die 26 Neuzulassungen der FDA in 2009...
http://www.fiercebiotech.com/slideshows/fda-approvals-2009
1. Savella - Forest Labs
2. Uloric - Takeda
3. Afinitor - Novartis
4. Coartem - Novartis
5. Ulesfia - Sciele Pharma
6. Simponi - Johnson & Johnson
7. Dysport - Ipsen, Medicis
8. Fanapt - Vanda Pharma
9. Samsca - Otsuka Pharma
10. Besivance - Bausch & Lomb
11. Ilaris - Novartis
12. Multaq - Sanofi-Aventis
13. Effient - Eli Lilly, Daiichi Sankyo
14. Onglyza - AstraZeneca, BMS
15. Livalo - Kowa Research
16. Saphris - Merck's Organon USA
17. Extavia - Novartis
18. Sabril - Lundbeck
19. Bepreve - Ista Pharma
20. Vibativ - Theravance, Astellas
21. Folotyn - Allos Therapeutics
22. Stelara - Johnson & Johnson
23. Votrient - GSK
24. Arzerra - GSK
25. Istodax - Gloucester Pharma
26. Kalbitor - Dyax Corp
zwei davon sind hier direkt relevant... Folotyn von Allos und Arzerra von Genmab
Drug: Folotyn
Indication: Relapsed peripheral T-cell lymphoma
Company: Allos Therapeutics
Date Approved: Sept. 24
Scoop: Folotyn is the first and only drug approved for PTCL, a rare form of blood cancer that has a poor prognosis and a high relapse rate. An expert panel backed the treatment despite questions about the drugmaker's clinical data and the safety profile. Allos has faced some criticism of the drug due to it's $30,000-per-month price tag, but the company says it's priced similarly to other rare disease drugs and adds that patients only receive Folotyn for a few months.
Drug: Arzerra
Indication: chronic lymphocytic leukemia
Company: GlaxoSmithKline
Date Approved: Oct. 26
Scoop: Arzerra is designed to attach to the CD20 molecule found on B cells, which are vulnerable to leukemia. It flags the cells for destruction, much like Rituxan does, though it uses a different mechanism. Arzerra is also undergoing clinical trials for rheumatoid arthritis. It was also in testing for non-Hodgkin's lymphoma, but produced underwhelming results for that indication. GSK licensed the drug, also known as ofatumumab or HuMax CD-20, in 2007 for $2.1 billion.
und zwei weitere sind indirekt relevant... Ilaris wurde zusammen mit REGN entwickelt... REGN erhält Royalties. Und CBST besitzt die Rechte zur Entwicklkung von Kalbitor gegen Blutungen.
Drug: Ilaris (canakinumab)
Indication: CAPS
Company: Novartis
Approval Date: June 17
Scoop: The FDA approved Ilaris for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS), which includes a number of rare but life-long auto-inflammatory disorders, last June. Only 300 cases of CAPS have been diagnosed in the U.S., but there are potentially many more undiagnosed patients with the condition due to poor disease recognition. The approval marks one of the first solid commercial successes for CEO Daniel Vasella's long quest to overhaul the pharma company's pipeline.
Drug: Kalbitor (ecallantide)
Indication: Sudden attacks of hereditary angioedema
Companies: Dyax
Approval Date: Nov. 27
Scoop: Last November the FDA approved Kalbitor for patients with hereditary angioedema, a rare and often lethal genetic disease characterized by pain and swelling in the face, lungs and upper airway. The approval marked a big win for Dyax, which has gone $335 million in the red as it pursued clinical development work. Kalbitor will be the 14-year-old biotech company's first marketed therapy. Dyax also licenses out its phage display technology to researchers.
mfg ipollit