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Blinding and blinding assessment rarely documented in trial reports

A paper published in the current issue of P&P? tests the widely accepted assumption in drug trials: neither evaluators nor patients know whether the patient is getting drug or placebo (double blindness).

28 May 2013

EADV spring symposium: Bioalliance Pharma presents Sitavig study results

BioAlliance Pharma SA, a Company dedicated to the development of orphan oncology products and supportive care products, has presented the results of the pharmacokinetic and pharmacodynamic study on Sitavig at the 10th EADV spring symposium (European Academy of Dermatology and Venereology) in Cracow (Poland) on May 24, 2013.

28 May 2013

OPKO reports more than 50% enrollment in phase 3 trial of Rayaldy for treatment of secondary hyperparathyroidism

OPKO Health, Inc., has surpassed 50% enrollment in the first phase 3 trial of RayaldyTM to treat patients with secondary hyperparathyroidism (SHPT), stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

24 May 2013

Smartphone solutions for clinical trials

mHealth broadly refers to the use of a mobile device to send patient information to or from a medical service provider. In most medication management mobile applications that are out there now, the “information” sent is usually a unidirectional nagging reminder to the patient. The application may populate a diary or it may not.

24 May 2013

Merck updates on preladenant clinical program for treatment of Parkinson's disease

Merck, known as MSD outside the United States and Canada, today provided an update on the clinical program for preladenant, Merck's investigational adenosine A2A receptor antagonist for the treatment of Parkinson's disease.

24 May 2013

Takeda begins MLN9708 phase 3 clinical trial in newly diagnosed myeloma patients

Takeda Pharmaceutical Company Limited today announced the initiation of an international phase 3 clinical trial evaluating once a week MLN9708 in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are not candidates for transplant.

24 May 2013

Spring Bank Pharmaceuticals starts Phase I study of SB 9200 for treatment of HCV infection

Spring Bank Pharmaceuticals, Inc., a biopharmaceutical company developing innovative medicines for the treatment of viral infections, today announced that it has initiated dosing in a Phase I study of SB 9200, its investigational, once daily, oral therapy for the treatment of HCV infection.

24 May 2013

Lightlake Therapeutics announces Phase II clinical trial results of nasal spray treatment for BED

Lightlake Therapeutics Inc., a biopharmaceutical company developing addiction treatments based on its expertise in opioid antagonists, announced today that results of the Company's Phase II clinical trial of its nasal spray treatment for Binge Eating Disorder were presented at the American Psychiatric Association Annual Meeting in San Francisco by Professor Hannu Alho, MD, professor of addiction medicine at the University of Helsinki and Principal Investigator for the trial.

23 May 2013

OncoGenex plans to initiate OGX-42 Phase 2 trial in patients with advanced squamous cell lung cancer

OncoGenex Pharmaceuticals, Inc. today announced plans for the initiation of the Cedar clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating OGX-427 in previously untreated patients with advanced squamous cell lung cancer.

23 May 2013

Prosonix commences Phase 2 clinical study of PSX1002 for treatment of moderate to severe COPD

Prosonix, an innovative speciality pharmaceutical company developing a portfolio of inhaled Respiratory Medicines by Design, has initiated a Phase 2 clinical study with PSX1002 that will assess its effect on lung function and the safety of a range of doses in patients with moderate to severe chronic obstructive pulmonary disease.

23 May 2013

$Upsher-Smith completes USL255 Phase III clinical trial in patients with refractory POS$

Upsher-Smith completes USL255 Phase III clinical trial in patients with refractory POS

Upsher-Smith Laboratories, Inc. today announced the successful completion of its global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology.

23 May 2013

GUVAX reports successful results in phase I study of oral, Escherichia coli diarrhea vaccine

The University of Gothenburg Vaccine Research Institute (GUVAX) announces successful results in a placebo controlled phase I study of an oral, inactivated Escherichia coli diarrhea vaccine.

22 May 2013

Naloxegol meets primary and secondary endpoints in two pivotal Phase III studies

AstraZeneca today presented the results of two pivotal Phase III studies of naloxegol showing the 25 mg dose of the investigational drug met its primary and secondary endpoints for efficacy and showed a safety profile consistent with previous studies.

