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FDA grants orphan drug designation for Edison's EPI-743 to treat inherited mitochondrial diseases

Edison Pharmaceuticals, Inc. announced today the United States Food and Drug Administration has granted orphan drug designation to EPI-743 for treatment of inherited mitochondrial respiratory chain diseases.

8 Jun 2011

Combined contraceptive pill does not cause weight gain in young women

Many young women do not want to start taking the contraceptive pill because they are worried that they will put on weight, or come off it because they think that they have gained weight because of it. However, a thesis from the University of Gothenburg, Sweden, has demonstrated that the combined contraceptive pill does not cause weight increase.

8 Jun 2011

FDA approves Mylan's ANDA for Donepezil HCl Tablets to treat dementia linked with Alzheimer's

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Donepezil Hydrochloride (HCl) Tablets, 5 mg and 10 mg, the generic version of Eisai's Aricept Tablets, which are used to treat dementia associated with Alzheimer's disease.

8 Jun 2011

Thermo Fisher Scientific launches new triple quadrupole gas chromatography-mass spectrometry system

Thermo Fisher Scientific Inc. has announced the launch of its new triple quadrupole gas chromatography-mass spectrometry (GC-MS/MS) system designed to offer best-in-class selectivity, analytical performance and productivity. The Thermo Scientific TSQ Quantum XLS Ultra delivers the increased matrix selectivity needed for challenging applications that require lower levels of quantitation in extremely complex matrix extracts. With its exceptional sensitivity, easy detection and reliable peak integration, the system provides superior performance for the most difficult of matrix challenges.

From Thermo Fisher Scientific Inc. 7 Jun 2011

Shire Canada receives expanded indication for MEZAVANT for treatment of ulcerative colitis

Shire Canada Inc., a division of Shire plc, the global specialty biopharmaceutical company, is proud to announce that MEZAVANT® (mesalamine delayed and extended release tablets), the first and only once-daily mesalamine indicated for the induction of clinical and endoscopic remission in patients with mild-to-moderate, active ulcerative colitis (UC), has received an expanded indication to include maintenance of clinical and endoscopic remission (mucosal healing) in patients with ulcerative colitis.

7 Jun 2011

FDA accepts Topaz's ivermectin NDA for treatment for head lice infestations

Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for the use of ivermectin topical cream as a treatment for head lice infestations in children and adults.

7 Jun 2011

$Zoledronate at lower dose effective in reducing risk of osteoporotic fractures$

Zoledronate at lower dose effective in reducing risk of osteoporotic fractures

A lower dose of zoledronic acid than currently recommended for prevention of bone fractures due to osteoporosis decreases bone resorption and increases bone density, and may be effective in reducing the risk of osteoporotic fractures, a study finds.

7 Jun 2011

Intrexon, Halozyme partner to develop subcutaneous alpha 1-antitrypsin for A1AT deficiency

Halozyme Therapeutics, Inc. and Intrexon Corporation, today announced the signing of a worldwide exclusive licensing agreement for the use of rHuPH20 in the development of a subcutaneous injectable formulation of Intrexon Corporation's recombinant human alpha 1-antitrypsin (rHuA1AT).

7 Jun 2011

Bayer HealthCare seeks EU marketing authorization of VEGF Trap-Eye for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

7 Jun 2011

EC approves Biogen Idec's AVONEX PEN to treat multiple sclerosis

Biogen Idec announced today that the European Commission (EC) has granted approval to AVONEX PEN for patients with relapsing multiple sclerosis (MS) and patients who have had a single demyelinating event.

7 Jun 2011

Increases in VEGF-family markers in metastatic colorectal cancer patients associated with Avastin resistance

Circadian Technologies Limited announced today the presentation of data at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago USA associating resistance to Avastin with increases in plasma VEGF-C and D concentrations.

7 Jun 2011

APP to commence marketing Letrozole Tablets for breast cancer in the U.S.

Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that APP Pharmaceuticals will immediately begin marketing Letrozole Tablets in the U.S., after the U.S. Food and Drug Administration granted approval to market the breast cancer treatment medication to Fresenius Kabi Oncology Limited.

