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pSivida submits MAA for Iluvien to UK MHRA

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has submitted a Marketing Authorization Application (MAA) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) for Iluvien®.

8 Jul 2010

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Rockwell Medical, a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease, chronic kidney disease, and iron deficiency anemia, announced today that it has successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration regarding the Company's lead drug candidate Soluble Ferric Pyrophosphate, a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients.

8 Jul 2010

Shire files patent infringement lawsuit against Zydus

Shire plc, the global specialty biopharmaceutical company, announces that its subsidiaries Shire Development Inc. and Shire Pharmaceutical Development Inc. have filed a lawsuit in the U.S. District Court for the District of Delaware against Cadila Healthcare Limited, doing business as Zydus Cadila and Zydus Pharmaceuticals, Inc. for the infringement of U.S. Patent No. 6,773,720.

8 Jul 2010

Standard Process launches new ProSynbiotic product

By our first birthday, we've acquired over 400 bacterial passengers in our gastrointestinal tract. Our gut microbes, or "bugs," work to keep our complex and diverse gut ecosystem in balance. Unfortunately, the trials of daily life-stressful events, aging, diet, or immune challenges-can be hard on these bugs. Standard Process Inc. introduces a new product, ProSynbiotic, to help our body maintain a healthy, balanced gut ecosystem.

8 Jul 2010

Article related to MN-166 mechanism of action included in PNAS USA

MediciNova Inc, a biopharmaceutical company publicly traded on the NASDAQ Global Market and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), today reported that the June 22, 2010 issue of Proceedings of the National Academy of Sciences USA included an article related to the mechanism of action of MN-166 (ibudilast), as an emerging therapeutic for neurological disorders.

8 Jul 2010

Local anesthetics have potential therapeutic effects on IBD: Research article

Inflammatory bowel disease is a disease of the gastrointestinal tract, mainly the intestines that may occur in the people who have genetic potential with a contribution of environmental factors. There has been no definitive medical treatment and drugs usually help the symptoms just to relieve.

8 Jul 2010

York University study shows misoprostol prevents cell communication

A York University study has shown for the first time how the drug misoprostol, which has been linked to neurodevelopmental defects associated with autism, interferes with neuronal cell function.

8 Jul 2010

TB Alliance, DNDi announce inter-PDP agreement to develop potential anti-TB compounds

The Global Alliance for TB Drug Development and Drugs for Neglected Diseases initiative announced today a unique first-ever royalty-free license agreement between two not-for-profit drug developers that speeds progress toward markedly improved therapy of multiple neglected diseases. The TB Alliance has granted rights to DNDi to develop a class of potential anti-TB compounds that also show significant promise for treating other neglected diseases that largely affect the world's poor.

8 Jul 2010

Regular use of fish oil supplements reduces risk of invasive ductal breast cancer

A recent report in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research, adds to the growing evidence that fish oil supplements may play a role in preventing chronic disease.

8 Jul 2010

Marijuana legalization in California will lower drug price and increase consumption

Legalizing the production and distribution of marijuana in California could cut the price of the drug by as much as 80 percent and increase consumption, according to a new study by the nonprofit RAND Corporation that examines many issues raised by proposals to legalize marijuana in the state.

8 Jul 2010

ASA provides tips to help parents protect children from over-the-counter drug abuse

In recent years, a growing and potentially life-threatening trend known as Robo tripping, the abuse of over-the-counter cough and cold medications, has emerged among America's youth. As the Society representing the front-line physicians responsible for treating patients in the Intensive Care Unit (ICU) who have overdosed on over-the-counter medications, the American Society of Anesthesiologists (ASA) has developed information to help parents recognize the signs of Robo tripping and to prevent overdose and longer-term health complications.

8 Jul 2010

FDA-approved bioidentical estrogens help women manage common symptoms of menopause

Women looking for the best method to manage common symptoms of menopause, like hot flashes and night sweats, may not have access to credible information, especially when it comes to understanding their estrogen therapy options. In fact, there are an array of celebrities and authors who are simply not qualified to give medical advice about managing menopause, yet they dominate the internet and media space simply because of their popularity.

