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
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
Additional funding of up to €9 million is anticipated in the following three years...In other news, Elan priced its offering of $850 million aggregate principal amount of 6.25 percent senior notes due 2021 by its wholly owned subsidiaries, Elan Finance public limited co
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
In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting an indication extension to include treatment of earlier-line metastatic breast cancer patients
Addex Therapeutics SA, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications...for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments
Omeros Corp., of Seattle, said the European Medicines Agency granted eligibility for centralized review of the company's planned marketing authorization application (MAA) for ophthalmology candidate OMS302 (ketorolac and phenylephrine
Novartis has worldwide rights to the drug, along with certain backup compounds in all indications, with Incyte retaining a co-development option to INC280 in the U.S...Due to third-party manufacturing issues, distribution of Janssen Products LP's Caelyx in Europe has been intermittently disrupted since 2011
BioMarin Pharmaceutical Inc., of San Rafael, Calif., said it submitted a marketing authorization application to the European Medicines Agency for Vimizim (BMN-110, elosulfase alfa), an enzyme replacement therapy for patients with rare lysosomal storage disorder mucopolysaccharidosis Type IVA, also called Morquio A syndrome
Medivir AB, of Stockholm, Sweden, said Janssen-Cilag International NV, of Beerse, Belgium, part of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking approval for the protease inhibitor simeprevir (TMC435) for hepatitis C virus patients
Gilead said it will file for regulatory approval of sofosbuvir in other territories during the second quarter, including the European Union, where the European Medicines Agency accepted the company's request for accelerated assessment
Pharming Group NV, of Leiden, the Netherlands, said it received approval from the European Medicines Agency for Sanofi Chimie to manufacture drug substance for Pharming's Ruconest (recombinant human C1 inhibitor) at its Aramon, France, site
Pharming Group NV, of Leiden, the Netherlands, said it received approval from the European Medicines Agency for Sanofi Chimie to manufacture drug substance for Pharming's Ruconest (recombinant human C1 inhibitor) at its Aramon, France, site
Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency for a fixed-dose combination of canglifozin and immediate-release metformin for Type II diabetes
BioWorld International | Wednesday, March 13, 2013
after approval by the FDA in February, and the compound is under review by the European Medicines Agency