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Gamida Cell reaches agreements with FDA and EMA regarding NiCord Phase III study design outline

Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that the company has reached agreements with the FDA and EMA regarding the Phase III study design outline of NiCord.

10 Aug 2015

Investigational topical drug shows promise in patients with early stage cutaneous T cell lymphoma

Results of a phase one trial show that an investigational topical drug, resiquimod gel, causes regression of both treated and untreated tumor lesions and may completely remove cancerous cells from both sites in patients with early stage cutaneous T cell lymphoma (CTCL) - a rare type of non-Hodgkin lymphoma that affects the skin.

7 Aug 2015

Experimental Ebola virus vaccine protects cynomolgus macaques against current EBOV outbreak strain

National Institutes of Health scientists report that a single dose of an experimental Ebola virus (EBOV) vaccine completely protects cynomolgus macaques against the current EBOV outbreak strain, EBOV-Makona, when given at least seven days before exposure, and partially protects them if given three days prior.

7 Aug 2015

Celsion reports updated results from HEAT Study of ThermoDox in patients with primary liver cancer

Celsion Corporation, an oncology drug development company, today announced updated results from its retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC).

6 Aug 2015

Vtesse reports preliminary results from VTS-270 Phase 1 trial for treatment of Niemann-Pick Disease Type C

Vtesse, Inc. announced preliminary results today from an open-label Phase 1 clinical trial with VTS-270 (a formulation of (2-hydroxypropyl)-beta-cyclodextrin) for treatment of Niemann-Pick Disease Type C (NPC) conducted by researchers at the National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development.

6 Aug 2015

Antiva raises $16 million in Series B financing to advance antiviral compound through Phase 1 clinical trials

Antiva Biosciences, Inc. (formerly Hera Therapeutics), a biopharmaceutical company developing antiviral therapeutics, today announced that it has raised $16 million in a Series B financing, its first institutional round.

6 Aug 2015

Clinical study shows two-drug combination can prolong survival in men with metastatic prostate cancer

Newly diagnosed patients with metastatic, hormone-sensitive prostate cancer gained a dramatic survival benefit when started on two drugs simultaneously, rather than delaying the second drug until the cancer began to worsen, according to results of a clinical trial led by a Dana-Farber Cancer Institute scientist.

6 Aug 2015

Genetic test may help identify better treatment option for HER2-positive breast cancer patients

A genetic test for PIK3CA mutations may help to identify patients with HER2-positive breast cancer who are less likely to benefit from combination anti-HER2 therapy, according to a study published in The Oncologist on August 5, 2015.

6 Aug 2015

WI Harper Group announces investment in Cold Genesys

WI Harper Group, a leading US & China, cross-border early growth and expansion stage venture capital firm, today announced an investment in Cold Genesys Inc, a clinical-stage privately-held biotech company developing oncolytic immunotherapies for cancer.

6 Aug 2015

EORTC study: Irradiation of regional nodes in breast cancer patients has marginal effect on overall survival

At a median follow-up of 10.9 years, an EORTC study has shown that irradiation of regional nodes in patients with stage I, II, or III breast cancer has a marginal effect on overall survival, the primary endpoint (at 10 years, overall survival was 82.3 % for regional irradiation versus 80.7% for no regional irradiation, (HR=0.87 (95%CI: 0.76, 1.00), p=0.06).

4 Aug 2015

Resverlogix announces formation of international Clinical Steering Committee for RVX-208 "apabetalone" Phase 3 trial

Resverlogix Corp. is pleased to announce the formation of an international Clinical Steering Committee for the RVX-208 "apabetalone" Phase 3 clinical trial BETonMACE assessing major adverse cardiac events (MACE) in high-risk vascular patients with diabetes mellitus and a recent Acute Coronary Syndrome event. BETonMACE is expected to start in the fall of 2015.

4 Aug 2015

Ironshore partners with Restore Health to participate in HLD-200 clinical trial to treat ADHD

Ironshore Pharmaceuticals & Development, Inc. has signed an agreement with Restore Health, a company specializing in personalized medicine, to participate in the fulfillment of a double-blind clinical trial, designed to evaluate the safety and efficacy of HLD-200, a new drug in development to treat Attention-deficit/hyperactivity disorder (ADHD).

