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QRxPharma completes patient enrolment of pivotal MoxDuo IR phase 3 study

QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today it has completed patient enrolment for a pivotal Phase 3 registration trial (Study 009) for MoxDuo IR. The comparative study was designed to evaluate analgesic efficacy and safety of MoxDuo IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone, for managing moderate to severe pain in patients who have undergone total knee replacement surgery.

5 Dec 2010

Clinical studies participated by three investigators to be presented at ASH Annual Meeting and Exposition

US Oncology, Inc., the nation's leading integrated oncology company, announced today that three investigators affiliated with US Oncology Research participated in studies that will be presented orally at the 52nd American Society of Hematology Annual Meeting and Exposition at the Orange County Convention Center in Orlando, Fla. Dec. 4-7. Five other investigators in the US Oncology Research Network participated in a study that will be displayed as a poster during the conference.

4 Dec 2010

Positive results from Neuraltus NP002 Phase 1/2 study for levodopa-induced dyskinesias in Parkinson's disease

Neuraltus Pharmaceuticals, a privately held biopharmaceutical company dedicated to developing and commercializing high-impact therapeutics that address critical unmet medical needs, primarily for the treatment of neurodegenerative diseases, announced today top-line results from the Company's Phase 1/2 clinical study of NP002 for the treatment of dyskinesias (muscle movement disorders) resulting from levodopa therapy for patients with Parkinson's disease.

4 Dec 2010

Pharnext receives French approval for Pleodrug Phase II clinical trial in Charcot-Marie Tooth disease type 1A

Pharnext SAS, a biopharmaceutical company specializing in the development of innovative treatments for severe neurological diseases and other major unmet medical needs, today announced that the French Agency for Healthcare Product Safety (AFSSAPS) has authorized a Phase II clinical trial with the first drug (a Pleodrug™) generated by the company's Pleotherapy™ technology platform in patients suffering from Charcot-Marie Tooth disease type 1A (CMT1A.

4 Dec 2010

Pfizer plans regulatory submissions of bosutinib for CML based on BELA study

Pfizer Inc. announced today it is planning regulatory submissions of bosutinib in patients with chronic myeloid leukemia (CML) based on data from a clinical program evaluating the compound in newly diagnosed and previously treated patients. These regulatory submissions are planned for 2011.

4 Dec 2010

Onconova announces three presentations on Estybon- (ON 01910.Na) at ASH 2010

Onconova Therapeutics announces its late-stage anticancer agent, Estybon- (ON 01910.Na), will be featured in three presentations at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, FL, December 4-7, 2010.

4 Dec 2010

Merck to present multiple clinical studies of dinaciclib at ASH Annual Meeting

Ligand Pharmaceuticals Incorporated today announced that multiple clinical studies of dinaciclib (SCH 727965) will be presented by Merck at the upcoming 52nd American Society of Hematology Annual Meeting being held in Orlando, Florida at the Orange County Convention Center, December 4-7, 2010.

4 Dec 2010

Mitoxantrone increases survival for children with relapsed ALL, trial results show

A new treatment increases survival to almost 70 per cent for children whose acute lymphoblastic leukaemia returns, according to the results of a trial published online in the Lancet today (Saturday).

4 Dec 2010

Zometa improves OS, PFS in newly diagnosed multiple myeloma patients: Phase III study

A newly published study in the Lancet suggested that a first-line treatment regimen including Zometa (zoledronic acid) significantly improved overall survival and progression-free survival in newly diagnosed multiple myeloma patients compared with a regimen that included oral clodronate. The impact on survival was independent of the effect of Zometa on bone complications (also known as skeletal-related events or SREs).

4 Dec 2010

FDA extends PDUFA review target date for BENLYSTA BLA to treat systemic lupus erythematosus

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of the Biologics License Application (BLA) for BENLYSTA® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE) from December 9, 2010 to March 10, 2011.

4 Dec 2010

Phase III studies should make meaningful difference in patients' quality of life: Commentary

Randomized phase III studies should be designed to find out whether a new drug or treatment makes a meaningful difference in patients' survival or quality of life, according to a commentary published online December 3rd in The Journal of the National Cancer Institute.

4 Dec 2010

SuperGen to present SGI-110 data for MDS, AML at ASH annual meeting

SuperGen, Inc. today announced that a summary of preclinical efficacy, safety, and pharmacokinetics data of SGI-110 will be presented at the American Society of Hematology in Orlando on Saturday, December 4, 2010 at 5:30 pm ET.

