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.

Advanced Life Sciences announces positive results from preclinical studies of Restanza IV

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced positive results from preclinical toxicology and pharmacokinetic studies of an intravenous (IV) formulation of its novel antibiotic, Restanza™ that support its use in a hospital setting.

8 Jul 2010

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

NOXXON Pharma AG announced today that it has permission to commence a multiple ascending dose study of its Monocyte Chemoattractant Protein-1 (MCP-1) targeting anti-inflammatory Spiegelmer®, NOX-E36. NOXXON plans to develop NOX-E36 for the treatment of diabetic nephropathy and other diabetes related complications.

7 Jul 2010

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has initiated dosing in a Phase I human clinical study with ALN-TTR01. The study is aimed at evaluating the safety and tolerability of ALN-TTR01 in patients with transthyretin -mediated amyloidosis, and is also designed to provide preliminary data on human proof of concept based on measurements of TTR serum levels.

7 Jul 2010

Data on activity of Nektar's NKTR-102 in gastrointestinal cancer presented at ESMO 12th World Congress

Nektar Therapeutics announced today that data presented at the European Society for Medical Oncology (ESMO) 12th World Congress on Gastrointestinal Cancer demonstrates that NKTR-102, the company's lead oncology compound, exhibits superior activity compared to irinotecan as part of either a monotherapy or combination regimen in tumor models of gastrointestinal cancers.

7 Jul 2010

Molecular Templates enters into oncology drug discovery and translation research agreement with ImClone

Molecular Templates announced today that it has entered into a collaborative oncology drug discovery and translation research agreement with ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company.

7 Jul 2010

Debiopharm's achievement of Phase I milestone in Debio 0932 trial triggers $3M milestone payment to Curis

Curis, Inc. announced today that its licensee Debiopharm S.A. has treated the fifth patient in its ongoing Phase I clinical trial for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of the August 2009 license agreement between Curis and Debiopharm, Curis will receive a $3 million milestone payment from Debiopharm for the achievement of this development objective.

7 Jul 2010

Initial Phase II study results of ofatumumab in patients with RRMS announced

Genmab A/S announced today positive interim results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis.

7 Jul 2010

Elsevier releases 'Infectious Diseases,' 3rd edition

Elsevier, the world-leading publisher of scientific, technical and medical information products and services, proudly announces the release of Infectious Diseases, 3rd Edition.

6 Jul 2010

QR Pharma to present clinical data from mechanism of action study in MCI patients at ICAD 2010

QR Pharma, Inc., a developer of novel drugs to treat Alzheimer's disease (AD), announced today that it has been accepted to present a poster on clinical data from its recent mechanism of action study in mild cognitive impaired (MCI) patients at the International Congress on Alzheimer's Disease (ICAD 2010).

2 Jul 2010

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Studies of a more-rapid-acting injectable human insulin formulation (VIAject®) in the treatment of type 1 and type 2 diabetes and of a novel insulin analog formulation (Vialog™) in an animal model of diabetes were reported this week in three poster presentations at the 70th Scientific Sessions of the American Diabetes Association in Orlando, Florida. The findings are based upon results from recent clinical and preclinical studies sponsored by Biodel Inc..

1 Jul 2010

BioSante reports positive results from Phase II study of Pill-Plus "triple hormone" oral contraceptive

BioSante Pharmaceuticals, Inc. announced today positive results in a Phase II study of the Pill-Plus "triple hormone" oral contraceptive (OC). Results showed an increase in the frequency of sexual activity (p< 0.05) and reduced frequency of rejection of initiation of sexual activity by partner (p< 0.05).

30 Jun 2010

Transition commences dosing in TT-301 Phase 1 clinical study for rheumatoid arthritis, ICH, TBI

Transition Therapeutics Inc. announced today that the first patient has been dosed with drug candidate TT-301 in a Phase 1 clinical study. TT-301 is a small molecule compound that has demonstrated efficacy in preclinical models of rheumatoid arthritis, intracerebral haemorrhage and traumatic brain injury.

