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Fibrocell Science submits response to FDA CR letter for azficel-T BLA

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today that it has submitted its complete response to the Complete Response (CR) letter issued by the U.S. Food & Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) for azficel-T, proposed brand name laViv®, for the treatment of moderate to severe nasolabial folds and wrinkles.

20 Dec 2010

Aeterna Zentaris reaches agreement with FDA for Solorel SPA as a diagnostic test in AGHD

Aeterna Zentaris Inc. today announced that it has reached agreement with the Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for Solorel® (AEZS-130, macimorelin) which will enable the Company to complete the ongoing registration study required to gain approval as a diagnostic test for Adult Growth Hormone Deficiency (AGHD).

20 Dec 2010

Icagen, Pfizer commence Nav1.7 Phase I clinical studies for pain and related disorders

Icagen, Inc. today provided an update on its sodium channel program for pain and related disorders, which is being conducted in collaboration with Pfizer. As previously reported, the companies recently selected a candidate compound to advance into further clinical studies. Dosing of this candidate compound has now been initiated in a Phase I study in healthy volunteers.

20 Dec 2010

Positive top-line results from VEGF Trap-Eye Phase 3 studies in macular edema due to CRVO

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the COPERNICUS study, which is led by Regeneron, the first of two Phase 3 studies in patients with macular edema due to central retinal vein occlusion (CRVO).

20 Dec 2010

Chelsea completes successful NORTHERA pre-NDA assessment with FDA

Chelsea Therapeutics International, Ltd. announced it has completed a pre-NDA assessment with the U.S. Food and Drug Administration (FDA) and intends to accelerate its new drug application (NDA) for NORTHERA™(droxidopa) for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), a chronic and potentially debilitating drop in blood pressure upon standing commonly associated Parkinson's disease, multiple system atrophy and pure autonomic failure.

20 Dec 2010

SEEK announces new joint venture entity with Pernix Therapeutics for antitussive drug development

SEEK, a leading UK privately-owned drug-discovery group, is pleased to announce the establishment of a new joint venture entity with Pernix Therapeutics Holdings, an integrated specialty pharmaceutical company focused primarily on the United States pediatric market.

20 Dec 2010

Cardio3 BioSciences presents positive C3BS-GQR-1 results in patients with acute myocardial infarction

Cardio3 BioSciences, a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces positive pre-clinical results from its in-house product candidate C3BS-GQR-1, to treat patients suffering from acute myocardial infarction in order to protect cardiac tissue from damage and direct heart stem cells to mature and restore pump function.

20 Dec 2010

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

Inspire Pharmaceuticals, Inc. announced today that the results from its first Phase 3 clinical trial with denufosol tetrasodium for cystic fibrosis (CF), TIGER-1, have been published in the peer-reviewed publication, American Journal of Respiratory and Critical Care Medicine (AJRCCM). Denufosol is an investigational, inhaled, novel ion channel regulator currently in Phase 3 clinical development for the treatment of CF.

20 Dec 2010

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today reported that it has completed enrolment of its COMPONENT Phase IIb study with vidofludimus, an oral inhibitor of IL-17 release, in rheumatoid arthritis (RA) patients. Data from the trial are expected to be announced in Q2 2011.

20 Dec 2010

CF patients with normal to mildly impaired lung function may benefit from new investigational drug

Cystic fibrosis patients with normal to mildly impaired lung function may benefit from a new investigational drug designed to help prevent formation of the sticky mucus that is a hallmark of the disease, according to researchers involved in a phase 3 clinical trial of the drug.

19 Dec 2010

Viron's Phase 2a trial for VT-111 meets primary, secondary endpoints in ACS patients

Viron Therapeutics Inc. today announced that the results of Viron's Phase 2a trial for VT-111 were published today in Circulation: Cardiovascular Interventions. In the study led by Dr. Jean-Claude Tardif, Director of the Research Centre at the Montreal Heart Institute, VT-111, also known as Serp-1, met both its primary and secondary endpoints of safety and biological activity in Acute Coronary Syndrome patients receiving coronary stents.

17 Dec 2010

Catalyst receives $4.0M milestone payment from Pfizer under hemophilia Factor VIIa program

Catalyst Biosciences, Inc., the leading company in the discovery and development of engineered proteases, today announced the receipt of a $4.0 million milestone payment from Pfizer Inc. under the terms of the collaboration agreement for the development of improved recombinant human Factor VIIa variants for the treatment of hemophilia and other bleeding disorders.

