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SuppreMol completes successful pre-IND meeting with U.S. FDA

SuppreMol GmbH, a privately held biopharmaceutical company developing innovative therapeutics for the treatment of autoimmune diseases, today announced that it has successfully completed a pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for its lead compound SM101, which is being developed for the treatment of Primary Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE).

24 Jan 2011

FibroGen announces FG-3019 interim results from phase 1/2 trial against pancreatic cancer

FibroGen, today announced interim results of a phase 1/2 trial of FG-3019, a therapeutic antibody against connective tissue growth factor, in combination with gemcitabine and erlotinib in individuals with unresectable pancreatic cancer.

23 Jan 2011

Immunomedics reports encouraging results from Y-90-labeled clivatuzumab tetraxetan study in pancreatic cancer

Immunomedics, Inc., a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that repeated therapy cycles of its proprietary antibody, clivatuzumab tetraxetan, labeled with yttrium-90 plus low-dose gemcitabine, extended median overall survival.

21 Jan 2011

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

NewLink Genetics Corporation today announced that additional data from its Phase 2 clinical trial of the company's investigational HyperAcute® Pancreas cancer immunotherapy will be presented during a poster session at the American Society of Clinical Oncology 2011 Gastrointestinal Cancers Symposium in San Francisco, California.

21 Jan 2011

Sunshine and Binghamton University enter research agreement for cancer compound

Sunshine Biopharma, Inc. a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has executed an agreement with The Research Foundation of the State University of New York (SUNY), acting for and on behalf of Binghamton University (Binghamton, NY).

21 Jan 2011

MedImmune announces MEDI-573 preclinical results against many solid tumors

MedImmune's Oncology group announced today preclinical results showing that MEDI-573, a targeted monoclonal antibody, broadly suppresses pathways that have been shown to play a critical role in the development and progression of many solid tumors.

21 Jan 2011

Pervasis to present PVS-10200 interim data from Phase 1/2 PAD clinical study at IC3D

Pervasis Therapeutics, Inc. today announced it will present interim data from the company's Phase 1/2 clinical study of PVS-10200, an investigational cell-based therapy under development to prevent restenosis in patients with peripheral arterial disease (PAD) who undergo an angioplasty and stent procedure in the superficial femoral artery.

21 Jan 2011

Teva invests $3.95M in Rexahn for development of anti-cancer compound RX-3117

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and central nervous system (CNS) therapeutics, announced that Teva Pharmaceutical Industries Limited (Teva) purchased 2,334,515 shares of Rexahn's common stock in a private offering for $3.95 million, or $1.692 per share.

21 Jan 2011

MGH Bipolar CHOICE trial to evaluate effectiveness of new medications compared to lithium

The Massachusetts General Hospital (MGH) Bipolar Clinic and Research Program with the Bipolar Trials Network is launching Bipolar CHOICE, a 10-site nationwide trial evaluating the real-world advantages and disadvantages of quetiapine, a widely prescribed second generation antipsychotic mood stabilizing medication, compared to lithium, the gold standard mood stabilizer, for the treatment of outpatients with bipolar disorder.

21 Jan 2011

Positive results from nimotuzumab Phase II study for gastric cancer

YM BioSciences, a life sciences product development company advancing a diverse portfolio of promising hematology and cancer-related products at various stages of development, today announced that results were reported from a randomized Phase II gastric cancer study of nimotuzumab being conducted by its licensees, Daiichi Sankyo Co., Ltd. in Japan and Kuhnil Pharma Co. Ltd., in Korea.

21 Jan 2011

ACT Biotech releases telatinib Phase 2 trial data for metastatic stomach cancer

ACT Biotech, a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, today released data on additional analysis of the Phase 2 clinical trial of telatinib in patients with metastatic stomach cancer that further supports the highly-potent nature of the antiangiogenic agent.

21 Jan 2011

Preliminary top-line results from levomilnacipran Phase III study for MDD

Forest Laboratories, and Pierre Fabre Medicament today announced preliminary top-line results from a Phase III study of levomilnacipran for the treatment of major depressive disorder.

