The following companies made the news for the Health Care Industry on Monday, June, 28, 2010
Cardiome, (NASDAQ:CRME): BRINAVESS, Intravenous or IV Vernakalant announced, EMA issued positive opinion for marketing approval for conversion of recent onset atrial fibrillation to sinus rhythm in adults, marketing authorization is expected later this year and will include 27 EU member countries.
Bio-Path, (OTC:BPTH): Liposomal Grb-2, (BP-100-1.01), anti-sense nucleic acid anti cancer agent announced FDA clearance (IND) to conduct clinical trials in patients with chronic myelogenous leukemia (CML), acute myeloid (AML), acute lymphobiastic leukemia (ALL) and myelodysplastic syndrome (MDS) ; estimate for start of phase 1 clinical trial during 2nd half of 2010.
AstraZeneca, (NYSE:AZN): The U.S food and drug administration has changed the decision date for its review of motavizumab to Aug 27. Motamizumab is an investigational monoclonal antibody being considered to help prevent serious respiratory synctial virus disease. The original biologics Liscence Application was filled on Jan 30,2008. Motavizumab was reviewed by the FDA antiviral Drugs advisory committee on June 2.
Cyclacel, (NASDAQ:CYCC): Sapacitabine (CYC682) (oral capsules) a nucleoside analogue anti-cancer agent. Announced interim results for myelodysplastic syndromes (MDS) with 1-year survival data expected late 2010, expects interim results for non-small cell lung cancer (NSCLC) during 2h10, expects decision on SPA request for phase 3 acute myeloid leukemia study.
Celgene, (NASDAQ:CELG): Amrubicin, 1 3rd generation, synthetic anthracycline, analogue has completed patient enrolment of amrubucin for small cell lung cancer (SCLC) with top line data expected during 3rd qtr 2010, orphan drug designation for the treatment of SCLC.