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Daily news and top headlines for manufacturing professionals

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...

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...

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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...

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...

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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 Issues Regulatory Science Report

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

Regulatory Science, report, initiative

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 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...

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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...

Deaths prompt CPSC, FDA warning on infant sleep positioners

September 29, 2010 8:46 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) today warned consumers to stop using infant sleep positioners.

Amgen Pulls Anemia Drugs Due To Glass Flakes

September 24, 2010 5:59 am | News | Comments

Biotechnology company is recalling some lots of its Epogen and Procrit anemia treatments because they may contain glass flakes.

Medline Industries Plans Georgia Plant

September 24, 2010 5:04 am | News | Comments

An Illinois-based manufacturer of medical supplies says it plans to open a manufacturing plant in Douglas County, creating 141 jobs.

Qualcomm Joins African Telecommunications Union

September 23, 2010 11:45 am | by Qualcomm | News | Comments

Nairobi, Kenya – September 23, 2010 – African Telecommunications Union (ATU) and Qualcomm Incorporated (NASDAQ: QCOM) today announced that Qualcomm has joined the ATU as an associate member. The Company will work together with the ATU’s 18 other associate members and 46 members toward...

Cleveland Clinic to research head injuries

September 23, 2010 4:36 am | by BARRY WILNER - AP Pro Football Writer - Associated Press | News | Comments

The Cleveland Clinic is combining with helmet-maker Rawlings on independent research of concussions and other sports-related head and neck injuries that could include measuring the impact on the brain.Doctors and scientists from the clinic's Neurological Institute and its Spine Research Laboratory...

Surmodics names former Medtronic exec to board

September 22, 2010 2:36 pm | by The Associated Press | News | Comments

Drug delivery company SurModics Inc. said Wednesday it added a former executive from Medtronic Inc. to its board of directors.Surmodics said Scott Ward will become the company's ninth board member. Ward has spent more than 30 years in the medical device industry, most recently as president of...

Study backs new heart valve without cracking chest

September 22, 2010 1:36 pm | by LAURAN NEERGAARD - AP Medical Writer - Associated Press | News | Comments

Thousands of older Americans who need new heart valves but are too frail to survive the surgery might soon get a chance at an easier option — a way to thread in an artificial aortic valve without cracking their chests.The aortic valve is the heart's main doorway, and a major new study found...

FDA approves first oral drug to reduce MS relapses

September 22, 2010 6:46 am | by U.S. Food & Drug Administration | News | Comments

The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS). (HR)

Report: Obesity hurts your wallet and your health

September 21, 2010 4:35 am | by LAURAN NEERGAARD - AP Medical Writer - Associated Press | News | Comments

Obesity puts a drag on the wallet as well as health, especially for women.Doctors have long known that medical bills are higher for the obese, but that's only a portion of the real-life costs.George Washington University researchers added in things like employee sick days, lost productivity,...

Boston Scientific To Buy Asthmatx

September 20, 2010 10:43 am | News | Comments

Medical device maker will buy privately held Asthmatx Inc. in a deal that could be worth more than $440 million, the company said Monday.

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