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Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

Rhythm announced today the initiation of two Phase 2 clinical trials focused on evaluating the safety and effectiveness of setmelanotide (RM-493), the company's novel melanocortin 4 receptor (MC4R) agonist, for the treatment of Prader-Willi Syndrome (PWS) and POMC-null obesity.

4 Jun 2015

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 ("miR-21").

4 Jun 2015

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

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 it has filed an application with China's Food and Drug Administration to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076.

4 Jun 2015

Egalet announces top-line results from Egalet-002 study in moderate drinkers

Egalet Corporation, a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain treatments, today announced top-line results from a randomized, four-way crossover alcohol-interaction study in healthy male and female moderate drinkers with Egalet-002, an abuse-deterrent, extended-release, oral oxycodone-based product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.

4 Jun 2015

ProBioGen initiates clinical trials of Ebola vaccine using AGE1.CR.pIX cell line

Complex biologics development and manufacturing specialist ProBioGen today announced that an investigational vaccine against Ebola virus disease, produced on its proprietary, continuous muscovy duck AGE1.CR.pIX cell line, has proceeded into clinical trials at the Jenner Institute, Oxford University, UK.

3 Jun 2015

Nivolumab and pembrolizumab therapies continue to show promise against advanced melanomas

Results of two clinical trials reported at the American Society for Clinical Oncology Annual Meeting 2015 show continued promise of immune therapies nivolumab and pembrolizumab against advanced melanomas, specifically in the context of PD1 signaling that some tumors use to avoid immune system attack. Dr. Rene Gonzalez, MD, investigator at the University of Colorado Cancer Center and director of the Melanoma Research Clinics at the CU School of Health, is an author of both studies.

2 Jun 2015

MorphoSys' MOR202 proprietary drug candidate meets primary endpoints in multiple myeloma patients

MorphoSys AG today published first safety and efficacy data on its proprietary drug candidate MOR202. The data are from a phase 1/2a study in 42 heavily pretreated patients with relapsed/refractory multiple myeloma.

2 Jun 2015

Celldex’s lead program RINTEGA demonstrates overall survival benefit in patients with recurrent glioblastoma

Celldex Therapeutics, Inc. today presented positive results from the Company’s randomized, double‐blind Phase 2 study of RINTEGA (rindopepimut) in patients with EGFRvIII‐positive, recurrent glioblastoma at the 2015 American Society of Clinical Oncology in Chicago.

2 Jun 2015

ASCO 2015: Berg presents data from BPM 31510 Phase Ib trial for solid tumors

Berg, a biopharmaceutical company committed to uncovering health solutions through a data-driven, biological approach, presented clinical research from its trials using its cancer drug BPM 31510 on Phase Ib solid tumors and preclinical data on triple negative breast cancer, at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), May 29 – June 2 in Chicago.

2 Jun 2015

Apatorsen added to first-line chemotherapy benefits metastatic bladder cancer patients

OncoGenex Pharmaceuticals, Inc. announced that results from an exploratory analysis of the Phase 2 Borealis-1 trial showed that metastatic bladder cancer patients with poor prognostic features benefited from apatorsen 600mg added to first-line chemotherapy compared to chemotherapy alone.

2 Jun 2015

ASCO 2015: AMGEN presents new data evaluating less-frequent dosing of kyprolis for multiple myeloma patients

Amgen today announced the initiation of the ARROW trial, a global Phase 3 study evaluating the benefit of Kyprolis®

2 Jun 2015

NW Bio releases promising new data on DCVax-Direct Phase I trial for inoperable solid tumors

Northwest Biotherapeutics, a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, over the weekend in Chicago released promising new data on their Phase I trial of DCVax-Direct for direct injection into all types of inoperable solid tumors.

2 Jun 2015

EMA grants Orphan Drug Designation to Stempeucel for treatment of Thromboangiitis Obliterans

Stempeutics Research, a group company of Manipal Education & Medical Group and a joint venture with Cipla Group, announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation for its drug Stempeucel® for the treatment of Thromboangiitis Obliterans.

