Clinical Trial News and Research

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FDA approves LILETTA (levonorgestrel-releasing intrauterine system) to prevent pregnancy

Actavis plc, a leading global specialty pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company, today announced the approval of LILETTA (levonorgestrel-releasing intrauterine system) by the U.S. Food and Drug Administration for use by women to prevent pregnancy for up to three years.

27 Feb 2015

Feast-or-famine diet may extend lifespan, improve age-related diseases

University of Florida Health researchers have found that putting people on a feast-or-famine diet may mimic some of the benefits of fasting, and that adding antioxidant supplements may counteract those benefits.

27 Feb 2015

NIAID partners with Liberian government to test ZMapp drug for Ebola virus disease

In partnership with the Liberian government, the National Institute of Allergy and Infectious Diseases today launched a clinical trial to obtain safety and efficacy data on the investigational drug ZMapp as a treatment for Ebola virus disease. The study, which will be conducted in Liberia and the United States, is a randomized controlled trial enrolling adults and children with known Ebola virus infection.

27 Feb 2015

ERT signs definitive agreement to acquire PHT

ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, and PHT Corporation, the eClinical innovator leading the adoption of patient-driven mobile apps for improved clinical research, announced today that they have signed a definitive agreement under which ERT will acquire PHT.

27 Feb 2015

New cancer drug enters phase I clinical trials in humans

A new drug that prompts cancer cells to self-destruct while sparing healthy cells is now entering phase I clinical trials in humans. The drug, called PAC-1, first showed promise in the treatment of pet dogs with spontaneously occurring cancers, and is still in clinical trials in dogs with osteosarcoma.

27 Feb 2015

ABIVAX doses first patient in ABX203 Phase IIb/III trial for treatment of chronic hepatitis B

ABIVAX, a clinical stage biotech company developing and commercialising anti-viral compounds and human vaccines, today announced that it has dosed in New Zealand the first patient in a Phase IIb/III clinical trial of ABX203 which is taking place in several countries of the Asia-Pacific region.

26 Feb 2015

HeartWare International's revenue increases 38% to $73.2 million in Q4 2014

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenue of $73.2 million for the fourth quarter ended December 31, 2014, a 38% increase compared to $53.1 million in revenue for the same period of 2013. For the fiscal year 2014, the company generated revenue of $278.4 million, a 34% increase compared to revenue of $207.9 million in 2013.

26 Feb 2015

New four-way collaboration aims to improve clinical decision-making in the treatment of colon cancer

EKF Diagnostics subsidiary, Selah Genomics, has announced a major, four-way collaboration with Greenville Health System, DecisionQ Corporation, and BD.

From EKF Diagnostics 26 Feb 2015

Hospira launches first biosimilar monoclonal antibody (mAb) InflectraTM (infliximab) in the UK

Inflectra is licensed for the treatment of inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis and plaque psoriasis.

26 Feb 2015

Sanofi announces FDA approval of Toujeo insulin to improve glycemic control in people with diabetes

Sanofi announced today that the U.S. Food and Drug Administration approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2 2015.

26 Feb 2015

Researchers find that unique emotion recognition treatment highly effective for children with HFASD

Researchers at the Institute for Autism Research at Canisius College have found a unique emotion recognition treatment highly effective for high-functioning children with autism spectrum disorder (HFASD).

25 Feb 2015

Gates Foundation awards $2.5 million to support development of vaccine-filled microneedles

The Georgia Institute of Technology and Micron Biomedical have been awarded $2.5 million in grants from the Bill & Melinda Gates Foundation to advance the development of dissolvable microneedle patches for polio immunization. The patches will be studied to evaluate their potential role as part of the worldwide efforts to eradicate polio.

25 Feb 2015

UTHealth study explores use of app to help improve health of minority stroke patients

A clinical trial investigating the use of a physician-monitored app to help first-time minority stroke patients become healthier has begun at The University of Texas Health Science Center at Houston.

25 Feb 2015

Researchers identify first genetic variation linked to increased risk of peripheral neuropathy

Researchers have identified the first genetic variation that is associated with increased risk and severity of peripheral neuropathy following treatment with a widely used anti-cancer drug. Investigators also found evidence of how it may be possible to protect young leukemia patients without jeopardizing cures.

