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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

Santhera says ready availability of idebenone complicating clinical trial process

Sanofi-Aventis could face antitrust charges if company loses Lovenox patent case

Medarex’s Phase III melanoma drug Ipilimumab likely to be rejected by FDA due to missed primary endpoint, physicians say

Takeda and Teva await Delaware judgement on whether Prevacid patent is invalid

Genentech’s bid to expand Avastin label for breast cancer seen facing negative FDA ruling

Abbott’s and Medtronic’s new stents may be easier to insert, but not safer than earlier generation products, physicians say

Bristol-Myers’ leukaemia drug Sprycel causes significant pleural effusions that have led patients to discontinue treatment, physicians say

Bayer’s Trasylol facing FDA questions but remains a proper option for certain heart surgery patients, physicians say

Amylin does not see itself as a takeover target in near term, despite market speculation

Myriad Genetics’ Flurizan trials will not see setbacks encountered in Neurochem’s failed Phase III Alzhemed trial, physicians say

Vanda’s Zomaril will allow more targeted treatment; cardiac concerns unlikely to deter prescribing

Pfizer: Securing new Lipitor patent could reopen infringement case with Ranbaxy - sources

ArthroCare rumoured to be next acquisition target; one of few pure spine targets left, sources say

Cell Genesys: GVAX for prostate cancer has its skeptics, though more data could sway some physicians

GSK: Avandia expected to receive label change, potentially boosting use of older diabetes drugs, doctors say

MGI Pharma’s Aloxi could get broader label for post-operative setting, but current treatments are already preferred - physicians

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