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The Partnership at Drugfree.org issues statement on FDA approval of VIVITROL for opioid dependence

The U.S. Food and Drug Administration's approval of Alkermes' opioid dependence medication (VIVITROL) for the prevention of relapse to opioid dependence following opioid detoxification is positive news for families of young adults and all those who are struggling to overcome opioid addiction. Addiction, a disease of the human brain, is a chronic illness while opioid dependence is frequently characterized by relapse.

13 Oct 2010

LifeWise improves access to common immunizations at pharmacies

LifeWise Health Plan of Oregon is announcing a new step to remove barriers to care by providing improved access to common immunizations at pharmacies. LifeWise members can now simply present their member card at a pharmacy just as they do at their doctor's office to receive immunizations.

13 Oct 2010

BioRx receives limited distribution rights from Baxter for AATD drug GLASSIA

BioRx, a specialty pharmacy company, has received limited distribution rights from Baxter International Inc. for a new drug, GLASSIA™ [Alpha 1-Proteinase Inhibitor (Human)], the first and only liquid, ready-to-use treatment for alpha-1 antitrypsin deficiency (AATD) in the United States. AATD is a genetic disorder that causes low levels of alpha 1-antitrypsin, resulting in emphysema. AATD is also referred to as "genetic" or "congenital" emphysema.

From Baxter International Inc. 13 Oct 2010

CyDex terminates joint development agreement on Captisol-enabled clopidogrel with Prism Pharmaceuticals

CyDex Pharmaceuticals, Inc. today announced a mutual decision with Prism Pharmaceuticals to terminate their existing joint development agreement on novel Captisol-enabled® intravenous formulations of clopidogrel. This provides CyDex with full development and commercialization rights to the product candidate - an injectable formulation of clopidogrel. Clopidogrel is the active ingredient in PLAVIX®, an orally available antiplatelet drug, which currently is marketed by Bristol-Myers Squibb Company and Sanofi-Aventis, Inc.

13 Oct 2010

B. Braun Medical announces availability of FDA-approved Cefepime in DUPLEX System

In an effort to meet industry demands for expanded Cephalosporin offerings delivered to patients through safe and accurate administration, B. Braun Medical Inc. (B. Braun) announced that FDA-approved 1g and 2g Cefepime for Injection USP and Dextrose Injection USP in B. Braun Medical Inc.'s DUPLEX Drug Delivery System will be available for purchase beginning today.

From B. Braun Melsungen AG 13 Oct 2010

Alkermes' VIVITROL medication for treatment of opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL(naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification.

13 Oct 2010

High Court to hear vaccine case

The New York Times: A Supreme Court case scheduled for today will examine whether the 1986 National Childhood Vaccine Injury Act should protect manufacturers from "virtually all product liability lawsuits."

13 Oct 2010

Auxilium receives USPTO patent for XIAFLEX product

Auxilium Pharmaceuticals, Inc. a specialty biopharmaceutical company, today announced that the United States Patent and Trademark Office issued U.S. Patent No. 7,811,560 claiming, among other things, purified collagenase, the active component in Auxilium's product XIAFLEX (collagenase clostridium histolyticum).

13 Oct 2010

Centice introduces new PINPOINT Rx system for drug identification

Centice Corporation, a pioneer in chemical verification and identification using Raman spectroscopy and computational sensor technology, announced today the availability of the new PINPOINT Rx™ system. Combining advanced spectroscopy hardware technology, analytical software and internal databases, PINPOINT Rx™ captures the spectral signature of a prescription drug and checks this signature against a known database.

13 Oct 2010

More insured Americans avoid prescription drugs due to cost

The Wall Street Journal: "Growing numbers of Americans with health insurance are walking away from their prescriptions at the pharmacy counter, the latest indication that efforts to contain costs may be curbing health-care consumption. A review of insurance-claims data shows that so-called abandonment — when a patient refuses to purchase or pick up a prescription that was filled and packaged by a pharmacist — was up 55% in the second quarter of this year, compared with four years earlier.

13 Oct 2010

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