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26 February 2016 | By Victoria White
TAF is a novel, targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to Gilead’s Viread at one-tenth of the dose...
AstraZeneca and Acerta Pharma have announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product.
22 January 2016 | By Victoria White
The decision includes an update of the product information of all ambroxol and bromhexine containing products to include the rare risk of hypersensitivity reactions and a Precaution and Warning regarding severe cutaneous adverse reactions...
12 January 2016 | By Victoria White
Eisai has submitted the MAA to the EMA for the use of lenvatinib in combination with everolimus to treat people with unresectable advanced or metastatic renal cell carcinoma who have received one prior vascular endothelial growth factor targeted therapy...
8 December 2015 | By Victoria White
Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...
4 December 2015 | By Victoria White
Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the EU...
6 November 2015 | By Victoria White
Validation of the application confirms the submission is complete and begins the EMA’s centralised review process...
3 September 2015 | By Victoria White
If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously for the treatment of SHPT in patients with chronic kidney disease...
23 July 2015 | By Victoria White
The EMA has validated two type II variation applications which seek to extend the indication of Opdivo in non-squamous NSCLC and advanced melanoma...
30 June 2015 | By Victoria White
Intercept Pharmaceuticals has achieved two important regulatory milestones for obeticholic acid in primary biliary cirrhosis (PBC)...
24 June 2015 | By Victoria White
EMA grants Orphan Drug designation to AveXis' gene transfer therapeutic currently in clinical development for the treatment of spinal muscular atrophy...
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)...
