Archive for the 'Pharmaceutical products' Category

A Step Towards A New Therapy For Chronic Bowel Disease

Scientists associated with VIB (Flanders Institute for Biotechnology) and Ghent University (UGent) have discovered that A20 protein plays an important protective role in diseases associated with chronic bowel inflammation. This makes A20 into a promising therapeutic target for the development of new anti-inflammatory drugs. The NF-kB protein plays a critical role in the inflammatory response and is activated by e.g. TNF, which is produced by the white blood cells.

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Mylan Receives FDA Approval For Nabumetone

Mylan Inc. received the FDA approved for its generic version of the osteoarthritis and rheumatoid arthritis drug Nabumetone. The FDA approval allows Mylan to sell 500 milligram and 750 milligram tablets of Nabumetone. It is a nonsteroidal anti-inflammatory drug, which is a popular type of arthritis and inflammation treatment.

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FDA Approves Daytrana for ADHD

The FDA has approved an expanded age range for a methylphenidate transdermal system (Daytrana; Shire, under license from Noven Pharmaceuticals, Inc) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. Previously approved for use in children aged 6 to 12 years, the methylphenidate patch is indicated as an integral part of a total treatment program that may include psychological, educational, and social measures.

Roxane Receives FDA Approval For Anastrozole Tablets

Roxane Laboratories has received approval of its Abbreviated New Drug Application (ANDA) for Anastrozole Tablets, 1mg by the FDA. The product is available in bottles of 30 for immediate shipment to wholesalers and pharmacies across the US. Roxane Laboratories’ Anastrozole Tablets are AB rated to ARIMIDEX® (anastrozole) tablets.

A Novel Brain-based Computational Model Of How Parkinson’s Disease And Dopamine Medications Affect Learning And Attention

Journal of Cognitive NeuroscienceA new brain-based computational model is helping to understand how Parkinson’s disease and dopamine medications – used to treat motor symptoms caused by the disease – can affect learning and attention. As reported in a forthcoming article in the Journal of Cognitive Neuroscience, a new computational model, at the Center for Molecular and Behavioral Neuroscience at Rutgers University, Newark, has shown how Parkinson’s disease affects attentional performance during learning.

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TetraLogic Pharmaceuticals Initiates Phase 1 Clinical Trial Of TL32711 In Patients With Refractory Solid Tumors Or Lymphoma

TetraLogic PharmaceuticalsTetraLogic Pharmaceuticals announced that the Company has completed dosing of the first cohort in a Phase 1 clinical trial of its selective SMAC mimetic, TL32711. The Phase 1 trial is an open-label, dose-escalation study evaluating the safety and tolerability of TL32711 in adults with solid tumors or lymphoma refractory to standard therapies. The study will also assess the pharmacokinetics, pharmacodynamics and anti-tumor activity of TL32711.

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Switching To Letrozole Helps Breast Cancer Patients With Anastrozole-Related Rheumatologic Symptoms

Annual San Antonio Breast Cancer SymposiumPostmenopausal women with hormone receptor-positive (HR+) breast cancer who develop arthralgia and/or myalgia (A/M) while being treated with anastrozole may want to consider a switch to letrozole therapy, researchers said at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). Women who experienced greater than equal to grade 2 A/M while receiving anastrozole and switched to letrozole developed significantly less A/M and had an improved quality of life compared with baseline.

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CleveMed Receives ISO 13485, CE Mark, Canadian Certificate Approval

CleveMedCleveMed has received ISO 13485 certification issued by BSI Management Systems America Inc. CleveMed has also received the CE Mark and CMDCAS allowing its products to be distributed to the large European and the Canadian markets which will strengthen its worldwide market presence. CleveMed designs and manufactures a number of telemetry-based patient monitors for sleep disorders such as sleep apnea and movement disorders including Parkinson’s disease.

Dey Launches Needle-Protected EpiPen(R) (Epinephrine) Auto-Injector with Enhanced Features

Dey PharmaDey Pharma, L.P., has launched a newly designed, patient-friendly EpiPen® Auto-Injector 0.3/0.15 mg. This next-generation EpiPen Auto-Injector maintains the simplicity, speed, safety and reliability of EpiPen Auto-Injector with several new, user-friendly features, including being the only auto-injector with needle-protection before and after use. Side effects may include an increase in heart rate, a stronger or irregular heartbeat, sweating, nausea and vomiting. If you have Parkinson’s disease, your symptoms may temporarily get worse.

Salix Pharma gets FDA approval for Metozolv

SalixSalix Pharmaceuticals Ltd has received the FDA approval for the marketing of a fast-dissolving drug called Metozolv intended for treating diabetic gastroparesis and heartburn. The FDA’s approval covers 5 mg and 10 mg tablets of Metozolv ODT. The drug’s main ingredient, metoclopramide, has long been used to treat the two conditions in different forms. Diabetic gastroparesis is a condition in which the stomach takes too long to clear out food.

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