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Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review classification to its Supplemental New Drug Application (sNDA) regarding ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.

28 Feb 2011

Positive results from Trius torezolid Phase 1 lung study

Trius Therapeutics, Inc. today announced results from its Phase 1 clinical trial to evaluate the ability of torezolid to penetrate into the lung for potential use to treat lung infections. In this study a 200 mg dose of torezolid phosphate was administered orally once-daily for three days to healthy adult volunteers. The trial achieved its primary goal of establishing the steady-state plasma pharmacokinetics and distribution of active drug into epithelial lining fluid (ELF).

28 Feb 2011

Immunitor to present latest results from imm01 trial in tuberculosis patients at African conference

Immune Network Ltd. advises that Immunitor will present latest results from its imm01 clinical trial in tuberculosis patients in Abuja, Nigeria at the 18th Union TB and Lung Diseases Conference of the African Region, 2nd to 5th March, 2011.

28 Feb 2011

MEPs, OETC visit new TB vaccine trial site to express support for candidate development

Emergent BioSolutions Inc. announced that a joint delegation of Members of the European Parliament and representatives from the Oxford-Emergent Tuberculosis Consortium today visited the trial site where MVA85A, the world's most clinically advanced tuberculosis vaccine candidate in development, is being studied in a Phase IIb infant efficacy clinical trial.

28 Feb 2011

Preliminary top-line results from cariprazine 8-week Phase II trial against major depressive disorder

Forest Laboratories, Inc. and Gedeon Richter Plc. today announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine as adjunctive therapy in major depressive disorder.

28 Feb 2011

First patient treated in KUR-023 pilot clinical trial to assess safety and efficacy of product candidate

Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced today that it has treated the first patient in a pilot clinical trial investigating the safety and efficacy of KUR-023, its novel dural sealant product candidate.

28 Feb 2011

Final data from 4SC vidofludimus ENTRANCE Phase IIa trial against IBD presented at ECCO IBD Conference

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, announces the final data from the ENTRANCE Phase IIa trial in inflammatory bowel disease with vidofludimus, an oral inhibitor of interleukin-17 release and DHODH, including the secondary endpoints comprising the analysis of CDAI and CAI disease scores, change of prednisolone intake and threshold doses, safety, pharmacokinetics and biomarkers.

28 Feb 2011

Phase III trial results: Erlotinib has comparable efficacy to chemotherapy with better tolerability against lung cancer

The targeted cancer drug erlotinib has comparable efficacy to chemotherapy, and is better tolerated, in hard-to-treat cases where a patient's cancer has progressed quickly after treatment with first-line therapy, the results of a new phase III trial show.

27 Feb 2011

Encouraging preliminary results from Synta's ganetespib Phase 2 trial against non-small cell lung cancer

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that encouraging preliminary results of a Phase 2 trial of ganetespib as a single agent in non-small cell lung cancer were presented at the International Association for the Study of Lung Cancer 11th Annual Targeted Therapies for the Treatment of Lung Cancer Meeting.

27 Feb 2011

Less-toxic combination of immune-based drug and chemotherapy drug produce long-term remissions in CLL

New research shows that a less-toxic combination of a targeted immune-based drug and a chemotherapy drug can produce long-term remissions in some chronic lymphocytic leukemia patients. And it does so without increasing the risk of later therapy-related myelodysplastic syndrome and acute myeloid leukemia, which can often occur with a three-drug combination used to treat these patients.

25 Feb 2011

Neoprobe's Lymphoseek Phase 2 study data published in Annals of Surgical Oncology

Neoprobe Corporation (NEOP), a diversified developer of innovative oncology surgical and diagnostic products, today announced that results from a Phase II study of Lymphoseek® (Tilmanocept) have been published online in the Annals of Surgical Oncology and demonstrate the tracing agent's ability to identify tumor-draining lymph nodes in breast cancer and melanoma patients.

25 Feb 2011

Preclinical data of Zalicus sodium channel compound published in journal PAIN

Zalicus Inc. today announced the publication of preclinical data in the journal PAIN. The paper describes the activity of Z212, a novel proprietary small organic compound that acts to modulate Nav1.7 and Nav1.8 sodium channels and to reduce neuropathic pain by targeting the hyper-excitability associated with chronic pain signaling pathways.

