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Other News To Note
Halozyme Therapeutics Inc., of San Diego, said the European Commission granted partner Baxter International Inc., of Deerfield, Ill., marketing authorization in all European Union (EU) member states for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adults with primary and secondary immunodeficienciesBioWorld Today | Wednesday, May 22, 2013 -
Other News To Note
The compound is available in Germany for prescribing according to local guidance after the European Commission granted conditional marketing authorization for Pixuvri in May 2012BioWorld Today | Tuesday, May 21, 2013 -
Week in Review
said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancerBioWorld Insight | Monday, May 13, 2013 -
Pharma: Other News To Note
Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancerBioWorld Today | Wednesday, May 8, 2013 -
EC Plans Education Campaign to Kick-Start Biosimilars Uptake
Details of the study – which sits under the umbrella of a larger European Commission project that aims to increase access to medicines following their marketing authorization – were presented at the BIO International Convention in Chicago last week...The European Commission is keen to keep pushing at the barriers to access, not only in an attempt to prop up the reputation of a treasured project, but also to deliver greater cost savings for Europe's hard-pressed health care systemsBy Nuala Moran | BioWorld International | Wednesday, May 1, 2013 -
EC Plans Education Campaign to Kick-Start Biosimilars Uptake
Details of the study – which sits under the umbrella of a larger European Commission project that aims to increase access to medicines following their marketing authorization – were presented at the BIO International Convention in Chicago last week...The European Commission is keen to keep pushing at the barriers to access, not only in an attempt to prop up the reputation of a treasured project, but also to deliver greater cost savings for Europe's hard-pressed health care systemsBy Nuala Moran | BioWorld Today | Tuesday, April 30, 2013 -
Other News To Note
A final decision from the European Commission is expected within the next few months...A final decision from the European Commission is expected in about two monthsBioWorld Today | Monday, April 29, 2013 -
Pharma Clinical & FDA Action Update: March 2013
Inc. (Whitehouse Station, N.J.) Tredaptive Extended-release niacin/laropiprant To reduce vascular events The composite primary endpoint of major vascular events occurred in only 13.2% of patients taking Tredaptive plus statin therapy compared to 13.7% of patients taking statin therapy alone 3/12/13 Novartis AG (Basel, Switzerland) Ilaris Canakinumab Gouty arthritis European Commission approved it 3/5/13 Novartis AG (Basel, Switzerland) TOBI Podhaler Tobramycin inhalation powder Cystic fibrosisBioWorld Insight | Monday, April 15, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: March 2013
European Commission designated it an orphan medicinal product 3/26/13 ViroPharma Inc. (Exton, Pa.) Cinryze C1 inhibitor (human) Hereditary angioedema Approved in Wales 3/25/13 CENTRAL NERVOUS SYSTEM Biotie Therapies Corp. (Turku, Finland) and H. Lundbeck A/S (Copenhagen, Denmark) Selincro Nalmefene...an opioid system modulator To reduce alcohol consumption in adults with alcohol dependence Received marketing authorization from the European Commission 3/1/13 Santhera Pharmaceuticals AG (LiestalBioWorld Insight | Monday, April 15, 2013 -
Clinic Roundup
The compound has received orphan drug status from the FDA and the European Commission in CLLBioWorld Today | Monday, April 8, 2013 -
Other News To Note
Regenx Biosciences LLC, of Washington, said it received a grant award from the European Commission's (EC) Seventh Framework Program as part of the MEUSIX consortiumBioWorld Today | Friday, March 29, 2013 -
Pharma: Other News To Note
Pfizer Inc., of New York, said the European Commission granted conditional marketing authorization for Bosulif (bosutinib) for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome-positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitors and for whom Gleevec (imatinib, Novartis AG), Tasigna (nilotinib, Novartis AG) and Sprycel (dasatinib, Bristol-Myers Squibb Co.) are not considered appropriateBioWorld Today | Friday, March 29, 2013 -
Other News To Note
Mast Therapeutics Inc., of San Diego, said the European Commission designated MST-188 (purified poloxamer 188) as an orphan medicinal product for the treatment of sickle cell diseaseBioWorld Today | Tuesday, March 26, 2013 -
CHMP's Latest Opinions: Seven Positive, One Negative
A final decision from the European Commission is due in about two monthsBy Catherine Shaffer | BioWorld Today | Monday, March 25, 2013 -
Other News To Note
Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patchBioWorld International | Wednesday, March 20, 2013 -
Grants, Contracts And Awards To Biotech Companies: Oct. 1, 2012 - March 14, 2013
European Commission €6 ($7.8) FP7 grant To support clinical testing of the company's anti-interferon gamma drug candidate, NI-0501BioWorld Insight | Monday, March 18, 2013 -
Pharma: Other News To Note
Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patchBioWorld Today | Friday, March 15, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: February 2013
Company (Location) Product Description Indication Status Date CANCER Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) Zaltrap Ziv-aflibercept Metastatic colorectal cancer European Commission granted marketing authorization in the European Union 2/6/13 Seattle Genetics Inc. (Bothell, Wash.) Adcetris Brentuximab vedotin Hodgkin lymphoma and systemic anaplastic large cell lymphoma Health Canada approved it for HL after failure of autologous stem cell transplant or failure ofBioWorld Insight | Monday, March 11, 2013 -
Week in Review
The European Commission announced $187 million of new funding for rare diseases projectsBioWorld Insight | Monday, March 11, 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 Today | Thursday, March 7, 2013
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