Developer of digital respiratory test sees scope for other diseases

The developer of a digital medical device that tests for different respiratory illnesses, such as flu A and B strains and strep A, sees additional scope for the respiratory test as a testing platform for sexually transmitted diseases along with a broader range of infectious diseases.The BD Veritor System, developed by Alverix and marketed by [...]

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Meningitis vaccine company inks licensing deal for Japan

Meningitis vaccine HibTITER, acquired from Wyeth, has been licensed to MitsubishiTanabe Pharma Corp. for the Japanese market.Nuron Biotech acquired the vaccine from Wyeth, a subsidiary of Pfizer (NYSE:PFE) in January of last year. Wyeth stopped making the vaccine in 2004, according to a spokesman for the Exton, Pennsylvania-based biologics and vaccines company.Currently, the market for [...]

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FDA delays Takeda diabetes drug decision; FURX awaits $25M milestone

Furiex Pharmaceuticals (NASDAQ:FURX) must wait until April to learn whether the type 2 diabetes compound it licensed to a drug partner will secure regulatory approval and a $25 million milestone payment for the company.The U.S. Food and Drug Administration has notified drug partner Takeda Pharmaceuticals that review of investigational diabetes drug alogliptin has been delayed [...]

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FDA to medical device makers: Check Japanese parts for tsunami damage

The March 11 earthquake and tsunami in Japan may mean compromised medical devices and device components, according to a Food & Drug Administration letter to industry.The U.S. regulatory body addressed a letter to foreign and domestic medical device industries yesterday, advising companies to take increased precautions in assessing Japanese exports.The FDA [...]

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Eisai’s Alzheimer’s disease skin patch falls short of FDA approval

Japanese drug company Eisai‘s (TYO:4523) bid to extend the patent life of its blockbuster Alzheimer’s drug Aricept with a new skin patch formulation has been dealt a blow by the U.S. Food and Drug Administration.Eisai’s drug partner Teikoku Pharma has received a complete response letter from the FDA stating that the agency cannot approve the [...]

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Dry eye drug from Inspire gets patent extension in Japan

Two dry eye therapy patents owned by Inspire Pharmaceuticals (NASDAQ:ISPH) have received extensions in Japan, which gives the drug Diquas patent protection until February 2023.Raleigh, North Carolina-based Inspire disclosed in a securities filing that the extension gives one Diquas patent an additional five years of exclusivity; another patent received approximately 4.5 years of exclusivity. The [...]

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Japan earthquake impacts medical device makers’ stocks

The earthquake in Japan, which killed at least 10,000 and shut down vast portions of the country, is also hurting the medical device industry. In Japan, they’re dealing with a death toll sure to rise above 10,000, rolling blackouts and a nuclear disaster of as-yet-undetermined proportions. On Wall Street, investors in medical device makers are contending with issues of their own, as share prices slide and the long-term impact of the Japan earthquake remains unknown.

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Japan earthquake could have deep impact on medical device industry

These are tense times for the more than 13,000 employees of American medical device and diagnostic companies in Japan and their employers back stateside, as the country tries to recover from a devastating 8.9 magnitude earthquake and accompanying tsunami. The impact of the quake will be felt far beyond the shores of the Pacific Ocean and into the heart of the medical device industry.

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Eisai will market epilepsy drug but sepsis drug candidate fails in trials

Eisai releases clinical trial results on two compounds and the drug development company will seek marketing approval on an epilepsy drug but withdraw such plans for a sepsis treatment after that drug fails in clinical trials.

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Alzheimer’s testing technology licensed to Takeda in $87 million deal

A new Alzheimer’s disease biomarker test developed by Durham, North Carolina-based Zinfandel Pharmaceuticals is licensed by Takeda Pharmaceutical Co. in a deal worth up to $87 million.

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