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Advaxis advances lead prostate cancer immunotherapeutic toward clinical trials

Advaxis, the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, is advancing the clinical development of its lead prostate cancer immunotherapeutic toward clinical trials.

3 May 2010

Results from VeriStrat biomarker analysis of Phase III trial presented at European Lung Cancer Conference

Results from the VeriStrat biomarker analysis of a multicenter Phase III trial were presented today at the 2nd European Lung Cancer Conference currently being held in Geneva, Switzerland. Results showed that the VeriStrat test identified patients who were likely to have a survival benefit from treatment with erlotinib, a commonly prescribed oral therapy for advanced non-small cell lung cancer.

3 May 2010

FDA approves continuation of Phase IIb clinical trial for superficial bladder cancer

Tikcro Technologies Ltd. today announced that BioCancell Therapeutics, Inc., concluded the first 18 patient group treated pursuant to a Phase IIb clinical trial of the drug candidate BC-819 for use in superficial bladder cancer. These patients had not responded to conventional treatment.

3 May 2010

GeNOsys sponsors Phase I safety trial in collaboration with Nitric Solutions

GeNOsys, Inc. today announced they are sponsoring a Phase I safety trial in collaboration with Nitric Solutions Inc. GeNOsys will be testing their patented nitric oxide generator and nitric oxide producing formula for safety and effectiveness in treating disease. In a parallel study Nitric Solutions will be testing the efficacy of their prophilactic nitric oxide producing formula Nitrisol.

30 Apr 2010

Pieris AG announces preclinical data for proprietary PRS-110 Anticalin compound

Pieris AG announced today preclinical data for its proprietary PRS-110 Anticalin compound, which targets the c-Met receptor, demonstrating a dose-dependant reduction of tumor growth in a xenograft mouse model.

30 Apr 2010

Celtic Pharma commences enrolment in Phase III trial of TDT 067 for onychomycosis

Celtic Pharmaceutical Holdings L.P., the global private equity firm focused on the biotechnology and pharmaceutical industries, announced today the enrolment of the first patient into its Phase III trial of TDT 067, terbinafine in Transfersomes®, for the topical treatment of onychomycosis (also known as a fungal nail infection).

30 Apr 2010

Repligen granted Notice of Allowance covering use of uridine for treatment of bipolar disorder

Repligen Corporation announced today that the United States Patent and Trademark Office has granted a Notice of Allowance of a patent covering the use of uridine in the treatment of patients with bipolar disorder. The patent, which upon issue will remain in force until 2025 prior to any patent term extensions, covers the use of an effective dose of a uridine composition to improve one or more of the symptoms of bipolar disorder including depression, mania, mixed episodes, hypomania and anxiety.

30 Apr 2010

Repros Therapeutics receives FDA guidance for lifting clinical hold status of Proellex

Repros Therapeutics Inc. today announced that a teleconference was held with the FDA to review the clinical hold status of Proellex®. Previously clinical studies were stopped due to findings of changes in liver enzymes at higher doses of the oral drug resulting in serious adverse events. Proellex is being studied as a treatment for uterine fibroids and endometriosis.

30 Apr 2010

Novavax reports positive results from Phase II study of trivalent VLP influenza vaccine in older adults

Novavax, Inc. reported today that its trivalent seasonal influenza virus-like-particle (VLP)-based vaccine candidate was safe and immunogenic against the 2009-2010 seasonal influenza virus strains in older adults 60 years or higher in age.

30 Apr 2010

TenX Biopharma signs Clinical Trial Agreement with NCI

TenX Biopharma, Inc., announced today it has signed a Clinical Trial Agreement with the National Cancer Institute to conduct an investigator sponsored Phase II clinical trial.

30 Apr 2010

Lotus Pharmaceuticals receives Chinese SFDA approval to commence Laevo-Bambuterol clinical trials

Lotus Pharmaceuticals, Inc., a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China today reported that its innovative asthma drug Laevo-Bambuterol has received approval from China's State Food & Drug Administration's (SFDA) to commence clinical trials (No.2010L01309 and 2010L01399).

30 Apr 2010

$EnzymeRx reports positive results from first clinical trial of pegsitacase for refractory gout$

EnzymeRx reports positive results from first clinical trial of pegsitacase for refractory gout

EnzymeRx, LLC, a clinical-stage biotechnology company, announced top line results from its first clinical trial of pegsitacase (formerly called Uricase‑PEG 20). Pegsitacase is a pegylated uricase being developed by EnzymeRx for the treatment of refractory gout and for the management of hyperuricemia associated with tumor lysis syndrome.

