Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Drug Approvals

Set Alert for Drug Approvals

Latest From Approvals

European CHMP Opinions And MAA Updates

A monthly-updated listing of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Approvals Performance Tracker

Roche Fails Again To Convince CHMP On Ocrevus, Only Teva Gets A Thumbs Up

Roche has once again failed to convince the EMA’s key advisory panel, the CHMP, that the company’s novel multiple sclerosis treatment, Ocrevus (ocrelizumab), should be approved for marketing throughout Europe. The CHMP was considering an unusually low number of products for an opinion this month – just three – and only Teva’s generic tacrolimus got a positive recommendation. As with Ocrevus, no opinion was taken on the third product – carmustine, another generic.

Europe Regulation

FDA's NDA And BLA Approvals: Zilretta, Lyrica CR

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Row Erupts Over “Third Way” For Biosimilar Approvals In Colombia

Colombia’s health ministry has accused the R&D-based pharmaceutical industry association of prioritizing monopolies over patients after its attempts to suspend legislation that promises a faster route to market for biosimilars.

Colombia BioPharmaceutical

CHMP Readies ‘Outstanding Issues’ Lists For Products Nearing EU Review End

Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.

Europe Approvals

Ocrevus Tries Again For EU Approval Nod

Just three initial marketing authorization applications are up for an opinion this week on whether they should be approved for sale across the EU. Roche’s new multiple sclerosis treatment, Ocrevus (ocrelizumab), is one, after failing to secure a positive opinion earlier. The October meeting of the panel that will decide, the European Medicines Agency’s CHMP, is under way in London.

Europe Regulation
See All
UsernamePublicRestriction

Register