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With Natco poised to debut the first batch of Revlimid generics in the US in March next year, fellow Indian ANDA sponsor Dr Reddy’s Laboratories has secured its own approval from the FDA for two strengths of the blockbuster multiple myeloma treatment.
Zydus Cadila has failed to prove to a US court that a US patent expiring in October 2025 that shields AstraZeneca’s Farxiga (dapagliflozin) SGLT2 inhibitor is obvious, keeping the firm’s proposed ANDA product off of the market for now.
Zentiva’s Zent2U B2B unit has reported progress on a bioequivalence study for its sitagliptin tablets, indicating that its version will be ready for day-one entry in Europe. The development comes shortly after Zent2U announced the successful completion of a sertraline study.
Xbrane Biopharma has celebrated after being granted two Swedish patents covering its “high-yield” protein expression platform that the biosimilars specialist expects to act as the basis for international applications.
Padagis, the former Perrigo Rx business that was acquired by Altaris in July, has seen litigation initiated by Eucrisa originator Anacor over its Paragraph IV ANDA filing for crisaborole 2% ointment.
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.
One part of a multi-pronged attack launched by AbbVie against Alvotech over the company’s proposed Humira (adalimumab) biosimilar has fallen, with a US district court stating that AbbVie’s US trade secrets lawsuit should be dismissed because it lacks a form of jurisdiction.
Danish originator Lundbeck says it is “unthinkable” that proposed generic versions of its Trintellix treatment for major depressive disorder will find a way to the US market before 2027 following a US district court decision.
The incentives system, access to medicines, future proofing for novel products and antimicrobial resistance are just some of the topics included in a new consultation.
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