European Commission approves marketing of Celgene drug
BOUDRY, Switzerland The European Commission has approved the marketing of a cancer drug by Celgene International Sarl, the Swiss biotech company announced Tuesday.
The company described Vidaza (azacitidine) as the first epigenetic cancer therapy to significantly extend survival for patients with intermediate-2 and higher-risk myelodysplastic syndromes and acute myeloid leukemia.
“The European Commission approval of Vidaza is recognition of the significant survival benefited afforded by this therapy for critical hematological malignancies,” Celgene Europe president Philippe Van Holle.
“We will now begin working with local regulatory authorities on a country-by-country basis for reimbursement and distribution for all European Union member states.”
FDA approves Novadel’s Zolpimist for short-term insomnia treatment
FLEMINGTON, N.J. The Food and Drug Administration has approved a drug by NovaDel Pharma for the short-term treatment of insomnia characterized by difficulties with sleep initiation, NovaDel announced Monday.
NovaDel said that Zolpimist (zolpidem tartrate) is its second product approved by the FDA that uses its proprietary NovaMist spray technology. The active ingredient in Zolpimist is the same as the one in Sanofi-Aventis’ Ambien.
“We believe that the FDA’s approval of Zolpimist provides patients with an important treatment option for insomnia, as Zolpimist provides rapid absorption from the oral mucosa,” NovaDel board chairman and interim CEO Steven Ratoff said.
Ambien had worldwide sales of $559.3 million for first six months of 2008, according to Sanofi-Aventis financial data.
AstraZeneca considering entering biosimilars market
LONDON AstraZeneca may soon start developing biosimilars, according to published reports.
David Brennan, the company’s CEO, told the Financial Times that depending on legislation being considered, the Anglo-Swedish drug maker might expand into creating follow-on versions of biologics that have lost patent protection.
Merck and Eli Lilly have also said they might develop biosimilars. Merck announced earlier this month that it would create a new biosimilars division, Merck BioVentures, to make follow-on and novel biologics using engineering technology from GlycoFi, a company it acquired in 2006. The Whitehouse Station, N.J.-based drug maker plans to launch its first biosimilar, the anemia drug MK-2578, in 2012 and have at least five biosimilar candidates at that time.