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FDA stops Neilgen Pharmaceuticals and Advent Pharmaceuticals from making unapproved drugs

The U.S. Food and Drug Administration today announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs.

12 Apr 2009

FDA acts to avoid shortage of medically necessary opioid

The U.S Food and Drug Administration today amended its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis.

12 Apr 2009

FDA approves Benzyl alcohol lotion for head lice

The U.S. Food and Drug Administration has approved a new prescription medication for the treatment of head lice (Pediculosis capitis) infestation.

12 Apr 2009

CDC reports progress in foodborne illness prevention has reached a plateau

The incidence of the most common foodborne illnesses has changed very little over the past three years, according to a 10-state report released Thursday by the Centers for Disease Control and Prevention.

12 Apr 2009

Treatment for acid reflux does not improve asthma symptoms

A commonly used treatment for acid reflux does not improve asthma symptoms or control in patients who do not have symptoms of gastroesophageal reflux (GER), according to a new study supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health and by the American Lung Association (ALA).

12 Apr 2009

Deficiency in vitamin D may exacerbate autoimmune disease

Deficiency in vitamin D has been widely regarded as contributing to autoimmune disease, but a review appearing in Autoimmunity Reviews explains that low levels of vitamin D in patients with autoimmune disease may be a result rather than a cause of disease and that supplementing with vitamin D may actually exacerbate autoimmune disease.

9 Apr 2009

Johns Hopkins tightens rules on industry interactions

Johns Hopkins Medicine has adopted a new policy that significantly limits interactions with industry while ensuring effective, principled and appropriate partnerships with drug and medical device makers.

9 Apr 2009

Mylan settles Clarinex patent case

Mylan Inc. has announced the settlement of all patent litigation relating to Desloratadine Tablets, 5 mg, the generic version of Schering- Plough's Clarinex allergy medication.

9 Apr 2009

Merck & Co and Cardiome sign agreement for Vernakalant

Merck & Co., Inc. and Cardiome Pharma Corp. has announced a collaboration and license agreement for the development and commercialization of vernakalant, an investigational candidate for the treatment of atrial fibrillation.

9 Apr 2009

Seroquel XR supplemental NDA recommended for approval

The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review of the safety and efficacy of supplemental new drug applications (sNDA) for Seroquel XR (quetiapine fumarate) extended-release tablets proposed for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD).

9 Apr 2009

Cancer vaccines receive orphan drug designation for advanced head and neck cancer

Two experimental vaccines from the University of Maryland, Baltimore (UMB) recently received a federal orphan drug designation for advanced head and neck cancer, according to a company official.

9 Apr 2009

Health problems associated with Chinese slimming capsules

Taking herbal food supplements is certainly not free of risk. Since 2005, the poison emergency centers in the German cities of Freiburg and Gottingen have registered a total of 17 patients with health problems after taking Chinese slimming capsules.

8 Apr 2009

FDA to review 25 medical devices marketed prior to 1976

The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type.

8 Apr 2009

Coartem tablets approved in U.S. to treat malaria

The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds).

8 Apr 2009

Too much dietary protein and fat may lead to insulin resistance

A clue about the blood chemistry of obese people who develop insulin resistance, a precursor to diabetes, has been confirmed in animal studies at the Duke University Medical Center.

8 Apr 2009

Two major obesity studies involve kids, teens and their families

Obesity has become the most common chronic health condition of childhood. According to the Centers for Disease Control and Prevention, nearly 1 out of 3 children in the United States, ages 2 to 19, is overweight or at risk of becoming overweight.

8 Apr 2009

Omega-3 EPA/DHA may reduce risk of prostate cancer

A new study presented in Clinical Cancer Research, a journal of the AACR (American Association for Clinical Cancer Research), shows diets high in Omega-3 EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) may decrease the risk of prostate cancer.

8 Apr 2009