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FDA grants orphan drug designation to EffRx Pharmaceuticals' EX404 for treatment of PCOS

FDA grants orphan drug designation to EffRx Pharmaceuticals' EX404 for treatment of PCOS

EffRx Pharmaceuticals SA, a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to its proprietary metformin-based product candidate, EX404, for the treatment of pediatric polycystic ovary syndrome (PCOS). [More]
Celsion signs definitive asset purchase agreement to acquire EGEN

Celsion signs definitive asset purchase agreement to acquire EGEN

Celsion Corporation (Celsion) (NASDAQ: CLSN), an oncology drug development company, and EGEN, Inc. (EGEN), a privately-held biopharmaceutical company focused on the development of nucleic acid-based therapeutics for the treatment of cancer and other difficult to treat diseases, today announced the signing of a definitive asset purchase agreement in which Celsion will acquire substantially all of the assets of EGEN, including its Phase Ib DNA-based immunotherapy product candidate EGEN-001 and its therapeutic platform technologies, TheraPlas™ for delivery of DNA and mRNA, TheraSilence™ for delivery of RNA, and RAST™ for Cell Enabled Expression and Secretion of RNA. [More]
Merck enrolls first patient in reformulated raltegravir Phase 3 trial for treatment of HIV-1 infection

Merck enrolls first patient in reformulated raltegravir Phase 3 trial for treatment of HIV-1 infection

Merck, known as MSD outside the United States and Canada, today announced that the first patient has been enrolled in the company's global Phase 3 clinical trial, ONCEMRK. [More]
Edge Therapeutics commences enrollment in second cohort of EG-1962 Phase 1/2 NEWTON study for aSAH

Edge Therapeutics commences enrollment in second cohort of EG-1962 Phase 1/2 NEWTON study for aSAH

Edge Therapeutics, a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies for acute, life-threatening neurological conditions, today announced that it has initiated patient enrollment in the second cohort of the NEWTON study, a multicenter, randomized, controlled, open-label, Phase 1/2 clinical trial of the company's lead product candidate, EG-1962. [More]
PsiOxus Therapeutics presents positive study results of anti-cancer vaccine Enadenotucirev at ASCO Annual Meeting

PsiOxus Therapeutics presents positive study results of anti-cancer vaccine Enadenotucirev at ASCO Annual Meeting

PsiOxus Therapeutics, Ltd. (PsiOxus), an award-winning biotechnology company developing innovative, novel treatments for cancer, announced that updates for its on-going international multicentre clinical program of the oncolytic vaccine enadenotucirev (previously known as ColoAd1) were presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. [More]
NeuroVive extends collaboration with Hospices Civils de Lyon

NeuroVive extends collaboration with Hospices Civils de Lyon

NeuroVive is extending its collaboration with Hospices Civils de Lyon (HCL) and Professor Ovize, which broadens the scope of NeuroVive's cardiovascular business area and creates the right conditions for the company to retain its leading position in mitochondrial medicine. [More]
Autifony Therapeutics awarded £2.2 million to progress first-in-class drug for tinnitus into Phase IIa study

Autifony Therapeutics awarded £2.2 million to progress first-in-class drug for tinnitus into Phase IIa study

Autifony Therapeutics Limited (“Autifony”), which is pioneering the development of novel pharmaceutical treatments for hearing disorders, today announced that it has been awarded funding of £2.2 million towards a Phase IIa clinical trial in tinnitus patients with its lead compound AUT00063, by the UK’s innovation agency, the Technology Strategy Board. [More]
Syngene International, Bristol-Myers Squibb extend drug discovery and development collaboration

Syngene International, Bristol-Myers Squibb extend drug discovery and development collaboration

Bristol-Myers Squibb and Syngene International, India's largest contract research organization, today announced a five-year extension of their drug discovery and development collaboration in India. [More]

AMRI agrees to acquire OsoBio for $110 million

AMRI today announced that it has signed a definitive agreement to acquire all of the outstanding membership interests of Oso Biopharmaceuticals Manufacturing, LLC for $110 million in cash. [More]
Fibrogen reports FG-3019 Phase 2 study results for treatment of pancreatic cancer

Fibrogen reports FG-3019 Phase 2 study results for treatment of pancreatic cancer

