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Archive for the ‘ clinical trials ’ Category

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 â€“ 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 toÂ shiftÂ attentionÂ fromÂ aÂ series of recentÂ clinical-trial setbacks,Â willÂ be inÂ New York City tomorrow for the company's first investor conference since itsÂ buyout of Genentech.Â They are expected to emphasize theÂ potential created byÂ Roche's new biotech armÂ andÂ highlight severalÂ promisingÂ pipeline drugs, led byÂ Phase III blockbuster candidates dalcetrapib, aleglitazar, and RG1678.Â 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 â€“ both for drug research and commercial medicines â€“ has ...

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

Kareem news puts rare cancer in spotlight

Wednesday, November 18th, 2009

As a lifelong Philadelphia 76ers fan, I grew up rooting against Kareem Abdul-Jabbar. After all, the big, bad Lakers were always the one team blocking my beloved Sixers â€“ led by Dr. J and company â€“ from winning the NBA championship until â€œweâ€ finally broke through in 1983, sweeping L.A. ...

Posted in cancer, clinical trials | No Comments »

Palifosfamide lacks resistance, side effects of forebears

Monday, November 16th, 2009

Cancer drugs have come a long way and work very effectively today, but they create a tremendous expense for patients because treatment requires them to be admitted to the hospital. Drugs such as doxorubicin, ifosfamide, and cyclophosphamide can have severe side effects, including brain, kidney, and bladder issues, diminishing the ...

Posted in cancer, clinical trials | No Comments »

Acceleron looks past VEGF in cancer treatment

Friday, November 6th, 2009

Many cancer treatments being developed in the clinic focus on the VEGF pathway by blocking multiple kinase inhibitors or different proliferative agents simultaneously, which usually leads to serious side effects. But VEGF is just one piece of the tumor angiogenesis puzzle. Executives with Acceleron Pharma Inc. believe that a need exists ...

Posted in cancer, clinical trials | 1 Comment »

More proof of vaccine boom

Monday, October 26th, 2009

In case you missed it, the World Health Organization released a comprehensive new vaccines report late last week, its unveiling no doubt timed with the uptick in swine flu immunization campaigns around the world (read the latest on H1N1 vaccine supply shortages here.) Hereâ€™s the WHO press release on the study. ...

Posted in clinical trials, infectious diseases, vaccines | 1 Comment »

Lupus drought: 50 years and counting

Thursday, October 8th, 2009

In this monthâ€™s issue of R&D Directions, we examine the 10 most active areas of therapeutic research, and also highlight some promising therapies for diseases in these categories. One condition researchers are particularly hesitant to lump into that â€œpromisingâ€ group is lupus â€“ and who could blame them? There have ...

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

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