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Other News To Note
In other news, Biotie and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro (nalmefene), an opioid system modulator, for the reduction of alcohol consumption in adults with alcohol dependenceBioWorld International | Wednesday, March 6, 2013 -
Rare Diseases Get $187M from European Commission
LONDON – The European Commission (EC) finally put some financial firepower behind its pledge to find treatments for 200 rare diseases by 2020, announcing €144 million (US$187 million) of new funding for 26 separate projectsBy Nuala Moran | BioWorld International | Wednesday, March 6, 2013 -
Adcoms Recommend Higher Standards for Calcitonin Drugs
A formal decision by the European Commission is pendingBy Mari Serebrov | BioWorld Today | Wednesday, March 6, 2013 -
Other News To Note
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., may receive an additional royalty stream with the European Commission approval of Basel, Switzerland-based Novartis AG's Ilaris (canakinumab/ACZ885) for gouty arthritisBioWorld Today | Tuesday, March 5, 2013 -
Clinic Roundup
Both vintafolide and etarfolatide have been granted orphan drug status by the European CommissionBioWorld Today | Monday, March 4, 2013 -
FDA Briefing Docs: Calcitonin Cancer Risk 'Appears Plausible'
A formal decision by the European Commission is pendingBy Jennifer Boggs | BioWorld Today | Monday, March 4, 2013 -
Milestone Payments From Corporate Partners: February 2013
European Commission marketing approval of Glybera in the orphan disease lipoprotein lipase 2/6/13 Notes: Currency conversions are based on exchange rates at the time of the dealBioWorld Insight | Monday, March 4, 2013 -
Other News To Note
Biotie Therapies Corp., of Turku, Finland, and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro (nalmefene), an opioid system modulator, for the reduction of alcohol consumption in adults with alcohol dependenceBioWorld Today | Friday, March 1, 2013 -
Industry-Academic Research Gets $261M Boost in Ireland
Monday's funding announcement represents the single biggest bet that SFI has made in its 13-year history, and the award winners are expected to win further funding from the European Commission's (EC) upcoming Horizon 2020 programs and from the European Research Council, an area in which Ireland has underperformed to dateBy Cormac Sheridan | BioWorld International | Wednesday, February 27, 2013 -
Other News To Note
Alexza Pharmaceuticals Inc., of Mountain View, Calif., and Grupo Ferrer Internacional SA, of Barcelona, Spain, said the European Commission granted marketing authorization for Adasuve (Staccato loxapineBioWorld Today | Friday, February 22, 2013 -
Other News To Note
Intercell AG, of Vienna, Austria, said the pediatric indication for Ixiaro, a vaccine to protect against Japanese encephalitis (JE), was granted marketing authorization by the European Medicines Agency and the European CommissionBioWorld International | Wednesday, February 20, 2013 -
Pharma Clinical & FDA Action Update: January 2013
European Commission approved it 1/17/13 Merck & Co...tyrosine kinase inhibitor Philadelphia chromosome-positive acute lymphoblastic leukemia FDA approved a new use of Gleevec to treat children newly diagnosed 1/28/13 Pfizer Inc. (New York) Prevnar 13 Pneumococcal polysaccharide conjugate vaccine Invasive disease, pneumonia and acute otitis media European Commission approved expanding its useBioWorld Insight | Tuesday, February 19, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: January 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Savient Pharmaceuticals Inc. (Bridgewater, N.J.) Krystexxa Pegloticase Gout European Commission granted approval 1/9/13 CANCER Del Mar Pharmaceuticals Ltd. (Vancouver, British Columbia) VAL-083 Small-molecule chemotherapeutic Glioma CHMP recommended it be designated an orphan drug 1/8/13 Emergent BioSolutions Inc. (Rockville, Md.) TRU-016 Humanized single-chain monoclonal antibody against CD37 Chronic lymphocytic leukemiaBioWorld Insight | Tuesday, February 19, 2013 -
Regeneron Earnings Driven by Strong Sales of Eylea
Sales of Zaltrap (ziv-aflibercept), for metastatic colorectal cancer, began in August 2012 and the product received marketing authorization from the European Commission for the European Union in February 2013By Catherine Shaffer | BioWorld Today | Friday, February 15, 2013 -
Other News To Note
Prolor Biotech Inc., of Ness-Ziona, Israel, received orphan drug designation from the European Commission and the European Medicines Agency for hGH-CTP, a longer-acting human growth hormone being developed for growth hormone deficiencyBioWorld Today | Thursday, February 14, 2013 -
Other News To Note
Intercell AG, of Vienna, Austria, said the pediatric indication for Ixiaro, a vaccine to protect against Japanese encephalitis (JE), was granted marketing authorization by the European Medicines Agency and the European CommissionBioWorld Today | Wednesday, February 13, 2013 -
Other News To Note
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Sanofi SA, of Paris, said the European Commission granted marketing authorization in the European Union for Zaltrap (ziv-aflibercept) for infusion in combination with irinotecan/5-fluorouracil/folinic acid (Folfiri) chemotherapy in metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen...Xenon Pharmaceuticals Inc., of Vancouver, British Columbia, received a milestone payment from uniQure BVBioWorld Today | Wednesday, February 6, 2013 -
EMA's CHMP Declines to OK Santhera's Raxone for Blindness
The product, developed by uniQure BV, of Amsterdam, the Netherlands, finally was pushed over the finish line in November 2012 after the European Commission had taken the unprecedented step of refusing to rubber stamp the CHMP's recommendation that it should not be approved and told the committee to think againBio Perspectives | Wednesday, January 23, 2013 -
EMA's CHMP Declines to OK Santhera's Raxone for Blindness
The product, developed by uniQure BV, of Amsterdam, the Netherlands, finally was pushed over the finish line in November 2012 after the European Commission had taken the unprecedented step of refusing to rubber stamp the CHMP's recommendation that it should not be approved and told the committee to think againBy Nuala Moran | BioWorld International | Wednesday, January 23, 2013 -
EMA's CHMP Declines to OK Santhera's Raxone for Blindness
The product, developed by uniQure BV, of Amsterdam, the Netherlands, finally was pushed over the finish line in November 2012 after the European Commission had taken the unprecedented step of refusing to rubber stamp the CHMP's recommendation that it should not be approved and told the committee to think againBy Nuala Moran | BioWorld Today | Tuesday, January 22, 2013
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