4 Aug 2015

Prokarium receives funding to complete pre-clinical development of new Chlamydia vaccine

Prokarium Ltd, a biotechnology company developing transformational oral vaccines, today announced new funding from SynbiCITE, the UK’s Innovation and Knowledge Centre for Synthetic Biology.

4 Aug 2015

First patient enrolled in Contravir‘s FV-100 Phase 3 study to prevent shingles, shingles-associated pain

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the first patient has been enrolled in the Company's pivotal Phase 3 clinical study, study 007, of FV-100 to prevent the debilitating shingles-associated pain known as post-herpetic neuralgia (PHN).

3 Aug 2015

Shionogi’s naldemedine meets primary, secondary endpoints for treatment of opioid-induced constipation

Shionogi today announced that once-daily naldemedine met its primary and secondary endpoints in a phase III study (COMPOSE II) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

3 Aug 2015

Exalenz Bioscience, Galectin Therapeutics to use BreathID test to assess GR-MD-O2 efficacy in NASH Cirrhosis patients

Exalenz Bioscience, a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced a collaboration with Galectin Therapeutics to use the BreathID test to monitor patients in a Phase II study evaluating GR-MD-02.

3 Aug 2015

Charleston Laboratories begins Phase 1 study on CL-H1T migraine drug candidate

Charleston Laboratories, Inc., an emerging specialty pharmaceutical company, announced initiation of its second clinical development program with a Phase 1 study on its migraine drug candidate, CL-H1T.

3 Aug 2015

First large field trial shows VSV-ZEBOV is effective against Ebola

A vaccine against the Ebola virus, tested in West Africa for the first time in a field trial, has proved to be effective. People who had come into close contact with someone recently infected, and who are therefore at particularly high risk, were vaccinated.

3 Aug 2015

Tests show VSV-ZEBOV vaccine safe and effective against Ebola

Tests of the experimental Ebola vaccine VSV-ZEBOV in over 7500 participants in Guinea suggest that the vaccine provides high protection against the disease as early as ten days after vaccination, in adults who have potentially been exposed to the virus by coming in close contact with a recently infected person.

31 Jul 2015

Guinea Phase III trial shows VSV-EBOV vaccine highly effective against Ebola

Results from an interim analysis of the Guinea Phase III efficacy vaccine trial show that VSV-EBOV (Merck, Sharp & Dohme) is highly effective against Ebola.

31 Jul 2015

Drug Trial News

Gamida Cell reaches agreements with FDA and EMA regarding NiCord Phase III study design outline

Investigational topical drug shows promise in patients with early stage cutaneous T cell lymphoma

Experimental Ebola virus vaccine protects cynomolgus macaques against current EBOV outbreak strain

Celsion reports updated results from HEAT Study of ThermoDox in patients with primary liver cancer

Vtesse reports preliminary results from VTS-270 Phase 1 trial for treatment of Niemann-Pick Disease Type C

Antiva raises $16 million in Series B financing to advance antiviral compound through Phase 1 clinical trials

Clinical study shows two-drug combination can prolong survival in men with metastatic prostate cancer

Genetic test may help identify better treatment option for HER2-positive breast cancer patients

WI Harper Group announces investment in Cold Genesys

EORTC study: Irradiation of regional nodes in breast cancer patients has marginal effect on overall survival

Resverlogix announces formation of international Clinical Steering Committee for RVX-208 "apabetalone" Phase 3 trial

Ironshore partners with Restore Health to participate in HLD-200 clinical trial to treat ADHD

Prokarium receives funding to complete pre-clinical development of new Chlamydia vaccine

First patient enrolled in Contravir‘s FV-100 Phase 3 study to prevent shingles, shingles-associated pain

Shionogi’s naldemedine meets primary, secondary endpoints for treatment of opioid-induced constipation

Exalenz Bioscience, Galectin Therapeutics to use BreathID test to assess GR-MD-O2 efficacy in NASH Cirrhosis patients

Charleston Laboratories begins Phase 1 study on CL-H1T migraine drug candidate

First large field trial shows VSV-ZEBOV is effective against Ebola

Tests show VSV-ZEBOV vaccine safe and effective against Ebola

Guinea Phase III trial shows VSV-EBOV vaccine highly effective against Ebola

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