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Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST.

27 Jan 2010

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

EpiCept Corporation announced today that EpiCeptTM NP-1 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of post-herpetic neuralgia (PHN). NP-1 is a prescription topical analgesic cream designed to provide long-term relief from the pain of peripheral neuropathies.

27 Jan 2010

Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

Osiris Therapeutics, Inc. today announced that it has achieved a $750,000 milestone payment from the Juvenile Diabetes Research Foundation (JDRF) for completing enrollment in a Phase II clinical trial evaluating Prochymal, an adult mesenchymal stem cell (MSC) therapy, as a treatment for patients recently diagnosed with type 1 diabetes. The milestone is the fourth in a series of payments resulting from JDRF’s partnership with Osiris for the development of a therapy for type 1 diabetes.

27 Jan 2010

Pfizer reports final results from randomized Phase 3 trial of Sutent

Pfizer Inc. today announced final results from a randomized Phase 3 trial of Sutent (sunitinib malate) in patients with advanced pancreatic neuroendocrine tumors, a type of cancer which originates in the hormone-producing area of the pancreas.

23 Jan 2010

FDA's Ampyra approval wonderful news for people with MS experiencing walking problems

The U.S. Food and Drug Administration has approved the marketing of Ampyra™ (dalfampridine, formerly known as fampridine SR, from Acorda Therapeutics) for its ability to improve walking speed in people with any type of multiple sclerosis.

23 Jan 2010

Ampyra receives FDA approval for improving walking in MS patients

The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo). This is the first drug approved for this use.

23 Jan 2010

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Biovail Corporation today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial is intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug. The trial was described in a Dow Jones Newswire article dated December 2, 2009.

22 Jan 2010

Progress in Anadys Pharmaceuticals' Phase II study of ANA598 announced

Anadys Pharmaceuticals, Inc. today announced that ANA598 dosing has been completed in the first dose cohort, 200 mg bid, in an ongoing Phase II study of ANA598 in combination with pegylated interferon and ribavirin (SOC) in HCV patients.

22 Jan 2010

Acorda Therapeutics receives marketing approval from FDA for AMPYRA

Acorda Therapeutics, Inc. today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for AMPYRA™ (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS).

22 Jan 2010

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

BioNumerik Pharmaceuticals, Inc. today announced the treatment of the first patients in a global multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer. In previous studies, Tavocept demonstrated the potential to substantially increase overall and one year patient survival while concurrently preventing and reducing the incidence and severity of common chemotherapy side-effects as compared to other currently available treatments for advanced lung cancer.

21 Jan 2010

Results of two pivotal Phase III clinical trials with oral FTY720 published

Results of the TRANSFORMS and FREEDOMS studies, the two pivotal Phase III clinical trials with oral FTY720 (fingolimod), have been published in The New England Journal of Medicine, providing comprehensive evidence to support the efficacy and safety profile of this first-in-class therapy for multiple sclerosis (MS).

21 Jan 2010

Phase 3 clinical trial results of Inspire Pharmaceuticals' PROLACRIA announced

Inspire Pharmaceuticals, Inc. announced today that its Phase 3 clinical trial (Trial 03-113) of PROLACRIA™ (diquafosol tetrasodium ophthalmic solution) 2% for the treatment of dry eye disease did not meet its primary endpoint (p = 0.526) or its secondary endpoint (p = 0.368).

21 Jan 2010

EMD Serono announces results from CLARITY Phase III trial in MS patients

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today the online publication of the results from the CLARITY Phase III trial using Cladribine Tablets (EMD Serono's proprietary investigational oral formulation of cladribine) in The New England Journal of Medicine. The CLARITY study was a two-year (96-week), randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in 1,326 people with relapsing-remitting multiple sclerosis (MS).

21 Jan 2010

Acyclovir does not reduce risk of HIV transmission for people infected with both HIV and HSV-2

A five-year international multi-center clinical trial has found that acyclovir, a drug widely used as a safe and effective treatment taken twice daily to suppress herpes simplex virus-2 (HSV-2), which is the most common cause of genital herpes, does not reduce the risk of HIV transmission when taken by people infected with both HIV and HSV-2.