17 Dec 2010

MDA awards Repligen $1.4M for research of new compound with therapeutic potential for SMA

The Muscular Dystrophy Association today announced it has awarded $1.4 million in new research funding to the biopharmaceutical firm Repligen of Waltham, Mass., to complete the preclinical work needed to begin human clinical trials of a promising therapeutic compound for spinal muscular atrophy (SMA).

17 Dec 2010

NovImmune obtains additional financing of CHF 20 million

NovImmune announced today, following its July 2010 deal with Genentech/Roche, that it obtained further financing of CHF 20 million. The series B financing round of CHF 20M was led by BZ Bank Aktiengesellschaft.

17 Dec 2010

Repros prepares for dosing 3 mg cohort in low dose Proellex study in uterine fibroids and endometriosis

Repros Therapeutics Inc. today announced it has commenced preparation for dosing the 3 mg cohort in the Company's low dose study of Proellex® following a safety review of data from women that have completed 8 weeks of treatment at a 1 mg dose. No signals of liver toxicity were detected to date in the 1 mg group. Unexpectedly, low levels of drug activity were detected in this first cohort. The Company plans to commence dosing of the second group, 3 mg Proellex, next week.

17 Dec 2010

GSK, Impax enter global development, commercialization agreement for PD investigational product, IPX066

GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (Impax), today announced an agreement for the development and commercialization of IPX066, Impax's novel extended release carbidopa-levodopa product, outside the United States and Taiwan. IPX066, an investigational product under development for the treatment of Parkinson's Disease (PD), is currently in Phase III clinical trials.

17 Dec 2010

FDA approves Neuralstem's IND to initiate NSI-189 Phase Ia safety trial in major depression

Neuralstem, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase Ia safety trial to test NSI-189, its first small molecule compound, in major depression. NSI-189 is a proprietary new chemical entity discovered by Neuralstem that stimulates new neuron growth in the hippocampus, an area of the brain that is believed to be involved in depression and other diseases, such as Alzheimer's disease.

17 Dec 2010

Recordati, Nymox sign European licensing agreement for BPH investigational drug, NX-1207

Recordati and Nymox Pharmaceutical Corporation announced today the signing of a European licensing agreement for the development and commercialization of NX-1207, Nymox's Phase III investigational drug currently in clinical development in the U.S. for the treatment of benign prostatic hyperplasia (BPH).

17 Dec 2010

FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

Novavax, Inc. announced today that the company's Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration (FDA) and is no longer on clinical hold. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.

16 Dec 2010

Anacor Pharmaceuticals initiates AN2690 phase 3 program for onychomycosis fungal infection

Anacor Pharmaceuticals announced today that enrollment has been initiated and the first patient has been dosed in the Phase 3 program of AN2690, a topical antifungal product candidate for the treatment of onychomycosis.

16 Dec 2010

Drug Trial News

Fibrocell Science submits response to FDA CR letter for azficel-T BLA

Aeterna Zentaris reaches agreement with FDA for Solorel SPA as a diagnostic test in AGHD

Icagen, Pfizer commence Nav1.7 Phase I clinical studies for pain and related disorders

Positive top-line results from VEGF Trap-Eye Phase 3 studies in macular edema due to CRVO

Chelsea completes successful NORTHERA pre-NDA assessment with FDA

SEEK announces new joint venture entity with Pernix Therapeutics for antitussive drug development

Cardio3 BioSciences presents positive C3BS-GQR-1 results in patients with acute myocardial infarction

Inspire's denufosol tetrasodium TIGER-1 Phase 3 trial for CF published in AJRCCM

4SC AG's Phase IIb study evaluates efficacy of vidofludimus in RA patients

CF patients with normal to mildly impaired lung function may benefit from new investigational drug

Viron's Phase 2a trial for VT-111 meets primary, secondary endpoints in ACS patients

Catalyst receives $4.0M milestone payment from Pfizer under hemophilia Factor VIIa program

MDA awards Repligen $1.4M for research of new compound with therapeutic potential for SMA

NovImmune obtains additional financing of CHF 20 million

Repros prepares for dosing 3 mg cohort in low dose Proellex study in uterine fibroids and endometriosis

GSK, Impax enter global development, commercialization agreement for PD investigational product, IPX066

FDA approves Neuralstem's IND to initiate NSI-189 Phase Ia safety trial in major depression

Recordati, Nymox sign European licensing agreement for BPH investigational drug, NX-1207

FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

Anacor Pharmaceuticals initiates AN2690 phase 3 program for onychomycosis fungal infection

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