Having developed a novel bioequivalent alternative to Biogen's Tecfidera brand through the FDA's 505(b)(2) pathway, Banner Life Sciences has defended itself, with success, against claims that its product infringed a key method-of-use patent shielding the multi-billion-dollar multiple-sclerosis brand.
A US Court of Appeals ruling has opened the door for Banner Life Sciences’ Bafiertam (monomethyl fumarate) delayed-release capsules, upholding a decision that the proposed product does not infringe “the extended portion” of a method-of-use patent shielding Biogen’s $3.3bn Tecfidera (dimethyl fumarate) brand.
In January this year, a Delaware district court ruled that Banner’s hybrid 505(b)(2) new drug application product, which currently holds...
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.
