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Merck reports results from global EMEND Phase 3 study for CINV prevention in pediatric cancer patients

Merck, known as MSD outside the United States and Canada, today announced results from a global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.

30 Jun 2014

Actavis seeks FDA ANDA approval for generic Zubsolv, confirms patent challenge

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base. Actavis' ANDA product is a generic version of Orexo's Zubsolv, which is a partial opioid agonist indicated for the maintenance treatment of opioid dependence.

30 Jun 2014

Synthetic Biologics supports SYN-004 C.difficile preventative program with formation of Clinical Advisory Board

Synthetic Biologics, Inc., a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced today the formation of a Clinical Advisory Board (CAB) to support development of SYN-004, the Company's lead anti-infective product candidate for the prevention of the devastating effects of Clostridium difficile (C. difficile)

30 Jun 2014

EMA accepts for review Merck’s pembrolizumab MAA for treatment of advanced melanoma

Merck, known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company's investigational anti-PD-1 antibody, for the treatment of advanced melanoma.

30 Jun 2014

Genervon generates biomarker data for its Phase 2a clinical trial for ALS

Genervon Biopharmaceuticals LLC ("Genervon") today announced that it has analyzed and generated a Biomarker Data Report for its recent Phase 2a clinical trial for ALS disease modification.

30 Jun 2014

Conventional fertility hormones do not increase risk of breast, gynecological cancers

There is "little evidence" that the use of conventional fertility hormones used for ovarian stimulation in the treatment of infertility increases the long-term risk of breast and gynecological cancers, according to the results of a substantial 30-year follow-up study.

30 Jun 2014

Phase III TAS-102 study for metastatic colorectal cancer shows improved survival

The new combination agent TAS-102 is able to improve overall survival compared to placebo in patients whose metastatic colorectal cancer is refractory to standard therapies, researchers said at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.

30 Jun 2014

Taiho Oncology presents TAS-102 Phase III RECOURSE trial results in mCRC patients

Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced today detailed findings from its global Phase III RECOURSE trial of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug.

28 Jun 2014

BRI to present clinical-stage product data at International Symposium on Pediatric Neuro-Oncology

The Burzynski Research Institute, Inc. (BRI) announced today that it will present data on two of the Company's clinical-stage product candidates, Antineoplaston A10 injections (Atengenal®) and Antineoplaston AS2-1 injections (Astugenal®), at the 16th International Symposium on Pediatric Neuro-Oncology held in Singapore from June 28, 2014 to July 2, 2014.

28 Jun 2014

Dosing commences in Essentialis’ DCCR clinical study in obese Prader-Willi syndrome patients

Essentialis announced today the dosing of the first patient in clinical study PC025, which is designed to evaluate the safety and efficacy of diazoxide choline controlled release tablets (DCCR) in obese Prader-Willi syndrome patients.

27 Jun 2014

ASPIRE completes patient enrollment in Phase III trial of vaginal ring for HIV prevention

ASPIRE, one of two Phase III trials of a promising method for preventing HIV in women - a vaginal ring worn for a month at a time - has completed enrollment of participants, with 2,629 women from 15 clinical research sites in Malawi, South Africa, Uganda and Zimbabwe now taking part in the study.

27 Jun 2014

Scientists report first successful step toward vaccine that targets mutation in brain cancer

Astrocytomas and oligodendrogliomas are subtypes of a brain cancer called 'glioma'. These incurable brain tumors arise from glial cells, a type of support cell found in the central nervous system.

26 Jun 2014

EnGeneIC plans for Phase 2a trial of EGFR-targeted doxorubicin-packaged EDV nanocells for GBM

EnGeneIC, Ltd., an emerging biopharmaceutical company focused on revolutionizing the treatment of cancer through the targeted delivery of therapeutic agents directly to cancer cells, today announced plans to move forward with a Phase 2a clinical trial in the U.S. using its formulation of EGFR-targeted, EDV nanocells packaged with doxorubicin for the treatment of recurrent glioblastoma (GBM), a common and aggressive type of brain tumor.

