Show us the data! Economists tackle clinical trial cost triggers

April 13, 2011 – 2:19 pm by Michael Christel

After hearing the recent news that the National Bureau of Economic Research is investigating the rising costs of drug development, you might be wondering why the non-profit group is even taking a stab at what has long been a difficult area to pin down statistically. We caught up with one of the study’s principal investigators to find out what compelled NBER to tackle the nebulous road of clinical trial spending. [...]

Tags: clinical trial management

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Benlysta nod should benefit remaining lupus prospects

March 10, 2011 – 2:44 pm by Michael Christel

FDA’s approval of Benlysta is indeed an historic moment for lupus patients, a community that has waited 50 years for a new treatment. The milestone, however, may have even bigger ramifications going forward. The door for additional – and perhaps more effective – new drugs for the autoimmune disorder has suddenly been kicked open, a welcomed departure for a disease segment long fraught with clinical heartache. [...]

Tags: Benlysta, Eli Lilly, epratuzumab, GlaxoSmithKline, Human Genome Sciences, Immunomedics, lupus, Lupus Research Institute, UCB Inc.

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Personalized med prototype? Plexxikon discusses melanoma hopeful

March 4, 2011 – 6:10 pm by Michael Christel

Plexxikon Inc., the small 45-person biotech in Northern California, made international news this week when big pharma Daiichi Sankyo, Japan’s third-largest drugmaker, agreed to buy the company for as much as $935 million, enticed largely by Plexxikon’s anticipated late-stage targeted drug, PLX4032, for advanced melanoma. R&D Directions spoke with Gideon Bollag, Ph.D., Plexxikon’s senior VP of research, to discuss the latest trial results for PLX4032, the unique technology behind the drug, and the product’s potential to reshape views on personalized medicine. [...]

Tags: biomarkers, BRAF V600, Daiichi Sankyo, Genentech, M&A, melanoma, oral kinase inhibitor, personalized medicine, Plexxikon, PLX4032, Roche

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Roche appoints head of discovery

February 22, 2011 – 11:13 am by Colette Pilkus

Roche named Anirvan Ghosh, Ph.D., head of discovery for the company’s central nervous system and translational area, where he will oversee discovery research in the central nervous system discovery and translational area with an emphasis on disorders such as schizophrenia, neurodegeneration, treatment-resistant depression, and neurodevelopment disorders.
Using a combination of cellular, molecular, and electrophysiological approaches, Dr. [...]

Tags: CNS, neural circuits, neuroscience, People on the move, R&D, Roche, schizophrenia

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J&J’s new lean, green lab to be key R&D hub

February 8, 2011 – 10:36 am by Michael Christel

In a rare day that didn’t include yet another punch from Old Man Winter, Johnson & Johnson executives Friday unveiled ambitious plans for the company’s two-year-old Spring House, Pa., research lab, providing media members with their first formal tour of the facility, one leaders expect to become a major J&J hub in North America for small molecule and biologics drug discovery. The new lab – dubbed Building 42 – is focused on [...]

Tags: Centocor, drug discovery, Johnson & Johnson, large molecule, lead optimization, medicinal chemistry, small molecule, Spring House, target identification

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Innovative delivery system gives boost to cancer vaccine development

January 25, 2011 – 12:37 pm by Colette Pilkus

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 despite promising results in early [...]

Tags: cancer, DepoVax, Immunovaccine

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Co-development guidance sets road map, but hurdles remain

January 18, 2011 – 2:57 pm by Michael Christel

You have about a month left to weigh in publicly, if so moved, on FDA’s new draft guidance on the co-development of drugs designed for use in combination therapy. Deadline for written comments is Valentine’s Day. One longtime researcher says the guidance is a good start in addressing certain scientific and regulatory roadblocks to co-development, but it doesn’t solve the legal hurdles that often prevent drugmakers from working together or with academic researchers. [...]

Tags: co-development, FDA

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Drug repositioning a timely strategy

December 27, 2010 – 5:26 pm by Michael Christel

With patent expirations looming for several major pharmaceutical companies, the practice of drug repositioning is becoming increasingly important. Drugmakers, in bids to replenish pipelines, are focused on identifying alternate indications and disease targets for existing compounds. We explore the advantages of this approach ahead, including the efforts of one technology provider active in the space. [...]

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Biosimilars picture has ‘so many unknowns’

November 18, 2010 – 10:35 am by Michael Christel

I don’t know about you, but I can’t get enough biosimilars talk these days. FDA’s two-day hearing earlier this month featured many opinions, and though most didn’t stray too far from party lines, the festivities did at least advance the discussion. For more perspective on the topic, I spoke recently with [...]

Tags: biosimilars, FDA

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Behind the NICE Alzheimer’s reversal

November 5, 2010 – 10:37 am by Michael Christel

You may be wondering what convinced the National Institute for Health and Clinical Excellence, U.K.’s controversial drug-cost watchdog, to reverse its restrictions on four top Alzheimer’s disease medicines last month, opening up potential access to hundreds of thousands of sufferers previously denied coverage. No, it doesn’t appear the result of a sudden epiphany or the beginnings of a kinder and gentler NICE, but rather long and exhaustive efforts in [...]

Tags: Alzheimer's disease, NICE

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