20 Jan 2011

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C.

20 Jan 2011

Cognition Therapeutics closes $2.5 million Series A1 financing

Cognition Therapeutics Inc., a drug discovery company developing novel, small molecule disease-modifying treatments for Alzheimer's, has closed on a $2.5 million Series A1 financing it will use to bring one or more of its compounds to Investigational New Drug (IND) candidate status. The round was led by Golden Seeds, one of the nation's largest angel investing groups, and was syndicated with Tech Coast Angels.

20 Jan 2011

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication. RiVax™ is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals.

20 Jan 2011

Chelsea reports top-line data from Phase III NORTHERA extension study in NOH

Chelsea Therapeutics International, Ltd. reported new 12-month data from Study 303, a safety extension study from its Phase III NORTHERA™ (droxidopa) registration program in symptomatic neurogenic orthostatic hypotension (NOH). Preliminary, top-line results demonstrate Northera provides clinically meaningful and durable symptomatic improvements in patients with NOH throughout a one-year observation period.

20 Jan 2011

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

ZIOPHARM Oncology, Inc., announced today that The Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) adopted a positive opinion for darinaparsin (Zinapar™ or ZIO-101) designation as an orphan medicinal product for the treatment of peripheral T-cell lymphoma (PTCL).

20 Jan 2011

Merck provides additional information about DSMB recommendations for vorapaxar TRA-2P study

Merck reported today that investigators in the TRA-2P study of vorapaxar have been provided with additional information about the recommendations of the Data and Safety Monitoring Board (DSMB) regarding the TRA-2P study. The additional information was sent yesterday in a communication to investigators from the Operations Committee of the TRA-2P study of vorapaxar. Vorapaxar is one of Merck's investigational cardiovascular medicines.

20 Jan 2011

FOLOTYN Phase 2 peripheral T-cell lymphoma study results published in Journal of Clinical Oncology

Allos Therapeutics, Inc. today announced that the Journal of Clinical Oncology has published data from the Company's pivotal Phase 2 PROPEL study demonstrating clinical activity of FOLOTYN® (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

20 Jan 2011

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

Pervasis Therapeutics, Inc. today announced that the company is pursuing a matrix-embedded endothelial cell-based therapy (PVS-30200) to target and regulate cell stroma (the tumor environment or "ecosystem" that is comprised of various supporting cell types distinct from cancer cells) in order to prevent key processes that play a role in advancing solid tumor growth and metastasis.

20 Jan 2011

Drug Trial News

SuppreMol completes successful pre-IND meeting with U.S. FDA

FibroGen announces FG-3019 interim results from phase 1/2 trial against pancreatic cancer

Immunomedics reports encouraging results from Y-90-labeled clivatuzumab tetraxetan study in pancreatic cancer

Additional data from HyperAcute Pancreas cancer immunotherapy Phase 2 trial to be presented at ASCO 2011

Sunshine and Binghamton University enter research agreement for cancer compound

MedImmune announces MEDI-573 preclinical results against many solid tumors

Pervasis to present PVS-10200 interim data from Phase 1/2 PAD clinical study at IC3D

Teva invests $3.95M in Rexahn for development of anti-cancer compound RX-3117

MGH Bipolar CHOICE trial to evaluate effectiveness of new medications compared to lithium

Positive results from nimotuzumab Phase II study for gastric cancer

ACT Biotech releases telatinib Phase 2 trial data for metastatic stomach cancer

Preliminary top-line results from levomilnacipran Phase III study for MDD

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

Cognition Therapeutics closes $2.5 million Series A1 financing

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

Chelsea reports top-line data from Phase III NORTHERA extension study in NOH

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

Merck provides additional information about DSMB recommendations for vorapaxar TRA-2P study

FOLOTYN Phase 2 peripheral T-cell lymphoma study results published in Journal of Clinical Oncology

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

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