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CASI receives CFDA approval for ENMD-2076 Phase 2 clinical trial in ovarian clear cell carcinoma

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that the China Food and Drug Administration (CFDA) has approved the Company's application to conduct a Phase 2 global clinical trial in ovarian clear cell carcinoma (OCCC) patients for its proprietary drug candidate ENMD-2076.

30 Mar 2015

Synthetic Biologics begins SYN-004 Phase 2a clinical trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced the initiation of a Phase 2a clinical trial to evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, the Company's investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent C. difficile infection (CDI).

30 Mar 2015

Clonidine Topical Gel fails to meet primary endpoint in Phase 3 study for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced that the primary efficacy endpoint in the Phase 3 clinical study of Clonidine Topical Gel compared to placebo for the treatment of painful diabetic neuropathy did not meet statistical significance, although certain secondary endpoints showed statistically significant improvement over placebo. In addition, a strong safety profile for the product was observed.

30 Mar 2015

Naldemedine meets primary and secondary endpoints in phase III study for OIC treatment

Naldemedine, an investigational peripherally acting mu-opioid receptor antagonist (PAMORA) under development by Shionogi & Co., Ltd., met its primary and secondary endpoints in a phase III study (COMPOSE I) for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain receiving opioid therapy.

30 Mar 2015

Two experimental Ebola vaccines appear to be safe in PREVAIL clinical trial in Liberia

Two experimental Ebola vaccines appear to be safe based on evaluation in more than 600 people in Liberia who participated in the first stage of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) Phase 2/3 clinical trial, according to interim findings from an independent Data and Safety Monitoring Board review.

30 Mar 2015

Experimental immunotherapy shows promise in women with stage III or IV ovarian cancer

Personalized medicine is getting closer to reality for women with late-stage ovarian cancer. An experimental immunotherapy is in the works that can target an individual woman's tumor and extend the time period between initial treatment and the cancer's return.

29 Mar 2015

Promising clinical trial results for ebola vaccines

Interim findings from a clinical trial (PREVAIL) in which two experimental Ebola vaccines were given to more than 600 people in Liberia indicate that the vaccines are safe for use in humans. Based on these positive results, the vaccines may continue into the next stage of clinical evaluation; a phase 3 trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

27 Mar 2015

Roseroot extract may be beneficial for treating major depressive disorder

Rhodiola rosea (R. rosea), or roseroot, may be a beneficial treatment option for major depressive disorder (MDD), according to results of a study in the journal Phytomedicine led by Jun J. Mao, MD, MSCE, associate professor of Family Medicine, Community Health and Epidemiology and colleagues at the Perelman School of Medicine of University of Pennsylvania.

27 Mar 2015

New Ebola vaccine shows promise in first phase 1 clinical trial

Results from the first phase 1 trial of an Ebola vaccine based on the current (2014) strain of the virus are today published in The Lancet. Until now, all tested Ebola virus vaccines have been based on the virus strain from the Zaire outbreak in 1976. The results suggest that the new vaccine is safe, and provokes an immune response in recipients, although further long-term testing will be needed to establish whether it can protect against the Ebola virus.

27 Mar 2015

Guinean Government initiates first efficacy trial of Ebola vaccine in Basse-Guinée

The Guinean Government with the World Health Organization initiated the very first efficacy trial of an Ebola vaccine this week in an affected community of the Basse-Guinée, one of the areas where most Ebola cases are found in the country.

27 Mar 2015

apceth begins Agenmestencel-T Phase II clinical trial in gastrointestinal cancer patients

apceth, a global leader in engineered cell therapies, today announced the successful completion of the Phase I and initiation of the Phase II part of its ongoing monocentric Phase I/II clinical trial TREAT-ME 1 with the engineered cell therapeutic product Agenmestencel-T, at the Klinikum Grosshadern in Munich.

27 Mar 2015

GFT505 demonstrates dose-dependent efficacy on primary endpoint in phase 2 NASH trial

GENFIT, today announces topline results of the phase 2 GOLDEN-505 trial in NASH. Due to the unexpected rate of resolution of NASH in patients randomized to placebo who had early NASH (NAS of 3, placebo response rate>57%), along with the high number of sites for a limited sample size, the study as initially designed did not enable the trial to meet directly the primary endpoint.

27 Mar 2015

Aridis Pharmaceuticals begins Aerucin Phase 1 clinical study for treatment of acute pneumonia

Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today the initiation of a Phase 1 clinical study of Aerucin, the Company's fully human IgG1 monoclonal antibody (mAb) against Pseudomonas aeruginosa bacteria, which is being developed as an adjunctive treatment for acute pneumonia.

