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EMEA (Others)
Multiple sclerosis oral drug
07-13-2010 |  19:37 hs.
German Merck KGaA announced that Russia is the first country to approve multiple sclerosis oral drug, Movectro (Cladibrine). The drug will be launched in 2011.

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Cannabis-based spray drug
06-21-2010 |  16:19 hs.
GW Pharmaceuticals Plc and Bayer AG announced that the Medicines and Heathcare Regulatory Agency (MHRA) in the United Kingdom approved Sativex (Tetrahydrocannabinol (THC) + Cannabidiol (CBD), a spray type drug indicated to treat spasticity in patients with multiple sclerosis and based in cannabis.

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06-17-2010 |  19:55 hs.
The European Medicines Agency delivered conditional approva,l for GlaxoSmithKline Plc. drug, Votrient (Pazopanib), indicated to treat advanced renal cell carcinoma (RCC). The drug was approved by the FDA in 2009

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06-04-2010 |  15:41 hs.
According to the European Medicines Agency (EMEA), of the 179 million doses of H1N1 influenza vaccines, manufactured and distributed in the continent by Glaxo, Novartis and Baxter International, only a fifth was administered.

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Also for men with prostate cancer and risk of bone fracture
05-28-2010 |  15:28 hs.
The European Medicines Agency (EMEA) cleared AMGEN Inc. and GlaxoSmithKline Plc. to market injectable drug Prolia (Denosumab) in Europe. The product is indicated to treat women with post-menopausal osteoporosis with an increase risk of bone fracture, as well as men with prostate cancer who, as a result of hormone therapy, are at increased risk of bone fractures. Prolia is administered every six months.

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05-25-2010 |  20:50 hs.
Javelin Pharmaceuticals Inc. US business unit Therabel Pharma NV, decided to withdraw all batches of post surgery pain injection drug Dyloject (Diclofenac 75mg/3mL) from the European Union countries.

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05-25-2010 |  20:41 hs.
The European Medicines Agency said in a statement today that although traces of porcine circovirus were found, Merck & Co. RotaTeq vaccine (Rotavirus Vaccine Live Oral Pentavalent) and GlaxoSmithKline Plc. Rotarix Vaccine (Rotavirus Vaccine Live Oral) are safe to use on children.

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Asthma
03-25-2010 |  17:24 hs.
British SkypePharma Plc. announced documentation filling process, will be concluded by the end of march, for European Medicines Agency approval of Flutiform drug (formoterol + fluticasone) indicated to treat asthma. The Food and Drug Administration delivered a complete response letter last September.

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06-18-2009 |  14:33 hs.
Biotechnology Pharming NV, said the agreed with an EMEA pediatric committee a research plan for Rhucin in the therapeutic area of immunology-rheumatology-transplantation. The company will present the drug for EMEA approval for the above conditions by the end of the third quarter.


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06-12-2009 |  15:20 hs.
A European Medicines Agency recommended Wyeth’s, Enbrel (Etanercept) drug for continuous or intermittent treatment of plaque psoriasis in adults.

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Diabetes Type 2 Drug
06-11-2009 |  12:25 hs.
Japanese Takeda Pharmaceutical Co. said that they will delay at least 3 years presentation of experimental drug to treat diabetes type 2, that belongs to the DPP4 class or dipeptidil peptidasa 4 inihitors, Alogliptin (SYR 322)


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06-11-2009 |  11:34 hs.
US-based Schering-Plough Corp. announced data presentation to the European Medicines Agency for approval atypical antipsychotic Sycrest (Asenapine) drug to treat schizophrenia.


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06-02-2009 |  18:45 hs.
The European Medicines Agency authorized marketing of six generic versions of Sanofi-Aventis SA and Bristol-Myers Squibb Co. blockbuster blood thinner, Plavix (Clopidogrel).



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06-01-2009 |  14:14 hs.
A European Medicines Agency recommended lifting restrictions over UCB drug Neupro (Rotigotine) drug to treat Parkinsons disease and restless leg syndrome. The transdermal patch drug is owned by Belgic UCB, had been withdrawn from the US market in 2008.

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Fabry Disease
04-13-2009 |  18:48 hs.
Shire´s enzyme therapy drug Replagal (agalsidase alfa), indicated to treat Fabry’s disease, is seeking approval for early use as it showed that slows progression for this specific condition

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01-05-2009 |  18:27 hs.
Schering-Plough Corp. announced that they have sent documentation to the European Medicines Agency for marketing approval for Corifollitropin Alfa, the company's experimental, sustained follicle stimulant (SFS).

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12-19-2008 |  16:15 hs.
The E.U. Commitee for Medicinal Products for Humans Use (CHMP) said that Eli Lilly & Co and Daiichi’s experimental antiplatelet, prasugrel, was suitable for use in preventing clots in patients who are to undergo percutaneous coronary intervention, or PCI, a procedure to widen narrowed arteries.

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12-19-2008 |  15:56 hs.
California-based biotechnology IDM Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) regulatory agency for the European Medicines Agency recommended the marketing approval for experimental drug Mifarmutide to treat osteosarcoma for adolescents.

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12-04-2008 |  20:37 hs.

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12-01-2008 |  16:26 hs.
German Merck KGaA announced that the European Medicines Agency (EMEA) approved blockbuster cancer drug Erbitux (cetuximab) as first-line use in patients with recurrent and/or mestastic squamous cell carcinoma of the head and neck.

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