30 Jun 2010

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

29 Jun 2010

BIND Biosciences announces $12.4 million Series C-1 financing

BIND Biosciences, Inc. (BIND), a privately held biopharmaceutical company developing best in class therapeutics based on its proprietary targeted nanotechnology platform, announced today that it has secured a $12.4 Million Series C-1 financing. This financing included all of BIND's current investors (including Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners, NanoDimension and DHK Investments) as well as a new venture investor, Endeavour Vision, and private investors.

29 Jun 2010

Daiichi Sankyo, Eli Lilly respond to ACCF/AHA clinical alert on FDA's clopidogrel boxed warning

Daiichi Sankyo, Inc. and Eli Lilly and Company appreciate the availability of a "Clinical Alert" from the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) in response to the FDA's Boxed Warning about Plavix® (clopidogrel), and commend the leading cardiovascular medical societies for providing perspective on the importance of genetic make-up and the variability in response of certain oral anti-platelet (OAP) therapy for patients with acute coronary syndrome (ACS) who are managed with angioplasty and stenting (known as PCI).

29 Jun 2010

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

Astellas Pharma Inc. announced that the company presented results from a Japanese Phase 2 study conducted with ASP1941, a selective SGLT2 inhibitor, at the 70th Scientific Sessions of the American Diabetes Association (ADA) on June 26, 2010 (EST). ASP1941 is designed to block the re-absorption of glucose in the kidney and excrete glucose in the urine.

29 Jun 2010

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Raptor Pharmaceutical Corp. announced that it has enrolled the first patient in a pivotal Phase 3 clinical trial of its proprietary delayed-release oral formulation of cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis").

28 Jun 2010

Halozyme presents new data from Ultrafast Insulin development program at 70th ADA

Halozyme Therapeutics, Inc. today announced Phase 2 results demonstrating that the subcutaneous coinjection of rHuPH20 (recombinant human hyaluronidase, PH20) with lispro significantly improves postprandial hyperglycemia, reduces hypoglycemia, and accelerates the absorption of mealtime insulin in patients with type 2 diabetes.

28 Jun 2010

Merck challenges New York jury decision in federal FOSAMAX retrial

Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.

28 Jun 2010

FDA grants orphan drug designation for Chiasma's Octreolin

Chiasma, Inc., a privately held biopharma company, announced that the Food and Drug Administration has granted orphan drug designation for Chiasma's investigational new drug, Octreolin, an oral form of octreotide acetate that uses the Company's proprietary Transient Permeability Enhancer technology for the oral treatment of acromegaly, a hormonal disorder that results from an excess of growth hormone.

28 Jun 2010

Pharmacokinetics News and Research

Further Reading

Advanced Life Sciences announces positive results from preclinical studies of Restanza IV

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Data on activity of Nektar's NKTR-102 in gastrointestinal cancer presented at ESMO 12th World Congress

Molecular Templates enters into oncology drug discovery and translation research agreement with ImClone

Debiopharm's achievement of Phase I milestone in Debio 0932 trial triggers $3M milestone payment to Curis

Initial Phase II study results of ofatumumab in patients with RRMS announced

Elsevier releases 'Infectious Diseases,' 3rd edition

QR Pharma to present clinical data from mechanism of action study in MCI patients at ICAD 2010

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

BioSante reports positive results from Phase II study of Pill-Plus "triple hormone" oral contraceptive

Transition commences dosing in TT-301 Phase 1 clinical study for rheumatoid arthritis, ICH, TBI

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

BIND Biosciences announces $12.4 million Series C-1 financing

Daiichi Sankyo, Eli Lilly respond to ACCF/AHA clinical alert on FDA's clopidogrel boxed warning

Astellas presents ASP1941 selective SGLT2 inhibitor Phase 2 study results at 70th ADA

Raptor initiates enrollment in pivotal Phase 3 clinical trial of DR Cysteamine for nephropathic cystinosis

Halozyme presents new data from Ultrafast Insulin development program at 70th ADA

Merck challenges New York jury decision in federal FOSAMAX retrial

FDA grants orphan drug designation for Chiasma's Octreolin

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