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Teva Pharmaceuticals USA Inc.

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Latest From Teva Pharmaceuticals USA Inc.

US FDA Biosimilar Review Information Requests Should Come Earlier, With Longer Response Times

An FDA consultant and industry representatives recommend streamlining information requests during 351(k) application reviews and giving companies more than two days to respond; Eastern Research Group’s final assessment of the BsUFA II program finds positive views, but industry says more transparency is needed on timelines for delayed inspections.

Biosimilars User Fees

US FDA Biosimilar Review Information Requests Should Come Earlier, With Longer Response Times

An FDA consultant and industry representatives recommend streamlining information requests during 351(k) application reviews and giving companies more than two days to respond; Eastern Research Group’s final assessment of the BsUFA II program finds positive views, but industry says more transparency is needed on timelines for delayed inspections.

Biosimilars User Fees

Sanofi Challenges J&J’s Darzalex With Blackstone Pact For SC Sarclisa

The French major has entered a risk-sharing collaboration with Blackstone focused on a new formulation of multiple myeloma drug Sarclisa, which could help it take on market leader Darzalex.

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Judge Jackson’s Patent, FDA Rulings Show She Is ‘Super Smart’ And Would Be Beneficial For Pharma

Supreme Court nominee issued three decisions on Hatch-Waxman regime as district court judge, including case in which she ruled against the FDA’s denial of orphan drug designation and another in which she deferred to the agency’s view on exclusivity. Her analysis of facts may play a role if the court takes up a case on administrative agency deference.

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