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Ortho Biotech unblinded abiraterone acetate Phase 3 study for prostate cancer patients

Ortho Biotech Oncology Research & Development, a unit of Cougar Biotechnology, Inc., today announced that it has unblinded the Phase 3 study of abiraterone acetate plus prednisone for the treatment of patients with metastatic advanced prostate cancer (also referred to as castration-resistant prostate cancer) whose disease has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel.

10 Sep 2010

John Theurer Cancer Center plays major role in FDA's fast tracking of ipilimumab for metastatic melanoma

Researchers from the John Theurer Cancer Center at Hackensack University Medical Center played an important role in a study that led to the Food & Drug Administration's (FDA) recent fast tracking of ipilimumab, a promising treatment for metastatic melanoma. The FDA based its decision largely on the results of a pivotal study published in the New England Journal of Medicine on August 19, 2010 – the same day the agency accepted Bristol-Myers Squibb's application for the drug's approval and granted the application priority review status.

10 Sep 2010

Seaside reports positive data from STX209 Phase 2 study in ASD

Seaside Therapeutics, Inc. announced today positive data from an open-label Phase 2 study of STX209 conducted in patients with autism spectrum disorders (ASD). The primary endpoint of the study, an improvement on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I), achieved statistical significance (p<0.001).

9 Sep 2010

CombinatoRx is now Zalicus

CombinatoRx, Incorporated today announced that it has changed its name to Zalicus Inc. The company will begin trading under the new ticker symbol ZLCS on the NASDAQ Global Market at market open on September 9, 2010.

9 Sep 2010

DARA BioSciences presents KRN5500 study results at World Congress on Pain

DARA BioSciences announced today that it presented study results from its Phase 2 multicenter, placebo controlled, double-blind, randomized dose escalation study for KRN5500 at the 13th World Congress on Pain held recently in Montreal.

9 Sep 2010

Researchers find minocycline antibiotics effective for fragile X syndrome

One of the antibiotics most commonly prescribed to treat adolescent acne can increase attention spans and communication and decrease anxiety in patients with fragile X syndrome, the most common inherited cause of mental impairment, according to a new survey study that is the first published on parents' reports of their children's responses to treatment with the medication.

9 Sep 2010

Energy drink consumption can improve performance in young sports people: Study

Consuming energy drinks during team sports could help young people perform better, a study suggests. Sports scientists found that 12-14 year olds can play for longer in team games when they drink an isotonic sports drink before and during games.

9 Sep 2010

Santarus, VeroScience enter agreement to commercialize CYCLOSET drug for type 2 diabetes

Santarus, Inc., S2 Therapeutics, Inc. and VeroScience LLC today announced that they have entered into a distribution and license agreement granting Santarus exclusive rights to manufacture and commercialize CYCLOSET (bromocriptine mesylate) tablets in the U.S.

9 Sep 2010

Hemispherx Biopharma to present clinical data on XMRV retrovirus at International Workshop

Hemispherx Biopharma, Inc. will present new clinical data on the possible inter-relationships of XMRV positivity/chronic fatigue syndrome/Ampligen responsiveness at the 1st International Workshop on XMRV being held at the National Institutes of Health in Bethesda, MD, on September 7 and 8, 2010.

9 Sep 2010

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals, Inc. today announced that all non-asthmatic patients and a subset of asthmatic patients have completed 12 months of treatment in the open-label safety trial of LEVADEX™. In addition, the Company has completed patient treatment in a thorough QT trial, the last trial necessary to support a New Drug Application (NDA) for LEVADEX.

8 Sep 2010

MAP Pharmaceuticals reports results from PD trial that compares effects of LEVADEX, IV DHE

MAP Pharmaceuticals, Inc. today reported results from a pharmacodynamics trial comparing the acute effects on pulmonary artery pressure of LEVADEX, dihydroergotamine mesylate administered intravenously and placebo. In the trial, there was no statistically significant difference between the LEVADEX and placebo groups in the primary endpoint of pulmonary artery pressure over two hours after administration.

