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FDA issues final guidance to help develop safe and effective cell-based viral vaccines

The U.S. Food and Drug Administration today issued final guidance to help manufacturers who are developing safe and effective cell-based viral vaccines to address emerging and pandemic threats.

3 Mar 2010

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

Data demonstrating the effectiveness of KALBITOR (ecallantide) to treat hereditary angioedema (HAE) acute attacks by primary attack location were provided in an oral presentation yesterday at the American Academy of Allergy, Asthma and Immunology 2010 Annual Meeting in New Orleans.

3 Mar 2010

FDA approves Mylan Pharmaceuticals' ANDA for Ursodiol Capsules

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Ursodiol Capsules USP, 300 mg, the generic version of Watson's gastrointestinal agent Actigall® Capsules.

3 Mar 2010

Novo Nordisk awarded contract by VA as primary source provider of insulin

Novo Nordisk, a global healthcare company and leader in diabetes care, announced it has been awarded a contract by the U.S. Department of Veterans Affairs as the primary source provider of insulin. The one year contract began on March 1, 2010 and the VA has the option to renew the contract annually for up to an additional four years.

From Novo Nordisk 3 Mar 2010

Benefits of aspirin therapy for patients with peripheral artery disease remain unproven

Individuals who were identified as being at increased risk of cardiovascular or cerebrovascular events based on screening for low ankle brachial index, a type of pressure measurement used in the diagnosis of peripheral artery disease, did not significantly reduce their risk of these events with the use of aspirin, according to a study in the March 3 issue of JAMA.

3 Mar 2010

Solasia Pharma K.K. signs License and Supply Agreement with Kyowa Hakko Kirin to market SP-01

Solasia Pharma K.K. (http://www.solasia.co.jp), a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced today the signing of a License and Supply Agreement with Kyowa Hakko Kirin that provides Kyowa Hakko Kirin with an exclusive right to market and sell SP-01 (extended release transdermal granisetron patch; brand name: Sancuso®) in Taiwan, Hong Kong, Singapore and Malaysia.

3 Mar 2010

NPS Pharmaceuticals sells royalty rights from sales of REGPARA to DRI Capital's fund

NPS Pharmaceuticals, Inc. today announced the sale of its royalty rights from sales of REGPARA® (cinacalcet HCl) to a fund managed by DRI Capital, Inc., (Fund) for $38.4 million. Royalties in excess of cumulative royalties of $96 million or 2.5 times the upfront purchase price have been retained by NPS.

3 Mar 2010

Pycnogenol counteracts kidney damage caused by hypertension, improves blood flow to the kidneys

An estimated one in ten adults suffers from kidney disease, according to the National Institute of Diabetes and Digestive and Kidney Diseases. A leading cause of kidney disease is hypertension, which effects one out of every four U.S. adults. Chronically high blood pressure damages capillaries of the kidneys which in turn affects the organ's ability to filter waste and remove excess fluids from the body.

3 Mar 2010

Enlarged prostate: Dutasteride-tamsulosin combination therapy more effective

Like any successful team effort, the best qualities of two drugs commonly prescribed for enlarged prostate yielded better results than either of the medicines alone, according to a new study from UT Southwestern Medical Center.

3 Mar 2010

Bisphosphonates may lower risk of breast cancer

Women who take some types of bone-building drugs used to prevent and treat osteoporosis may be at lower risk of breast cancer, according to a study by U.S. researchers published today in the British Journal of Cancer.

3 Mar 2010

Shionogi, QuatRx Pharmaceuticals enter into worldwide license agreement to develop and market ospemifene

Shionogi & Co., Ltd. and QuatRx Pharmaceuticals Company, a privately-held pharmaceutical company, today announced that they have entered into a worldwide license agreement to develop and market ospemifene, a selective estrogen receptor modulator ("SERM").

3 Mar 2010

Geron highlights telomerase inhibitor's activity against cancer stem cells at AACR Special Conference

Geron Corporation today announced several presentations at the American Association for Cancer Research Special Conference on The Role of Telomeres and Telomerase in Cancer Research held in Fort Worth, TX between February 27th and March 1st.

