Almirall SA, of Barcelona, Spain, said the European Commission granted marketing approval to Eklira/Bretaris Genuair (aclidinium 322 mcg twice daily) in European Union member states, plus Iceland and Norway, for chronic obstructive pulmonary disease...With the certification, Fraunhofer can manufacture the dendritic cell-based vaccine in Germany and supply it for clinical trials throughout the European Union

Already approved for seven other indications in the European Union, Humira is the first drug approved for non-radiographic axSpA

German approval is the fifth national approval in the European Union

Almirall SA, of Barcelona, Spain, said the European Commission granted marketing approval to Eklira/Bretaris Genuair (aclidinium 322 mcg twice daily) in European Union member states, plus Iceland and Norway, for chronic obstructive pulmonary disease

With the certification, Fraunhofer can manufacture the dendritic cell-based vaccine in Germany and supply it for clinical trials throughout the European Union

The committee is recommending that the product be granted conditional marketing authorization in the European Union for the treatment of adults with previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer

Nuvo Research Inc., of Mississauga, Ontario, said it will receive $6 million in milestone payments from partner Galderma SA, of Lausanne, Switzerland, which received its first three marketing licenses for Pliaglis from European Union countries

The French authorization is the fourth national approval in the European Union following the completion of Europe's decentralized regulatory procedure

and European Union for once-daily fluticasone furoate/vilanterol in patients with chronic obstructive pulmonary disease and submitted another application in Europe for asthma

Buccolam was approved in September 2011 by the European Union through the Pediatric Use Marketing Authorization (PUMA), a marketing authorization procedure for medicines exclusively developed for use in children that are already authorized, but no longer covered by patents

In other news, Boehringer said findings from an analysis of four Phase III trials, comparing Pradaxa (dabigitran etexilate) to enoxaparin recently published in Thrombosis Research, supported the positive safety profile of Pradaxa for the prevention of venous thromboembolism in patients undergoing total knee or hip arthroplasty...In other news, Celgene reported that its new drug application for pomalidomide plus low-dose dexathasone in patients with relapsed and refractory multiple myeloma was

and India, with a first right of refusal for member states of the European Union, plus Canada, Brazil and Japan...markets, including the European Union and Japan

Biovest International Inc., of Tampa, Fla., a subsidiary of Accentia Biopharmaceuticals Inc., said it notified the European Medicines Agency (EMA) of its intent to file a marketing authorization application seeking approval in the European Union (EU) for BiovaxID, its personalized cancer vaccine in follicular non-Hodgkin's lymphoma...Cell Therapeutics Inc., of Seattle, said it is re-aligning its resources and re-prioritizing its pipeline to focus on the launch of Pixuvri (pixantrone) in the

Addex is seeking a partner to advance dipraglurant into a Phase IIb trial for PD-LID and other indications...The vaccine, BM32, is based on a recombinant peptide carrier technology designed to allow for fewer injections and fewer side effects compared with other immunotherapy treatments...In other news, Boehringer and Eli Lilly and Co., of Indianapolis, presented results from two Phase II studies of their investigational basal insulin analogue LY2605541 at the American Diabetes Association meeting in

Orphan status would guarantee 10 years of marketing exclusivity in the European Union upon approval

The consortium plans to develop an integrated platform to identify diverse small molecules active against drug targets using very large peptide libraries to explore chemical space...To date, the component technologies have been used individually in more 170 drug discovery projects

OxThera is in discussions with regulatory agencies in the European Union and the U.S

Almirall recently signed a deal granting Menarini Group, of Florence, Italy, rights across a majority of European Union member states, as well as Russia, Turkey and other CIS countries, where it will market the drug as Bretaris Genuair

The marketing authorization follows the completion of the decentralized regulatory procedure in the European Union (EU), with the UK's Medicines and Healthcare Products Regulatory Agency serving as the reference member state