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FDA accepts filing and grants priority review for DX-88 for hereditary angioedema

Dyax Corp. has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) and has designated the application for Priority Review.

21 Nov 2008

Ortho Biotech submits NDA for Trabectedin in relapsed ovarian cancer

Ortho Biotech Products, L.P. has announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer (ROC).

20 Nov 2008

FDA approves GSK's Promacta (Eltrombopag)

GlaxoSmithKline has announced that the United States Food and Drug Administration (FDA) granted accelerated approval for PROMACTA (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

20 Nov 2008

FDA approves Banzel (rufinamide) for Lennox-Gastaut syndrome

The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome.

20 Nov 2008

FDA strengthens safety of Sucraid (sacrosidase) oral solution

The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.

20 Nov 2008

FDA accepts Vanda Pharmaceuticals Iloperidone resubmission

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, reported today that the FDA has accepted Vanda's resubmission of the iloperidone New Drug Application (NDA).

20 Nov 2008

EPA seeks public comment on proposal to add hazardous pharmaceutical waste to universal waste rule

To help provide a streamlined system for disposing of hazardous pharmaceutical waste that is protective of public health and the environment, the U.S. Environmental Protection Agency is proposing to add hazardous pharmaceutical waste to the Universal Waste Rule.

20 Nov 2008

Viral Genetics completes acquisition of V-Clip Pharmaceuticals

Viral Genetics, Inc. has announced it has completed its acquisition of V-Clip Pharmaceuticals, Inc. ("V-Clip").

19 Nov 2008

Prana Biotechnology's compound could halt Alzheimer's pathology

Prana Biotechnology has announced that a recent independent study conducted by Massachusetts General Hospital (MGH) has demonstrated that the Company's Metal-Protein Attenuating Compounds (MPACs) could halt Alzheimer's pathology.

19 Nov 2008

Phosphaplatins kill ovarian, testicular, head and neck cancer cells

A new class of compounds called phosphaplatins can effectively kill ovarian, testicular, head and neck cancer cells with potentially less toxicity than conventional drugs, according to a new study published this week in the journal Proceedings of the National Academy of Sciences.

19 Nov 2008

Breakthrough could revolutionise drug development

Scientists in Leeds have devised a new way to create the next generation of man-made molecules in a breakthrough that could revolutionise drug development.

19 Nov 2008

Garlic drug treats diabetes

A drug based on a chemical found in garlic can treat diabetes types I and II when taken as a tablet, a study in the new Royal Society of Chemistry journal Metallomics says.

19 Nov 2008

Systems biology brings hope of speeding up drug development

Almost every day brings news of an apparent breakthrough against cancer, infectious diseases, or metabolic conditions like diabetes, but these rarely translate into effective therapies or drugs, and even if they do clinical development usually takes well over a decade.

19 Nov 2008

Common ADHD drugs do not cause genetic damage in children

In contrast to recent findings, two of the most common medications used to treat attention deficit hyperactivity disorder (ADHD) do not appear to cause genetic damage in children who take them as prescribed, according to a new study by researchers at the National Institutes of Health (NIH) and Duke University Medical Center.

19 Nov 2008

Scientists discover new compounds to target muscular dystrophy

Using a drug-discovery technique in which molecules compete against each other for access to the target - the strand of toxic RNA that causes the most common form of muscular dystrophy in adults - a team at the University of Rochester Medical Center has identified several compounds that, in the laboratory, block the unwanted coupling of two molecules that is at the root of the disease.

19 Nov 2008

Cancer drug bevacizumab linked to significantly increased risk of blood clots

An analysis of randomized controlled trials indicates that use of the cancer drug bevacizumab is associated with an increased risk of venous thromboembolism (blood clots in the deep veins of the legs or in the lungs), according to an article in the November 19 issue of JAMA, the Journal of the American Medical Association.

18 Nov 2008

Medications containing barbiturates or narcotics may make migraine worse

A team of researchers led by investigators at the Albert Einstein College of Medicine of Yeshiva University has determined that certain commonly-prescribed medications may have the unintended consequence of increasing the frequency of migraine attacks.

18 Nov 2008

Mylan receives FDA approval for Fluoxetine capsules

Mylan Inc. has announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg.

18 Nov 2008

Musculoskeletal Center wins $2.2 million to study biologics safety

The UAB Center for Education and Research on Therapeutics has won a $2.2 million federal grant to study the risks and benefits of a class of drugs called ‘biologics' -- genetically engineered agents targeting the immune system of patients with rheumatoid arthritis, Crohn's disease, psoriasis and other autoimmune disorders.

18 Nov 2008