25 Feb 2011

Medwell commits $2,000,000 investment in Mimetogen

Medwell Capital Corp. today announced that it has committed to invest up to $2,000,000 in Mimetogen Pharmaceuticals Inc. ("Mimetogen"), a privately-held, clinical-stage company developing a treatment for dry eye disease. Medwell Capital participated in a Series B equity financing with existing Mimetogen investors, iNovia Capital, MSBi Valorisation and VIMAC Milestone Medica.

25 Feb 2011

U.S.-Chile collaborate to study new long-acting local anesthetic derived from algae

A U.S.-Chile collaboration is bringing surgical patients closer to having a long-acting local anesthetic. In a randomized, double-blind trial, patients given neosaxitoxin, a new local anesthetic derived from algae, had significantly less postoperative pain and recovered about two days sooner than those given the commonly used local anesthetic bupivacaine.

25 Feb 2011

Targets against MRSA in microgravity

NASA astronauts onboard Space Shuttle Discovery's final mission to the International Space Station (ISS) will carry out the eleventh scientific payload for Astrogenetix, a commercial biotech company based out of Austin, Texas. The research on STS-133 will focus on changes that occur to methicillin-resistant Staphylococcus aureus (MRSA) in microgravity, which can be targeted to create new vaccines and therapeutics.

25 Feb 2011

Protalix receives FDA CRL for taliglucerase alfa NDA for Gaucher disease

Protalix BioTherapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease. Taliglucerase alfa is a plant-cell expressed form of glucocerebrosidase (GCD).

25 Feb 2011

Journal of Clinical Virology publishes positive outcome from CMX001 treatment against AdV infection

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of the first reported case in which adenovirus infection was successfully eradicated following treatment with its broad-spectrum antiviral drug, CMX001.

25 Feb 2011

Radioactive tracing agent can identify tumor-draining sentinel nodes in breast cancer, melanoma patients

Researchers say a new kind of tracing agent is more accurate than current methods in helping identify tumor-draining sentinel lymph nodes in breast cancer and melanoma patients. That's the finding in a new study that appears in the online version of the Annals of Surgical Oncology.

25 Feb 2011

The Lancet journal publishes XGEVA Phase 3 study results against prostate cancer, bone metastases

Amgen today announced the publication of results from a Phase 3 head-to-head trial that compared XGEVA to Zometa in preventing bone complications called skeletal-related events in 1,901 men with prostate cancer and bone metastases.

25 Feb 2011

Enobia completes patient enrollment in ENB-0040 Phase II study for HPP

Enobia Pharma Inc., today announced that it has successfully completed enrollment in its Phase II study of ENB-0040, a bone targeted enzyme replacement therapy being investigated in adolescents and adults with hypophosphatasia, a serious, rare metabolic bone disorder.

25 Feb 2011

Drug Trial News

Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Positive results from Trius torezolid Phase 1 lung study

Immunitor to present latest results from imm01 trial in tuberculosis patients at African conference

MEPs, OETC visit new TB vaccine trial site to express support for candidate development

Preliminary top-line results from cariprazine 8-week Phase II trial against major depressive disorder

First patient treated in KUR-023 pilot clinical trial to assess safety and efficacy of product candidate

Final data from 4SC vidofludimus ENTRANCE Phase IIa trial against IBD presented at ECCO IBD Conference

Phase III trial results: Erlotinib has comparable efficacy to chemotherapy with better tolerability against lung cancer

Encouraging preliminary results from Synta's ganetespib Phase 2 trial against non-small cell lung cancer

Less-toxic combination of immune-based drug and chemotherapy drug produce long-term remissions in CLL

Neoprobe's Lymphoseek Phase 2 study data published in Annals of Surgical Oncology

Preclinical data of Zalicus sodium channel compound published in journal PAIN

Medwell commits $2,000,000 investment in Mimetogen

U.S.-Chile collaborate to study new long-acting local anesthetic derived from algae

Targets against MRSA in microgravity

Protalix receives FDA CRL for taliglucerase alfa NDA for Gaucher disease

Journal of Clinical Virology publishes positive outcome from CMX001 treatment against AdV infection

Radioactive tracing agent can identify tumor-draining sentinel nodes in breast cancer, melanoma patients

The Lancet journal publishes XGEVA Phase 3 study results against prostate cancer, bone metastases

Enobia completes patient enrollment in ENB-0040 Phase II study for HPP

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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