Clinical Intelligence

Valley Hospital to begin phase II trial of personalized vaccine for brain tumors

Friday, February 10, 2012 03:43 PM

Valley Hospital in Ridgewood, N.J., is now offering patients with newly diagnosed glioblastoma multiforme (GBM) (brain tumor) the opportunity to take part in a clinical trial that produces and uses a vaccine produced from patients' own tissue.

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Lorediplon has best-in-class results for insomnia

Friday, February 10, 2012 03:38 PM

Ferrer, a privately-held Spanish pharmaceutical company, has released results from a phase I trial of Lorediplon in insomnia showing it has a best-in-class efficacy profile in terms of sleep maintenance and sleep quality when compared to market leader zolpidem.

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Vyvanse capsules approved to treat adults with ADHD

Friday, February 10, 2012 12:08 PM

The FDA has approved Vyvanse (lisdexamfetamine dimesylate) capsules as a maintenance treatment for adults with ADHD, according to Shire Pharmaceuticals, a global specialty biopharmaceutical company.

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FDA clears IND for treatment of acute seizures

Friday, February 10, 2012 12:06 PM

The FDA has cleared Neurelis’ Investigational New Drug application (IND) to commence clinical trials advancing the development of NRL-1, a diazepam nasal spray for the treatment of acute breakthrough seizures, according to Neurelis.

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GW receives Austrian approval for cannabis-based oral spray for MS

Friday, February 10, 2012 12:04 PM

GW Pharmaceuticals’ Sativex (THC and cannabidiol) oral spray has received regulatory approval in Austria as a treatment of spasticity due to Multiple Sclerosis (MS).

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FDA approves Sklice lotion for head lice

Friday, February 10, 2012 12:01 PM

The FDA has approved Sklice (ivermectin) lotion 0.5% for the topical treatment of head lice in patients 6 months of age and older, according to Sanofi.

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Myelin Repair and ENDECE Neural to develop MS treatment

Friday, February 10, 2012 11:58 AM

The Myelin Repair Foundation (MRF), a nonprofit research organization, and ENDECE Neural have formed a partnership to expedite the advancement of myelin regeneration drug candidates for Multiple Sclerosis (MS) patients through pre-clinical studies and into phase I trials.

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Positive phase III results with investigational antipsychotic Cariprazine

Friday, February 10, 2012 11:52 AM

Forest Laboratories and Gedeon Richter have released preliminary top-line results from a phase III clinical trial of cariprazine (RGH-188), an investigational antipsychotic agent, in patients with acute mania associated with bipolar I disorder.

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Soligenix demonstrates proof of concept with vaccine technology

Tuesday, February 7, 2012 10:49 AM

Soligenix, a development-stage biopharmaceutical company, has released results from pre-clinical studies of its proprietary vaccine thermostabilization technology indicating that Soligenix is able to produce stable vaccine formulations using adjuvants, protein immunogens and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions.

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Phase I study of OGX-427 shows evidence of activity in bladder cancer

Tuesday, February 7, 2012 08:28 AM

OncoGenex Pharmaceuticals has announced preliminary results from an investigator-sponsored phase I study of patients with superficial bladder cancer with its investigational compound OGX-427, designed to inhibit the production of Hsp27.

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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