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Archive for the ‘ clinical trials ’ Category

CROs juggle uncertainty, optimism

Tuesday, August 10th, 2010

The latest earnings season for the top publicly traded contract research organizations is over (Parexel released fiscal year 2010 results yesterday), leaving eyes now focused ahead at just what path clinical outsourcing will take the rest of the year and beyond. Many CROs are unsure whether continued market conditions will ...

Posted in CRO, clinical trials | 1 Comment »

Mental illness R&D reaches record level

Tuesday, July 20th, 2010

Offering further proof of the lucrative appeal of mental health drugs despite the continuing minefield for researchers, there are a record 313 new drugs in development to treat conditions ranging from Alzheimer’s disease and depression to schizophrenia and addictive disorders, according to a new report by the Pharmaceutical Researchers and ...

Posted in Uncategorized, clinical trials | 2 Comments »

Recruitment reigns at DIA

Friday, June 18th, 2010

Patient recruitment and retention was a major theme at this week’s 46th DIA Annual Meeting in Washington, both in the educational sessions and on the show floor. By my count, the conference featured at least 11 panels exploring the topic, ranging in focus from who should be accountable for patient ...

Posted in CRO, Uncategorized, clinical trials | 1 Comment »

Wave of momentum for cancer immunotherapies

Friday, June 4th, 2010

Since the landmark approval of Provenge in late April for prostate cancer, much has been made of the significant buzz created for similar cancer immunotherapies (see stories here and here) that stimulate a patient’s immune system to recognize, attack, and kill tumor cells. Clinical data for a new wave of ...

Posted in antibodies, cancer, clinical trials | No Comments »

Autoimmune breakthrough evades resistance issue

Thursday, April 8th, 2010

Although commercially successful, Remicade, Humira, and Enbrel have many limitations due to allergies or infections. Their high immunogenicity, their loss of effectiveness over time, and their expense (typically costing $15,000 to $20,000 per patient per year) make these monoclonal antibodies less than ideal treatments. French biotechnology company, Neovacs SA is ...

Posted in clinical trials | 1 Comment »

Report: Fixing trial start-up woes requires new way of thinking

Friday, March 19th, 2010

Life sciences R&D is becoming an increasingly networked and externalized practice – just see the latest merger, licensing deal, or joint venture for proof. Therefore, experts say, it is even more critical for drug companies to rethink the way they mange the various components of a clinical trial, where several ...

Posted in CRO, clinical trials | 1 Comment »

Roche pipeline takes stage

Wednesday, March 17th, 2010

Top executives with the Swiss pharma giant, eager to shift attention from a series of recent clinical-trial setbacks, will be in New York City tomorrow for the company's first investor conference since its buyout of Genentech. They are expected to emphasize the potential created by Roche's new biotech arm and highlight several promising pipeline drugs, led by Phase III blockbuster candidates dalcetrapib, aleglitazar, and RG1678.  I will be on ...

Posted in Uncategorized, clinical trials | No Comments »

Dual-filing feat a rarity for little guy

Wednesday, February 17th, 2010

You may have read recently about a small biotech outfit in New Jersey having successfully submitted simultaneous regulatory filings in the United States and Europe for Luveniq, a new oral treatment for non-infectious uveitis, an inflammatory condition of the eye that can lead to blindness (see the release here). You ...

Posted in Uncategorized, clinical trials, filed for approval | No Comments »

StudyOptimizer gets patient enrollment programs back on track

Friday, December 11th, 2009

Bringing a drug to market in a timely fashion is difficult and one of the biggest challenges facing pharmaceutical companies. Due to patent expirations, shrinking drug pipelines, and the financial crisis on Wall Street, manufacturers are being forced to speed up the drug-delivery process to bring drugs to market and ...

Posted in clinical trials | No Comments »

Emerging markets push has CRO at ready

Wednesday, December 2nd, 2009

A common theme echoed by big pharma these days, particularly during the recent blitz of third-quarter earnings releases, is a renewed focus on emerging markets. (Sanofi-Aventis and GlaxoSmithKline are two notable examples). Of course, the importance of tapping emerging markets – both for drug research and commercial medicines – has ...

Posted in CRO, Uncategorized, clinical trials | No Comments »

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