Welcome to Pink Sheet
Create an account to read this article
Already a subscriber?
Roche Succeeds In Changing EMA Ruling On Avastin
The Committee for Medicinal Products for Human Use has reversed its previous rejection and is granting an indication for treatment of first-line breast cancer in combination with capecitabine.
More from Archive
More from Pink Sheet
• By
European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.
• By
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
• By
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.