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Teva Pharmaceuticals USA Inc.

www.tevausa.com

Latest From Teva Pharmaceuticals USA Inc.

US FDA’s PANDA Policy Could Pose Legal Problems For Biosimilars, Attorney Says

Agency’s apparent intellectual exercise in treating pre-Hatch-Waxman ANDAs as NDAs could expose biosimilars to liability, Teva deputy general counsel notes at FDLI conference.

Biosimilars Legal Issues

Keeping Track: New Formulations Dominate In CNS; Immunocore Brings First TCR Therapy To US FDA

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Are Regeneron And Pfizer/BioNTech COVID-19 Products Covered By Patent Safe Harbor?

Allele claims Regeneron’s monoclonal antibody cocktail and Pfizer/BioNTech’s COVID-19 vaccine infringe its fluorescent protein patent. Regeneron asks court to toss suit against it, arguing use of protein for FDA submission is protected. A different court denied Pfizer/BioNTech’s motion to dismiss similar suit.

Intellectual Property Legal Issues

J&J, Distributors May Be Free Of Opioid Litigation If Enough States Sign On To $26bn Settlement

NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead. 

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