8 Jul 2010

New York Times examines India's growing influence on global drug industry

"India's drug industry — on track to grow about 13 percent this year, to just over $24 billion — was once notorious for making cheap knockoffs of Western medicines and selling them in developing countries. But India, seasoned in the basics of medicine making, is now starting to take on a more mainstream role in the global drug industry, as a result of recent strengthening of patent law here and cost pressures on name-brand drug makers in the West," the New York Times writes.

8 Jul 2010

LSUHSC awarded $4M grant to study cannabinoid treatment for HIV infection

Patricia Molina, MD, PhD, Professor and Head of Physiology at LSU Health Sciences Center New Orleans, has been awarded a $4 million grant over five years by the National Institute on Drug Abuse of the National Institutes of Health to study how cannabinoids, the principal psychoactive component of marijuana, produce subtle changes in gene activity that affect how a person responds to HIV infection.

8 Jul 2010

Drug initiative granted rights to develop TB compounds for potential treatment of NTDs

The Drugs for Neglected Diseases Initiative now has the rights to "develop a class of potential anti-[tuberculosis] compounds" for the treatment of Chagas disease, African sleeping sickness and leishmaniasis, Reuters reports (Nebehay, 7/7).

8 Jul 2010

Olaparib shows promising results against inherited forms of breast and ovarian cancer

Olaparib, a new type of experimental drug called a PARP inhibitor, has shown promising results against inherited forms of breast and ovarian cancer in two small clinical trials led by scientists at the Breakthrough Breast Cancer Research Unit at King's College London.

8 Jul 2010

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, in collaboration with APR Applied Pharma Research s.a. of Switzerland and Labtec GmbH of Germany, today announced that its partner, Strativa Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for Zuplenz® oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

8 Jul 2010

Vitamin E may help prevent cognitive deterioration in elderly people: Study

High levels of several vitamin E components in the blood are associated with a decreased risk for Alzheimer's disease in advanced age, suggesting that vitamin E may help prevent cognitive deterioration in elderly people. This is the conclusion reached in a Swedish study published in the July 2010 issue of the Journal of Alzheimer's Disease.

8 Jul 2010

FDA approves Beech Tree Labs' IND for Phase 1/2a clinical evaluation of BTL-TML-HSV

Beech Tree Labs, Inc., announced today that the FDA has approved its IND for a Phase 1/2a clinical evaluation of BTL-TML-HSV, a novel therapeutic agent for treating recurrent oral herpes infections. The study will be a 210 patient, multi-site, placebo-controlled trial and is anticipated to begin later this summer.

8 Jul 2010

Winston submits NDA for CIVANEX to U.S. FDA

Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its civamide (zucapsaicin) 0.075% cream, CIVANEX®, for the treatment of signs and symptoms of osteoarthritis of the knee.

7 Jul 2010

Pharmaceutical News

pSivida submits MAA for Iluvien to UK MHRA

Rockwell Medical completes End of Phase II meeting with FDA regarding SFP

Shire files patent infringement lawsuit against Zydus

Standard Process launches new ProSynbiotic product

Article related to MN-166 mechanism of action included in PNAS USA

Local anesthetics have potential therapeutic effects on IBD: Research article

York University study shows misoprostol prevents cell communication

TB Alliance, DNDi announce inter-PDP agreement to develop potential anti-TB compounds

Regular use of fish oil supplements reduces risk of invasive ductal breast cancer

Marijuana legalization in California will lower drug price and increase consumption

ASA provides tips to help parents protect children from over-the-counter drug abuse

FDA-approved bioidentical estrogens help women manage common symptoms of menopause

New York Times examines India's growing influence on global drug industry

LSUHSC awarded $4M grant to study cannabinoid treatment for HIV infection

Drug initiative granted rights to develop TB compounds for potential treatment of NTDs

Olaparib shows promising results against inherited forms of breast and ovarian cancer

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

Vitamin E may help prevent cognitive deterioration in elderly people: Study

FDA approves Beech Tree Labs' IND for Phase 1/2a clinical evaluation of BTL-TML-HSV

Winston submits NDA for CIVANEX to U.S. FDA

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