Founder of Sorenson Companies and the wealthiest man in Utah, James L. Sorenson, passed away at the age of 86 on January 20.  He was known for being a generous philanthropist, medical pioneer, and real estate investor.

Sorenson overcame dyslexia to invent the disposable surgical mask in the 1950s.  Then he invented the first real-time computerized heart monitoring systems and the automated intravenous drug pump.

The entrepreneur also donated millions to a wide variety of causes – from medical facilities to religious organizations.  According to Forbes magazine’s 2007 rankings, Sorenson’s net worth is estimated at $4.5 billion.

Johnson & Johnson Pharmaceutical Research & Development has submitted an NDA (New Drug Application) for its tapentadol hydrochloride immediate release (IR) tablets to the FDA. Tapentadol is an investigational oral analgesic for treating moderate to severe acute pain. Clinical studies show that tapentadol has efficacy comparable to strong opioids. Over 25 million Americans suffer from acute pain every year, according to the American Pain Foundation.

Teva Pharmaceutical Industries Ltd. has received tentative FDA approval for its ANDA (abbreviated new drug application) to market a gastric-acid pump inhibitor. Teva is currently in patent dispute litigation over the product, which is a generic form of TAP Pharmaceutical’s drug Prevacid (Lansoprazole) Delayed-release Capsules, 15 mg and 30 mg.

A diet comprising mainly of meat and fried foods increases the risk of developing metabolic syndrome, according to research published in Circulation: Journal of the American Heart Association. Metabolic syndrome refers to the presence of three or more cardiovascular risk factors, including obesity, high blood pressure, elevated blood sugar and low levels of HDL (high-density lipoprotein or “good”) cholesterol.

The study also confirmed an earlier finding that the consumption of diet soda raises the risk of metabolic syndrome. Dairy products were found to prevent metabolic syndrome to some extent.

A new study has found that Nexavar, a drug used for the treatment of kidney and liver cancer, can substantially raise blood pressure. According to the authors of the study, published in U.K. medical journal Lancet Oncology, patients on Nexavar (sorafenib) should be closely monitored and treated for high blood pressure in order to prevent cardiovascular problems.

Nexavar, which is being co-developed by Bayer AG and Onyx Pharmaceuticals Inc., is now being reviewed for treating small-cell lung cancer, prostate cancer and melanoma. Bayer said the drug’s high-blood-pressure risks are covered by the labeling.

Women undergoing breast surgery have a more than 5% chance of developing surgical site infections, according to a study published in the January issue of Archives of Surgery. Such infections could result in hospital bills exceeding $4,000, researchers at the Washington University School of Medicine said. On average, it took 47 days after surgery for the diagnosis of an infection to be made.

The researchers added that the incidence of infection could be lowered by measures including “strategies to optimize the timing and dosage of prophylactic antibiotics administered before the surgical incision, glucose control in diabetic patients, promotion of meticulous hand hygiene, and strategies to promote timely removal of drains.”

Abiomed Inc. has received FDA approval, under special humanitarian device exemption, for system upgrades to its AbioCor implantable artificial heart. The device replaces severely damaged hearts for patients who are not eligible for a transplant or alternative treatment. The approval restricts the device from being sold to more than 4,000 patients in the U.S. per year. The company expects to charge $250,000 per AbioCor unit.

The FDA Humanitarian Device Exemption (HDE) is an application that is similar to the FDA premarket approval (PMA) application. An HDE is granted for an HUD (Humanitarian Use Device), which, according to the FDA, is a:

“Medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.”

St. Jude Medical Inc. has received FDA approval for software and firmware updates to its Internet-based data management system for implantable cardiac devices. The Merlin.net PCN (Patient Care Network) will now enable doctors to remotely monitor patients nationwide, who send data via phone lines. The updated version also allows patients with these implantable cardiac devices to transmit data from outside the U.S.

Johnson & Johnson has received FDA approval for its anti-HIV drug Intelence for treating patients resistant to other HIV therapies. The FDA had granted the drug, which is also known as etravirine or TMC125, a priority review status. The company expects to make the drug available in the U.S. wholesale market within a week. The drug is still awaiting approval in Canada, Europe, Australia, Switzerland and Russia.

Virginia House has voted for a delay in the mandating of the vaccination of sixth-grade schoolgirls against a sexually-transmitted virus that can cause cervical cancer. The vote was to delay the implementation of the mandatory HPV (human papillomavirus) vaccination to July 2010 from October 2008. Virginia was the first U.S. state to make the vaccination mandatory last year. The delay allows for more time for studying the vaccine’s effects on young girls.