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FDA approves Vivitrol for treatment of opioid-dependent patients

The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

13 Oct 2010

Vaccine lawsuits – Justices divided

The US Supreme Court is seemingly divided over the lawsuits on childhood vaccines. The Justices acquiesced that the Congress has done its bit to shield vaccine-makers from suits by the few who have had an adverse reaction to a vaccine approved by the Food and Drug Administration. Now the matter revolves around whether those hurt by vaccines have the right to sue manufacturers if they can prove that a safer version was available.

12 Oct 2010

Smart for Life(R) to add Lepticore(R) to product line

Smart for Life(R), the trailblazing company featuring weight management products will begin adding Lepticore(R) to its product line this month.

12 Oct 2010

EMA approves TWYNSTA therapy that reduces BP in hypertensive patients

Boehringer Ingelheim announced today that the European Commission confirmed the positive opinion of the European Medicines Agency (EMA) approving TWYNSTA. TWYNSTA is indicated for the treatment of hypertension in adults whose blood pressure is not adequately controlled on amlodipine or as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets containing the same component doses.

12 Oct 2010

Lundbeck, Merck announce commercialization agreement for SYCREST sublingual tablets

H. Lundbeck A/S (Lundbeck) and Merck, known outside the United States and Canada as MSD, today announced a commercialization agreement for SYCREST (asenapine) sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck will pay an undisclosed fee as well as product supply payments in exchange for exclusive commercial rights to SYCREST in all markets outside the United States, China and Japan. Lundbeck expects to launch SYCREST in the European Union (EU), where it is already approved, at the beginning of 2011.

12 Oct 2010

Abbott agrees to voluntarily withdraw obesity drug Meridia from U.S. market

Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.

12 Oct 2010

Study finds no link between AMD treatments and increase in cardiovascular complication

Newer treatments for age-related macular degeneration (AMD)-including an intravitreous (into the eye) injection of a chemotherapy drug and use of a related compound approved for use against the eye disease-do not appear to be associated with an increased risk of cardiovascular complications or death when compared with existing therapies, according to a report in the October issue of Archives of Ophthalmology, one of the JAMA/Archives journals.

12 Oct 2010

Folic acid supplement does not reduce cardiovascular events, cancer or death

Use of folic acid supplements appears to lower blood levels of the amino acid homocysteine—theorized to be a risk factor for heart and blood vessel disease—but does not appear to be associated with reduced rates of cardiovascular events, cancer or death over a five-year period, according to a meta-analysis of previously published studies in the October 11 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

12 Oct 2010

Combination therapy for ovarian cancer leads to greater toxicity

Adding topotecan to carboplatin plus paclitaxel, the standard treatment for ovarian cancer, does not improve progression-free survival in patients and leads to greater toxicity, according to a study published online October 11 in the Journal of the National Cancer Institute.

12 Oct 2010

Women with epilepsy at risk of infertility

Women with epilepsy may be more likely to experience infertility, according to new research published in the October 12, 2010, print issue of Neurology, the medical journal of the American Academy of Neurology.

12 Oct 2010

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