3 Dec 2010

Arthritis drug reduces incidence of non-melanoma skin cancers

A widely-used arthritis drug reduces the incidence of non-melanoma skin cancers - the most common cancers in humans - according to a study published this week in the Journal of the National Cancer Institute. The COX-2 inhibitor celecoxib (brand name Celebrex), which is currently approved for the treatment of osteoarthritis, rheumatoid arthritis and acute pain in adults led to a 62 percent reduction in non-melanoma skin cancers, which includes basal cell carcinomas and squamous cell carcinomas.

3 Dec 2010

MHRA issues notice of acceptance for BioMarin's BMN 673 for genetically-defined cancers

BioMarin Pharmaceutical Inc. today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has completed review of the Clinical Trial Application (CTA) and has issued a notice of acceptance for BMN 673 for genetically-defined cancers.

3 Dec 2010

FDA accepts IND application to initiate human clinical trial to evaluate BNC

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug application (IND) to begin human clinical trials and evaluate the safety and efficacy of the company's second product, bisnorcymserine (BNC).

3 Dec 2010

Sirnaomics cemented partnership with Chinese pharmaceutical to develop siRNA therapeutics

Sirnaomics, Inc. announced today that the company has cemented a partnership with a Chinese pharmaceutical company for development of its small interfering RNA (siRNA) therapeutic (STP705) for scarless wound healing.

3 Dec 2010

Geron commences enrollment in imetelstat Phase 2 clinical trial for metastatic breast cancer

Geron Corporation today announced enrollment of the first patient in a randomized Phase 2 clinical trial of its telomerase inhibitor drug, imetelstat (GRN163L), in combination with paclitaxel (with or without bevacizumab) in patients with locally recurrent or metastatic breast cancer.

3 Dec 2010

Xencor, MorphoSys initiate XmAb5574 Phase 1 study in CLL

Xencor, Inc. and MorphoSys AG announced today that they have initiated Phase 1 testing for XmAb®5574 (MOR208), and the first patient has been dosed. XmAb5574 (MOR208) is a potent monoclonal anti-CD19 antibody to which MorphoSys recently gained worldwide access via an exclusive license and collaboration agreement with Xencor.

2 Dec 2010

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Amgen today announced that it will present data from several key Nplate (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla.

2 Dec 2010

Spherix announces results of D-tagatose Phase 3 trial for Type 2 diabetes

Spherix Incorporated, an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced results from its first Phase 3 trial post hoc analysis in which the higher body mass index (BMI) of the U.S. population relative to the Indian population was a likely key contributor to the more positive effects of D-tagatose in the lowering of HbA1c levels in the U.S. population. Initial results were announced on October 7.

2 Dec 2010

Drug Trial News

QRxPharma completes patient enrolment of pivotal MoxDuo IR phase 3 study

Clinical studies participated by three investigators to be presented at ASH Annual Meeting and Exposition

Positive results from Neuraltus NP002 Phase 1/2 study for levodopa-induced dyskinesias in Parkinson's disease

Pharnext receives French approval for Pleodrug Phase II clinical trial in Charcot-Marie Tooth disease type 1A

Pfizer plans regulatory submissions of bosutinib for CML based on BELA study

Onconova announces three presentations on Estybon- (ON 01910.Na) at ASH 2010

Merck to present multiple clinical studies of dinaciclib at ASH Annual Meeting

Mitoxantrone increases survival for children with relapsed ALL, trial results show

Zometa improves OS, PFS in newly diagnosed multiple myeloma patients: Phase III study

FDA extends PDUFA review target date for BENLYSTA BLA to treat systemic lupus erythematosus

Phase III studies should make meaningful difference in patients' quality of life: Commentary

SuperGen to present SGI-110 data for MDS, AML at ASH annual meeting

Arthritis drug reduces incidence of non-melanoma skin cancers

MHRA issues notice of acceptance for BioMarin's BMN 673 for genetically-defined cancers

FDA accepts IND application to initiate human clinical trial to evaluate BNC

Sirnaomics cemented partnership with Chinese pharmaceutical to develop siRNA therapeutics

Geron commences enrollment in imetelstat Phase 2 clinical trial for metastatic breast cancer

Xencor, MorphoSys initiate XmAb5574 Phase 1 study in CLL

Amgen to present data on Nplate studies for chronic ITP at ASH Annual Meeting

Spherix announces results of D-tagatose Phase 3 trial for Type 2 diabetes

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