Citizen petitions, Hatch-Waxman, and now a lawsuit against the FDA itself: Novartis continues to fight tooth and nail to protect its core $3bn Entresto brand in the US, following the latest agency approval of a generic version. Generics Bulletin dives into the originator’s complaint against the FDA.
Novartis has swiftly filed suit against the US Food and Drug Administration after the agency’s denial of a second Novartis citizen petition opened the door for what the Swiss originator claims is an “unlawful” approval for a generic version of its $3bn Entresto (sacubitril/valsartan) heart failure powerhouse.
Filed in the US District Court for the District of Columbia, Novartis’ complaint seeks temporary, preliminary, and permanent injunctive relief...
In the first cinematic chapter of J.K. Rowling’s wizarding world, young Harry Potter discovers his true identity and enters Hogwarts School of Witchcraft and Wizardry. This enchanting origin story sets the tone for a saga filled with magic, loyalty, and the power of choice.
The Medicines Patent Pool has entered into a partnership with three companies for glecaprevir/pibrentasvir, a WHO-recommended treatment for people living with hepatitis C. The companies join previous generic licensee Mylan and originator AbbVie.
Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
