Last year saw the most new drug approvals in the U.S. since 1996, with 39 new chemical entities cleared for marketing. Also this week: ER physicians back a new model for emergency care.

2012: Banner Year for FDA Drug Approval

More new drugs won FDA approval last year than in more than 15 years, with 39 new chemical entities (NCEs) cleared for U.S. marketing in 2012.

It's the highest total since 1996, when 53 new drugs were approved.

The 2012 total was also nearly double the number OK'd in 2010, when the number of NCE approvals was only 21. In 2011, the FDA approved 30 new medicines.

Ed Silverman, who produces the widely read Pharmalot drug-industry blog, noted that eight of the 2012 approvals came in December alone. Two of those came right before the new year -- the oral anticoagulant apixaban (Eliquis) and bedaquiline (Sirturo). The latter is the first drug specifically for multidrug-resistant tuberculosis.

Eleven of the 2012 approvals were for oncology drugs.

ER Docs Call for Integration

The American College of Emergency Physicians (ACEP) backed a "new model" for emergency medicine under which it would be integrated more closely into the overall healthcare system.

The goal, according to an editorial published in the group's flagship journal, Annals of Emergency Medicine, would be to provide better care coordination than is currently the case in most healthcare systems.

ER care should also focus more on outcomes than on merely stabilizing patients, the group indicated.

"It is unclear how emergency departments fit in the new payment models of healthcare reform, but according to this new model of emergency medicine, there should be a much stronger focus on patient care coordination," said Andy Sama, MD, president of ACEP, in a statement.

"And to save money in the healthcare system, the focus must be on reducing hospital admissions, rather than on diverting minor injuries and illnesses from the ER, which has inconsequential savings," he added.

But the group also argued that, no matter what changes in healthcare organization are made, "the ability of emergency departments to respond to disasters and mass casualty events must be preserved."

Another Anti-Amyloid Alzheimer Drug To Be Tested

Yet another drug company has signalled that beta-amyloid protein remains a worthwhile drug target for patients with established cognitive impairments.

EnVivo Pharmaceuticals said it was beginning a phase II trial of a novel agent that modulates the gamma-secretase enzyme, a critical factor in beta-amyloid secretion. The study will evaluate the drug, EVP-0962, in healthy volunteers and in patients with mild cognitive impairment or "early" Alzheimer's disease.

The compound does not completely inhibit gamma-secretase, which the company believes will help it perform better than previous agents with the same target. Those drugs failed to show benefit in late-stage clinical testing.

Indeed, those failures had persuaded many in the Alzheimer's disease community that, once mental impairments have become apparent, it is too late to slow the cognitive decline by targeting beta-amyloid.

But in recent weeks, both Eli Lilly and Merck announced major new trials of anti-amyloid agents in patients with symptomatic Alzheimer's disease, with EnVivo now following suit.

CDC: Sleepy Drivers Abound

More than 4% of adult drivers in a large government survey admitted to falling asleep at the wheel in the previous month, the CDC reported last week.

Among nearly 150,000 adult participants in the Behavioral Risk Factor Surveillance Survey in 2009 and 2010, 4.2% responded "yes" when asked whether they had "nodded off or fallen asleep" while driving in the past 30 days.

Men and respondents indicating that they normally slept no more than 6 hours nightly, as well as those who reported frequent snoring, were more likely to acknowledge driving while sleepy, according to an article in the CDC Morbidity and Mortality Weekly Report.

The American Academy of Sleep Medicine seized on the report to urge "the importance of seeking treatment for an ongoing sleep illness such as sleep apnea."

The group noted that snoring is often a sign of sleep apnea, which in turn reduces sleep efficiency and contributes to daytime drowsiness.