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Daily news and top headlines for manufacturing professionals

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

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...

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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...

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.

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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...

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.

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: 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...

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...

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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...

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.

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...

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

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...

FDA awards $904,000 to Pan American Health Organization for information ‘hub’

October 6, 2010 8:45 am | by U.S. Food & Drug Administration | News | Comments

PAHO

FDA Issues Regulatory Science Report

October 6, 2010 8:45 am | by U.S. Food & Drug Administration | News | Comments

Regulatory Science, report, initiative

FDA awards nearly $3 million for TB research

October 6, 2010 5:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today announced the award of $2.9 million to support six research projects that will help with the diagnosis, treatment, and prevention of tuberculosis (TB).

FDA schedules public hearing on Biologics Price Competition and Innovation Act

October 4, 2010 6:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration has scheduled a two-day public hearing on Nov. 2 - 3, 2010, on the implementation of the Biologics Price Competition and Innovation (BPCI) Act of 2009. The hearing will be held from 8:30 a.m. to 4:30 p.m. at the FDA’s White Oak Campus, 10903 New...

No laps for warm laptops; skin damage is possible

October 4, 2010 5:35 am | by LINDSEY TANNER - AP Medical Writer - Associated Press | News | Comments

Have you ever worked on your laptop computer with it sitting on your lap, heating up your legs? If so, you might want to rethink that habit.Doing it a lot can lead to "toasted skin syndrome," an unusual-looking mottled skin condition caused by long-term heat exposure, according to medical...

FDA Orders Halt to Marketing of Unapproved Single-Ingredient Oral Colchicine

September 30, 2010 10:45 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial...

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