FDA Law Blog: Biosimilars

APRIL 30, 2023

110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub. As background, FDC Act § 505(q) states that FDA shall not delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. 112-144 (2012).

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

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PharmaShots

APRIL 13, 2023

In 2008, Johnson acquired tissue sealing system developer, SurgRx Pfizer's pharmaceutical segment revenue increased after the acquisitions of Serenex, Encysive Pharmaceuticals, CovX, and Coley Pharmaceuticals Novartis reported a total revenue of $41.4B, under which, its pharmaceutical division faced a revenue loss of $2.6B

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