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HGS and GSK announce results from phase III clinical trials of BENLYSTA

Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today announced positive results from BLISS-76, the second of two large-scale phase III clinical trials of BENLYSTA(TM) (belimumab) for treating systemic lupus. A full presentation of results from BLISS-52 was recently shared at the 73rd Annual Scientific meeting of the American College of Rheumatology. Both trials succeeded in meeting their primary endpoints, which should make BENLYSTA eligible for approval by the U.S. Food and Drug Administration (FDA).

2 Nov 2009

Gilead Sciences to present Viread Phase III clinical trial data

Gilead Sciences, Inc. today announced the presentation of three-year (144-week) open label data from two pivotal Phase III clinical trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread® (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus (HBV) infection.

2 Nov 2009

Obese Britons suffer the real cost of obesity in every area of their lives, says new study

Half of Britain's obese are seriously damaging their wealth prospects as well as their health, a new study has revealed.

1 Nov 2009

Congressman Mike Thompson lauded for endorsing the Lung Cancer Mortality Reduction Act

Today, Lung Cancer Alliance (LCA) praised Congressman Mike Thompson (D-CA) for his endorsement of the Lung Cancer Mortality Reduction Act of 2009. Thompson joins Representatives Michael Honda (D-CA), Barbara Lee (D-CA) and Lucille Roybal-Allard (D-CA) in strengthening California's Congressional support for this critically needed legislation.

31 Oct 2009

Response and investigation of the outbreak of foodborne illnesses vary greatly

A survey of state health departments regarding their capacity to track produce-related foodborne illnesses found that the response and investigation of outbreaks varies greatly and can lead to delays in public-health response.

31 Oct 2009

Philadelphia coalition calls on U.S. Chamber President to end his campaign against health care reform

The President of the U.S. Chamber of Commerce was greeted in Philadelphia today by a coalition demanding that he end his campaign against health care and clean energy reform.

31 Oct 2009

RESPOND program to improve global perspective on emerging diseases

Experts from the University of Minnesota will soon be on the frontlines working to help developing countries better respond to emerging animal diseases that pose a threat to human health.

31 Oct 2009

Shire announces Phase IIIb study results of Daytrana

Shire plc, the global specialty biopharmaceutical company, today announced findings at a major medical meeting from a Phase IIIb study of the tolerability and effectiveness of Daytrana® (methylphenidate transdermal system) in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

31 Oct 2009

New study results of INTUNIV presented at a major psychiatric medical meeting

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended Release Tablets, at a major psychiatric medical meeting today.

31 Oct 2009

Schering-Plough receives FDA complete response letter regarding PEGINTRON

Schering-Plough Corp. announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.

31 Oct 2009

Shire announces third quarter 2009 financial results

Shire plc, the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.

31 Oct 2009

Exposure to mercury-based preservative in vaccines is minimal, says researchers

The injectable, multi-dose H1N1 vaccine contains the mercury-based preservative thimerosol to reduce risks of bacterial contamination. The presence of thimerosol has once again raised concerns whether there are risks posed to children when the tiny amount of mercury contained in thimerosol is included in a vaccine.

31 Oct 2009

Replenish+ delays the progression of AIDS in HIV-infected patients not receiving ART

Data presented today from a 310 patient, 52 week, double-blind, controlled clinical trial demonstrates that a micronutrient supplement, Replenish+™ delays the progression of AIDS in HIV-infected patients not receiving antiretroviral treatment (ART).

31 Oct 2009

Revised standards for four ingredients widely used in prescription and over-the-counter drugs announced

To further protect patients from adulterated medicines, the U.S. Pharmacopeial Convention (USP) today announced revised standards for four ingredients widely used in prescription and over-the-counter drugs.

31 Oct 2009

Procter & Gamble's Vicks products containing vitamin C being marketed unlawfully, FDA warns

The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.

31 Oct 2009

FDA approves Covidien's Abbreviated New Drug Application for CII

Covidien, a leading global provider of healthcare products, today announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Oral Transmucosal Fentanyl Citrate (CII).

31 Oct 2009

FDA approves an expanded indication for BYETTA injection

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes.

31 Oct 2009

Recent releases in Global Health

"Action always leads to reaction, a fundamental law of nature," write the authors of an introduction appearing in a Journal of Acquired Immune Deficiency Syndromes (JAIDS) supplemental issue that focuses on global health systems.

30 Oct 2009

ABC News reports on U.S. food aid policy

ABC News examines U.S. food aid policy, which "requires that food aid money be spent on food grown in the U.S., at least half of it must be packed in the U.S. and most of it must be transported in U.S. ships." But "critics are complaining that" these policies are "exacerbating the cycle of starvation."

30 Oct 2009

Impax Laboratories initiates patent challenge for TRICOR

Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICOR® (fenofibrate) tablets, 48 mg and 145 mg.

30 Oct 2009