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Clementia's palovarotene receives FDA Fast Track designation for FOP treatment

Clementia Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has granted Fast Track designation to palovarotene, which is being developed for the treatment of fibrodysplasia ossificans progressiva (FOP).

1 Dec 2014

Australian Prescriber publishes top 10 subsidised drugs in Australia

The annual publication of the top 10 subsidised drugs appears in the December edition of Australian Prescriber. Statins (cholesterol-lowering medicines) top the lists again.

1 Dec 2014

EMA accepts new IMBRUVICA (ibrutinib) application for treatment of Waldenstrom's macroglobulinemia

Pharmacyclics, Inc.today announced the acceptance of a Type II variation application for IMBRUVICA (ibrutinib) by the European Medicines Agency.

1 Dec 2014

New active substance effectively combats Philadelphia chromosome-positive leukaemia

Haematologists from Goethe University Frankfurt, working with a Russian pharmaceutical company, have developed a new active substance that effectively combats the most aggressive forms of Philadelphia chromosome-positive leukaemia.

29 Nov 2014

Researchers investigate FDA influence for improving pivotal drug studies

An examination of the potential interaction between pharmaceutical companies and the U.S. Food and Drug Administration (FDA) to discuss future studies finds that one-quarter of recent new drug approvals occurred without any meeting, and when such meetings occurred, pharmaceutical companies did not comply with one-quarter of the recommendations made by the FDA regarding study design or primary outcome, according to a study in the November 26 issue of JAMA.

28 Nov 2014

Experimental drug works best when patients' immune cells surrounding tumors express PD-L1

A promising experimental immunotherapy drug works best in patients whose immune defenses initially rally to attack the cancer but then are stymied by a molecular brake that shuts down the response, according to a new study led by researchers at Dana-Farber Cancer Institute and the Yale University School of Medicine.

28 Nov 2014

Canada's current vitamin D intake recommendations need to be re-evaluated: Study

New research finds that current national vitamin D intake recommendations are too low and that body weight must be taken into account to determine the appropriate vitamin D dose in any given individual. This is currently not the case, posing a serious Canadian public health issue with significant cost and health impacts.

27 Nov 2014

Hovione submits first IND Application with FDA for minocycline gel

Hovione announced today it has filed its first Investigational New Drug (IND) Application with the U.S. Food and Drug Administration. This event represents a milestone in Hovione's strategy of developing improved drug delivery options for established drugs.

27 Nov 2014

US Special Forces funding breakthrough drug therapy for treating wounded soldiers

US Special Forces are funding a world first, breakthrough drug therapy for treating battle casualties that's being developed by James Cook University scientists in Australia.

27 Nov 2014

Researchers use EHRs to uncover hidden drug benefits

With research and development costs for many drugs reaching well into the billions, pharmaceutical companies want more than ever to determine whether their drugs already at market have any hidden therapeutic benefits that could warrant putting additional indications on the label and increase production.

27 Nov 2014

Cimetidine drug could be one of many common over-the-counter medicines to treat cancer

A popular indigestion medication can increase survival in colorectal cancer, according to research published in ecancermedicalscience. But in fact, scientists have studied this for years - and a group of cancer advocates want to know why this research isn't more widely used.

27 Nov 2014

European scientists develop, test drug that could reduce harmful side-effects of 'binge drinking'

A drug that could reduce the harmful side-effects of 'binge drinking', especially by teenagers, has been successfully developed and tested by a team of European scientists, including the University of Huddersfield's Professor Mike Page and Dr Karl Hemming. There is also the potential for new ways to treat Alzheimer's and other neurological diseases that damage the brain.

27 Nov 2014

Researchers discover why advanced melanoma patients respond to pembrolizumab drug

Work supported by the Stand Up To Cance - Cancer Research Institute - Immunology Translational Research Dream Team, launched in 2012 to focus on how the patient's own immune system can be harnessed to treat some cancers have pioneered an approach to predict why advanced melanoma patients respond to a new life-saving melanoma drug.

