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Transcept Pharmaceuticals Scheduled To Meet With FDA To Discuss Intermezzo(R) Complete Response Letter

November 24, 2009 Health News No Comments

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, 2009, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

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Millennium Announces First Clinical Data For TAK-700 Prostate Molecule At ASCO GU

March 10, 2010

Millennium: The Takeda Oncology Company today announced the presentation of safety, pharmacokinetic and efficacy data from the Phase I portion of a Phase I/II clinical trial evaluating TAK-700 in patients with metastatic castration resistant prostate cancer (mCRPC). These data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), held March 5-7, 2010 in San Francisco, CA…

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ImmunoGen, Inc. Announces Orphan Drug Designation Granted To IMGN901 For Treatment Of Merkel Cell Carcinoma By US FDA And EU COMP

March 10, 2010

ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its IMGN901 compound when used for the treatment of Merkel cell carcinoma (MCC). Through a separate process, the European Union (EU) Committee for Orphan Medicinal Products (COMP) concurrently also granted IMGN901 orphan medicinal product designation for the treatment of MCC…

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BG Medicine And Abbott To Develop Galectin-3 Test For The I-STAT(R) System

March 10, 2010

BG Medicine, Inc. announced that it has entered into an agreement with Abbott Laboratories (NYSE: ABT) to extend its current development and commercialization collaboration to include the development of a galectin-3 test for Abbott Point of Care’s i-STAT® System. Galectin-3 is a novel biomarker that may play a role in detecting the development and progression of heart failure…

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Refresher: What’s In The Health Reform Bills

March 10, 2010

Since the Senate passed its version of a health overhaul on Christmas Eve, most of the debate has focused on the politics of the effort. By now, many people have forgotten — if they ever knew — what the bill would actually do.

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So here’s a short refresher. According to the Congressional Budget Office, the Senate-passed bill would expand coverage to roughly 30 million of the 46 million people in the U.S. who lack health insurance. Most of the remaining uninsured would be undocumented immigrants, who would be ineligible for benefits… Continue reading

InterMune’s Lung Drug Gets Backing From FDA Panel

March 10, 2010

Another day, another stock-price jump.
First, the preliminaries: An advisory panel this afternoon recommended the FDA approve a lung drug developed by InterMune, with majorities of the outside experts saying the proposed treatment appeared effective and safe.
The FDA is expected to decide by early May whether to go along with the panel’s recommendation on pirfenidone, which is intended to treat patients with idiopathic pulmonary fibrosis. The FDA usually follows the lead of its advisory committees.
This all comes as good news for investors in InterMune, whose shares streaked nearly 60% higher Friday because the questions posed by the FDA staff for today’s… Continue reading

Vets Welcome Extension To UK Pet Travel Protection

March 10, 2010

The European Parliament has voted 618 votes to 17 for an extension to the transitional arrangements contained within the regulation on the non-commercial movement of pet animals (Reg. 998/2003) which afford the UK additional protection against rabies, ticks and tapeworms. The British Veterinary Association (BVA) and British Small Animal Veterinary Association (BSAVA) have been lobbying MEPs to support the extension and have strongly welcomed this decision…

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Baby slings to get safety warning after deaths

March 10, 2010

The U.S. government is preparing a safety warning about baby slings — those popular and fashionable infant carriers that parents can sling around their chests to carry their baby. Go to Source… Continue reading

Britain may force owners to microchip dogs

March 10, 2010

British dog owners may be forced to microchip their pets and take out insurance, part of a proposed crackdown on the country’s dangerous canines. Go to Source… Continue reading

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