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IRMA, Population Council and MTN release Rectal Revolution video project

International Rectal Microbicide Advocates (IRMA), the Population Council, and the Microbicide Trials Network (MTN) today released a collaborative video project called "The Rectal Revolution Is Here: An Introduction to Rectal Microbicide Clinical Trials." The jointly produced video, the first of its kind, is designed to educate communities affected by HIV about rectal microbicide development and the importance of participating in clinical trials to help speed the search for new HIV prevention options.

18 Dec 2012

GTx achieves enrollment goal for pivotal Phase III clinical studies of enobosarm

GTx, Inc. today announced that it has attained its enrollment goal for both of its pivotal Phase III clinical studies of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients.

17 Dec 2012

Cognitive test used in Alzheimer's drug trials is flawed: Study

New research led by Plymouth University Peninsula Schools of Medicine and Dentistry suggests that the cognitive test used in Alzheimer's drug trials is flawed.

16 Dec 2012

AcelRx announces top-line data from Sufentanil NanoTab PCA System Phase 3 trial

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that top-line data from its previously announced open-label, active-comparator study of its lead product candidate, the Sufentanil NanoTab PCA System, will be featured in poster presentations to be held at the 66th annual New York State Society of Anesthesiologists PostGraduate Assembly meeting in New York City to be held December 14-18, 2012.

15 Dec 2012

Ibrutinib continues to show unprecedented results in patients with mantle cell lymphoma

An international study of ibrutinib in people with relapsed or refractory mantle cell lymphoma (MCL) continues to show unprecedented and durable results with few side effects.

15 Dec 2012

Cempra commences CEM-102 Phase 2 trial in prosthetic joint infections

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 the initiation of its Phase 2 clinical trial of CEM-102 in patients with prosthetic joint infections (PJIs).

15 Dec 2012

High-dose vitamin D can reduce risk of respiratory tract infections

Treating infection-prone patients over a 12-month period with high doses of vitamin D reduces their risk of developing respiratory tract infection - and consequently their antibiotic requirement. This according to a new study by researchers at Karolinska Institutet and Karolinska University Hospital published in the online scientific journal BMJ Open.

14 Dec 2012

ETA receptor antagonism reduces novel cardiovascular risk factors in patients with CKD

Blocking the receptor for proteins that constrict blood vessels reduces markers of heart-related problems in patients with chronic kidney disease (CKD), according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN).

14 Dec 2012

NovaDigm announces data from NDV-3 vaccine Phase 1 study on Candida and Staph infections

NovaDigm Therapeutics, a company developing innovative vaccines for fungal and bacterial infections, today announced the publication of data from its first-in-human Phase 1 study of its NDV-3 vaccine program in the journal Vaccine.

13 Dec 2012

Top-line results from AstraZeneca’s fostamatinib Phase IIb monotherapy study on RA

AstraZeneca today announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen tyrosine kinase) in development as an oral treatment for rheumatoid arthritis (RA).

13 Dec 2012

Positive data from Oncolytics’ REOLYSIN Phase III combination study on head and neck cancers

Oncolytics Biotech Inc. today announced initial positive top line data from the first endpoint in its double-blinded randomized Phase III clinical study examining REOLYSIN in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers (REO 018).

13 Dec 2012

Medivir commences cohort 2 simeprevir and sofosbuvir phase II combination trial in HCV GT1

Medivir AB, announced today the initiation of cohort 2 in the interferon-free phase II trial combining simeprevir with sofosbuvir (GS7977) based on a safety and efficacy planned interim analysis of cohort 1 including prior null responder HCV genotype 1 infected patients without advanced hepatic fibrosis.

13 Dec 2012

Eli Lilly provides update on solanezumab Phase 3 clinical study for mild Alzheimer's

Eli Lilly and Company today provided an update on the next steps planned for solanezumab, its Phase 3 monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease.

13 Dec 2012

Bumetanide could treat children with severe autism or Asperger's syndrome

Although this therapy is not curative, it nevertheless reduced the autistic disorders' severity in three-quarters of the children. The researchers have filed a request for authorisation to perform a multi-centre European clinical trial in order to determine more precisely the population concerned by this therapy.

