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Nonprescription drug manufacturing and marketing costs increase: Kline

A number of costs associated with nonprescription drug manufacturing and marketing have increased over the past two and a half years. Certain material costs for plastic bottles and blister packs have risen by double digits during this time, increasing packaging expenses.

21 Oct 2010

FDA asks manufacturers to add new warnings to labeling of prostate cancer drugs

The U.S. Food and Drug Administration today asked manufacturers to add new warnings to labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer.

21 Oct 2010

PMAI offers new addiction treatment options for opioid dependence

Punyamurtula S. Kishore MD, MPH, FASAM, of Preventive Medicine Associates, Inc. (PMAI), the largest outpatient substance dependence provider in Massachusetts, announced today his 37 clinical locations will be offering new addiction treatment options through the use of VIVITROL (naltrexone for extended-release injectable suspension), which was approved on Tuesday, October 12, 2010 by the U.S. Food and Drug Administration (FDA) for the prevention of relapse to opioid dependence.

21 Oct 2010

Valensa enters agreement with Mercola for Flex Pro ES formulation

Valensa International and Mercola Health Resources, LLC announced today that they have entered into a license and supply agreement that provides Mercola Health Resources with Valensa's new Flex Pro ES(TM) joint health formulation.

21 Oct 2010

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

FDA approves Herceptin with chemotherapy for HER2-positive metastatic cancer

Genentech, a member of the Roche Group today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin (trastuzumab) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic (cancer that has spread) cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for their metastatic disease.

21 Oct 2010

Cipla launches generic Pirfenidone for IPF

Cipla, among the world's leading generic pharmaceutical companies, has introduced Pirfenidone in India under the brand name Pirfenex, for the treatment of IPF. A chronic progressive form of lung disease, IPF has average survival rates as low as 3-5 years which is less than many cancers. Till now there is no approved treatment for IPF.

20 Oct 2010

BREAKYL drug receives European approval

BioDelivery Sciences International, Inc. and Meda today announced approval of BEMA Fentanyl in Europe via the Decentralized Procedure, with Germany acting as Reference Member State.

20 Oct 2010

Pfizer enters partnership with Teuto to develop, commercialize generic medicines

Pfizer Inc. announced today that it is entering into a partnership with Laboratorio Teuto Brasileiro S.A., a leading company in the Brazilian generics industry, to develop and commercialize generic medicines.

20 Oct 2010

CRN reinforces importance of DHA before, during and after pregnancy

In response to a study regarding fish oil use during pregnancy published in the October 19 issue of the Journal of the American Medical Association (JAMA), the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement industry, reminds pregnant and lactating women of the undisputed importance of consuming the recommended amounts of docosahexaenoic acid (DHA) throughout pregnancy.

20 Oct 2010

PBS-Bio announces three new contracts to develop cancer therapy

In an industry that faces increasing challenges in delivering new drugs to patients, Predictive Biomarker Sciences (PBS-Bio) today announced three new contracts aimed at bringing new medicines to the marketplace.

20 Oct 2010

$More studies needed on bisphosphonates therapy and fracture risk$

More studies needed on bisphosphonates therapy and fracture risk

On October 13, the Food and Drug Administration published a warning to doctors and patients about an increased risk of thigh fractures with a widely used group of bone-strengthening drugs called bisphosphonates. This warning was much awaited in the light of a report published in the American Journal of Bone and Mineral Research in September titled "Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Report of a Task Force of the American Society for Bone and Mineral Research."

20 Oct 2010

Pharsight launches Phoenix Pharmacometric Productivity Challenge

Pharsight, a market-leading provider of software and scientific consulting services to improve productivity and decision-making in clinical drug development, announced today that it has launched the Phoenix Pharmacometric Productivity Challenge, a competition to recognize excellence in the application of pharmacometric software to critical problems in drug development.

20 Oct 2010

FDA approves Boehringer Ingelheim's Pradaxa for stroke risk reduction in patients with non-valvular AF

The US Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate), Boehringer Ingelheim's novel, oral direct thrombin inhibitor for stroke risk reduction in patients with non-valvular atrial fibrillation (AF) marking the first approval of a new oral anticoagulant in the U.S. in more than 50 years.

20 Oct 2010

Nitric oxide inhalation reduces pain in sickle cell disease patients

Inhaling nitric oxide appears to safely and effectively reduce pain crises in adults with sickle cell disease, researchers report.

20 Oct 2010

Aspirin before cardiac surgery reduces postoperative cardiocerebral complications

A study presented at the American Society of Anesthesiologists 2010 Annual Meeting revealed that use of aspirin before cardiac surgery reduced postoperative cardiocerebral complications, including stroke, myocardial ischemia, heart block and cardiac arrest by more than 33 percent when compared to patients who did not use aspirin.

20 Oct 2010

Study finds ketamine-propofol combination effective for pediatric procedural sedation

Procedural sedation and analgesia is an essential element of care for children requiring painful procedures in the emergency department. The practice of combining ketamine and propofol, two common medications used in emergency departments, has become more popular. However, until recently, it was unclear whether this practice was superior to the use of either agent alone, especially in children.

20 Oct 2010

Particle Sciences enters licensing, technology agreement with Solubest

Particle Sciences Inc. (PSI), a leading pharmaceutical CRO and SoluBest have entered into a licensing and technology development agreement. Under the agreement, Particle Sciences will be the exclusive contract research provider in the U.S. for SoluBest's Solumer technology.

20 Oct 2010

Salix acquires rights to colon cancer screening agent from Photocure

Salix Pharmaceuticals, Ltd. today announced that the Company has acquired rights to Lumacan™ from Photocure, a Norwegian specialty pharmaceutical company. Lumacan is a novel agent designed to assist in the detection of precancerous and cancerous lesions in the colon.

20 Oct 2010

Osteoporosis drug heals bone wounds in gum disease patients

A drug marketed to grow bone in osteoporosis patients also works to heal bone wounds in gum disease patients, a University of Michigan study suggests.

20 Oct 2010