3 Mar 2010

Storing vitamins in bathrooms and kitchens may degrade their effectiveness

High humidity present in bathrooms and kitchens could be degrading the vitamins and health supplements stored in those rooms, even if the lids are on tight, a Purdue University study shows.

3 Mar 2010

Bisphosphonate drugs used to prevent osteoporosis may also help reduce risk of breast cancer

A DRUG commonly used to prevent and treat bones losing density and becoming brittle - known as osteoporosis - may also help reduce the risk of breast cancer by one third or more according to new research published in the British Journal of Cancer today (Wednesday).

3 Mar 2010

Impax Laboratories' generic FLOMAX ANDA: FDA grants final approval

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. The Company also announced that it is commencing shipment through Global Pharmaceuticals, Impax’s generic division.

3 Mar 2010

EMA accepts the filing of Lux Biosciences' MAA for Luveniq

Lux Biosciences, Inc. today announced that the European Medicines Agency has accepted the filing of the company’s Marketing Authorization Application (MAA) for the company’s lead product, Luveniq™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

3 Mar 2010

Combination of two targeted therapies effective against subset of gastric cancers: Study

A combination of two targeted therapies already shown to be effective in breast cancer packs an effective one-two punch against a subset of gastric cancers that have a specific genetic mutation, a study at UCLA's Jonsson Comprehensive Cancer Center has found.

3 Mar 2010

EMA validates Lux Biosciences' voclosporin MAA

Isotechnika Pharma Inc. today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) filed by its partner, Lux Biosciences, Inc., for voclosporin. Following validation of the MAA, the dossier is distributed to members of the Committee for Medicinal Products for Human Use (CHMP) for formal review, which is expected to take one year.

2 Mar 2010

Generic Hyzaar and Cozaar litigation: Court of Appeals rules in favor of Teva Pharmaceutical Industries

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the District of Columbia Circuit has ruled in Teva’s favor by overturning a July 31, 2009, district court decision which held that Teva forfeited 180-day marketing exclusivity for its generic versions of Merck's antihypertensive agents Hyzaar® (hydrochlorothiazide; losartan potassium) and Cozaar® (losartan potassium).

2 Mar 2010

Generic version of Flomax Capsules receives FDA approval

The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination.

2 Mar 2010

Pharmaceutical News

FDA issues final guidance to help develop safe and effective cell-based viral vaccines

Data demonstrating effectiveness of KALBITOR to treat acute HAE presented at AAAAI 2010 Annual Meeting

FDA approves Mylan Pharmaceuticals' ANDA for Ursodiol Capsules

Novo Nordisk awarded contract by VA as primary source provider of insulin

Benefits of aspirin therapy for patients with peripheral artery disease remain unproven

Solasia Pharma K.K. signs License and Supply Agreement with Kyowa Hakko Kirin to market SP-01

NPS Pharmaceuticals sells royalty rights from sales of REGPARA to DRI Capital's fund

Pycnogenol counteracts kidney damage caused by hypertension, improves blood flow to the kidneys

Enlarged prostate: Dutasteride-tamsulosin combination therapy more effective

Bisphosphonates may lower risk of breast cancer

Shionogi, QuatRx Pharmaceuticals enter into worldwide license agreement to develop and market ospemifene

Geron highlights telomerase inhibitor's activity against cancer stem cells at AACR Special Conference

Storing vitamins in bathrooms and kitchens may degrade their effectiveness

Bisphosphonate drugs used to prevent osteoporosis may also help reduce risk of breast cancer

Impax Laboratories' generic FLOMAX ANDA: FDA grants final approval

EMA accepts the filing of Lux Biosciences' MAA for Luveniq

Combination of two targeted therapies effective against subset of gastric cancers: Study

EMA validates Lux Biosciences' voclosporin MAA

Generic Hyzaar and Cozaar litigation: Court of Appeals rules in favor of Teva Pharmaceutical Industries

Generic version of Flomax Capsules receives FDA approval

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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