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Imclone addresses shortcomings of FLEX trial, development of KRAS biomarker to guide future patient selection
Imclone’s cancer drug Erbitux and the use of KRAS as a biomarker in lung cancer needs further validation. by Pharmawire
Auxilium Pharma retains Merrill Lynch to find partner for European Xiaflex rights, CFO says; could turn into outright takeout
Auxilium Pharmaceuticals, a Pennsylvania specialty pharmaceutical company, has retained Merrill Lynch to find a partner for the European rights to Xiaflex in Dupuytren’s contracture, CFO James Fickenscher told this news service. by Pharmawire
Imclone’s Erbitux BMS-099 trial not powered to show overall survival, FLEX remains pivotal registrational trial
Imclone’s Erbitux BMS-099 trial was not powered to show overall survival and expectations for conclusive data remain low, said Dr Eric Rowinsky, executive vice president and chief medical officer. by Pharmawire
Genentech’s Avastin study should evaluate drug’s effect on overall survival as primary endpoint, physicians say
Genentech’s study of Avastin in patients with colorectal cancer in the adjuvant setting should examine the drug’s effect on a primary endpoint of overall survival, physicians said. by Pharmawire
Schering’s HIV CCR5 antagonist vicriviroc will likely face similar hurdles seen with Selzentry’s launch - analysis
Schering’s vicriviroc, an antiviral that inhibits the CCR5 receptor in HIV 1 strains, may face similar issues seen in Pfizer’s initial launch of its CCR5 antagonist Selzentry, physicians said. by Pharmawire
United Therapeutics’ inhaled treprostinil may have limited efficacy due to missed secondary endpoint, physicians say
United Therapeutics inhaled treprostinil may have limited efficacy due to a lack of improvement on the New York Heart Association (NYHA) functional class scale, physicians say. by Pharmawire
Viropharma’s Camvia may change current treatment paradigm in stem cell transplant market
ViroPharma’s Phase III drug Camvia (maribavir) for the prevention of cytomegalovirus (CMV) disease may change the current treatment paradigm in the stem cell transplant market from preemptive therapy to prophylaxis, according to physicians. by Pharmawire
Merck’s Singulair likely to see prescription drop-off only in high-risk populations
A recent suicidality warning will likely cause the biggest prescription fall-off among patients with a personal or family history of depression, or patients with mild disease, physicians said. by Pharmawire
Merck’s Gardasil vaccine encounters skepticism from some physicians regarding wide-scale use, long-term safety and efficacy
Merck says that, despite recent news on adverse events, there is the chance for discrepancies in the reporting of these events. by Pharmawire
Celgene’s Revlimid warrants research in active-controlled clinical trials for EMEA approval, physicians say
Celgene’s attempt to gain European approval for Revlimid based on a single-arm clinical study is a risky move and should be studied in active-controlled clinical trials. by Pharmawire




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