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Vanda Pharmaceuticals announces submission of tasimelteon NDA to FDA

Vanda Pharmaceuticals Inc. today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for tasimelteon, a circadian regulator.

31 May 2013

First Edition: May 31, 2013

Today's early morning highlights from the major news organizations, including reports from the administration about the number of insurers that will be offering policies on the new online marketplaces.

31 May 2013

University of Strathclyde uses new imaging technique to track nanomedicines' effects on patients

A pioneering imaging technique to track the effects of next-generation nanomedicines on patients has been harnessed by a University of Strathclyde academic.

31 May 2013

Comprehensive analyses of the benefits and risks of NSAIDs

Charles H. Hennekens, MD, DrPH, the first Sir Richard Doll professor and senior academic advisor to the dean in the Charles E. Schmidt College of Medicine at Florida Atlantic University has published in the current issue of The Lancet the most comprehensive analyses of the benefits and risks of non-steroidal anti-inflammatory drugs, which include cyclo-oxygenase-2 inhibitors (coxibs).

31 May 2013

Extremely low doses of THC protect the brain from long-term cognitive damage

Though marijuana is a well-known recreational drug, extensive scientific research has been conducted on the therapeutic properties of marijuana in the last decade. Medical cannabis is often used by sufferers of chronic ailments, including cancer and post-traumatic stress disorder, to combat pain, insomnia, lack of appetite, and other symptoms.

31 May 2013

Innovative approach helps Virginia mount effective response to contaminated steroid crisis

An innovative "hybrid" surveillance strategy-highlighted by close cooperation between public health officials and clinical partners-helped Virginia mount an efficient and effective response to the ongoing outbreak of fungal meningitis and other infections, according to a report in the July/August issue of Journal of Public Health Management and Practice.

31 May 2013

Safer, more effective treatment option for ovarian cancer

A novel, targeted approach to chemotherapy that makes ovarian cancer cells more susceptible to the cytotoxic effects of an antitumor drug may offer a safer, more effective treatment option for this often deadly form of cancer.

31 May 2013

CREON Delayed-Release Capsules now available in US for patients with EPI

AbbVie announced that a new, higher-dose capsule of CREON (pancrelipase) Delayed-Release Capsules is commercially available in the United States. The U.S. Food and Drug Administration recently approved CREON in a 36,000 lipase-unit dose to treat patients with exocrine pancreatic insufficiency due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions.

31 May 2013

FDA issues complete response letter to Endo's NDA for AVEED injection

Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. announced today that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for Endo's long-acting testosterone undecanoate injection, AVEED, for men diagnosed with hypogonadism.

31 May 2013

FDA accepts Teva Pharmaceutical's sNDA for COPAXONE

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has accepted for review the company's supplemental new drug application for COPAXONE (glatiramer acetate injection) 40mg/ 1mL, a higher concentration dose of COPAXONE that offers a less frequent three times a week dosing regimen administered subcutaneously for patients with relapsing-remitting multiple sclerosis.

31 May 2013

Oncothyreon, Array BioPharma to develop and commercialize ARRY-380 for breast cancer patients

Oncothyreon Inc. and Array BioPharma Inc. today announced that they will collaborate to develop and commercialize ARRY-380, an orally active, reversible and selective small-molecule HER2 inhibitor.

30 May 2013

Researchers examine quality of information given by sales reps when promoting drugs to physicians

Dr. Genevi-ve Durrieu (from the Pharmaco-epidemiology team assessing the use of medication and the risks involved, Unit 1027 "Epidemiology and public health analyses: risks, chronic diseases and handicaps" - Inserm / Universit- Toulouse III - Paul Sabatier) led the French part of this study, the results of which are published in the Journal of General Internal Medicine. Within the framework of this international study, is France proving to be a model student?

30 May 2013

Injectable drugs used in TPN to be imported into US, says FDA

The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition in critical shortage will be imported into the United States and available to patients this week.

30 May 2013

Taking blood thinners before minor procedures safe for stroke patients

Many patients who have experienced strokes or mini strokes take blood thinners such as aspirin or warfarin (Coumadin) to reduce the risk of blood clots that can cause strokes.

30 May 2013

Tafinlar, Mekinist get FDA approval to treat patients with advanced melanoma

The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

30 May 2013

Perrigo receives final approval for generic Sanctura XR

Perrigo Company today announced that it has received final approval for the generic version of Sanctura XR. Perrigo had previously prevailed in litigation at both the district and appellate levels. The product has begun shipping immediately.

29 May 2013

Atopix awarded grant to pursue development of OC459 for atopic dermatitis

Atopix Therapeutics Ltd, a biopharmaceutical company developing a novel class of anti-allergic medicines, has been awarded a £1.7 million grant from the UK Biomedical Catalyst fund to pursue development of OC459 in the treatment of moderate-to-severe atopic dermatitis (a form of eczema).

29 May 2013

EMA grants Sucampo orphan drug designation for unoprostone isopropyl to treat retinitis pigmentosa

Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, today announced that it has received orphan drug designation in the European Union for unoprostone isopropyl for the treatment of retinitis pigmentosa (RP). RP is a genetic disease characterized by progressive, irreversible vision loss and decreasing visual acuity, and there are no drugs or therapeutic procedures currently approved for the treatment of RP today.

29 May 2013

Patented nicotinamide riboside launched by Chromadex

ChromaDex Corporation, an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, animal health, cosmetic and pharmaceutical industries, announced today the launch of NIAGEN, its novel, patented, branded nicotinamide riboside.

29 May 2013

Teh Seng’s generic Lidoderm manufacturing facility in Taiwan successfully completes FDA cGMP audit

TWi Pharmaceuticals, Inc., today announced that Teh Seng Pharmaceutical Mfg. Co., the manufacturing partner for its generic version of Lidoderm (5% lidocaine patch) located in Taiwan, has completed the cGMP audit and pre-approval inspection by US Food and Drug Administration and been granted "acceptable" status under the FDA's regulatory guidelines.

29 May 2013