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New targeted therapy adds benefit to erlotinib in some patients with advanced lung cancer

A subset of lung cancer patients seem to live longer and experience delays in disease progression when a new drug that targets a cancer-associated molecule called MET is added to treatment with erlotinib, the results of a double-blind Phase-II trial show.

11 Oct 2010

Erlotinib improves progression-free survival as first-line therapy in advanced lung cancer

For patients with advanced lung cancer whose tumors carry EGFR activating mutations, first-line treatment with erlotinib nearly tripled progression-free survival compared to a standard chemotherapy combination, show results from the first prospective Phase-III study to report findings in this setting.

11 Oct 2010

Sexual issues a major concern for cancer patients taking new targeted drugs

New drugs that target specific molecular mechanisms of cancer have improved the treatment of cancer patients in recent years, but those benefits may come with a cost to the patient’s sex life, researchers have found. At the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, Italy, French researchers reported on one of the few studies to investigate the impact of cancer therapy on the sexual functioning of patients.

11 Oct 2010

Early cancer drug trials flawed by inconsistencies in prohibited drug lists, study finds

Researchers in Canada and France have raised concerns about substantial inconsistencies in a basic aspect of the way Phase-I and Phase-II cancer clinical trials are designed.

11 Oct 2010

Attorney Keith Jensen announces $3.78 million settlement with Pfizer on TEN case

Attorney Keith Jensen of the Fort Worth, Texas-based law firm of Jensen, Belew & Gonzalez is announcing a $3.78 million settlement with pharmaceutical manufacturer Pfizer Inc. on behalf of the family of a nine-year-old New York girl who died in June 2004 as the result of a drug-induced disease known as Stevens Johnson Syndrome, which caused all of her skin to peel off.

11 Oct 2010

Sales of Merck's telcagepant and CoLucid's lasmiditan in world's major markets to reach $1.3 billion in 2019

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that two first-in-class agents — Merck's telcagepant and CoLucid's lasmiditan — will earn combined sales of approximately $1.3 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.

11 Oct 2010

Genta announces EMA Orphan Drug designation for tesetaxel

Genta Incorporated today announced that tesetaxel, the leading oral taxane in clinical development, has been designated as an Orphan Drug by the European Medicines Agency for gastric cancer. The drug has previously received Orphan Drug designation by the U.S. Food and Drug Administration for both gastric cancer and melanoma, as well as Fast Track designation by FDA for gastric cancer.

11 Oct 2010

FDA approves Warner Chilcott's ACTONEL for postmenopausal osteoporosis

Warner Chilcott plc today announced that the United States Food and Drug Administration (FDA) has approved its next generation ACTONEL® (risedronate sodium) product for the treatment of postmenopausal osteoporosis in the United States. The product will be marketed as ATELVIA™ (risedronate sodium) delayed-release tablets.

11 Oct 2010

Valeant announces Alexza's receipt of FDA CRL for AZ-004 NDA

Valeant Pharmaceuticals International, Inc. announced today that Alexza Pharmaceuticals, Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding Alexza's New Drug Application (NDA) for AZ-004 (Staccato® loxapine) submitted as Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg.

11 Oct 2010

FDA issues CRL for AZ-004 NDA application

Alexza Pharmaceuticals, Inc. announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato loxapine), submitted as Adusuve Staccato (loxapine) inhalation aerosol, 5 mg and 10 mg.

11 Oct 2010

FDA issues CRL to Jazz for JZP-6 NDA for fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has sent the company a complete response letter (CRL) regarding the company's New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. The CRL states that the FDA cannot approve the NDA in its present form.

11 Oct 2010

FDA warns of harmful stimulant in Slimming Beauty capsules

The U.S. Food and Drug Administration today advised consumers who have Slimming Beauty Bitter Orange Slimming Capsules not to use the product. FDA warns that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions.

11 Oct 2010

HHS awards Sanofi Pasteur 3-year, $56.94M egg supply contract for pandemic vaccine preparedness

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, has been awarded a three-year contract for $56.94 million by the U.S. Department of Health and Human Services (HHS) to maintain flocks to enable manufacturing pandemic influenza vaccine at full capacity on a year-round basis.

11 Oct 2010

Abbott to withdraw sibutramine from Canadian market

Abbott will voluntarily withdraw sibutramine from the Canadian market after discussion with Health Canada. Sibutramine is marketed by Abbott in Canada as Meridia.

11 Oct 2010

Drugs may prevent temporary combativeness in children after surgery

Temporary combativeness after surgery-a complication affecting up to half of anesthetized children-may be preventable with drugs that decrease epinephrine production, according to a Medical College of Georgia pediatric anesthesiologist.

11 Oct 2010

Takeda, Envoy enter three-year research alliance to develop schizophrenia drug

Takeda Pharmaceutical Company Limited, a global pharmaceutical company, and Envoy Therapeutics Inc., a recently formed drug discovery company, today announced that they have formed a three-year research alliance aimed at discovering drugs for schizophrenia that will have greater efficacy and safety compared to current therapies.

11 Oct 2010

Abbott to withdraw Meridia medicine from the U.S. market

Abbott will voluntarily withdraw Meridia (sibutramine) from the U.S. market at the request of the U.S. Food and Drug Administration (FDA).

11 Oct 2010

Researchers create experimental vaccine for Alzheimer's disease

Researchers at UT Southwestern Medical Center have created an experimental vaccine against beta-amyloid, the small protein that forms plaques in the brain and is believed to contribute to the development of Alzheimer's disease.

11 Oct 2010

Meridia – weight loss pill off the shelves in US

Abbott Pharmaceuticals has announced the withdrawal of weight loss drug Meridia from shelves in the United States and urged patients to stop taking it after regulators questioned its safety. The withdrawal happened last Friday in the US. In January, Meridia sales were suspended in Europe.

10 Oct 2010

Weight loss pill off shelves due to heart attack risk

Final verdict on a popular weight loss drug Reductil is to be delivered today. It is being debated whether the pill should be taken off the shelves in Australia and New Zealand. The drug Sibutramine sold as Reductil is linked to increased risk of heart attacks.

10 Oct 2010