Archive for the 'Pharmaceutical products' Category

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.

Telavancin receives approval from the FDA

TheravanceTheravance Inc and partner Astella Pharma won the FDA approval for their superbug-fighting drug telavancin. The drug will hit the market in the fourth quarter as a treatment for adults with complicated skin and skin structure infections caused by methicillin-resistant Staphylococcus aureus, commonly known as the superbug MRSA and other Gram-positive bacteria. The drug is the first approved specifically to target MRSA, which currently is treated largely with the antibiotic vancomycin.

Unichem receives ANDA for clonidine hydrochloride tablets

UnichemUnichem Lab has received Abbreviated New Drug Abbreviation (ANDA) approval from the US FDA for clonidine hydrochloride tablets. Clonidine Hydrochloride is a low dose potent and popular molecule in the antihypertensive category. Clonidine hydrochloride tablets USP 0.1mg, 0.2mg and 0.3mg are therapeutically equivalent to Catapres tablets USP 0.1mg, 0.2mg and 0.3mg from Boehringer Ingelheim. Clonidine hydrochloride formulations have annual sales of roughly $334 million in the US.

Watson Pharma receives FDA approval for generic Toprol

watsonWatson Pharmaceuticals has received FDA approval for a generic version of the high blood pressure and angina drug Toprol XL. Watson Pharma expects to starts shipping the metoprolol drug immediately. The drug would be available in 25 mg and 50 mg extended-release tablets. According to Watson Pharma, the US sales of Toprol XL and generic equivalents totaled $628 million for the year ended June 30, 2009.

Azithromycin injection approved by FDA

HospiraHospira has obtained approval for its anti-infective Azithromycin injection from the FDA. Azithromycin is a generic variant of Pfizer’s Zithromax and is ADD-Vantage system compatible. ADD-Vantage is an advanced drug delivery system that does not need a needle and syringe to mix the drug with the solution. This lowers the risk of accidental needle pricks, improves workflow and prevents waste due to stability and shelf-life elements.

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