26 Jun 2014

Adding MM-398 to standard treatment improves survival in metastatic pancreatic cancer patients

Adding the novel MM-398 to standard treatment for metastatic pancreatic cancer patients who have already received gemcitabine improves survival, researchers said at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.

26 Jun 2014

Aerie Pharmaceuticals' Roclatan meets all clinical endpoints in Phase 2b trial

Aerie Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today reported the successful results of its Phase 2b trial for once-daily, quadruple-action RoclatanTM, a combination of Aerie's triple-action RhopressaTM with latanoprost, a prostaglandin analogue (PGA).

25 Jun 2014

Henry Ford launches clinical trial for treatment of tinnitus caused by noise trauma

Henry Ford Health System has launched a clinical trial to investigate a new drug for the treatment of tinnitus, a chronic ringing of the head or ears that affects more than 600 million people worldwide.

25 Jun 2014

Cardium reports positive results from Generx Ad5FGF-4 Phase 3 study for treatment of myocardial ischemia

Taxus Cardium Pharmaceuticals Group Inc. will report today at the Biotechnology Industry Organization’s 2014 BIO International Convention on a pre-specified interim analysis from its international ASPIRE Phase 3 registration clinical study of Generx Ad5FGF-4, Cardium Therapeutics’ angiogenic gene therapy product candidate for patients with myocardial ischemia due to coronary artery disease.

25 Jun 2014

Trevena's Phase 1b data for TRV130 published in the journal Pain

Trevena, Inc., a clinical stage biopharmaceutical company and the leader in the discovery of G protein coupled receptor (GPCR) biased ligands, today announced the publication of its Phase 1b data for TRV130 in the journal Pain.

24 Jun 2014

Forest Laboratories reports positive results from three Phase III trials of vilazodone for GAD treatment

Forest Laboratories, Inc. today announced positive topline results from three Phase III trials evaluating the efficacy, safety and tolerability of vilazodone in adult patients with generalized anxiety disorder (GAD).

24 Jun 2014

XenoPort initiates XP23829 Phase 2 clinical trial in patients with psoriasis

XenoPort, Inc. announced today that it has initiated a Phase 2 clinical trial of XP23829, its proprietary investigational next-generation fumaric acid product candidate. The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of XP23829 as a potential treatment of patients with moderate-to-severe chronic plaque-type psoriasis.

23 Jun 2014

Drug Trial News

Merck reports results from global EMEND Phase 3 study for CINV prevention in pediatric cancer patients

Actavis seeks FDA ANDA approval for generic Zubsolv, confirms patent challenge

Synthetic Biologics supports SYN-004 C.difficile preventative program with formation of Clinical Advisory Board

EMA accepts for review Merck’s pembrolizumab MAA for treatment of advanced melanoma

Genervon generates biomarker data for its Phase 2a clinical trial for ALS

Conventional fertility hormones do not increase risk of breast, gynecological cancers

Phase III TAS-102 study for metastatic colorectal cancer shows improved survival

Taiho Oncology presents TAS-102 Phase III RECOURSE trial results in mCRC patients

BRI to present clinical-stage product data at International Symposium on Pediatric Neuro-Oncology

Dosing commences in Essentialis’ DCCR clinical study in obese Prader-Willi syndrome patients

ASPIRE completes patient enrollment in Phase III trial of vaginal ring for HIV prevention

Scientists report first successful step toward vaccine that targets mutation in brain cancer

EnGeneIC plans for Phase 2a trial of EGFR-targeted doxorubicin-packaged EDV nanocells for GBM

Adding MM-398 to standard treatment improves survival in metastatic pancreatic cancer patients

Aerie Pharmaceuticals' Roclatan meets all clinical endpoints in Phase 2b trial

Henry Ford launches clinical trial for treatment of tinnitus caused by noise trauma

Cardium reports positive results from Generx Ad5FGF-4 Phase 3 study for treatment of myocardial ischemia

Trevena's Phase 1b data for TRV130 published in the journal Pain

Forest Laboratories reports positive results from three Phase III trials of vilazodone for GAD treatment

XenoPort initiates XP23829 Phase 2 clinical trial in patients with psoriasis

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

Exploring electron microscopy for plant and microbial imaging at the John Innes Centre

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