30 Apr 2010

Kissei to commercialize Protox's PRX302 PSA-activated pro-drug for BPH, prostate cancer in Japan

Protox Therapeutics Inc., a leader in the development of receptor targeted fusion proteins, today announced that it has entered into an exclusive US $75 million license agreement with Kissei Pharmaceutical Co., Ltd. for the development and commercialization of its PSA-activated pro-drug, PRX302, in Japan for BPH, prostate cancer and other diseases of the prostate. Protox retains exclusive rights to PRX302 in all other territories.

30 Apr 2010

Artisan Pharma enrolls 750 patients in Phase 2b study of ART-123 in sepsis patients with DIC

Artisan Pharma, Inc., a private biopharmaceutical company dedicated to bringing best-in-class critical care therapeutics to patients, today announced the completion of patient enrollment in its Phase 2b study of ART-123 (Recomodulin® - recombinant human thrombomodulin) in sepsis patients with disseminated intravascular coagulation (DIC). The clinical trial was a randomized, double-blind, placebo-controlled Phase 2b study to assess the safety and efficacy of ART-123 in patients with sepsis and DIC.

30 Apr 2010

Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Celgene Corporation announced non-GAAP net income of $294.6 million, or non-GAAP diluted earnings per share of $0.63 for the quarter ended March 31, 2010. Non-GAAP net income for the first quarter of 2009 was $205.1 million or non-GAAP diluted earnings per share of $0.44. Based on U.S. GAAP, Celgene reported net income of $234.4 million, or diluted earnings per share of $0.50 for the quarter ended March 31, 2010. GAAP net income for the first quarter of 2009 was $162.9 million, or diluted earnings per share of $0.35.

29 Apr 2010

Provectus reports on end-of-Phase 2 meeting with FDA on licensure of PV-10 for metastatic melanoma

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that it has held an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to seek consensus on clinical program scope and endpoints for licensure of PV-10 for metastatic melanoma. The meeting was held at the Agency's White Oak Campus in Silver Spring, MD.

29 Apr 2010

Human Genome Sciences reports net loss of $47.9M for first-quarter 2010

Human Genome Sciences, Inc. today announced financial results for the quarter ended March 31, 2010, and provided highlights of recent key developments.

29 Apr 2010

AVEO Pharmaceuticals reports net loss of $14.4 million for first-quarter 2010

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced financial results for the quarter ended March 31, 2010, provided an update on progress towards achievement of 2010 goals as well as 2010 financial guidance.

29 Apr 2010

Incorporation of NexACT technology helps reduce dose of Å6 compound for ovarian cancer treatment

NexMed, Inc., a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that results from a pre-clinical study showed significant improvement in the delivery and half life of Å6, a proprietary peptide treatment for ovarian cancer currently in Phase 2 development by Angstrom Pharmaceuticals. Specifically, the incorporation of NexACT® enabled the dose of Å6 to be cut by half, or from twice per day to once per day delivered subcutaneously, while achieving the same level of efficacy in the mouse lung metastasis model.

29 Apr 2010

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Gilead Sciences, Inc. announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).

29 Apr 2010

Drug Trial News

Advaxis advances lead prostate cancer immunotherapeutic toward clinical trials

Results from VeriStrat biomarker analysis of Phase III trial presented at European Lung Cancer Conference

FDA approves continuation of Phase IIb clinical trial for superficial bladder cancer

GeNOsys sponsors Phase I safety trial in collaboration with Nitric Solutions

Pieris AG announces preclinical data for proprietary PRS-110 Anticalin compound

Celtic Pharma commences enrolment in Phase III trial of TDT 067 for onychomycosis

Repligen granted Notice of Allowance covering use of uridine for treatment of bipolar disorder

Repros Therapeutics receives FDA guidance for lifting clinical hold status of Proellex

Novavax reports positive results from Phase II study of trivalent VLP influenza vaccine in older adults

TenX Biopharma signs Clinical Trial Agreement with NCI

Lotus Pharmaceuticals receives Chinese SFDA approval to commence Laevo-Bambuterol clinical trials

EnzymeRx reports positive results from first clinical trial of pegsitacase for refractory gout

Kissei to commercialize Protox's PRX302 PSA-activated pro-drug for BPH, prostate cancer in Japan

Artisan Pharma enrolls 750 patients in Phase 2b study of ART-123 in sepsis patients with DIC

Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Provectus reports on end-of-Phase 2 meeting with FDA on licensure of PV-10 for metastatic melanoma

Human Genome Sciences reports net loss of $47.9M for first-quarter 2010

AVEO Pharmaceuticals reports net loss of $14.4 million for first-quarter 2010

Incorporation of NexACT technology helps reduce dose of Å6 compound for ovarian cancer treatment

Gilead announces bioequivalence of Truvada in combination with Tibotec Pharmaceuticals' TMC278 NNRTI

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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