2023 guidance and mid-term outlook - Vimarsana News

Novartis will appeal to U.S. Court of Appeals to uphold validity of Entresto® combination patent; maintains 2023 guidance and mid-term outlook

Ad hoc announcement pursuant to Art. 53 LR U.S. District Court for the District of Delaware ruled the Entresto (sacubitril / valsartan) ‘combination patent’ to be invalid Novartis will appeal to the U.S. Court of Appeals for the Federal Circuit to reverse the District Court’s rulingNo generic Entresto product has received FDA approval as of todayPending a final appeal decision and other ongoing litigation involving multiple patents, any launch once generics receive FDA approval would be ‘at risk

Source: yahoo.com
Have Children Truly Ever Been 'Therapeutic Orphans?' - Vimarsana News

Have Children Truly Ever Been 'Therapeutic Orphans?'

Imposing the FDA on-label/off-label framework on administratively defined "children" resulted in a regulatory demand for pediatric studies that had no basis in clinical medicine, with the exception of the small group of preterm newborns.

FDA Clarifies Approach To Pediatric Drug Development - Life Sciences, Biotechnology & Nanotechnology - Vimarsana News

FDA Clarifies Approach To Pediatric Drug Development - Life Sciences, Biotechnology & Nanotechnology

On May 17, the U.S. Food & Drug Administration ("FDA") issued two important draft guidance documents, which clarify the agency's approach to requirements and incentives in the realm of pediatric drug development...

Source: mondaq.com
Haug Partners Successfully Defends Takeda's Vyvanse® Patents At Trial Against Generic Challenge | Haug Partners LLP - Vimarsana News

Haug Partners Successfully Defends Takeda's Vyvanse® Patents At Trial Against Generic Challenge | Haug Partners LLP

On December 27, 2022, Haug Partners LLP and Gibbons PC obtained a key victory as to all counts for its client, plaintiffs Takeda Pharmaceutical Co. Ltd. and Takeda Pharmaceuticals...