2 Jun 2015

MedImmune, AstraZeneca present encouraging results from new combination-focused immuno-oncology portfolio at ASCO 2015

AstraZeneca and MedImmune, the company’s global biologics research and development arm, today presented encouraging results from their novel combination-focused immuno-oncology portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting 2015.

2 Jun 2015

Experimental drug and common antibiotic combination holds promise for pancreatic cancer treatment

Despite surgical advances, pancreatic cancer continues to be one of the most deadly and difficult cancers to manage due to a lack of effective therapies. However, VCU Massey Cancer Center and VCU Institute of Molecular Medicine (VIMM) scientists in the lab of Paul B. Fisher, M.Ph., Ph.D., are hoping to change that with a novel combination of an experimental drug and a common antibiotic that has shown promising results in preclinical experiments.

2 Jun 2015

DNA Therapeutics to present DT01 phase 1/2a trial results at ASCO 2015

DNA Therapeutics, a private biopharmaceutical company developing DT01, a first-in-class clinical pan DNA repair inhibitor to treat tumors resistant to conventional treatments, will today present the results of the first-in-man phase 1/2a trial of DT01 in combination with radiation therapy in patients with cutaneous metastatic melanoma.

2 Jun 2015

Maintenance therapy with lenalidomide benefits patients with multiple myeloma

A large cooperative-group study directed by the Alliance for Clinical Trials in Oncology has confirmed previous evidence that the drug lenalidomide delays time to disease progression for patients with multiple myeloma and is an important treatment option for patients with this rare but increasingly common cancer of the blood and marrow.

2 Jun 2015

ASCO 2015: Novartis presents data on Zykadia and Tafinlar studies for non-small cell lung cancer

Novartis today announced new data from two Phase II studies of Zykadia (ceritinib), as well as one Phase II study of Tafinlar® (dabrafenib) in combination with Mekinist (trametinib) in certain patients with non-small cell lung cancer.

2 Jun 2015

Boehringer Ingelheim presents afatinib LUX-Lung 8 trial data at ASCO 2015

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy.

2 Jun 2015

New treatment option for postmenopausal women with non-invasive breast cancer

Anastrozole provides a significant benefit compared with tamoxifen in preventing recurrence after a lumpectomy and radiation therapy in postmenopausal women ages 60 years or younger who had DCIS (ductal carcinoma in situ), a common diagnosis of non-invasive breast cancer. In women over age 60, it works as well as tamoxifen.

2 Jun 2015

Drug Trial News

Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

Regulus Therapeutics begins RG-012 Phase I clinical study for treatment of Alport syndrome

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

Egalet announces top-line results from Egalet-002 study in moderate drinkers

ProBioGen initiates clinical trials of Ebola vaccine using AGE1.CR.pIX cell line

Nivolumab and pembrolizumab therapies continue to show promise against advanced melanomas

MorphoSys' MOR202 proprietary drug candidate meets primary endpoints in multiple myeloma patients

Celldex’s lead program RINTEGA demonstrates overall survival benefit in patients with recurrent glioblastoma

ASCO 2015: Berg presents data from BPM 31510 Phase Ib trial for solid tumors

Apatorsen added to first-line chemotherapy benefits metastatic bladder cancer patients

ASCO 2015: AMGEN presents new data evaluating less-frequent dosing of kyprolis for multiple myeloma patients

NW Bio releases promising new data on DCVax-Direct Phase I trial for inoperable solid tumors

EMA grants Orphan Drug Designation to Stempeucel for treatment of Thromboangiitis Obliterans

MedImmune, AstraZeneca present encouraging results from new combination-focused immuno-oncology portfolio at ASCO 2015

Experimental drug and common antibiotic combination holds promise for pancreatic cancer treatment

DNA Therapeutics to present DT01 phase 1/2a trial results at ASCO 2015

Maintenance therapy with lenalidomide benefits patients with multiple myeloma

ASCO 2015: Novartis presents data on Zykadia and Tafinlar studies for non-small cell lung cancer

Boehringer Ingelheim presents afatinib LUX-Lung 8 trial data at ASCO 2015

New treatment option for postmenopausal women with non-invasive breast cancer

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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