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FDA lifts clinical hold on Icagen's IND for ICA-105665 epilepsy drug candidate

Icagen, Inc. today announced that, following a review of data from recently completed clinical studies as well as the Company's proposed protocol for a Phase II clinical trial in patients with treatment resistant epilepsy, the FDA has notified the Company that the clinical hold on Icagen's IND for ICA-105665, a novel orally available small molecule KCNQ potassium channel agonist, has been removed.

3 Feb 2011

ImmunoCellular Therapeutics initiates enrollment in ICT-107 Phase II trial for GBM

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune-based therapies for the treatment of various forms of cancer, announced today that the first patient has been enrolled in its Phase II trial of ICT-107 at the New Jersey Neuroscience Institute at JFK Medical Center. ICT-107 is the company's dendritic cell based cancer vaccine candidate for the treatment of glioblastoma multiforme (GBM).

3 Feb 2011

Enrollment stopped in one of two global necitumumab Phase III studies in NSCLC

Eli Lilly and Company and Bristol-Myers Squibb Company announced today that they have stopped enrollment in one of their two global Phase III studies evaluating necitumumab, an investigational anti-cancer agent, as a first-line treatment for advanced non-small cell lung cancer (NSCLC).

3 Feb 2011

Positive results from Factor IX-CTP comparative study in hemophilic mice

PROLOR Biotech, today reported positive results from a comparative study of its biobetter longer-acting version of the hemophilia drug Factor IX in Factor IX-depleted hemophilic mice.

3 Feb 2011

EGEN receives 4-year, $1.6M FDA grant for EGEN-001 Phase II clinical study in ovarian cancer

EGEN, Inc. today announced that the Food and Drug Administration (FDA) has awarded the company a four-year grant of $1,600,000 to assist in the Phase II clinical development of EGEN-001, the company's lead product. EGEN-001 is under clinical development for the treatment of advanced recurrent ovarian cancer.

2 Feb 2011

Isis commences ISIS-FXIRx Phase 1 study for treatment of clotting disorders

Isis Pharmaceuticals, Inc. announced the initiation of a Phase 1 study of ISIS-FXIRx, an antisense drug designed to treat clotting disorders. ISIS-FXIRx inhibits the production of Factor XI, a clotting factor that is an important component of the coagulation pathway. Because of its role in the intrinsic coagulation pathway, inhibition of Factor XI could offer an effective approach for preventing the formation of blood clots with a lower risk of bleeding.

2 Feb 2011

DARA BioSciences' KRN5500 Phase 2 study in advanced cancer selected for presentation at ADEPT 2011

The Company announced that the University of Rochester in concert with ADEPT has selected the study results from the KRN5500 Phase 2 study to be presented at its March 25-26, 2011 conference. The presentation is entitled, "Management of Placebo Response in a Randomized Trial of KRN5500 in Patients with Neuropathic Pain and Cancer."

2 Feb 2011

Inovio publishes scientific paper detailing SynCon DNA vaccine preclinical study for prostate cancer

Inovio Pharmaceuticals, a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the publication of a scientific paper in the journal Human Vaccines detailing potent immune responses in a preclinical study of Inovio's SynCon DNA vaccine for prostate cancer targeting two antigens.

2 Feb 2011

FDA to inspect Lannett's manufacturing facility for review of Morphine Sulfate NDA

Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it recently met with the U.S. Food and Drug Administration (FDA) to discuss the status of the company's New Drug Application (NDA) for Morphine Sulfate Oral Solution as well as other pending product applications.

2 Feb 2011

Sanofi-aventis announces GetGoal-X Phase III study of lixisenatide against type 2 diabetes

Zealand Pharma A/S, a biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, is pleased to announce that its partner, sanofi-aventis, today announced that the GetGoal-X Phase III study of lixisenatide, a once-daily GLP-1 receptor agonist licensed from Zealand Pharma, achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline, compared with exenatide twice-daily.

2 Feb 2011

FDA issues Complete Response Letter for approval of Eisai's rabeprazole sodium extended-release capsules

Eisai announced today that the company received a Complete Response Letter from the United States Food and Drug Administration (FDA) regarding the New Drug Application (NDA) of rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive gastroesophageal reflux disease (GERD), and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.

2 Feb 2011

Antares initiates dosing in VIBEX MTX clinical study for rheumatoid arthritis

Antares Pharma, Inc. today announced that the first patient has been dosed in a clinical study evaluating the VIBEX™ MTX product which is being developed for the treatment of rheumatoid arthritis. The clinical study will evaluate several dose strengths of VIBEX MTX delivered with a proprietary autoinjector versus conventional needle and syringe administration by a healthcare professional.

