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Omeros announces positive results from OMS824 Phase 1 clinical program

Omeros Corporation today announced positive results from its Phase 1 clinical program evaluating OMS824, the lead compound from its phosphodiesterase 10 (PDE10) program.

31 May 2013

Exelixis starts phase 3 pivotal trial of cabozantinib for treatment of metastatic renal cell carcinoma

Exelixis, Inc. today announced it has initiated METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with metastatic renal cell carcinoma who have experienced disease progression following treatment with at least one prior VEGFR tyrosine kinase inhibitor.

31 May 2013

PharmAthene announces lifting of clinical hold on proposed SparVax Phase II study

PharmAthene, Inc., a biodefense company developing medical countermeasures against biological and chemical threats, announced today that the U.S. Food and Drug Administration has lifted the clinical hold previously placed on a proposed Phase II study of SparVax, a next generation recombinant anthrax vaccine.

31 May 2013

New hope for children with multi-system LCH

A new international study finds that prolonged, intense initial treatment in children with multi-system Langerhans cell histiocytosis can achieve survival rates as high as 84 percent-a full 15 percent improvement over the previous clinical trial in this series.

30 May 2013

Targacept initiates TC-5214 Phase 2b clinical study in patients with OAB

Targacept, Inc., a clinical-stage biopharmaceutical company developing novel NNR Therapeutics, today announced the initiation of a Phase 2b clinical study of TC-5214 as a treatment for overactive bladder.

29 May 2013

Pacira Pharmaceuticals reports results of EXPAREL Phase 2/3 clinical trial for TKA

Pacira Pharmaceuticals, Inc. today announced findings from the completed first part of its Phase 2/3 clinical trial assessing the use and administration of EXPAREL (bupivacaine liposome injectable suspension) as a single-dose injection femoral nerve block for total knee arthroplasty surgery.

29 May 2013

Standalone labelling service announced by Packaging Coordinators Inc (PCI)

Packaging Coordinators Inc (PCI), formerly AndersonBrecon, a global supplier of pharmaceutical commercial packaging solutions and clinical trials services, today announced a standalone labelling service that can dramatically reduce design and printing turnaround times. The fast response labelling solution has been developed to meet the ever-evolving needs of customers in the industry, providing bespoke, around-the-clock support and ensuring that even projects where labelling requirements change unexpectedly are successfully kept on track.

From Packaging Coordinators Inc. (PCI) 29 May 2013

Alkermes reports positive results from phase 1 study of ALKS 3831 for treatment of schizophrenia

Alkermes plc today presented positive results from a phase 1 study of ALKS 3831, a novel drug candidate for the treatment of schizophrenia, in an oral session at the 53rd Annual New Clinical Drug Evaluation Unit Meeting in Hollywood, Fla.

28 May 2013

Sorrento Therapeutics, IGDRASOL announce publication of clinical data for Cynviloq and gemcitabine

Sorrento Therapeutics, Inc. and IGDRASOL announced today that clinical data for CynviloqTM, a non-biologic nanoparticle formulation of paclitaxel, plus gemcitabine was published for the upcoming Annual Meeting of the American Society of Clinical Oncology.

28 May 2013

DCPrime completes DCP-001 Phase I/IIa study in patients with acute myeloid leukemia

Cancer vaccine company DCPrime today announced the successful completion of its Phase I/IIa study in acute myeloid leukemia.

28 May 2013

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

Drug Trial News

Omeros announces positive results from OMS824 Phase 1 clinical program

Exelixis starts phase 3 pivotal trial of cabozantinib for treatment of metastatic renal cell carcinoma

PharmAthene announces lifting of clinical hold on proposed SparVax Phase II study

New hope for children with multi-system LCH

Targacept initiates TC-5214 Phase 2b clinical study in patients with OAB

Pacira Pharmaceuticals reports results of EXPAREL Phase 2/3 clinical trial for TKA

Standalone labelling service announced by Packaging Coordinators Inc (PCI)

Alkermes reports positive results from phase 1 study of ALKS 3831 for treatment of schizophrenia

Sorrento Therapeutics, IGDRASOL announce publication of clinical data for Cynviloq and gemcitabine

DCPrime completes DCP-001 Phase I/IIa study in patients with acute myeloid leukemia

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

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

Exploring electron microscopy for plant and microbial imaging at the John Innes Centre

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