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.

e-Therapeutics announces interim results from ETS2101 phase Ia trial for advanced solid tumours

e-Therapeutics plc announced today interim results from its phase Ia UK study evaluating the safety, dosing and anti-tumour activity of ETS2101 (dexanabinol) in patients with advanced solid tumours.

31 Mar 2014

NeuroVive presents clinical data of NVP018 for treatment of chronic hepatitis B infections at EASL

NeuroVive's anti-viral preclinical program, with compound designated NVP018, has generated significant data indicating that NVP018 has the potential to become an effective alternative or addition to current drugs for treating chronic hepatitis B infections.

29 Mar 2014

Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

Today Biogen Idec announced that the U.S. Food and Drug Administration has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.

29 Mar 2014

EC approves Roche's SC formulation of MabThera for common forms of non-Hodgkin lymphoma

Halozyme Therapeutics, Inc. announced today that the European Commission has approved Roche's new subcutaneous (SC) formulation of MabThera (rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma.

28 Mar 2014

$Patrys reports final results from PAT-SM6 Phase I/IIa study in patients with refractory or relapsed MM$

Patrys reports final results from PAT-SM6 Phase I/IIa study in patients with refractory or relapsed MM

Patrys Limited, a clinical stage biotechnology company, is pleased to announce the final results from its Phase I/IIa, open-label study in patients with refractory or relapsed multiple myeloma (MM).

28 Mar 2014

Novartis’ investigational compound achieves overall response rate of 58% in patients with ALK+ NSCLC

Novartis today announced that The New England Journal of Medicine (NEJM) published clinical trial results showing the investigational compound LDK378 (ceritinib) achieved an overall response rate (ORR, including complete response [CR] and partial response [PR]) of 58% and a median progression-free survival (PFS) of seven months in adults with advanced anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who received 400 mg or higher of LDK378 per day.

28 Mar 2014

Cytrx releases statement in response to two recent lawsuits

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today issued the following statement in response to two recent lawsuits filed in the name of CytRx shareholders:

27 Mar 2014

AM-Pharma reports positive results from recAP Phase I trial for Acute Kidney Injury

AM-Pharma B.V., a biopharmaceutical company focused on the development of recAP (recombinant human Alkaline Phosphatase) for inflammatory indications, announces the results of its Phase I trial with both single and multiple ascending doses, which demonstrate that recAP is safe and well tolerated at all doses.

26 Mar 2014

Agios initiates AG-120 Phase 1 study to evaluate advanced solid tumors with IDH1 mutation

Agios Pharmaceuticals, Inc., a leader in the fields of cancer metabolism and inborn errors of metabolism, today announced dose administration for the first patient in a Phase 1 study of AG-120 in patients with advanced solid tumors with an isocitrate dehydrogenase-1 (IDH1) mutation.

25 Mar 2014

CytRx initiates Phase 3 clinical trial to evaluate efficacy of aldoxorubicin in STS patients

CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has initiated a pivotal global Phase 3 clinical trial to evaluate the efficacy and safety of aldoxorubicin as a second-line treatment for patients with soft tissue sarcoma (STS) under a Special Protocol Assessment with the FDA.

25 Mar 2014

Antisense Therapeutics enrolls acromegalic patients in ATL1103 Phase II trial

Antisense Therapeutics Limited is pleased to report that 24 acromegalic patients have been successfully enrolled and randomized to one of the two treatment regimens of dosing in the Phase II trial of ATL1103 for the growth disorder, acromegaly. This satisfies the necessary patient numbers proposed for the trial.

24 Mar 2014

Biogen Idec's ALPROLIX gets Health Canada approval for hemophilia B

Today Biogen Idec announced that Health Canada has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with hemophilia B.

21 Mar 2014

Adocia announces positive final results for first clinical trial of BioChaperone Combo

Adocia announces today positive final results for the first clinical trial on its innovative formulation combining insulin analog glargine (Lantus, Sanofi), the gold standard basal insulin, with a rapid-acting insulin analog, lispro (Humalog, Eli Lilly) using Adocia's BioChaperone technology.

