EMEA (Others)
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.
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.
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)
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.
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).
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 The transdermal patch drug is owned by Belgic UCB, had been withdrawn from the US market in 2008.
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
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).
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.
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.
12-04-2008 |
20:37 hs.
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.
MRSA drug
Swiss Biotech Basilea Pharma Receives Positive Opinion from Europe’s CHMP for Zevtera (ceftobiprole) 
11-21-2008 |
10:22 hs.
10-24-2008 |
09:11 hs.
10-24-2008 |
08:25 hs.
Benefits no longer outweigh risks
10-24-2008 |
08:00 hs.
European authorities said Sanofi-Aventis´s anti-obesity drug Acomplia (rimonabant) should be withdrawn from sale over links to mental disorders, dealing a blow to the French drugmaker.
Telavasin
10-24-2008 |
00:45 hs.
First therapeutic vaccine
10-22-2008 |
11:06 hs.
New York-based biotechnology Antigenics Inc, submitted a Marketing Authorization Application to the European Medicines Agency requesting conditional approval for the Oncophage therapeutic vaccine, in earlier-stage, localized renal cell carcinoma.
10-21-2008 |
11:12 hs.
AstraZeneca Plc is seeking European health regulators´ approval to sell its drug Seroquel XR as a treatment for anxiety, the Anglo-Swedish group reported.
MDD drug Pristiq in the U.S.
10-15-2008 |
11:36 hs.
Wyeth Pharmaceuticals announced its decision to hold off its request for marketing approval by the European Medicines Agency (EMEA) of its anti-depressant Ellefore (desvenlafaxine) - Pristiq in the U.S. - under review by the Agency’s Committee for Medicinal Products for Human Use. The company stated a revision of its “global regulatory strategy”.
