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Positive outcome from AiCuris’ Letermovir phase 2b trial on HCMV infections

AiCuris announced today that data on the positive outcome of Letermovir (AIC246) tested in a phase 2b trial in transplant patients will be disclosed at several international meetings on behalf of the AIC246 study team.

3 Apr 2012

Merck announces data from ZOSTAVAX Phase III study on shingles

Merck, known as MSD outside the United States and Canada, announced today that data from the pivotal Phase III study with ZOSTAVAX(Zoster Vaccine Live) in adults ages 50 to 59 were published in the April 1 issue of Clinical Infectious Diseases.

3 Apr 2012

Nektar commences dosing in NKTR-192 Phase 1 clinical study for treatment of acute pain

Nektar Therapeutics announced today that the first subjects were dosed last week in a Phase 1 clinical study to evaluate the pharmacokinetics and safety of NKTR-192, the company's novel short-acting mu-opioid analgesic candidate.

2 Apr 2012

Ampio, Australian TGA reach agreement over Zertane submission plan

Ampio Pharmaceuticals, Inc., a company that discovers and develops new uses for previously approved drugs and new molecular entities, announced today that it reached agreement with the Therapeutic Goods Administration, Canberra, Australia, on a plan of drug manufacture and quality control for Zertane and the overall plan for the preparation of Common Technical Documents for the draft registration submission expected to be filed in June 2012.

2 Apr 2012

Enrollment complete in Oncolytics REOLYSIN combination trial for head and neck cancers

Oncolytics Biotech Inc. announced today that it has completed enrollment in the first, 80 patient stage of its Phase III clinical trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers (REO 018).

2 Apr 2012

NanoViricides reports positive pre-IND meeting with USFDA for FluCide

NanoViricides, Inc. announced today that its previously announced pre-IND Meeting was held with the USFDA on March 29th, 2012, as scheduled. This pre-IND meeting focused on FluCide, designated as NV-INF-1, the Company's novel anti-influenza drug.

2 Apr 2012

$Aeterna Zentaris X-PECT Phase 3 refractory advanced colorectal cancer trial fails to meet primary endpoint$

Aeterna Zentaris X-PECT Phase 3 refractory advanced colorectal cancer trial fails to meet primary endpoint

Aeterna Zentaris Inc. today announced that the Phase 3 "X-PECT" (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo.

2 Apr 2012

Clinical data for cabozantinib to be presented at ASCO annual meeting

Exelixis, Inc. announced today that its lead compound, cabozantinib, will be the subject of nine separate data presentations at the upcoming Annual Meeting of the American Society of Clinical Oncology.

2 Apr 2012

ViiV, Shionogi announce initial results from dolutegravir Phase III study on HIV-1

ViiV Healthcare and Shionogi & Co., Ltd. today announced that initial results have been received from the SPRING-2 (ING113086) Phase III study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1.

2 Apr 2012

RT3D may boost effects of two standard chemotherapy drugs in head and neck cancer patients

A naturally-occurring harmless human virus may be able to boost the effects of two standard chemotherapy drugs in some cancer patients, according to early stage trial data published today in Clinical Cancer Research.

2 Apr 2012

Novartis achieves primary endpoints in all three of QVA149 Phase III studies on COPD

Sosei Group Corporation, confirms the information released today by Novartis that the first three QVA149 Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints.

2 Apr 2012

Galeterone safe, effective for patients with CRPC

Patients with castration-resistant prostate cancer had limited side effects and in many cases a drop in prostate-specific antigen expression with galeterone (TOK-001), a small-molecule oral drug, according to phase I data presented at the AACR Annual Meeting 2012, held here March 31 - April 4.

2 Apr 2012

Combination of cixutumumab and temsirolimus shrinks tumors in patients with Ewing's sarcoma

A pair of targeted therapies shrank tumors in some patients with treatment-resistant Ewing's sarcoma or desmoplastic small-round-cell tumors, according to research led by investigators from The University of Texas MD Anderson Cancer Center reported at the AACR Annual Meeting 2012.