22 May 2013

Boehringer Ingelheim's tiotropium shows promising results in patients with severe persistent asthma

Boehringer Ingelheim today announced data from Phase 2 and Phase 3 studies from the Company's ongoing clinical trial program investigating the efficacy and safety of tiotropium in asthma. These data were presented at the American Thoracic Society International Conference in Philadelphia, Pennsylvania.

22 May 2013

Ongoing clinical study to evaluate benefits of high-dose simvastatin for patients with SAH

Can treatment with high doses of a cholesterol-lowering statin drug improve outcomes for patients with stroke caused by rupture and bleeding of brain aneurysms? An ongoing clinical trial will soon find out, according to an article in the May issue of Neurosurgery, official journal of the Congress of Neurological Surgeons.

22 May 2013

Studies show that LipiGesic M provides highly effective OTC solution to migraine pain

PuraMed BioScience, Inc., a researcher, developer, and marketer of over-the-counter medicinal and healthcare products, announced the results of clinical trials that found its over-the-counter migraine medication product, LipiGesic M, has "robust efficacy".

22 May 2013

Poliovirus vaccine study shows encouraging results in glioblastoma patients

An attack on glioblastoma brain tumor cells that uses a modified poliovirus is showing encouraging results in an early study to establish the proper dose level, researchers at Duke Cancer Institute report.

22 May 2013

TB clinical drug trials in jeopardy due to federal sequestration funding cuts

Innovative and potentially game-changing clinical trials to develop new drug regimens to prevent and treat tuberculosis, the second leading global infectious disease killer, are in jeopardy due to federal "sequestration" funding cuts.

21 May 2013

Pfizer halts Phase 3 open-label, two-arm study of lymphoma drug

Pfizer Inc. announced today the discontinuation of a Phase 3 randomized, open-label, two-arm study (B1931008) evaluating the safety and efficacy of the investigational compound inotuzumab ozogamicin in patients with relapsed or refractory CD22+ aggressive non-Hodgkin lymphoma who are not candidates for intensive high-dose chemotherapy.

From Pfizer, Inc. 21 May 2013

Research explores pharmaceutical advances for IBS, hepatitis C

Research presented at Digestive Disease Week explores pharmaceutical advances for treating irritable bowel syndrome with diarrhea and hepatitis C.

21 May 2013

Drug Trial News

Blinding and blinding assessment rarely documented in trial reports

EADV spring symposium: Bioalliance Pharma presents Sitavig study results

OPKO reports more than 50% enrollment in phase 3 trial of Rayaldy for treatment of secondary hyperparathyroidism

Smartphone solutions for clinical trials

Merck updates on preladenant clinical program for treatment of Parkinson's disease

Takeda begins MLN9708 phase 3 clinical trial in newly diagnosed myeloma patients

Spring Bank Pharmaceuticals starts Phase I study of SB 9200 for treatment of HCV infection

Lightlake Therapeutics announces Phase II clinical trial results of nasal spray treatment for BED

OncoGenex plans to initiate OGX-42 Phase 2 trial in patients with advanced squamous cell lung cancer

Prosonix commences Phase 2 clinical study of PSX1002 for treatment of moderate to severe COPD

Upsher-Smith completes USL255 Phase III clinical trial in patients with refractory POS

GUVAX reports successful results in phase I study of oral, Escherichia coli diarrhea vaccine

Naloxegol meets primary and secondary endpoints in two pivotal Phase III studies

Boehringer Ingelheim's tiotropium shows promising results in patients with severe persistent asthma

Ongoing clinical study to evaluate benefits of high-dose simvastatin for patients with SAH

Studies show that LipiGesic M provides highly effective OTC solution to migraine pain

Poliovirus vaccine study shows encouraging results in glioblastoma patients

TB clinical drug trials in jeopardy due to federal sequestration funding cuts

Pfizer halts Phase 3 open-label, two-arm study of lymphoma drug

Research explores pharmaceutical advances for IBS, hepatitis C

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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