7 Jun 2011

Female cancer survivors benefit from natural nutritional supplement

A natural nutritional supplement, marketed for the last decade as a sexual aid, has been shown to significantly improve overall quality of life for female cancer survivors, according to researchers at Wake Forest Baptist Medical Center.

7 Jun 2011

FDA issues revised PDUFA date for Lannett's Morphine Sulfate Oral Solution NDA

Lannett Company, Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a revised Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2011 for the company's 505(b)(2) New Drug Application for Morphine Sulfate Oral Solution

7 Jun 2011

Testosterone spray may slow cognitive decline in post-menopausal women

Post-menopausal women have better memory after daily treatment with a testosterone spray for six months, a new preliminary study finds. The results will be presented Saturday at The Endocrine Society's 93rd Annual Meeting in Boston.

7 Jun 2011

Women with low bone density more likely to benefit from bisphosphonate drug

Women with low bone density are seven times more likely to benefit from a bisphosphonate drug when their vitamin D blood levels are above recent recommendations from the Institute of Medicine (IOM) as adequate for bone health.

7 Jun 2011

Actavis receives final FDA approval for Zolpidem ER Tablets

Actavis, an international generic pharmaceuticals company, today announced that it has received final approval from the US Food & Drug Administration to market Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg CIV. Distribution of the product has commenced.

7 Jun 2011

Focus on getting more people on antiretroviral therapy as AIDS turns 30

Sunday marked the 30th anniversary of the first published report of the disease that came to be known as AIDS, the Los Angeles Times reports. Though the "promise" of a vaccine "has not materialized," "[s]ome progress has been made on other fronts," the newspaper writes.

7 Jun 2011

PATH malaria vaccine initiative to collaborate with GSK and Crucell in development of 2nd-generation malaria vaccine

The PATH Malaria Vaccine Initiative (MVI) announced today that it has entered into a collaboration with Dutch biopharmaceutical company Crucell N.V. and GlaxoSmithKline (GSK). This collaboration is aimed at developing a second-generation vaccine against malaria—a deadly disease that kills close to 800,000 people annually, most of them young children under age five in Africa. MVI drives the development of malaria vaccines by joining its scientific, managerial, and field expertise with companies, universities, and governments to test potential malaria vaccines and invest in those with the most promise.

6 Jun 2011

Several drug makers plan to lower prices of vaccines for GAVI purchase

Several pharmaceutical companies have pledged to lower the prices of vaccines against childhood illnesses ahead of the GAVI Alliance conference in London next week, the Guardian reports (Quinn, 6/6).

6 Jun 2011

Pharmaceutical News

FDA grants orphan drug designation for Edison's EPI-743 to treat inherited mitochondrial diseases

Combined contraceptive pill does not cause weight gain in young women

FDA approves Mylan's ANDA for Donepezil HCl Tablets to treat dementia linked with Alzheimer's

Thermo Fisher Scientific launches new triple quadrupole gas chromatography-mass spectrometry system

Shire Canada receives expanded indication for MEZAVANT for treatment of ulcerative colitis

FDA accepts Topaz's ivermectin NDA for treatment for head lice infestations

Zoledronate at lower dose effective in reducing risk of osteoporotic fractures

Intrexon, Halozyme partner to develop subcutaneous alpha 1-antitrypsin for A1AT deficiency

Bayer HealthCare seeks EU marketing authorization of VEGF Trap-Eye for treatment of wet AMD

EC approves Biogen Idec's AVONEX PEN to treat multiple sclerosis

Increases in VEGF-family markers in metastatic colorectal cancer patients associated with Avastin resistance

APP to commence marketing Letrozole Tablets for breast cancer in the U.S.

Female cancer survivors benefit from natural nutritional supplement

FDA issues revised PDUFA date for Lannett's Morphine Sulfate Oral Solution NDA

Testosterone spray may slow cognitive decline in post-menopausal women

Women with low bone density more likely to benefit from bisphosphonate drug

Actavis receives final FDA approval for Zolpidem ER Tablets

Focus on getting more people on antiretroviral therapy as AIDS turns 30

PATH malaria vaccine initiative to collaborate with GSK and Crucell in development of 2nd-generation malaria vaccine

Several drug makers plan to lower prices of vaccines for GAVI purchase

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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