2 Apr 2012

Tokai Pharmaceuticals announces data from galeterone Phase 1 trial for CRPC

Tokai Pharmaceuticals, Inc., a biopharmaceutical company focused on developing new treatments for prostate cancer, today announced that its lead candidate galeterone (TOK-001) was well-tolerated with minimal side effects and demonstrated efficacy in patients with castration-resistant prostate cancer (CRPC) in a Phase 1 study.

2 Apr 2012

Metformin may slow growth rate of prostate cancer in men

The use of metformin in men with prostate cancer before prostatectomy helped to reduce certain metabolic parameters and slow the growth rate of the cancer, according to the results of a phase II study.

2 Apr 2012

$Pazopanib demonstrates clinically meaningful activity in patients with refractory urothelial cancer$

Pazopanib demonstrates clinically meaningful activity in patients with refractory urothelial cancer

The antiangiogenic drug pazopanib has demonstrated clinically meaningful activity in patients with refractory urothelial cancer, according to results presented at the AACR Annual Meeting 2012, held here March 31 - April 4. The results also revealed that increases in interleukin-8 levels early after treatment with pazopanib may predict a lack of tumor response to the therapy.

2 Apr 2012

Data from Cempra's CEM-101 Phase 2 trial on N. gonorrhoeae infections to be presented at ECCMID

Cempra Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) demonstrating that CEM-101 (solithromycin) is active against antibiotic-resistant strains of N. gonorrhoeae.

31 Mar 2012

CSL Behring initiates rVIIa-FP Phase I study in hemophilia A and B

CSL Behring announced today the first in human dosing of recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP). The Phase I study will investigate in healthy volunteers the safety and pharmacokinetics of rVIIa-FP in comparison to placebo.

31 Mar 2012

Data from Cempra's CEM-101 Phase 2 trial on CABP to be presented at ECCMID

Cempra Inc., a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases,today announced that data will be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), in London, March 31 to April 3,demonstrating CEM-101's (solithromycin's) efficacy to be comparable to levofloxacin in a Phase 2 trial of patients with community-acquired bacterial infections.

31 Mar 2012

ImmunoGen commences IMGN901 Phase II evaluation for SCLC

ImmunoGen, Inc. today announced that it has initiated Phase II testing of its IMGN901 product candidate for first-line treatment of SCLC.

31 Mar 2012

Drug Trial News

Positive outcome from AiCuris’ Letermovir phase 2b trial on HCMV infections

Merck announces data from ZOSTAVAX Phase III study on shingles

Nektar commences dosing in NKTR-192 Phase 1 clinical study for treatment of acute pain

Ampio, Australian TGA reach agreement over Zertane submission plan

Enrollment complete in Oncolytics REOLYSIN combination trial for head and neck cancers

NanoViricides reports positive pre-IND meeting with USFDA for FluCide

Aeterna Zentaris X-PECT Phase 3 refractory advanced colorectal cancer trial fails to meet primary endpoint

Clinical data for cabozantinib to be presented at ASCO annual meeting

ViiV, Shionogi announce initial results from dolutegravir Phase III study on HIV-1

RT3D may boost effects of two standard chemotherapy drugs in head and neck cancer patients

Novartis achieves primary endpoints in all three of QVA149 Phase III studies on COPD

Galeterone safe, effective for patients with CRPC

Combination of cixutumumab and temsirolimus shrinks tumors in patients with Ewing's sarcoma

Tokai Pharmaceuticals announces data from galeterone Phase 1 trial for CRPC

Metformin may slow growth rate of prostate cancer in men

Pazopanib demonstrates clinically meaningful activity in patients with refractory urothelial cancer

Data from Cempra's CEM-101 Phase 2 trial on N. gonorrhoeae infections to be presented at ECCMID

CSL Behring initiates rVIIa-FP Phase I study in hemophilia A and B

Data from Cempra's CEM-101 Phase 2 trial on CABP to be presented at ECCMID

ImmunoGen commences IMGN901 Phase II evaluation for SCLC

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How industrial hygiene flow calibration supports defensible exposure data

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