27 Nov 2014

New research brings personalized cancer vaccine approach one step closer to reality

In the near future, physicians may treat some cancer patients with personalized vaccines that spur their immune systems to attack malignant tumors. New research led by scientists at Washington University School of Medicine in St. Louis has brought the approach one step closer to reality.

27 Nov 2014

Researchers demonstrate efficacy of Bozepinib drug against cancerogenic stem cells

An Andalusian team of researchers led by the University of Granada has demonstrated the efficacy of a new drug against cancerogenic stem cells, which cause the onset and development of cancer, of relapse after chemotherapy and metastasis. This drug, called Bozepinib, has proved to be effective in tests with mice.

26 Nov 2014

Taking folic acid supplementation before conception reduces risk of SGA at birth

Taking folic acid before conception significantly reduces the risk of small for gestational age (SGA) at birth, suggests a new study published today (26 November) in BJOG: An International Journal of Obstetrics and Gynaecology.

26 Nov 2014

Janssen submits YONDELIS NDA for treatment of advanced soft tissue sarcoma

PharmaMar announces that Janssen Research & Development, LLC has submitted a New Drug Application (NDA) for YONDELIS (trabectedin) to the U.S. Food and Drug Administration for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.

26 Nov 2014

Long-term T therapy in hypogonadal men is safe, does not increase PCa risk, study finds

Testosterone (T) therapy is routinely used in men with hypogonadism, a condition in which diminished function of the gonads occurs. Although there is no evidence that T therapy increases the risk of prostate cancer (PCa), there are still concerns and a paucity of long-term data.

25 Nov 2014

CHMP approves Victoza for use in adults with type 2 diabetes, moderate renal impairment

The Committee for Medicinal Products for Human Use today issued a positive opinion for the use of Victoza (liraglutide) in adults with type 2 diabetes and moderate renal impairment.

25 Nov 2014

MACROD2 gene may explain why some breast cancers are resistant to tamoxifen

After mining the genetic records of thousands of breast cancer patients, researchers from the Johns Hopkins Kimmel Cancer Center have identified a gene whose presence may explain why some breast cancers are resistant to tamoxifen, a widely used hormone treatment generally used after surgery, radiation and other chemotherapy.

25 Nov 2014

Pharmaceutical News

Clementia's palovarotene receives FDA Fast Track designation for FOP treatment

Australian Prescriber publishes top 10 subsidised drugs in Australia

EMA accepts new IMBRUVICA (ibrutinib) application for treatment of Waldenstrom's macroglobulinemia

New active substance effectively combats Philadelphia chromosome-positive leukaemia

Researchers investigate FDA influence for improving pivotal drug studies

Experimental drug works best when patients' immune cells surrounding tumors express PD-L1

Canada's current vitamin D intake recommendations need to be re-evaluated: Study

Hovione submits first IND Application with FDA for minocycline gel

US Special Forces funding breakthrough drug therapy for treating wounded soldiers

Researchers use EHRs to uncover hidden drug benefits

Cimetidine drug could be one of many common over-the-counter medicines to treat cancer

European scientists develop, test drug that could reduce harmful side-effects of 'binge drinking'

Researchers discover why advanced melanoma patients respond to pembrolizumab drug

New research brings personalized cancer vaccine approach one step closer to reality

Researchers demonstrate efficacy of Bozepinib drug against cancerogenic stem cells

Taking folic acid supplementation before conception reduces risk of SGA at birth

Janssen submits YONDELIS NDA for treatment of advanced soft tissue sarcoma

Long-term T therapy in hypogonadal men is safe, does not increase PCa risk, study finds

CHMP approves Victoza for use in adults with type 2 diabetes, moderate renal impairment

MACROD2 gene may explain why some breast cancers are resistant to tamoxifen

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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