13 Dec 2012

AZD6765 briefly improves treatment-resistant patients' depression symptoms in minutes

A drug that works through the same brain mechanism as the fast-acting antidepressant ketamine briefly improved treatment-resistant patients' depression symptoms in minutes, with minimal untoward side effects, in a clinical trial conducted by the National Institutes of Health. The experimental agent, called AZD6765, acts through the brain's glutamate chemical messenger system.

13 Dec 2012

Dantrolene may help combat Duchenne muscular dystrophy in boys

Drugs are currently being tested that show promise in treating patients with Duchenne muscular dystrophy (DMD), an inherited disease that affects about one in 3,600 boys and results in muscle degeneration and, eventually, death.

13 Dec 2012

Interim results from Inspiration’s OBI-1 and IB1001 hemophilia clinical study

Inspiration Biopharmaceuticals, Inc. (Inspiration) announced interim clinical results for the company's two lead product candidates, an intravenous recombinant porcine FVIII (OBI-1) in the treatment of serious bleeds in acquired hemophilia A (AHA) and an intravenous recombinant FIX (IB1001) for the treatment and prevention of bleeding in children less than 12 years of age with hemophilia B.

13 Dec 2012

Unigene announces results from oral PTH Phase 2 study on osteoporosis

Unigene Laboratories, Inc., a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that the results of its successful Phase 2 clinical trial evaluating an experimental oral parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women has been published online by Bone, the Official Journal of the International Bone and Mineral Society.

13 Dec 2012

Industry sponsored clinical trials present a more favourable picture of reported findings

Studies reporting the results of industry sponsored clinical trials present a more favourable picture of the effects of drugs and medical devices than those reporting on non-industry sponsored trials, according to a new Cochrane systematic review. The researchers call for a rethink of the way that industry bias is handled in medical guidelines and reviews.

12 Dec 2012

Inotuzumab ozogamicin selectively destroys malignant cells responsible for ALL in weekly dosing

A potent chemotherapy agent wrapped within a monoclonal antibody selectively destroys the malignant cells responsible for acute lymphocytic leukemia (ALL) in either weekly or monthly dosing, researchers report at the 54th ASH Annual Meeting and Exposition.

12 Dec 2012

Drug Trial News

IRMA, Population Council and MTN release Rectal Revolution video project

GTx achieves enrollment goal for pivotal Phase III clinical studies of enobosarm

Cognitive test used in Alzheimer's drug trials is flawed: Study

AcelRx announces top-line data from Sufentanil NanoTab PCA System Phase 3 trial

Ibrutinib continues to show unprecedented results in patients with mantle cell lymphoma

Cempra commences CEM-102 Phase 2 trial in prosthetic joint infections

High-dose vitamin D can reduce risk of respiratory tract infections

ETA receptor antagonism reduces novel cardiovascular risk factors in patients with CKD

NovaDigm announces data from NDV-3 vaccine Phase 1 study on Candida and Staph infections

Top-line results from AstraZeneca’s fostamatinib Phase IIb monotherapy study on RA

Positive data from Oncolytics’ REOLYSIN Phase III combination study on head and neck cancers

Medivir commences cohort 2 simeprevir and sofosbuvir phase II combination trial in HCV GT1

Eli Lilly provides update on solanezumab Phase 3 clinical study for mild Alzheimer's

Bumetanide could treat children with severe autism or Asperger's syndrome

AZD6765 briefly improves treatment-resistant patients' depression symptoms in minutes

Dantrolene may help combat Duchenne muscular dystrophy in boys

Interim results from Inspiration’s OBI-1 and IB1001 hemophilia clinical study

Unigene announces results from oral PTH Phase 2 study on osteoporosis

Industry sponsored clinical trials present a more favourable picture of reported findings

Inotuzumab ozogamicin selectively destroys malignant cells responsible for ALL in weekly dosing

Flow chemistry, AI, and NMR: A next-gen approach to scalable API production

Digital pathology and the PathoVerse: A conversation with Dr. Singh

Bioprocess Efficiency with Cell Density Monitoring

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