20 Mar 2014

Igenica Biotherapeutics doses first patient in Phase 1 clinical trial of IGN523 in patients with AML

Igenica Biotherapeutics, a company focused on the discovery and development of innovative antibodies and antibody-drug conjugates (ADCs) for the treatment of cancer, announced today that the first patient has been dosed in a Phase 1 clinical trial of IGN523 in patients with relapsed or refractory acute myeloid leukemia (AML).

18 Mar 2014

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use.

16 Mar 2014

N30 Pharma begins oral dosing in N91115 Phase 1 trial for treatment of cystic fibrosis

N30 Pharmaceuticals, Inc. announced today that it has begun oral dosing of N91115 in a Phase 1 clinical trial. N91115, a novel inhibitor of S-nitrosoglutathione reductase (GSNOR), is being developed for the treatment of cystic fibrosis (CF).

12 Mar 2014

Bayer and Onyx announce Phase 3 trial evaluating use of NEXAVAR for patients with HCC after local ablation

Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that a Phase 3 trial evaluating the investigational use of NEXAVAR® (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival.

11 Mar 2014

Fibrotech successfully completes Phase Ia trial of anti-fibrotic compound FT011

Fibrotech, an Australian biopharmaceutical company developing a new class of drugs to prevent a massive health burden associated with fibrosis, today announced that its lead anti-fibrotic compound FT011 has successfully completed a Phase Ia trial in healthy volunteers demonstrating safety and tolerability up to doses of 1000mg.

10 Mar 2014

Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Today Boehringer Ingelheim announced results from STARTVerso4 in patients with HCV/HIV co-infection. Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Patients were enrolled in either 120mg or 240mg faldaprevir dose groups.

6 Mar 2014

Verastem presents preliminary data from VS-6063 Phase 1 trial in Japanese patients with solid tumors

Verastem, Inc., focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, today presented preliminary data from an ongoing First-in-Asia Phase 1 trial of VS-6063 in Japanese patients with advanced solid tumors, including one patient with mesothelioma. The Phase 1 study assessed the safety and pharmacokinetics of single agent VS-6063.

5 Mar 2014

Pharmacokinetics News and Research

Further Reading

e-Therapeutics announces interim results from ETS2101 phase Ia trial for advanced solid tumours

NeuroVive presents clinical data of NVP018 for treatment of chronic hepatitis B infections at EASL

Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

EC approves Roche's SC formulation of MabThera for common forms of non-Hodgkin lymphoma

Patrys reports final results from PAT-SM6 Phase I/IIa study in patients with refractory or relapsed MM

Novartis’ investigational compound achieves overall response rate of 58% in patients with ALK+ NSCLC

Cytrx releases statement in response to two recent lawsuits

AM-Pharma reports positive results from recAP Phase I trial for Acute Kidney Injury

Agios initiates AG-120 Phase 1 study to evaluate advanced solid tumors with IDH1 mutation

CytRx initiates Phase 3 clinical trial to evaluate efficacy of aldoxorubicin in STS patients

Antisense Therapeutics enrolls acromegalic patients in ATL1103 Phase II trial

Biogen Idec's ALPROLIX gets Health Canada approval for hemophilia B

Adocia announces positive final results for first clinical trial of BioChaperone Combo

Igenica Biotherapeutics doses first patient in Phase 1 clinical trial of IGN523 in patients with AML

Merck's NOXAFIL injection gets FDA approval for intravenous use

N30 Pharma begins oral dosing in N91115 Phase 1 trial for treatment of cystic fibrosis

Bayer and Onyx announce Phase 3 trial evaluating use of NEXAVAR for patients with HCC after local ablation

Fibrotech successfully completes Phase Ia trial of anti-fibrotic compound FT011

Boehringer Ingelheim reports results from SVR12 Phase 3 trial in patients with HCV/HIV co-infection

Verastem presents preliminary data from VS-6063 Phase 1 trial in Japanese patients with solid tumors

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