FibroGen, Inc. today announced results from a Phase 2 open-label study of FG-3019, an investigational anti-fibrotic antibody, in combination with gemcitabine and erlotinib for the treatment of patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). [More]
AbbVie releases preliminary results from ABT-414 Phase I study in patients with recurrent or unresectable GBM

AbbVie releases preliminary results from ABT-414 Phase I study in patients with recurrent or unresectable GBM

AbbVie released preliminary results from an ongoing Phase I study with ABT-414, an anti-epidermal growth factor receptor (EGFR) monoclonal antibody drug conjugate, in combination with temozolomide, which showed four objective responses, including one complete response, in patients with recurrent or unresectable glioblastoma multiforme. [More]
ASCO: DelMar presents interim data from VAL-083 clinical trial in refractory GBM

ASCO: DelMar presents interim data from VAL-083 clinical trial in refractory GBM

DelMar Pharmaceuticals, Inc. announced the presentation of interim clinical data from the company's ongoing clinical trial with VAL-083 in refractory glioblastoma multiforme (GBM) during the Central Nervous System Tumor Session at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), which is being held at the McCormick Place Convention Center in Chicago. [More]
CytRx announces Phase 2b clinical trial results of aldoxorubicin in subjects with metastatic STS

CytRx announces Phase 2b clinical trial results of aldoxorubicin in subjects with metastatic STS

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced updated results from its ongoing multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas. [More]
Aradigm receives QIDP designation for its inhaled antibiotic candidate, Pulmaquin

Aradigm receives QIDP designation for its inhaled antibiotic candidate, Pulmaquin

Aradigm Corporation (the "Company") today announced that the U.S. Food and Drug Administration (FDA) has designated the Company's lead inhaled antibiotic candidate, Pulmaquin®, as a Qualified Infectious Disease Product (QIDP). [More]
Telormedix completes Phase II trial of Vesimune in CIS of the bladder

Telormedix completes Phase II trial of Vesimune in CIS of the bladder

Telormedix, a clinical stage biopharmaceutical company focused on TLR7 agonists in the treatment of cancer and inflammatory diseases, today announced that it has successfully completed a Phase II trial, conducted under an IND, of Vesimune (TMX-101) in CIS (carcinoma in situ) of the bladder. [More]
Phase I study reveals abemaciclib drug shows evidence of single-agent activity in NSCLC patients

Phase I study reveals abemaciclib drug shows evidence of single-agent activity in NSCLC patients

Abemaciclib, an oral drug administered twice daily, currently in development by Eli Lilly and Company (NYSE: LLY), has shown evidence of single-agent activity in patients with advanced non-small cell lung cancer in a Phase I study released ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Ill. [More]
Novozymes Biopharma, ThioLogics to collaborate on drug-albumin conjugation platform

Novozymes Biopharma, ThioLogics to collaborate on drug-albumin conjugation platform

Novozymes Biopharma has entered a new collaboration with UK-based biotechnology company, ThioLogics. The collaboration brings together Novozymes' modified recombinant human albumin (rAlbumin) Veltis technology, with ThioLogics' site-specific next generation maleimide conjugation platform. This allows Novozymes to offer the pharma industry serum stable albumin drug conjugates with enhanced pharmacokinetic and/or targeting capabilities. [More]
Covagen begins COVA322 Phase Ib/IIa study to treat patients with rheumatoid and psoriatic arthritis

Covagen begins COVA322 Phase Ib/IIa study to treat patients with rheumatoid and psoriatic arthritis

Covagen today announced it has initiated a Phase Ib/IIa study with COVA322, a bispecific TNF/IL-17A inhibitor. [More]
BeiGene receives $5M from Merck to develop BGB-283 BRAF inhibitor

BeiGene receives $5M from Merck to develop BGB-283 BRAF inhibitor

BeiGene (Beijing), Co., Ltd., an innovative oncology company focused on developing targeted and immune-oncology therapeutics, today announced the achievement of a clinical milestone in the company's collaboration with Merck Serono, the biopharmaceutical division of Merck, Darmstadt, Germany, for BGB-283, a second-generation BRAF inhibitor candidate currently in Phase 1 development. [More]
DNA 'sat nav' allows direct access to homes of ancestors alive 1,000 years ago

DNA 'sat nav' allows direct access to homes of ancestors alive 1,000 years ago

Tracing where your DNA was formed over 1,000 years ago is now possible due to a revolutionary technique developed by a team of international scientists led by experts from the University of Sheffield. [More]