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New study raises doubts about benefits of ezetimibe in patients suffering from high LDL cholesterol

More than 42 million Americans suffer from high cholesterol, and 63 million more have borderline high cholesterol. Over time, high levels of LDL cholesterol, often called "bad cholesterol," build up along the walls of arteries and blood vessels, a process called atherosclerosis, which can lead to a high risk of heart disease, stroke and heart attack.

21 May 2011

Edurant receives FDA approval for treatment of HIV-1 infection

The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naive).

21 May 2011

Local production of pharmaceuticals could improve access in developing countries, U.N. report says

A U.N. Conference on Trade and Development report issued last week suggested "[l]ocal production of pharmaceuticals in some poor African and Asian countries, such as Ethiopia, Uganda, and Bangladesh, has the potential to improve access to essential drugs for many of the one billion people who live in the world's least developed countries," BMJ News writes.

21 May 2011

Feeding SimplyThick to premature infants may cause NEC, warns FDA

FDA is warning parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks.

21 May 2011

FDA approves Sutent for patients with progressive neuroendocrine cancerous tumors in pancreas

The U.S. Food and Drug Administration today approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic).

21 May 2011

Most paediatric paracetamol prescriptions fails to comply with BNFc recommendations

Many of the prescriptions issued by GPs for paracetamol either give less than recommended doses to older children or exceed recommended doses in young children.

20 May 2011

EMA CHMP recommends conditional marketing authorization of FAMPYRA

The Committee for Medicinal Products for Human Use of the European Medicine Agency has recommended conditional marketing authorization of FAMPYRA (prolonged-release fampridine 10 mg tablets) for the improvement of walking in adult patients with multiple sclerosis with walking disability.

20 May 2011

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Amgen today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.

20 May 2011

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Merck, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS (boceprevir) for the treatment of chronic hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

20 May 2011

EMA CHMP issues positive opinion for marketing approval of BENLYSTA

GlaxoSmithKline and Human Genome Sciences, Inc. announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion, recommending marketing authorisation for BENLYSTA (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity, despite standard therapy.

20 May 2011

Cholesterol drug may help treat mitochondrial diseases

A human drug that both prevents and cures kidney failure in mice sheds light on disabling human mitochondrial disorders, and may represent a potential treatment in people with such illnesses.

20 May 2011

'No magic pill' for HIV prevention

AIDS Healthcare Foundation today released the results of a groundbreaking online survey designed to gain better understanding of community perceptions regarding the possible use of an HIV prevention pill.

20 May 2011

Abbott appreciates FDA Advisory Committee recommendations to retain Trilipix indication for mixed dyslipidemia

The U.S. Food and Drug Administration today held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of the ACCORD Lipid study as they relate to the use of fenofibric acid (sold as Trilipix in the United States) in combination with a statin in patients with mixed dyslipidemia and at high risk of heart disease.

20 May 2011

Naltrexone improves clinical, inflammatory activity in Crohn's disease patients

Naltrexone reduced inflammation in Crohn's patients in a research study at Penn State College of Medicine.

20 May 2011

Study: Costs get in way of cancer patients refilling their prescriptions

About 10 percent of cancer patients aren't taking the oral medicines they need either because of the cost or they feel they are already taking too many other drugs, according to a study released by health-care consulting company Avalere Health late Wednesday.

20 May 2011

Medical food resolves metabolic syndrome and cardiovascular risk factors

Researchers at the University of Florida and Metagenics Inc. today announced that a program consisting of a breakthrough medical food combined with a low-glycemic, Mediterranean-style diet is almost twice as effective as one of the best diets alone for lowering risk factors for cardiovascular disease, the leading cause of death in the U.S.

19 May 2011

AVAC calls on donors, policy makers to strengthen support for AIDS vaccine research

This year HIV Vaccine Awareness Day comes at the dawn of a true prevention revolution that could finally turn the tide of the AIDS epidemic. AIDS vaccine research is a critical part of that revolution and on this day AVAC calls on donors, policy makers and others to strengthen support for AIDS vaccine research.

19 May 2011

USPTO grants four key patents for Alvine's proteases to detect celiac disease

Alvine Pharmaceuticals, Inc., a biopharmaceutical company focused on the treatment of autoimmune and gastrointestinal diseases, today announced that the United States Patent and Trademark Office has issued four key patents: 7,943,312; 7,928,056; 7,923,532; and 7,910,541, protecting various aspects of Alvine's core technology.

19 May 2011

Study: 10% of cancer patients fail to fill initial oral oncolytic prescriptions

Ten percent of cancer patients failed to fill their initial prescriptions for oral anti-cancer drugs, according to a new study published jointly today in the Journal of Oncology Practice and American Journal of Managed Care.

19 May 2011

Modified vitamin A drug may help prevent age-related macular degeneration

Slowing down the aggregation or "clumping" of vitamin A in the eye may help prevent vision loss caused by macular degeneration, research from Columbia University Medical Center has found.

19 May 2011

Pharmaceutical News

New study raises doubts about benefits of ezetimibe in patients suffering from high LDL cholesterol

Edurant receives FDA approval for treatment of HIV-1 infection

Local production of pharmaceuticals could improve access in developing countries, U.N. report says

Feeding SimplyThick to premature infants may cause NEC, warns FDA

FDA approves Sutent for patients with progressive neuroendocrine cancerous tumors in pancreas

Most paediatric paracetamol prescriptions fails to comply with BNFc recommendations

EMA CHMP recommends conditional marketing authorization of FAMPYRA

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

EMA CHMP issues positive opinion for marketing approval of BENLYSTA

Cholesterol drug may help treat mitochondrial diseases

'No magic pill' for HIV prevention

Abbott appreciates FDA Advisory Committee recommendations to retain Trilipix indication for mixed dyslipidemia

Naltrexone improves clinical, inflammatory activity in Crohn's disease patients

Study: Costs get in way of cancer patients refilling their prescriptions

Medical food resolves metabolic syndrome and cardiovascular risk factors

AVAC calls on donors, policy makers to strengthen support for AIDS vaccine research

USPTO grants four key patents for Alvine's proteases to detect celiac disease

Study: 10% of cancer patients fail to fill initial oral oncolytic prescriptions

Modified vitamin A drug may help prevent age-related macular degeneration

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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