24 Feb 2015

Shire announces acquisition of Meritage Pharma

Shire plc and Meritage Pharma, Inc. announced today that Shire has acquired Meritage, a privately-held company, for an upfront fee of $70 million and additional contingent payments based on the achievement of development and regulatory milestones.

24 Feb 2015

Rigel, Bristol-Myers Squibb partner to develop, commercialize TGF beta receptor kinase inhibitors

Rigel Pharmaceuticals, Inc. and Bristol-Myers Squibb Company today announced that they have entered into a collaboration agreement for the discovery, development and commercialization of cancer immunotherapies based on Rigel's extensive portfolio of small molecule TGF beta receptor kinase inhibitors.

23 Feb 2015

RepliCel submits CTA for RCS-01 study to treat patients suffering from aged, UV-damaged skin

RepliCel Life Sciences Inc., a clinical stage regenerative medicine company focused on the development of autologous cell therapies, today announced the submission of a Clinical Trial Application (CTA) to the German Competent Authority, the Paul-Ehrlich-Institut (PEI), requesting clearance to initiate a Phase 1 clinical trial investigating the use of RCS-01 to treat patients suffering from aged and UV-damaged skin.

23 Feb 2015

Johns Hopkins researcher helps discover effectiveness of three drugs for treating patients with DME

A researcher from Johns Hopkins Medicine helped lead colleagues from across the country in a government-sponsored study by the Diabetic Retinopathy Clinical Research Network to discover that three drugs -- Eylea, Avastin and Lucentis -- used to treat diabetic macular edema are all effective. They also discovered that Eylea outperformed the other two drugs when vision loss was moderate to severe.

23 Feb 2015

UW ophthalmology researchers help show effectiveness of three drugs for treating DME

An ophthalmology research team at the University of Wisconsin-Madison took part in a nationwide clinical trial comparing treatments for a form of diabetic eye disease. The study found that three commonly used drugs perform much the same for those with mild vision problems, but one medication performed better for those with more serious vision loss.

23 Feb 2015

International phase 2/3 trial shows Gardasil 9 vaccine protects against nine HPV types

Approximately 12,000 women are diagnosed with cervical cancer each year in the United States and another 4,000 die annually from the disease. However, most cervical cancers are preventable through immunization against the human papillomavirus (HPV). A pivotal international phase 2/3 clinical trial involving Moffitt Cancer Center faculty demonstrated that vaccination with Gardasil 9 protects against nine HPV types, seven of which cause most cases of cervical, vulvar, and vaginal disease.

21 Feb 2015

Clinical Trial News and Research

FDA approves LILETTA (levonorgestrel-releasing intrauterine system) to prevent pregnancy

Feast-or-famine diet may extend lifespan, improve age-related diseases

NIAID partners with Liberian government to test ZMapp drug for Ebola virus disease

ERT signs definitive agreement to acquire PHT

New cancer drug enters phase I clinical trials in humans

ABIVAX doses first patient in ABX203 Phase IIb/III trial for treatment of chronic hepatitis B

HeartWare International's revenue increases 38% to $73.2 million in Q4 2014

New four-way collaboration aims to improve clinical decision-making in the treatment of colon cancer

Hospira launches first biosimilar monoclonal antibody (mAb) InflectraTM (infliximab) in the UK

Sanofi announces FDA approval of Toujeo insulin to improve glycemic control in people with diabetes

Researchers find that unique emotion recognition treatment highly effective for children with HFASD

Gates Foundation awards $2.5 million to support development of vaccine-filled microneedles

UTHealth study explores use of app to help improve health of minority stroke patients

Researchers identify first genetic variation linked to increased risk of peripheral neuropathy

Shire announces acquisition of Meritage Pharma

Rigel, Bristol-Myers Squibb partner to develop, commercialize TGF beta receptor kinase inhibitors

RepliCel submits CTA for RCS-01 study to treat patients suffering from aged, UV-damaged skin

Johns Hopkins researcher helps discover effectiveness of three drugs for treating patients with DME

UW ophthalmology researchers help show effectiveness of three drugs for treating DME

International phase 2/3 trial shows Gardasil 9 vaccine protects against nine HPV types

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