If those companies do not comply, Doshi and fellow campaigners said they will publish documents released by the European Medicines Agency (EMA) following freedom-of-information requests, or as part of litigation over off-label marketing

after approval by the FDA in February, and the compound is under review by the European Medicines Agency. (See BioWorld Today, Feb. 11, 2013

Cangene Corp., of Winnipeg, Manitoba, said it withdrew its marketing authorization application for hemophilia compound IB1001 in Europe and intends to refile the application with the additional clinical data requested by the European Medicines Agency

EMA = European Medicines Agency

Nanobiotix, of Paris, received authorization from the French Medicine Agency to begin a Phase I trial of NBTXR3 in head and neck cancer

The results form the basis of the company's ongoing efforts to pursue a marketing application authorization with the European Medicine Agency under the exceptional circumstances process, which is specifically designated for very rare diseases that have limited or no available therapeutic options and a significant unmet medical need

A few weeks after the ODAC meeting Aveo's partner Astellas said it didn't intend to submit a marketing authorization application to the European Medicines Agency for tivozanib for the treatment of RCC patients or fund any future trials in RCC under the firms' strategic collaboration inked in February 2011. (See BioWorld Today, May 28, 2013.) RBC Capital Markets LLC analyst Michael Yee wrote in a research note that Astellas' decision to drop the kidney cancer indication was not unexpected

A few weeks after the ODAC meeting AVEO's partner Astellas Pharma Inc., of Tokyo, said it didn't intend to submit a marketing authorization application to the European Medicines Agency for tivozanib for the treatment of RCC patients or fund any future trials in RCC under the firms' strategic collaboration inked in February 2011. (See BioWorld Today, May 28, 2013.) RBC Capital Markets LLC analyst Michael Yee said in a research note that Astellas' decision to drop the kidney cancer indication was

Ltd., of Tokyo, submitted a type-II variation to the European Medicines Agency (EMA) for Rienso (ferumoxytol

The company also submitted a marketing authorization application to the European Medicines Agency for Vimizim

The Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion on granting marketing authorization to Bavarian Nordic A/S, of Kvistgard, Denmark, for Imvanex, a smallpox vaccination for the general adult population, including those with immunodeficiencies...Celgene International Sarl, of Boudry, Switzerland, a subsidiary of Celgene Corp., said the European Medicines Agency's (EMA): Committee for Medicinal Products for Human Use (CHMP) has adopted a

The Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion on granting marketing authorization to Bavarian Nordic A/S, of Kvistgard, Denmark, for Imvanex, a smallpox vaccination for the general adult population, including those with immunodeficiencies...Novo Nordisk A/S, of Bagsvaerd, Denmark, applied to the European Medicines Agency for marketing authorization of IdegLira, a combination of insulin degludec (Tresiba) and liraglutide (Victoza), for

In addition to technical issues such as scaling up and the development of release assays for quality control, GSK has an interest in work the Catapult is doing with the UK Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency on defining the regulatory requirements to move cell therapies forward

The company moved its headquarters to Germany when it merged with GPC Biotech AG, of Martinsried, Germany, in November 2009, after GPC came unstuck over the European Medicines Agency's refusal to approve its cancer drug satraplatin, an orally delivered platinum compound

3SBio Inc., of Shenyang, China, said its shareholders voted in favor of the proposal to merge with Decade Sunshine Ltd. The merger would result in 3SBio becoming a privately held subsidiary of Decade Sunshine, with its American depository shares no longer listed on Nasdaq. The company's board previously recommended that shareholders vote to authorize the merger, and the parties expect to complete the deal as soon as practicable. Addex Therapeutics SA, of Geneva, said its gamma-aminobutyric

The company moved its headquarters to Germany when it merged with GPC Biotech AG, of Martinsried, Germany, in November 2009, after GPC came unstuck over the European Medicines Agency's refusal to approve its cancer drug satraplatin, an orally delivered platinum compound

AVEO Pharmaceuticals Inc., of Cambridge, Mass., said in an SEC filing that it was informed by partner Astellas Pharma Inc., of Tokyo, that Astellas no longer intends to submit a marketing authorization application to the European Medicines Agency for tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC

Gilead Sciences Inc., of Foster City, Calif., said its marketing authorization application (MAA) for sofosbuvir was validated by the European Medicines Agency (EMA) and is under assessment...Veloxis Pharmaceuticals A/S, of Horsholm, Denmark, said the European Medicines Agency agreed to review its marketing authorization application for LCP-Tacro to prevent organ rejection in kidney transplant patients

Last month, PTC initiated a confirmatory Phase III trial of ataluren in nmDMD, following submission of a marketing authorization application to the European Medicines Agency in October 2012 seeking conditional approval...The drug has orphan drug status from the FDA and orphan medicinal product status from the European Medicines Agency in both nmDMD and nmCF