Posts Tagged ‘pharmaceuticals’

Javelin Pharmaceuticals Announces 15 Percent Reduction in Workforce. News.

Monday, November 17th, 2008

"We have infatuated difficult, but unavoidable actions, to modify secure costs across the institution to preserve and extend valuable development dollars. Todays organizational changes are being effected in weather of our priorities to column lofty quality regulatory submissions in the US and the EU for Dyloject and Ereska in 2009 and consummate affluent commercialization partnerships for our dilatory grade acute slang Pain in the arse Care Product portfolio," said Martin Driscoll, CEO of Javelin Pharmaceuticals. Mr. Driscoll continued, "We comprehend the commitment and whilom efforts of those employees spurious by todays notification and thank them for their contributions in help Javelin attain its first commodity approval and launch in a major western market.

The Company will provender additional details on its progression and tariff efficiency measures on its 2008 year-end results meeting call. About Javelin Pharmaceuticals, Inc.: With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to manifest reborn drugs and improved formulations of existing drugs to end unmet and underserved medical needs in the soreness supervision market. The Company has one marketed hypnotic in the UK and three medicament candidates in US Phase 3 clinical development.

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FDA Approves Eovist to Detect and Characterize Focal Liver Lesions. Drug approbation.

Thursday, October 23rd, 2008

In these patients, dodge the use of gadolinium-based distinguish agents unless the diagnostic bumf is elemental and not at with non-contrast enhanced entrancing resonance imaging (MRI). NSF may consequence in terminal or debilitating systemic fibrosis affecting the Skin, Muscle and internal organs. Screen All patients for renal dysfunction by obtaining a curriculum vitae and/or laboratory tests.

When administering a gadolinium-based juxtapose agent, do not outshine the recommended measure and acknowledge a enough aeon of day for elimination of the agent from the body prior to any readministration. As with Other set media, the feasibility of serious or life- threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered. The most standard adverse reactions observed in clinical trials at the recommended portion included sensation hot, nausea and headache. Differentiated Mechanism of Nexavar Nexavar targets both the tumor room and tumor vasculature.

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Zipsor New Drug Application. Attentions.

Thursday, August 21st, 2008

"Xanodyne is gratified with this function and will form closely with the FDA to fix up a complete response. Importantly, no additional clinical trials have been requested," said Gregory D. Flexter, President and Chief Executive Officer of Xanodyne. Zipsor is a one of a kind formulation designed for immediate and predictable manumission while minimizing systemic exposure.

Xanodyne submitted a New Drug Application (NDA) for Zipsor to the FDA in September 2007. The NDA included observations from four Phase 3 clinical trials of Zipsor in patients with stabbing distress following bunionectomy or dental surgery in which Zipsor achieved the immediate efficacy endpoint of the Trial, and was well-tolerated. About Xanodyne Xanodyne Pharmaceuticals, Inc., which commenced operations in 2001, is an integrated specialty pharmaceutical presence with both occurrence and commercial capabilities focused on Women's healthcare and slang Pain in the arse management. Xanodyne markets a portfolio of return generating Products consisting of FDA approved pharmaceuticals and a string of prenatal vitamins.

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FDA Approves Eovist to Detect and Characterize Focal Liver Lesions. Drug approbation.

Tuesday, August 19th, 2008

In these patients, from the use of gadolinium-based oppose agents unless the diagnostic intelligence is intrinsic and not at with non-contrast enhanced winsome resonance imaging (MRI). NSF may outcome in damaging or debilitating systemic fibrosis affecting the Skin, Muscle and internal organs. Screen All patients for renal dysfunction by obtaining a report and/or laboratory tests. When administering a gadolinium-based differentiate agent, do not go beyond the recommended dosage and put up with a adequate era of day for elimination of the agent from the body prior to any readministration.

As with Other discriminate media, the conceivability of serious or life- threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered. The most proverbial adverse reactions observed in clinical trials at the recommended prescribe included climate hot, nausea and headache. Differentiated Mechanism of Nexavar Nexavar targets both the tumor room and tumor vasculature.

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Contact Information: Ashley Hull (310) 450-9100 opt 1 Broker Contact: Chesapeake Group (410) 825-. News.

Tuesday, April 29th, 2008

SANTA MONICA, Calif., March 27, 2008 /PRNewswire-FirstCall/ -- Aida Pharmaceuticals, Inc today announced that has acquired one of China's trim microbiology investigating institutes, the Jiangsu Institute of Microbiology Co., Ltd. ("JSIM") Aida's subsidiary, Hanzhou Aida Pharmaceuticals Co., Ltd acquired 43% of the inaugurate from Jinou Medicine Co., Ltd while another of Aida's subsidiaries, Changzhou Fangyuan Pharmaceutical Co., Ltd. acquired an additional 55% from Jiangyin Hi-tech Group.

The arrangement is expected to terminate shortly. After the wind-up of the acquisition, Jiangsu Institute of Microbiology Co., Ltd. will become a subsidiary of Aida Pharmaceuticals. The acquirement is expected to earnings multiple rejuvenated Products for Aida, including several that are already in clinical trials by China's State Food and Drug Administration. Mr. Jin Biao, Chairman and CEO of Aida Pharmaceuticals, noted, "This purchase will significantly energize the investigation resources of Aida.

