Anvisa believes there are no legal obstacles to its rule allowing generic products to have different indications from the reference drug, but some say the move could lead to challenges unless it is backed by legislative change.
A new rule allowing generics firms to “carve out” patented indications from their labeling to avoid possible patent infringement is due to come into effect on 6 February after it was approved last month by the Brazilian drugs regulator, Anvisa.
Under the existing legislation (Law No 6360 of 1976), the labeling of generics and similars (branded generics) must display all...
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.
