EMEA (Others)
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European authorities said Sanofi-Aventis´s anti-obesity drug Acomplia (rimonabant) should be withdrawn from sale over links to mental disorders, dealing a blow to the French drugmaker.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”.
09-26-2008 |
18:25 hs.
09-25-2008 |
17:44 hs.
09-25-2008 |
13:25 hs.
Diabetic Neuropathic pain
09-25-2008 |
13:11 hs.
Prostate cancer treatment
09-25-2008 |
09:35 hs.
Lovenox
09-23-2008 |
11:33 hs.
Although batches of French drugmaker Sanofi-Aventis´s Lovenox had very low levels of contamination, the company has recalled all remaining batches of blood thinner Lovenox (a heparin) distributed before May 2008, French drug regulator Afssaps reported. Heparin coming from China this year had high levels of contamination, and this was linked with severe allergic side effects and many deaths.
For complicated skin and soft tissue infections (cSSTI)
08-22-2008 |
11:09 hs.
Swiss biotech Arpida Ltd announced the European health authorities have accepted the company´s marketing authorization application (MAA) for their experimental intravenous Iclaprim, initially for the treatment of complicated skin and soft tissue infections (cSSTI).