21 Jan 2010

Dosing in First-in-Man Phase I study of 4SC AG's 4SC-203 commenced

4SC AG, a drug discovery and development company, today announced the start of dosing in a First-in-Man Phase I study in healthy volunteers evaluating 4SC-203, a novel multi-target kinase inhibitor, with particular specificity against selected kinases, including FMS-like tyrosine kinase 3 (FLT3), FLT3 mutants and vascular endothelial growth factor receptors (VEGF-R).

21 Jan 2010

Lexicon Pharmaceuticals reports positive results from its LX4211 Phase 2 trial in type 2 diabetic patients

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, obtained positive results from a recently completed Phase 2 study of LX4211 in patients with type 2 diabetes mellitus. LX4211 is a once-per-day, orally-delivered, small molecule drug candidate that inhibits the sodium-dependent glucose transporter 2 (SGLT2), lowering the accumulation of glucose in the body and reducing caloric load.

20 Jan 2010

Health Canada approves Novartis' Afinitor to treat patients with mRCC

Novartis Pharmaceuticals Canada Inc. (Novartis) announced today that Afinitor(R) (everolimus), a once-daily oral cancer treatment, has been approved by Health Canada for patients with metastatic renal cell carcinoma (mRCC), also known as advanced kidney cancer, after failure of initial treatment with VEGF-receptor targeted therapies Sutent(R) (sunitinib) or Nexavar(R) (sorafenib).

20 Jan 2010

$SIR supports use of vertebral augmentation for patients with spine fractures$

SIR supports use of vertebral augmentation for patients with spine fractures

Given the current controversy over vertebroplasty-a minimally invasive treatment performed by interventional radiologists in individuals with painful osteoporotic vertebral compression fractures that fail to respond to conventional medical therapy-what's a patient to do?

20 Jan 2010

PTC Therapeutics initiates additional clinical trial of ataluren in boys and young men with nmDBMD

PTC Therapeutics, Inc. (PTC) today announced the initiation of an additional clinical trial of ataluren (PTC124®) in boys and young men with nonsense mutation Duchenne/Becker muscular dystrophy (nmDBMD) who have permanently lost the ability to walk independently.

20 Jan 2010

Patient enrollment for Phase 2B clinical study of Oramed Pharmaceuticals' ORMD-0801 completed

Oramed Pharmaceuticals Inc. announced today the completion of patient enrollment in the Phase 2B clinical study of its oral insulin capsule, ORMD-0801.

20 Jan 2010

Placebo News and Research

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

EpiCept's NP-1 for treatment of PHN receives FDA orphan drug designation

Osiris Therapeutics completes enrollment in Prochymal MSC therapy Phase II trial for type 1 diabetes

Pfizer reports final results from randomized Phase 3 trial of Sutent

FDA's Ampyra approval wonderful news for people with MS experiencing walking problems

Ampyra receives FDA approval for improving walking in MS patients

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Progress in Anadys Pharmaceuticals' Phase II study of ANA598 announced

Acorda Therapeutics receives marketing approval from FDA for AMPYRA

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

Results of two pivotal Phase III clinical trials with oral FTY720 published

Phase 3 clinical trial results of Inspire Pharmaceuticals' PROLACRIA announced

EMD Serono announces results from CLARITY Phase III trial in MS patients

Acyclovir does not reduce risk of HIV transmission for people infected with both HIV and HSV-2

Dosing in First-in-Man Phase I study of 4SC AG's 4SC-203 commenced

Lexicon Pharmaceuticals reports positive results from its LX4211 Phase 2 trial in type 2 diabetic patients

Health Canada approves Novartis' Afinitor to treat patients with mRCC

SIR supports use of vertebral augmentation for patients with spine fractures

PTC Therapeutics initiates additional clinical trial of ataluren in boys and young men with nmDBMD

Patient enrollment for Phase 2B clinical study of Oramed Pharmaceuticals' ORMD-0801 completed

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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