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FDA issues a Complete Response Letter regarding NDA for Intermezzo

Transcept Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet).

29 Oct 2009

Cempra Pharmaceuticals stages a presentation on CEM-101

Cempra Pharmaceuticals today announced a presentation on its novel fluoroketolide antibiotic, CEM-101, at the Infectious Diseases Society of America, 47th Annual Meeting, October 29 to November 1, 2009, in Philadelphia.

29 Oct 2009

Treatment of angina patients with ivabradine reduces risk of cardiovascular death

Dramatic reductions in hospitalization for heart attacks and in the need for revascularization surgery were achieved in angina patients treated with the selective heart rate reduction medication ivabradine on top of current standard treatment, according to results of a major clinical study presented today at the 2009 Canadian Cardiovascular Congress in Edmonton.

29 Oct 2009

Modern techniques can reduce current shortage of H1N1 vaccine in the U.S.

President Barack Obama declared H1N1 a national emergency this weekend, a status that will give the federal government greater flexibility and authority to contain the pandemic. But the current shortage of H1N1 vaccine underscores the severe lack of U.S. preparedness in responding to pandemics, whether through natural disease transmission or manmade bioterrorist attacks, according to a new video from the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism.

29 Oct 2009

Dysport drug for treatment of cervical dystonia launched in the United States

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that Dysport® is now available in the United States for the treatment of cervical dystonia in adults.

29 Oct 2009

Steroid-induced osteoporosis can now be treated with Teriparatide

A recent study determined glucocorticoid-induced osteoporosis (OP) is now treatable with Teriparatide, a synthetic form of the human parathyroid hormone. Researchers found patients with glucocorticoid-induced OP who were treated with teriparatide for 36 months had a greater increase in bone mineral density (BMD) and fewer new vertebral fractures than those treated with alendronate.

29 Oct 2009

AAHP confirms homeopathic medicines for prophylaxis of infectious diseases

Recent news articles regarding Swine Flu H1N1 have been widespread. The virulence of the strain among humans and its implications for pandemic disease in humans may lead to increased interest in homeopathic treatments for Swine Flu H1N1.

29 Oct 2009

Iron-folic acid supplements during pregnancy can reduce offspring’s mortality rate

Offspring whose mothers had been supplemented with iron-folic acid during pregnancy had dramatically reduced mortality through age 7, according to researchers at the Johns Hopkins Bloomberg School of Public Health.

29 Oct 2009

New microcapsules can deliver drugs at required target in the body

Scientists in California are reporting development of a new generation of the microcapsules used in carbon-free copy paper, in which capsules burst and release ink with pressure from a pen. The new microcapsules burst when exposed to light, releasing their contents in ways that could have wide-ranging commercial uses from home and personal care to medicine. Their study appears in the Journal of the American Chemical Society, a weekly publication.

29 Oct 2009

No scientific proof that patients with Alzheimer's disease benefit from drugs containing the agent memantine

There is no scientific proof that patients with moderate or severe Alzheimer's disease benefit from drugs containing the agent memantine. This is the conclusion in the final report that the Institute for Quality and Efficiency in Health Care (IQWiG) published in September 2009.

29 Oct 2009

TNF therapy does not raise cancer risk in RA patients; overall cancer risk comparable to those not taking immunosuppressive drugs

A recent study by Swedish researchers found that rheumatoid arthritis (RA) patients did not experience an elevated cancer risk in the first 6 years after starting anti-tumor necrosis factor (TNF) therapy.

29 Oct 2009

iMDsoft and Codonics launch an anesthesia solution with a syringe labeling system

iMDsoft®, a global leader in clinical information systems for perioperative, critical, and acute care, and Codonics of Middleburg Heights, OH, a leading provider of image distribution solutions for the medical industry, have announced an agreement that will complement iMDsoft’s anesthesia solution with an innovative syringe labeling system. The system will be fully integrated with the MetaVision® Anesthesia Information Management System (AIMS).

28 Oct 2009

Nevada case raises question of pharmacies' liability in drug abuse accidents

A Nevada case causes concern for pharmacies about possible liability for actions taken by customers who may abuse drugs. The Wall Street Journal reports on the case of Patricia Copening, who pleaded guilty to reckless driving after her car swerved off a highway and struck and killed a 21-year-old and injured a 33-year-old.

28 Oct 2009

CDC says U.S. H1N1 vaccine supplies on the rise; Senators question government's handling of H1N1 vaccination program

Supplies of the H1N1 (swine flu) vaccine are steadily increasing in the U.S. and should soon be more widely accessible in the next two weeks, the CDC said on Tuesday, CQ HealthBeat reports. During a press briefing, CDC Director Thomas Frieden said that 22.4 million vaccine doses are now available for states to order (Norman, 10/27). "We're beginning to get to significant increases in the availability," Frieden said.

28 Oct 2009

Newspaper investigates dangerous mix of nursing homes and psychotropic drugs

Illinois nursing home patients often receive psychotropic drugs without cause, which poses various health dangers and even death, the Chicago Tribune reports as part of its Compromised Care series.

28 Oct 2009

CDC: H1N1 vaccine supplies on the rise

"More than 22 million doses of swine flu vaccine are available now, and most Americans should soon find it easier to get their dose, U.S. health officials said Tuesday, " according to The Associated Press/The Washington Post.

28 Oct 2009

FDA approves the 100th antiretroviral drug in association with PEPFAR

The U.S. Department of Health and Human Services (HHS) today marked the recent approval of the 100th antiretroviral drug in association with the President's Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide.

28 Oct 2009

Enrollment for Phase 2 clinical study of NKTR-102 completed ahead of schedule

Nektar Therapeutics today announced that it has completed enrollment ahead of schedule in its Phase 2 clinical study of NKTR-102 in platinum-resistant ovarian cancer. NKTR-102 is Nektar's investigational proprietary compound currently being evaluated in Phase 2 clinical development in ovarian, breast and colorectal cancers.

28 Oct 2009

73% increase in antiviral prescriptions in the past two weeks: SDI

According to SDI’s Vector One®: National, antiviral prescriptions rose dramatically last week to over 648,000, an increase of more than 73% in the past two weeks. Antiviral prescriptions have climbed each week since the week ending Aug. 21, but the increases in the past two weeks have been significant.

28 Oct 2009

Controlled trial in UC meets primary endpoint of non- inferiority for reducing ulcerative colitis

Results from the largest prospective controlled ulcerative colitis (UC) trial conducted to date, called the QD dosing investigation for efficacy IN UC maintenance (QDIEM), found that once-daily dosing of Asacol(R) (mesalamine) delayed-release 400 mg tablets at 1.6-2.4 g/day was comparable to twice-daily dosing for the maintenance of remission in patients with UC.

28 Oct 2009