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Archive for the ‘ clinical trials ’ Category

Personalized med prototype? Plexxikon discusses melanoma hopeful

Friday, March 4th, 2011

Plexxikon Inc., the small 45-person biotech in Northern California, made international news this week when big pharma Daiichi Sankyo, Japanâ€™s third-largest drugmaker, agreed to buy the company for as much as $935 million, enticed largely by Plexxikonâ€™s anticipated late-stage targeted drug, PLX4032, for advanced melanoma. By now, you likely know ...

Posted in cancer, clinical trials | No Comments »

Innovative delivery system gives boost to cancer vaccine development

Tuesday, January 25th, 2011

Development of a seal contraceptive has had a serendipitous result for one biotechnology company. Immunovaccine has begun making advances in cancer vaccine development through the use of its formulation system and DepoVax delivery technology. Cancer vaccines represent a multi-billion dollar market opportunity for pharmaceutical companies, but numerous vaccines fail clinical trials ...

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

Co-development guidance sets road map, but hurdles remain

Tuesday, January 18th, 2011

You have about a month left to weigh in publicly, if so moved, on FDAâ€™s new draft guidance on the co-development of drugs designed for use in combination therapy. Deadline for written comments is Valentineâ€™s Day. The agency, in its guidelines released before the holidays, acknowledged the need for a ...

Posted in FDA, cancer, clinical trials, drug discovery | No Comments »

Drug repositioning a timely strategy

Monday, December 27th, 2010

With patent expirations looming for several major pharmaceutical companies, the practice of drug repositioning is becoming increasingly important. Drugmakers, also faced with declining R&D productivity levels and an increasingly rigorous regulatory environment, are focused on identifying novel indications and disease targets for existing compounds and securing patent protection before their ...

Posted in Uncategorized, clinical trials, drug discovery | No Comments »

Fast-tracking proof of concept

Friday, September 17th, 2010

In this month's issue of R&D Directions, we talk about the need for contract research organizations to truly differentiate their services for a pharma client base that, given various circumstances, has become increasingly selective. For the clinical outsourcing provider, that means coming up with inventive and lasting solutions to help ...

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

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 Alzheimerâ€™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 weekâ€™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 patientâ€™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 »

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