Pharmaceutical News

RSS

FDA reinforces use of Sustiva in first-line HIV combination therapy

Bristol-Myers Squibb has announced that Sustiva® (efavirenz) has received approval from the U.S. Food and Drug Administration to include new long-term virologic and clinical data from BMS Study 006 in its prescribing information.

26 Aug 2004

Phase 1 clinical trial of new anticancer drug from Human Genome Sciences

Human Genome Sciences has begun dosing patients in a Phase 1 clinical trial of HGS-TR2J, a novel agonistic human monoclonal antibody to TRAIL Receptor 2, in patients with advanced solid malignancies.

25 Aug 2004

Cymbalta, a new treatment for major depression

Cymbalta, a new treatment for major depression, is now available by prescription in pharmacies across the United States, Eli Lilly and Company have announced.

25 Aug 2004

U.S. to vigorously defend against Vermont's lawsuit on importing drugs from Canada

The lawsuit seeks declaratory and injunctive relief based on FDA's denial of the State of Vermont's December 4, 2003, citizen petition requesting that the Vermont State Employee Medical Benefit Plan (VSEMBP) be allowed to establish a program for the importation of prescription drugs from Canada.

25 Aug 2004

Powerful new cancer-fighting property of Herceptin

For many patients with advanced breast cancer, the cancer drug Herceptin (trastuzumab) has offered new hope when traditional cancer drugs failed to work, shrinking tumors and sending some patients into remission.

23 Aug 2004

Pfizer receives approval for acute bipolar mania drug

Pfizer has announced that the U.S. Food and Drug Administration (FDA) has approved the use of its atypical antipsychotic Geodon(R) (ziprasidone HCI) for the treatment of acute bipolar mania including manic and mixed episodes.

23 Aug 2004

Genmab's HuMax-CD4 receives U.S. orphan drug designation

Genmab has announced that HuMax-CD4 for the treatment of Mycosis Fungoides (MF), which constitutes 75% of all Cutaneous T-cell Lymphomas (CTCL), has been designated an orphan drug by the US Food and Drug Administration (FDA). The US prevalence of MF is estimated at 16,000 to 20,000.

23 Aug 2004

Pfizer drug effectively treats overactive bladder symptoms

Women with mixed incontinence, a combination of overactive bladder and stress incontinence, reported a greater treatment benefit for overactive bladder symptoms from DETROL® LA (tolterodine tartrate extended release capsules) than placebo, according to new study results published in the August issue of Urology.

21 Aug 2004

Current information on the use of antidepressants in pediatric patients

The Food and Drug Administration has issued an update to provide health care providers and patients with the most current information on the use of antidepressants in pediatric patients.

21 Aug 2004

Consumer education campaign warning Connecticut residents of the dangers of illegal drug importation

Connecticut became the sixteenth state to join forces with the FDA to launch the "Looks Can Be Deceiving" educational campaign. During a press conference in Hartford, officials from CPA unveiled examples of the more than 40,000 flyers and prescription bag inserts that have been sent to 166 pharmacies across Connecticut.

18 Aug 2004

FDA fast tracks temsirolimus, first-line treatment of poor-prognosis patients with advanced renal cell carcinoma

Wyeth Pharmaceuticals has announced that the U.S. Food and Drug Administration has granted a new "fast track" designation for temsirolimus (CCI-779), an investigational mTOR kinase inhibitor, in the first-line treatment of poor-prognosis patients with advanced renal cell carcinoma (RCC).

18 Aug 2004

New guidelines urge early and long-term treatment with Aldosterone blockade therapy

Patients who have had a recent heart attack with ST-elevation (ST-Elevation Myocardial Infarction, or STEMI), complicated by heart failure should be treated with aldosterone blockers according to new guidelines issued recently by the American College of Cardiology (ACC) and the American Heart Association (AHA).

17 Aug 2004

Insomnia drug market will exceed $5.6 billion in 2013

The new Pharmacor study entitled Insomnia finds that upcoming launches of three new drugs from Sepracor, Pfizer, and Sanofi-Aventis will drive the market.

16 Aug 2004

Wyeth wins four combined diet drug cases

Wyeth has announced that the jury deliberating over four combined diet drug cases in the Court of Common Pleas of the First Judicial District of Pennsylvania has returned a verdict in favor of the Company.

13 Aug 2004

Drug company fights to keep toxin in vaccines

The UK announced Saturday they will remove the mercury preservative Thimerosal from their vaccines. The news comes days after an LA Times article reported that Aventis-Pasteur, a pharmaceutical giant, is pushing to keep the toxin in U.S. vaccines.

13 Aug 2004

Thyroid expert concerned about recently approved generic levothyroxine preparations

Levothyroxine is taken by more than 13 million Americans to treat an underactive thyroid, thyroid gland enlargement, nodules, or cancer. In June, the Food and Drug Administration (FDA) ruled that several generic levothyroxine preparations had the same clinical effect and safety profile as certain branded products.

11 Aug 2004

The U.S. FDA approves 2 drugs for treating radiation contamination

The U.S. Food and Drug Administration has approved two drugs, pentetate calcium trisodium injection (Ca-DTPA) and pentetate zinc trisodium injection (Zn-DTPA) for treating certain kinds of radiation contamination. The FDA is approving these two drugs as part of its ongoing effort to provide the American public the best available protection against nuclear accidents and terrorist threats.

11 Aug 2004

John Kerry outlines plan to bring down the costs of prescription drugs

Armed with the endorsement of the Alliance for Retired Americans, Democratic Presidential nominee John Kerry Wednesday outlined his plan to bring down the costs of prescription drugs as part of his overall plan to make health care more affordable for all Americans.

11 Aug 2004

IBM and Cellomics offer new solution to accelerate cell-based drug discovery

IBM and Cellomics have announced they have launched a customized information technology (IT) solution that allows biopharmaceutical scientists and academic researchers to better understand how potential drug candidates or targets of interest affect cellular function.

11 Aug 2004

Genentech announces FDA approval of Avastin manufacturing

Genentech has announced that the U.S. Food and Drug Administration approved the supplemental Biologics License Application (sBLA) for the manufacturing of Avastin™ (bevacizumab) bulk drug substance at the company's facility in Vacaville, California.

11 Aug 2004