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Daily news and top headlines for manufacturing professionals

FDA approves Latuda to treat schizophrenia in adults

October 28, 2010 12:46 pm | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved Latuda (lurasidone HCl) tablets for the treatment of adults with schizophrenia.

FDA approves additional medical indication for Sprycel

October 28, 2010 8:46 am | by U.S. Food & Drug Administration | News | Comments

Sprycel, CML

Stryker Corp. To Buy Boston Scientific Division

October 28, 2010 5:11 am | News | Comments

Company says it will pay up to $1.5 billion to buy the neurovascular division of fellow medical device maker Boston Scientific.

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U.S. Marshals seize FDA-regulated food stored at rodent-infested warehouse in Georgia

October 27, 2010 11:47 am | by U.S. Food & Drug Administration | News | Comments

U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized an estimated $700,000 worth of rice and other packaged food products from a rodent-infested warehouse in East Point, Ga. The FDA-regulated food products were stored in a warehouse...

Federal government takes action against Tennessee food distributor

October 27, 2010 7:46 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today announced that Peng Bandith, owner of the Lao Trading Company of Nashville has signed a consent decree that permanently prohibits Lao Trading Co. from distributing food held under insanitary conditions in interstate commerce. (DSK)

Hyland’s Teething Tablets may pose a risk to children

October 23, 2010 6:46 pm | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today is warning consumers that Hyland’s Teething Tablets may pose a risk to children. The FDA recommends that consumers not use this product and dispose of any in their possession. The manufacturer is issuing a recall of this product.

FDA Heightens Focus on Retail Food Safety

October 22, 2010 9:46 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration called today for stepped up efforts to improve food safety practices in retail food establishments, specifically pointing to the need for the presence of certified food safety managers to oversee safety practices. FDA pledged to work closely with state and...

FDA: Include warnings on risk for class of prostate cancer drugs

October 20, 2010 11:46 am | by U.S. Food & Drug Administration | News | Comments

GnRH agonists, prostate, cancer

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St. Jude Medical 3Q profit grows 25 percent

October 20, 2010 7:35 am | by The Associated Press | News | Comments

St. Jude Medical Inc. on Wednesday reported a 25 percent jump in third-quarter profit as it booked fewer charges and saw stronger sales of medical devices. The company also raised its outlook for the fourth quarter and full year above Wall Street expectations.St. Jude said its net income grew...

FDA approves Pradaxa to prevent stroke in people with atrial fibrillation

October 19, 2010 2:45 pm | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

Boston Sci posts 3Q profit despite sales drop

October 19, 2010 1:36 pm | by MATTHEW PERRONE - AP Business Writer - Associated Press | News | Comments

Shares of medical device maker Boston Scientific jumped Tuesday after the company said it swung to a profit in the third quarter thanks to lower restructuring costs.The higher earnings came despite a decline in sales of the company's top-selling devices, heart-pacing devices and artery-opening...

FDA Provides Update on LASIK Quality of Life Collaboration Project Status

October 19, 2010 7:46 am | by U.S. Food & Drug Administration | News | Comments

LASIK, eye, laser

Idex Corp. says 3Q profit surges 30 percent

October 18, 2010 3:35 pm | by The Associated Press | News | Comments

Idex Corp., which manufactures the Jaws of Life rescue equipment and other products, said Monday its third-quarter profit surged 30 percent on higher sales.For the month that ended Sept. 30, the manufacturer reported net income of $38.6 million, or 47 cents a share. That compared with net...

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FDA approves Botox to treat chronic migraine

October 15, 2010 1:45 pm | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month.

FDA participates in ‘International Internet Week of Action’

October 14, 2010 10:46 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a coordinated, cooperative effort to curb online sales and distribution of counterfeit and illicit medical products. IIWA took place...

Qualcomm Unveils RaptorQ Product for Enhanced Digital Content Delivery

October 14, 2010 8:45 am | by Qualcomm | News | Comments

SAN DIEGO – October 14, 2010 – Qualcomm Incorporated (NASDAQ: QCOM) today announced the commercial license availability of RaptorQ, a flexible and powerful software technology for forward-error correction (FEC). Based on technology acquired from Digital Fountain, Qualcomm’s RaptorQ...

FDA issues warnings to marketers of unapproved ‘chelation’ products

October 14, 2010 8:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today warned eight companies that their over-the-counter (OTC) chelation products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products.

FDA: Possible increased risk of thigh bone fracture with bisphosphonates

October 13, 2010 9:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients treated with bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide...

FDA schedules third orphan drug workshop for Nov. 4-5, 2010

October 13, 2010 6:46 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration has scheduled the third in a series of workshops on orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process for Nov. 3-4, 2010, in Lansdowne, Va.

Qualcomm Innovation Center, Inc. Acquires iSkoot Technologies Inc., a Leader in Mobilizing Internet Services on the Handsets Most People Use Today

October 13, 2010 6:46 am | by Qualcomm | News | Comments

SAN DIEGO – October 13, 2010 – Qualcomm Innovation Center, Inc. (QuIC), a wholly owned subsidiary of Qualcomm Incorporated (NASDAQ: QCOM), today announced it has acquired iSkoot Technologies Inc., a newly-formed corporation that has recently received substantially all of the assets of...

Firethorn Joins Forces with Pennsylvania State Employees Credit Union

October 13, 2010 6:46 am | by Qualcomm | News | Comments

ATLANTA and HARRISBURG, Pa. – October 13, 2010 – Firethorn Holdings, LLC, a wholly owned subsidiary of Qualcomm Incorporated (NASDAQ: QCOM), today announced that Pennsylvania State Employees Credit Union (PSECU) has joined its growing list of financial clients and recently began offering...

Abbott Laboratories agrees to withdraw its obesity drug Meridia

October 8, 2010 8:45 am | by U.S. Food & Drug Administration | News | Comments

Meridia, sibutramine, withdrawal

FDA: Potentially harmful stimulant found in Slimming Beauty capsules

October 8, 2010 8:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug...

Mich.'s Bernero takes aim at Snyder's jobs record

October 7, 2010 2:36 pm | by MIKE HOUSEHOLDER - Associated Press Writer - Associated Press | News | Comments

Democrat Virg Bernero took a swipe Thursday at his Republican opponent for governor, Rick Snyder, saying the Ann Arbor businessman who has portrayed himself as a creator of jobs "had a problem" because one of his former companies is leaving Michigan.Medical devices manufacturer HandyLab plans...

Study: Medical device buying rules waste billions

October 6, 2010 11:35 am | by MARLEY SEAMAN - AP Health Writer - Associated Press | News | Comments

A study published Wednesday says hospitals and the federal government could save tens of billions of dollars a year if they changed the way group purchasing organizations — which buy medical supplies in bulk for member hospitals — are compensated.The study said hospitals and health care...

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