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Regs & Legs


Turkey: A rising star in the pharmaceutical industry

10 March 2015 | By Özge Atılgan Karakulak and Zeynep Koray, Gün + Partners

You are waiting in line, trying to decipher several different languages spoken around you: English, Dutch, German, Arabic, French… This scene is not from an airport but rather from a Turkish hospital: thousands of foreigners, communicating through translators, visit healthcare institutions every day and numbers are increasing exponentially; in the…

Continued process verification – a challenge for the pharmaceutical industry?

10 March 2015 | By Michael Rommerskirchen, Boehringer Ingelheim

Nowadays, professional quality and process data trending is key for science-based pharmaceutical development and manufacturing. Recently, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) issued revised process validation guidance to enforce recurring data analysis as a regulatory core requirement1,2: Periodic product and process monitoring, also known…

Kuros announces grant of US patent for its synthetic hydrogel technology

24 February 2015 | By Kuros

Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for sealant, orthobiologic and surgical wound indications, announced that its patent application U.S.S.N 12/102,157 will issue today and has been assigned U.S. Patent No. 8,961,947...

Application submitted to the EMA to expand the therapeutic indication for IMBRUVICA® (ibrutinib) to include treatment of Waldenström’s macroglobulinemia

1 December 2014 | By Janssen-Cilag International

Janssen-Cilag International NV (Janssen) announced today the submission of a Type II variation application to the European Medicines Agency (EMA) to vary the marketing authorisation for IMBRUVICA® (ibrutinib), to include a new therapeutic indication, the treatment of adult patients with Waldenström’s macroglobulinemia (WM). If approved, this latest regulatory submission will…