Pharmacokinetics News and Research

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The term pharmacokinetics is derived from the ancient Greek words “pharmakon” and “kinetikos”, meaning “drug” and “putting in motion” respectively. It is one of the main branches of pharmacology, and refers to the way that the body reacts on and affects a pharmaceutical substance in the body.

Afrezza gets FDA approval to improve glycemic control in adults with diabetes mellitus

The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.

28 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

Scientists turn to old class of antibiotics to fight superbugs resistant to modern medicine

Scientists at the University at Buffalo are turning to an old class of antibiotics to fight new superbugs resistant to modern medicine.

24 Jun 2014

Aradigm begins Pulmaquin Phase III study for treatment of non-CF BE

Aradigm Corporation ("Aradigm" or the "Company") today announced the dosing of the first patient in the ORBIT-4 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) Phase III pivotal clinical trial of Aradigm's proprietary formulation of inhaled ciprofloxacin (Pulmaquin®) for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE).

23 Jun 2014

Trevena reports positive results from TRV734 Phase 1 trial for treating acute/chronic pain

Trevena, Inc. (NASDAQ:TRVN) today announced positive results from its Phase 1 trial of TRV734, which Trevena is developing with the goal of providing improved analgesia while avoiding gastrointestinal and respiratory side effects typically associated with opioids.

23 Jun 2014

Debiopharm launches Phase 1 study of anti-infective agent Debio 1450

Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs as well as companion diagnostics, today announced the launch of a Phase 1 dose-escalation study of Debio 1450 (previously known as AFN-1720), a highly potent anti-infective agent that is selectively active against a large number of Staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA).

19 Jun 2014

Researchers examine effects of testosterone on women after menopause

Testosterone supplementation for women is a hot topic. A new pharmacokinetics study of a brand of testosterone cream for women approved in Western Australia has been published online in Menopause, the journal of The North American Menopause Society (NAMS).

11 Jun 2014

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).

11 Jun 2014

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.

10 Jun 2014

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.

6 Jun 2014

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.

5 Jun 2014

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.

4 Jun 2014

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.

4 Jun 2014

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.

4 Jun 2014

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.

3 Jun 2014

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.

2 Jun 2014

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).

31 May 2014

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.

31 May 2014

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

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.

31 May 2014

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.

28 May 2014

Pharmacokinetics News and Research

Further Reading

Afrezza gets FDA approval to improve glycemic control in adults with diabetes mellitus

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

Scientists turn to old class of antibiotics to fight superbugs resistant to modern medicine

Aradigm begins Pulmaquin Phase III study for treatment of non-CF BE

Trevena reports positive results from TRV734 Phase 1 trial for treating acute/chronic pain

Debiopharm launches Phase 1 study of anti-infective agent Debio 1450

Researchers examine effects of testosterone on women after menopause

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

Celsion signs definitive asset purchase agreement to acquire EGEN

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

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

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

NeuroVive extends collaboration with Hospices Civils de Lyon

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

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

AMRI agrees to acquire OsoBio for $110 million

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

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

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

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

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