Analysis of:
Efficacy and Safety of Recombinant Activated Factor VII for Acute Intracerebral Hemorrhage (content.nejm.org)
"In summary, rFVIIa reduced hematoma growth but did not reduce the rate of death or severe disability after intracerebral hemorrhage."
Analysis of:
Novelos Therapeutics announces positive results in ongoing phase 2 neoadjuvant breast cancer trial as Musc Hollings Cancer Center (www.pipelinereview.com)
The positive interim results released by Novelos Therapeutics about its chemoprotectant / chemopotentiator NOV-002 were not very meaty: Divining the true implications of pathologic CRs in neo-adjuvant breast cancer can be tricky. Plus, this was a open label, phase II study, and the number of patients reported...
Analysis of:
Glaxo Tests Tykerb vs Herceptin in Early Cancer (www.therapeuticsdaily.com)
Glaxo is trying to move Tykerb ahead of Herceptin in a first line/neoajuvant/adjuvant setting in Her2Neu + Breast cancer.
Analysis of:
US Drug Stocks Edge Higher, But ImClone Falls On Downgrade (news.ino.com)
Erbitux was touted to have a positive study in Non Small Cell Lung Cancer (NSCLCA) but all they said was that is was a positive study. No further info at that time but an executive bought a block of stock a few days before the announcement which led to an inevitable rise in the stock price! Does this...
Analysis of:
Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market (www.pipelinereview.com)
Now that liquid Leukine (GM-CSF) has been withdrawn by Bayer, Amgen commands the North American G-CSF market with its Neupogen and Neulasta. However, Indian manufacturer INTAS Biopharmaceuticals Ltd. (IBPL) has been treating patients with a biosimilar G-CSF called Neukine since 2004. And...
Analysis of:
Genentech and Biogen Idec Announce Top-Line Results From Phase II/III Clinical Study of Rituxan in Systemic Lupus Erythematosus (www.pipelinereview.com)
The problem with lupus studies lies in study design. While true for all trials, this is specially true for lupus since the disease is not "uniform". Patients have so many different varieties of lupus that the inclusion/exclusion criteria can make or break a study before it starts.
Analysis of:
Proteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients with Relapsed Solid Tumors (www.pipelinereview.com)
The fact that they had a very small phase I studay of 14 patients only. This concerns me a bit. Usualy you enrol at least 30-40 patients in a phase I trial
Analysis of:
Oncothyreon files investigational new drug application for PX-866 oncology compound (www.pipelinereview.com)
PI-3-kinase inhibitors are the next class of anti-cancer drugs.
Analysis of:
Cancer-Gene Test Boosts Myriad's Sales (online.wsj.com)
Myriad Genetics Inc. went directly to the patients who then were tested whether the tests were indicated or paid for by insurers or out of their own pockets. If patients have "medical savings accts" as suggested by various political candidates, right or wrong patients will want it with this kind...
Analysis of:
Curis Announces Genentech's Initiation of Hedgehog Antagonist Phase II Clinical Trial In Metastatic Colorectal Cancer (www.pipelinereview.com)
GDC-0449 is an oral agent that will be added to "standard" therapy in metastatic colorectal carcinoma (CRC) and evaluating progression free survival as the primary objective.