26 Mar 2015

LEO Pharma A/S announces regulatory submission of ENSTILAR® for psoriasis in Europe

ENSTILAR® has the potential to be the first cutaneous foam approved for the treatment of psoriasis vulgaris.

26 Mar 2015

Transition announces positive results from ELND005 AME and renal clearance studies

Transition Therapeutics Inc. today announced results from two phase 1 clinical studies of neuropsychiatric drug candidate ELND005. These studies, an absorption-metabolism-excretion ("AME") study and a renal clearance study, are specialized clinical pharmacology trials that are required by the United States Food and Drug Administration for the approval of most drugs in development.

26 Mar 2015

C3BS plans to open new U.S.-based facility to manufacture C-Cure for use in Phase III trial

Cardio3 BioSciences, a leader in the discovery and development of engineered cell therapies, today confirmed plans to open a new U.S.-based manufacturing facility in Rochester, Minnesota. The facility will support the Company’s current and anticipated manufacturing needs in the United States for both the Phase III clinical trial evaluating lead cardiovascular product candidate C-Cure (CHART-2), and its recently acquired CAR T-cell therapies’ portfolio.

26 Mar 2015

Arno Therapeutics' AR-42 with cisplatin demonstrates anti-tumor effect in bladder cancer models

Arno Therapeutics, Inc., a clinical stage biopharmaceutical company primarily focused on the development of oncology therapeutics, today announced that data from a preclinical study demonstrate its histone-deacetylase (HDAC) inhibitor AR-42 in combination with cisplatin has a synergistic anti-tumor effect in bladder cancer models.

26 Mar 2015

IV cosyntropin therapy matches EBP in relieving pain from post-dural puncture headache

Intravenous (IV) cosyntropin therapy was equivalent to epidural blood patch (EBP) in relieving pain from post-dural puncture headache (PDPH) with potential for fewer complications and lower costs, data from a randomized, controlled trial showed.

25 Mar 2015

CASI initiates ENMD-2076 Phase 2 trial in Chinese patients with triple-negative breast cancer

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announces that it has initiated a Phase 2 trial of its target therapy drug candidate ENMD-2076 in triple-negative breast cancer (TNBC) at the Cancer Hospital of Chinese Academy of Medical Sciences in Beijing, China.

25 Mar 2015

Personalized gene therapy to fight against cancer

The fight to treat cancer and eradicate tumors will likely benefit from a new set of treatments if early development phases continue to show promise, according to Kalorama Information. The healthcare market research publisher stated that gene therapies that are able to deliver genetic material to a specific cell population or tumor that will result in the destruction of the tumor.

25 Mar 2015

Drug Trial News

CASI receives CFDA approval for ENMD-2076 Phase 2 clinical trial in ovarian clear cell carcinoma

Synthetic Biologics begins SYN-004 Phase 2a clinical trial to prevent C. difficile infection

Clonidine Topical Gel fails to meet primary endpoint in Phase 3 study for treatment of painful diabetic neuropathy

Naldemedine meets primary and secondary endpoints in phase III study for OIC treatment

Two experimental Ebola vaccines appear to be safe in PREVAIL clinical trial in Liberia

Experimental immunotherapy shows promise in women with stage III or IV ovarian cancer

Promising clinical trial results for ebola vaccines

Roseroot extract may be beneficial for treating major depressive disorder

New Ebola vaccine shows promise in first phase 1 clinical trial

Guinean Government initiates first efficacy trial of Ebola vaccine in Basse-Guinée

apceth begins Agenmestencel-T Phase II clinical trial in gastrointestinal cancer patients

GFT505 demonstrates dose-dependent efficacy on primary endpoint in phase 2 NASH trial

Aridis Pharmaceuticals begins Aerucin Phase 1 clinical study for treatment of acute pneumonia

LEO Pharma A/S announces regulatory submission of ENSTILAR® for psoriasis in Europe

Transition announces positive results from ELND005 AME and renal clearance studies

C3BS plans to open new U.S.-based facility to manufacture C-Cure for use in Phase III trial

Arno Therapeutics' AR-42 with cisplatin demonstrates anti-tumor effect in bladder cancer models

IV cosyntropin therapy matches EBP in relieving pain from post-dural puncture headache

CASI initiates ENMD-2076 Phase 2 trial in Chinese patients with triple-negative breast cancer

Personalized gene therapy to fight against cancer

Exploring the nanoscale: How AFM is transforming cosmetic science

Innovating Texture and Culture in Plant-Based Foods

Advancing brain microphysiological systems (bMPS)

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