Pharmaceutical News

RSS

Pfizer receives FDA approval for Eraxis to treat candidemia

Pfizer said today that Eraxis (anidulafungin) has been approved by the U.S. Food and Drug Administration to treat candidemia, a potentially life-threatening bloodstream infection. Candidemia is the most deadly of the common hospital-acquired bloodstream infections, with a mortality rate of approximately 40 percent.

21 Feb 2006

Blood clot warning to go on Ortho Evra birth control patch

The U.S. Food and Drug Administration (FDA) says early results of a new study show that women who use the Ortho Evra contraceptive patch are twice as likely to develop blood clots than others who took a birth control pill.

19 Feb 2006

Lessons for clinical trials from natalizumab in multiple sclerosis

Concerns over the fast tracking of new drugs for commercial licensing are raised by a senior doctor in this week's British Medical Journal.

17 Feb 2006

New flu vaccine takes weeks to mass produce

Using cell-based methods researchers have developed a commercially viable method for mass producing effective vaccines against potential pandemic influenza strains in weeks instead of the months required for traditional egg-based vaccines.

17 Feb 2006

Diabetics warned against using antibiotic drug Tequin

The Food and Drug Administration in the U.S. have issued strong warnings concerning the use of the antibiotic drug Tequin.

16 Feb 2006

Stealthyx Therapeutics and Cancer Research Technology announce co-development partnership for tumour-targeted therapy

Cancer Research Technology (CRT), the specialist oncology development and commercialisation company, and Stealthyx Therapeutics, the disease targeting drug company spin out of Queen Mary, University of London have entered into an agreement to co-develop Stealthyx’s proprietary drug delivery platform, Prothyx.

16 Feb 2006

New FDA report says earlier meetings w/FDA make drug review process more efficient

The FDA has released a new report that takes carefully examines the way the agency reviews applications for drugs and biologics that have not previously been approved by the FDA.

16 Feb 2006

WHO to take action against fake drug racket

The World Health Organization (WHO) has appealed for international action against fake and mislabelled medicines.

16 Feb 2006

British woman loses Herceptin court battle

A mother of three in the UK suffering from the early-stage of an aggressive form of breast cancer, has lost her high court battle to force her health authority to pay for the potentially life-saving drug Herceptin.

16 Feb 2006

So much for openness and enhanced oversight at FDA drug safety board!

The Drug Safety Oversight Board, created in February 2005, was originally introduced as a measure to speed up and help regulators respond to signs of unexpected side effects following a new drug hitting the market.

13 Feb 2006

Acne drug which causes birth defects too hard to monitor

According to the birth watchdog group the March of Dimes, preventing birth defects from a widely used acne drug is too heavy a burden on doctors, patients and pharmacists.

13 Feb 2006

Genzyme launches test to monitor Gleevec resistance

Genzyme Corporation has announced the availability of an important new test to monitor drug resistance in chronic myeloid leukemia (CML) patients who are treated with Gleevec (imatinib mesylate).

13 Feb 2006

FDA affirms safety of Aspartame

The Calorie Control Council has stated that a rat study conducted by Italy's Ramazzini Institute is totally contradictory to the extensive scientific research and regulatory reviews conducted on aspartame. The U.S. Food & Drug Administration (FDA) has said they are not recommending any changes in the use of aspartame.

13 Feb 2006

Heart risk warning wanted on ADHD drugs

A U.S. advisory panel has recommended that drugs used by millions to treat attention deficit hyperactivity disorder (ADHD), should carry a warning of the risk of heart problems.

12 Feb 2006

Sanofi pasteur delivers more H5N1 vaccines to U.S. Government

Sanofi pasteur has delivered more H5N1 vaccine to the U.S. government including investigational doses formulated with an adjuvant.

7 Feb 2006

FDA grants fast track status for ViroPharma's Maribavir

ViroPharma Incorporated has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for maribavir, an oral antiviral drug candidate for the prevention of cytomegalovirus (CMV) infection in allogeneic bone marrow (stem cell) and solid organ transplant patients.

7 Feb 2006

Viragen reports on Multiferon anti-viral studies

Viragen, Inc today reported on the progression of anti-viral studies using Multiferon (multi-subtype, natural human alpha interferon) being conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).

7 Feb 2006

Bristol-Myers Squibb and Otsuka Pharmaceutical announce availability of 2 mg Abilify (aripiprazole) tablet

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced two newly available options of Abilify (aripiprazole) -- a 2 mg tablet strength and a nonrefrigerated oral solution (1 mg/mL).

7 Feb 2006

Monotherapy phase I clinical trials of novel cytotoxics, targeted therapeutics, antimetastatic agents/angiogenesis inhibitors, and immunotherapeutics/vaccines

Numerous novel oncology agents are currently in phase I monotherapy trials. New Medicine's Oncology KnowledgeBASE (nm|OK) has updated the records of 92 such agents with preclinical or clinical results reported during the 2005 meetings of the American Association for Cancer Research (AACR)

7 Feb 2006