2 Feb 2011

BioMarin commences GALNS Phase 3 trial in patients with Morquio A Syndrome

BioMarin Pharmaceutical announced today that it has initiated a pivotal Phase 3 trial for N-acetylgalactosamine 6-sulfatase, intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA, also called Morquio A Syndrome.

1 Feb 2011

Positive interim results from H5N1 Avian Influenza VLP vaccine Phase II human clinical trial

Medicago, a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles, today reported positive interim results from a Phase II human clinical trial with its H5N1 Avian Influenza VLP vaccine candidate.

1 Feb 2011

Positive interim results from Medicago's Phase II clinical trial of H5N1 Avian Influenza VLP vaccine

Medicago Inc. a biotechnology company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a Phase II human clinical trial with its H5N1 Avian Influenza VLP vaccine candidate ("H5N1 vaccine"). The vaccine was found to be safe, well tolerated and also induced a solid immune response.

1 Feb 2011

Orexigen, Takeda announce FDA's issue of complete response letter for Contrave NDA

Orexigen® Therapeutics, Inc. and Takeda Pharmaceutical Company Limited announced today that the United States Food and Drug Administration (FDA) has issued a complete response letter dated January 31, 2011 regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.

1 Feb 2011

Discovery Labs provides expanded update on efforts to gain FDA marketing authorization for Surfaxin in RDS

Discovery Laboratories, Inc. is providing an expanded update regarding ongoing efforts to file a Complete Response intended to gain U.S. Food and Drug Administration (FDA) marketing authorization for Surfaxin® for the prevention of respiratory distress syndrome (RDS) in premature infants.

1 Feb 2011

AVEO commences enrollment in tivozanib Phase 2 study in renal cell carcinoma

AVEO Pharmaceuticals, Inc. today announced that it has initiated patient enrollment in a multi-center Phase 2 exploratory biomarker study of tivozanib, its lead product candidate designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors, in patients with renal cell carcinoma (RCC).

1 Feb 2011

Circassia Phase II clinical trial confirms safety profile of ToleroMune cat allergy treatment

Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced that the company's ToleroMune(R) cat allergy treatment significantly reduced patients' symptoms in a recently completed, large-scale phase II clinical trial. The study also confirmed the treatment's highly favourable safety profile.

1 Feb 2011

Highly favorable final results from ERGOFLEX initial clinical study for joint pain relief

OXIS International, today announced highly favorable final results from an initial clinical study to assess the beneficial effects of its patent-pending ERGOFLEX joint health formula, launched commercially in December 2010.

1 Feb 2011

Drug Trial News

FDA lifts clinical hold on Icagen's IND for ICA-105665 epilepsy drug candidate

ImmunoCellular Therapeutics initiates enrollment in ICT-107 Phase II trial for GBM

Enrollment stopped in one of two global necitumumab Phase III studies in NSCLC

Positive results from Factor IX-CTP comparative study in hemophilic mice

EGEN receives 4-year, $1.6M FDA grant for EGEN-001 Phase II clinical study in ovarian cancer

Isis commences ISIS-FXIRx Phase 1 study for treatment of clotting disorders

DARA BioSciences' KRN5500 Phase 2 study in advanced cancer selected for presentation at ADEPT 2011

Inovio publishes scientific paper detailing SynCon DNA vaccine preclinical study for prostate cancer

FDA to inspect Lannett's manufacturing facility for review of Morphine Sulfate NDA

Sanofi-aventis announces GetGoal-X Phase III study of lixisenatide against type 2 diabetes

FDA issues Complete Response Letter for approval of Eisai's rabeprazole sodium extended-release capsules

Antares initiates dosing in VIBEX MTX clinical study for rheumatoid arthritis

BioMarin commences GALNS Phase 3 trial in patients with Morquio A Syndrome

Positive interim results from H5N1 Avian Influenza VLP vaccine Phase II human clinical trial

Positive interim results from Medicago's Phase II clinical trial of H5N1 Avian Influenza VLP vaccine

Orexigen, Takeda announce FDA's issue of complete response letter for Contrave NDA

Discovery Labs provides expanded update on efforts to gain FDA marketing authorization for Surfaxin in RDS

AVEO commences enrollment in tivozanib Phase 2 study in renal cell carcinoma

Circassia Phase II clinical trial confirms safety profile of ToleroMune cat allergy treatment

Highly favorable final results from ERGOFLEX initial clinical study for joint pain relief

How GLP‑1 Agonists Are Shaping the Future of Obesity Treatment With Dr Bryony Henderson

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

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