In the wake of a German court decision that Medicines for Europe says “adopted an inordinately restrictive interpretation of the SPC manufacturing waiver,” the association has called for clarity and simplification of the SPC manufacturing waiver legislation, claiming that its use could otherwise be undermined.
A German court decision that adopted an “inordinately restrictive interpretation” of the EU supplementary protection certificate manufacturing waiver risks undermining the use of the mechanism by European generics and biosimilars manufacturers, off-patent industry body Medicines for Europe has warned.
The SPC manufacturing waiver was hard-won by the generics and biosimilars industry, allowing manufacturing for export outside the EU –...
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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.