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Such statements include, but are not reduced to, the aptitude therapeutic clobber of SIRT1 activators for diseases of aging, Hospital trials.

Wednesday, February 20th, 2008

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 20, 2008 - Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical actors focused on discovering and developing secondary molecule drugs to play host to diseases of aging, announced that Sirtris co-founder David Sinclair, PhD, Harvard Medical School Associate Professor of Pathology, will remaining text showing that SIRT1 activation can mute tumor generation and expansion in the intestine and colon in a preclinical consummate of colon Cancer.

These are the gold in-vivo observations showing that SIRT1 overexpression can cover up tumor pattern and Growth. These information are the turn out of Sirtris Scientific Advisory Board co-chairs Sinclair and Leonard Guarente, PhD, the Novartis Professor of Biology at the Massachusetts Institute of Technology. The display will be held on Thursday, February 28 at the J. David Gladstone Institutes, an independent, non-profit biomedical into or conglomerate united with the University of California, San Francisco. About Sirtris Pharmaceuticals Sirtris Pharmaceuticals is a biopharmaceutical public limited company focused on discovering and developing proprietary, orally available, minuscule molecule drugs with the likely to critique diseases associated with aging, including metabolic diseases such as Type 2 Diabetes.

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Injectafer New Drug Application. New numb use and attentions.

Saturday, February 16th, 2008

SHIRLEY, NY, Feb. 4, 2008 - Luitpold Pharmaceuticals, Inc. announced today that the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that the present security and efficacy facts subsistence a favorable jeopardy / sake describe of Injectafer (ferric carboxymaltose injection) (Internal big cheese VIT-45) for the healing of iron deficiency anemia patients with oppressive uterine (HUB) or postpartum bleeding who have an inferior retort to uttered iron or are illiberal to vocal iron.

"Although we are thwarted that the Advisory Committee didn?t face our proposed indication, we are contented with their recommendation for authorization with a restricted indication," said Mary Jane Helenek, President & CEO. ?The exhortation establishes a walk encourage with the FDA. We are committed to working closely with the FDA to undergo the merchandise through approval." The FDA is expected to turn out to be a resolving on the NDA, requesting approval for the use of Injectafer in these perseverant populations by mid-March, 2008.

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Leading Investigators Highlight Advances in Photodynamic Therapy at the American Academy of Dermatology Annual Meeting. Hospital trials.

Sunday, February 10th, 2008

WILMINGTON, MASSACHUSETTS--(Marketwire - Feb. 6, 2008) - DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA) - Photodynamic Therapy (PDT) was featured as a skeleton key point at the 66th Annual American Academy of Dermatology (AAD) Meeting in San Antonio, Texas. More than 25 presentations and posters by important investigators addressed PDT, focusing on the therapy's benefits and clinical developments, including the FDA-approved use of aminolevulinic acid (ALA) PDT for the healing of mellow to middle-of-the-road actinic keratoses (AKs) of the cheek or scalp, as well as investigational uses for incrustation Cancer, acne and numerous Other graze conditions. "ALA PDT is like appropriate the universal therapy for multiple AKs in the United States and internationally, with growing cut in PDT for the curing of acne, photorejuvenation, chemoprevention and Other abrade conditions," said Dr. Michael Gold, Medical Director, Gold Skin Care Center, Tennessee Clinical Research Center, Clinical Associate Professor of Dermatology at Vanderbilt University, and Visiting Professor of Dermatology at Shanghai Medical University, Shanghai, China.

"Clinical and pharmacoeconomic evidence presented at this year's AAD caucus underscores that PDT is a cost-effective, first-line remedying modality for patients and will margin to continued advancements in the area of dermatology." On February 4, more than 200 dermatologists attended Photodynamic Therapy - the third annual execution on PDT led by Dr. Gold. Dr. Gold and thirteen dermatologists from the U.S. and around the world, including Asia, Europe and South America, provided a broad clinical overview of PDT and the universal perspectives on its recent and emerging uses in dermatology.

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Lotus Pharmaceuticals, Inc. Achieves Significant Milestones in the Development of Isosorbide Mononitrate Sustained Release Tablets. Hospital trials.

Saturday, February 9th, 2008

BEIJING, February 06, 2008 /Xinhua-PRNewswire-FirstCall/ -- Lotus Pharmaceuticals, Inc. ("Lotus" or the "Company"), a pharmaceutical guest in the People's Republic of China ("PRC"), today announced that it has achieved significant milestones in the circumstance of isosorbide mononitrate interminable unfetter tablet, a praisefully outstanding sedate for the aborting and Care of angina. Based on great clinical trials, isosorbide mononitrate unchanged releasing slab has shown buoyant results in a boning up of 1,350 patients with angina who received the downer for over six months. Lotus plans to emancipation the details of the study, and expects to motor boat the medicine till such time as the approval from SFDA in 2009. Approximately 0.4 to 0.8 million kinfolk in China withstand from angina and that personality is anticipated to grow over the coming years due to increases in the aging population.

Lotus estimates it will carry out a 10% to 20% vend deal within two years of launching the hallucinogen and a 30% demand share within three years. The tranquillizer dilates the Blood vessels and lowers the Blood Pressure. AstraZeneca sells the panacea under the job eminence Imdur. The components of the benumb include matrix tablets, isosorbide mononitrate, and hydroxypropylmethylcellulose (HPMC).

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