8 Sep 2010

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

Emergent BioSolutions Inc. announced today that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject. Emergent's fully human monoclonal antibody product candidate is being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

8 Sep 2010

Octapharma announces new study of IVIG in chronic inflammatory demyelinating polyradiculoneuropathy

Octapharma AG today announced the imminent start of the biggest ever study of an intravenous immunoglobulin preparation (IVIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

8 Sep 2010

Penn receives $12M NIH grant to study pharmacogenetics of nicotine addiction treatment

A variety of smoking cessation treatments are currently available for the more than 18 million adult Americans try to quit smoking each year, but success rates vary widely. Despite the importance of quitting smoking, more personalized approaches to smoking cessation treatment are needed to help smokers pick the right method that will work best for them. A major new personalized medicine clinical trial, led by addiction researchers at the University of Pennsylvania, will study how a smokers' genetic make-up influences their quitting success.

8 Sep 2010

Can-Fite BioPharma opens IND with US-FDA for CF101 Phase 3 study in Dry Eye Syndrome

Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that it has opened an Investigational New Drug application (IND) with the US-FDA for a Phase 3 study of its lead drug, CF101, in patients with moderate to severe Dry Eye Syndrome.

8 Sep 2010

Methylphenidate facilitates recovery from drug addiction

A brain-scanning study at the U.S. Department of Energy's (DOE) Brookhaven National Laboratory, conducted with collaborators from Stony Brook University, reveals that an oral dose of methylphenidate, commonly known as Ritalin, improves impaired brain function and enhances cognitive performance in people who are addicted to cocaine.

7 Sep 2010

Rexahn submits Phase IIb protocol to FDA for study of Serdaxin for major depressive disorder

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase IIb protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin for the treatment of major depressive disorder (MDD).

7 Sep 2010

Promedior initiates PRM-151 Phase 2a clinical study in prevention of scarring post glaucoma filtration surgery

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today that it has initiated a Phase 2a clinical study of PRM-151 to evaluate the efficacy, safety, and tolerability of PRM-151 in preventing post-surgical scarring in glaucoma patients following glaucoma filtration surgery. There currently are no approved drugs for preventing post-surgical scarring in glaucoma, and there are no approved anti-fibrotic drug therapies in the U.S. or Europe for any fibrotic disease.

7 Sep 2010

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the company received verbal notice on Friday, September 3, 2010 from the U.S. Food and Drug Administration (FDA) that the IDX184 and IDX320 programs have been placed on clinical hold.

7 Sep 2010

Hallucinogen psilocybin safe for administration in patients with advanced-stage cancer and anxiety: Study

A pilot study suggests the hallucinogen psilocybin may be feasible and safe to administer to patients with advanced-stage cancer and anxiety, with promising effects on mood, according to a report published online today that will appear in the January 2011 print issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

7 Sep 2010

Placebo News and Research

Ortho Biotech unblinded abiraterone acetate Phase 3 study for prostate cancer patients

John Theurer Cancer Center plays major role in FDA's fast tracking of ipilimumab for metastatic melanoma

Seaside reports positive data from STX209 Phase 2 study in ASD

CombinatoRx is now Zalicus

DARA BioSciences presents KRN5500 study results at World Congress on Pain

Researchers find minocycline antibiotics effective for fragile X syndrome

Energy drink consumption can improve performance in young sports people: Study

Santarus, VeroScience enter agreement to commercialize CYCLOSET drug for type 2 diabetes

Hemispherx Biopharma to present clinical data on XMRV retrovirus at International Workshop

MAP Pharmaceuticals completes 12 months of treatment in LEVADEX open-label safety trial

MAP Pharmaceuticals reports results from PD trial that compares effects of LEVADEX, IV DHE

Emergent BioSolutions initiates Phase I clinical trial for anthrax monoclonal antibody therapeutic

Octapharma announces new study of IVIG in chronic inflammatory demyelinating polyradiculoneuropathy

Penn receives $12M NIH grant to study pharmacogenetics of nicotine addiction treatment

Can-Fite BioPharma opens IND with US-FDA for CF101 Phase 3 study in Dry Eye Syndrome

Methylphenidate facilitates recovery from drug addiction

Rexahn submits Phase IIb protocol to FDA for study of Serdaxin for major depressive disorder

Promedior initiates PRM-151 Phase 2a clinical study in prevention of scarring post glaucoma filtration surgery

Idenix Pharmaceuticals receives clinical hold order from FDA for IDX184, IDX320 programs

Hallucinogen psilocybin safe for administration in patients with advanced-stage cancer and anxiety: Study

Industry Focus eBook - Cell & Gene Therapy (1st Edition) eBook

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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