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6 May 2015 | By Victoria White
NDA Group's new Infographic looks at drug approvals in 2014 and highlights the fact that nearly 40% of approved products came from non top pharma companies...
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…
2 March 2015 | By Santen
Santen Pharmaceutical Co., Ltd. announced that the European Medicines Agency has accepted the company’s Marketing Authorization Application filing for the use of intravitreal sirolimus, an investigational mTOR inhibitor, for the treatment of noninfectious uveitis (NIU) of the posterior segment...
2 March 2015 | By Amgen
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix® (panitumumab) to include combination with FOLFIRI (an irinotecan-based chemotherapy) as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer (mCRC)...
23 February 2015 | By Eli Lilly & Company
Eli Lilly and Company announced a delay in the submission of basal insulin peglispro (BIL) to regulatory agencies beyond the first quarter of 2015...
6 February 2015 | By Janssen EMEA
Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved a variation to the terms of the marketing authorisation of VELCADE® (bortezomib) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for blood…
26 January 2015 | By NewCap.
Santen SAS announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the granting of a marketing authorization for Ikervis®...
23 January 2015 | By Novartis
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Jakavi® (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea...
Cocrystals can help to address the manufacturability (flow, compaction, processability) as well as solubility/dissolution,hygroscopicity and stability properties of an active pharmaceutical ingredient (API).
8 December 2014 | By Astellas
Astellas Pharma Europe Ltd. announced that the European Commission (EC) has granted a variation to amend the Marketing Authorisation for enzalutamide (trade name XTANDI™)...
2 December 2014 | By Inventiva
This follows an earlier positive opinion for IVA337 in October regarding the treatment of Systemic Sclerosis (SSc)...
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…
1 December 2014 | By Treeway
Treeway B.V. is pleased to announce that the European Medicines Agency has granted orphan drug designation for TW001 for the treatment of ALS...
19 November 2014 | By MSD
Application for approval of new indication for golimumab has been filed with the European Medicines Agency...
4 November 2014 | By Andrew Lloyd & Associates
With few approved drugs available in SSc, this approach could significantly improve the treatment options in the future...
