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Arena transfers BELVIQ NDA to Eisai

Eisai Inc. and Arena Pharmaceuticals, Inc. announced today that Arena has transferred the BELVIQ (lorcaserin hydrochloride) New Drug Application (NDA) to Eisai.

30 Jul 2012

New compound effective at blocking damage to the retina in diabetic retinopathy

Researchers at the University of Michigan Kellogg Eye Center have identified a compound that could interrupt the chain of events that cause damage to the retina in diabetic retinopathy. The finding is significant because it could lead to a novel therapy that targets two mechanisms at the root of the disease: inflammation and the weakening of the blood barrier that protects the retina.

30 Jul 2012

Neurotez receives U.S. patent for Leptin to treat Alzheimer's

Neurotez, Inc. today announced the grant of U.S. Patent number 8,227,408 by the United States Patent and Trademark Office covering the company's lead product candidate, Leptin. The patent protects use of the hormone Leptin for treating a progressive cognitive disease, disorder or condition, such as Alzheimer's disease (AD), resulting from accumulation of an amyloid peptide or for improving resilience of cognitive function by modulating the accumulation of the amyloid peptide in brain.

30 Jul 2012

Takeda resubmits alogliptin and fixed-dose combination therapy NDAs with FDA

Furiex Pharmaceuticals, Inc. today confirmed that Takeda Pharmaceutical Company Limited announced that its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc. has resubmitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone for the treatment of type 2 diabetes in adults.

28 Jul 2012

Confrontation looms for big pharmaceutical companies, generic drug makers

It would seem a business executive's dream: legally pay a competitor to keep its product off the market for years. Congress has failed to stop it, and for more than a decade generic drug makers and big-name pharmaceutical companies have been winning court rulings that allowed it.

28 Jul 2012

New drug can aid in losing weight and keeping it off

A new drug could aid in losing weight and keeping it off. The drug, described in the journal Cell Metabolism on July 26, increases sensitivity to the hormone leptin, a natural appetite suppressant found in the body. Although so far the new drug has only been tested on mice, the findings have implications for the development of new treatments for obesity in humans.

28 Jul 2012

ACT receives Australian patent for human retinal pigment epithelial cells

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that it has been issued a patent in Australia, patent number 2005325753, "Improved modalities for the treatment of degenerative diseases of the retina."

28 Jul 2012

EC approves Vertex's KALYDECO for treatment of cystic fibrosis

Vertex Pharmaceuticals Incorporated announced today that the European Commission has approved KALYDECOTM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

28 Jul 2012

Mylan receives FDA approval for generic Sporanox ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Itraconazole Capsules, 100 mg.

27 Jul 2012

New platform for detecting substandard and counterfeit medicines using microfluidics

A new platform for detecting substandard and counterfeit medicines using microfluidics has been recognized with a grant from Saving Lives at Birth's "Grand Challenge through Development." Dubbed PharmaCheck, the technology is a portable, field-based tool for assessing the quality of medicines in developing countries with increased accuracy, sensitivity and reliability.

27 Jul 2012

Orthognathic surgery requires a balancing act in anesthetic technique

Orthognathic surgery, affecting the jaws and face, requires a balancing act in anesthetic technique. Limiting blood loss, avoiding respiratory depression, and averting postoperative nausea and vomiting lead to optimum patient outcomes. The use of the drugs propofol and remifentanil are increasing because they can meet these needs; however, patients may subsequently experience more postoperative pain.

27 Jul 2012

Lymphoma drug dislodges hidden virus in HIV patients

Researchers from the University of North Carolina at Chapel Hill have published pioneering research showing that a drug used to treat certain types of lymphoma was able to dislodge hidden virus in patients receiving treatment for HIV.

27 Jul 2012

Biodel to develop ultra-rapid-acting insulin formulations for use in closed loop pump system

Biodel Inc. announced today that the Small Business Innovation Research (SBIR) program of the National Institutes of Health (NIH) has awarded Biodel a grant for the development of concentrated ultra-rapid-acting insulin formulations for use in an artificial pancreas, also known as a closed loop pump system.

27 Jul 2012

FDA DODAC recommends approval of ThromboGenics’ ocriplasmin for VMA

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic Vitreomacular Adhesion.

27 Jul 2012

High-dose IL-2 still the most effective treatment for patients with stage IV metastatic melanoma

Administering high-doses of interleukin-2 (IL-2) has been the preferred treatment for patients with stage IV metastatic melanoma. An article published in the current issue of Cancer Biotherapy and Radiopharmaceuticals, a peer-reviewed journal from Mary Ann Liebert, Inc., explores whether or not this regimen is still the most effective.

26 Jul 2012

FDA approves Horizon Pharma's RAYOS to treat key IL-6 mediated diseases

Horizon Pharma, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved RAYOS (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).

26 Jul 2012

Takeda, Sucampo file AMITIZA sNDA with FDA for treatment of opioid-induced constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A. Inc. today announced the filing of a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for AMITIZA (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

26 Jul 2012

Study shows potential for histone deacetylase inhibitors to eradicate latent HIV infection

Merck, known as MSD outside the United States and Canada, announced today the publication of a study in the July 26 issue of the leading scientific journal Nature that provided early evidence for the use of a drug to dislodge reservoirs of hidden virus in patients receiving treatment for HIV, the virus that causes AIDS.

26 Jul 2012

Rapamycin improves function and extends survival in mice with DCM and rare muscular dystrophies

Rapamycin, an immunosuppressant drug used in a variety of disease indications and under study in aging research labs around the world, improved function and extended survival in mice suffering from a genetic mutation which leads to dilated cardiomyopathy (DCM) and rare muscular dystrophies in humans.

26 Jul 2012

ZOLOFT holds promise against cryptococcal meningitis

New research conducted by biologists at Texas A&M University suggests that ZOLOFT, one of the most widely prescribed antidepressants in the world, also packs a potential preventative bonus - potent mechanisms capable of inhibiting deadly fungal infections.

26 Jul 2012