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Friday, Jul 19, 2024

Neurocrine Biosciences Resubmits Lower-Dose Sleeping Aid to FDA

Neurocrine Biosciences Inc. has resubmitted its 5- and 10-milligram sleeping pill capsules to the Food and Drug Administration after several months of interactions with the federal agency.

In May 2007, the FDA essentially denied approval for 15-milligram tablets of Indiplon, which was expected to be the fiercest competitor to currently approved prescription sleeping aids.

Chief Executive Officer Gary Lyons said last week that the company is conducting tests, including one focused on the elderly, for its 15-milligram tablets. He expects to resubmit that dose to the FDA in about two years.

With regard to the lower doses resubmitted June 12, the company said it has answered questions from the FDA about how Indiplon reacts with certain high-fat foods. Neurocrine said it has put together a “complete response to the May 15, 2006 approvable letter” issued by the FDA for the 5- and 10-milligram doses.

The company now has about 300 employees after two rounds of layoffs last year that came as a result of the lukewarm reception at the FDA. Shares in the company, which trade as NBIX on the Nasdaq, closed at $12.62 the day of the June 12 announcement, and were up nearly 3.5 percent in after-hours trading at $13.05.

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DexCom Gets FDA Nod:

DexCom Inc. has received federal approval for Seven, the company’s glucose monitoring system for diabetes patients.

The device has an alarm that sounds if a patient’s glucose is too high or low. It works through a tiny disposable sensor inserted just under the skin of the abdomen. The FDA approved the firm’s first such device about a year ago, and Seven is the new improved version, said Chief Financial Officer Steve Kemper.

Today, about 4,000 patients have used the first device.

Kemper wouldn’t say how much more revenue Seven is expected to generate for DexCom, which has 225 local employees. He also would not disclose the additional number of expected customers. Nationwide, about 20 million people have diabetes.

“It definitely has features that will appeal to a broader sector,” Kemper said, including improved electronic signal processing, a smaller needle with which to insert the wire, and the ability to use the sensor for seven days instead of three.

Each device costs around $800, and it is not typically covered by insurance.

Kemper said Minneapolis, Minn.-based Medtronic Inc. is DexCom’s main competitor. Eventually, Kemper said, DexCom’s three-day monitoring system will be phased out for the newer version.

Both versions come with software to allow patients to download historical glucose level data into a computer for analysis or safe-keeping.

DexCom’s stock trades as DXCM on the Nasdaq just under $7.

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Nanogen & Canada Team:

Nanogen Inc., a local developer of diagnostic products, is receiving funding for projects from several Canadian agencies, including the Canadian Food Inspection Agency.

The purpose of the funding is to develop diagnostic tools for detecting natural or potential bioterror threats to livestock, such as foot and mouth disease and avian flu.

No monetary terms were disclosed.

Nanogen stock trades as NGEN on the Nasdaq under $2.

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Artes Bulks Up:

Artes Medical Inc. formed a wholly owned subsidiary, Spheris Medical, to develop and commercialize non-aesthetic applications for ArteFill, its tissue bulking technology.

ArteFill is an FDA-approved injectable dermal filler for the correction of facial wrinkles, but Spheris will handle soft-tissue augmentation products.

In preclinical studies, reports Artes, materials produced with the technology have been used to provide the bulking of the esophageal sphincter and urinary sphincter to treat gastro-esophageal reflux disease and stress urinary incontinence. Other potential uses include the bulking of the soft palate and respiratory tissue to treat snoring and sleep apnea.

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Vical Secures $6M:

Vical Inc. has been awarded a three-year, $6 million grant from the National Institute of Allergy and Infectious Diseases.

The vaccine company will use the money to further develop its RapidResponse DNA vaccine manufacturing process, which speeds up the ability to produce vaccines.

“The standard manufacturing methods being used to produce conventional vaccines take several months to several years and require specialized, capital-intensive facilities,” said Vical CEO Vijay Samant.

The new system could produce millions of doses in a matter of days, the company reported , important especially in the event of a pandemic, Vical said.

Contact Katie Weeks with biotechnology news at


, or call her at (858) 277-6359.


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