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AstraZeneca Canada's IRESSA receives approval for treatment of NSCLC

AstraZeneca Canada announces the recently approved indication for IRESSA(R), a once-daily oral targeted therapy for the first-line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the epidermal growth factor receptor-tyrosine kinase (EGFR-TK). In conjunction with this approval, AstraZeneca is also announcing the availability of a diagnostic test which can now determine a patient's EGFR mutation status, representing a new era in personalized lung cancer treatment in Canada.

17 Mar 2010

Genetic test helps reduce hospitalization rates for heart patients on warfarin

Hospitalization rates for heart patients taking warfarin, the world's most-prescribed blood thinner, dropped by approximately 30 percent when genetic information was available to doctors prescribing the drug, researchers from Medco Health Solutions, Inc.-- in association with the Medco Research Institute™ -- and Mayo Clinic announced today.

17 Mar 2010

Can preventative vaccines curb the rising numbers of HIV cases?

According to a recent United Nations study, HIV infection rates among high-risk groups such as gays, drug users and sex workers are on the rise around the world.

17 Mar 2010

Unapproved drugs: National Minority Quality Forum launches new public information campaign

The National Minority Quality Forum (The Forum) is launching a new public information campaign aimed to help educate consumers, physicians, and policymakers about the risks associated with prescribing and taking unapproved drugs that have not been subjected to the rigorous Food and Drug Administration’s (FDA) review and approval process.

17 Mar 2010

Pew Prescription Project statement: Protect Americans from unsafe drugs made overseas

Two years after dozens of Americans lost their lives to contaminated heparin, we are still not able to protect U.S. consumers from many of the risks of pharmaceuticals manufactured in foreign factories. It is time for Congress to take action to better protect health.

17 Mar 2010

Primary results of CABG sub-analysis presented at ACC meeting

AstraZeneca (NYSE: AZN) today announced results of a new analysis of the PLATO (A Study of PLATelet Inhibition and Patient Outcomes) study which showed there were fewer deaths in patients with acute coronary syndromes (ACS) who took the investigational oral antiplatelet ticagrelor (BRILINTA™/BRILIQUE™) within seven days prior to having heart bypass surgery (coronary artery bypass graft, CABG) compared to those who took clopidogrel.

17 Mar 2010

Half of all NeeS dossiers rejected for poor formatting and inability to meet basic validation standards

The French health authority has revealed that it is rejecting half of all NeeS (non-eCTD electronic submissions) dossiers because they have been poorly formatted and do not meet basic validation standards. This is costing pharmaceutical companies time and money, as they re-work the submission format, and incur delays in getting their submissions reviewed and approved. Two-thirds of all electronic submissions to AFSSAPS currently are in the NeeS format.

17 Mar 2010

Black children less likely to develop shingles after receiving chickenpox vaccine

Black children are less likely than white or Asian children to develop shingles (herpes zoster) after receiving the varicella vaccine to prevent chickenpox, reports a study in the March issue of The Pediatric Infectious Disease Journal.

17 Mar 2010

Anti-obesity drugs fail to tackle wider issues of obesity

Scientists at the University of Liverpool argue that anti-obesity drugs fail to provide lasting benefits for health and wellbeing because they tackle the biological consequences of obesity, and not the important psychological causes of overconsumption and weight gain.

17 Mar 2010

Methamphetamine abuse during pregnancy leads to structural abnormalities in brain of children

It has long been known that alcohol exposure is toxic to the developing fetus and can result in lifelong brain, cognitive and behavioral problems. Now, a new report out of UCLA shows that the effects of prenatal methamphetamine exposure - or worse, a combination of methamphetamine and alcohol - may be even more damaging.

17 Mar 2010

Antidepressants effective against depression in patients suffering from physical illnesses

Antidepressants are effective against depression in patients suffering from physical illnesses, according to a new systematic review by Cochrane researchers at King's Health Partners Academic Health Sciences Centre in the UK. The researchers found the drugs were more effective than placebos at treating depression in these patients.

17 Mar 2010

Consumers are becoming more price-sensitive toward brand-name drugs

The results of a new Pharma Insight study released today by Wolters Kluwer Pharma Solutions, Inc., a leading provider of scientific information and analytics to the pharmaceutical and biotech fields, is not exactly what the doctor ordered. The company's annual analysis of the U.S. pharma market suggests that the economy has led to increased patient participation in decisions about prescription drugs.

17 Mar 2010

Shire receives Paragraph IV Notice Letter over generic INTUNIV ANDAs from Teva Pharmaceuticals

Shire plc, announces that it has received a Paragraph IV Notice Letter from Teva Pharmaceuticals USA, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1 mg, 2mg, 3 mg, and 4mg guanfacine hydrochloride extended release tablets, INTUNIV(TM).

17 Mar 2010

Generex Biotechnology's proprietary buccal insulin spray product presented at CODHy Congress

Generex Biotechnology Corporation (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that Philip Raskin, MD, of The University of Texas Southwestern Medical Center in Dallas, Texas, made a presentation in respect of Generex Oral-lyn™, the Company's proprietary buccal insulin spray product, at The Latin America Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension held in Buenos Aires, Argentina, March 11-14, 2010 (www.comtecmed.com/Codhy/argentina).

17 Mar 2010

Glenmark Generics, Konec ordered to stop marketing unapproved nitroglycerin tablets

The U.S. Food and Drug Administration today ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.

17 Mar 2010

Genentech submits ACTEMRA sBLA to FDA

Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ACTEMRA® (tocilizumab) for the prevention of structural joint damage (as assessed by radiograph) and improvement in physical function in adults with moderately to severely active rheumatoid arthritis (RA).

17 Mar 2010

IDSA calls for global commitment to develop 10 new antibiotics by 2020

As the deaths and suffering caused by antibiotic-resistant bacterial infections continue to rise around the world, the Infectious Diseases Society of America (IDSA) is urging a global commitment to develop 10 new antibiotics by 2020, known as the 10 x '20 initiative, to address this public health crisis and safeguard patients' health.

17 Mar 2010

Pharmaceutical News

AstraZeneca Canada's IRESSA receives approval for treatment of NSCLC

Genetic test helps reduce hospitalization rates for heart patients on warfarin

Can preventative vaccines curb the rising numbers of HIV cases?

Unapproved drugs: National Minority Quality Forum launches new public information campaign

Pew Prescription Project statement: Protect Americans from unsafe drugs made overseas

Primary results of CABG sub-analysis presented at ACC meeting

Half of all NeeS dossiers rejected for poor formatting and inability to meet basic validation standards

Black children less likely to develop shingles after receiving chickenpox vaccine

Anti-obesity drugs fail to tackle wider issues of obesity

Methamphetamine abuse during pregnancy leads to structural abnormalities in brain of children

Antidepressants effective against depression in patients suffering from physical illnesses

Consumers are becoming more price-sensitive toward brand-name drugs

Shire receives Paragraph IV Notice Letter over generic INTUNIV ANDAs from Teva Pharmaceuticals

Generex Biotechnology's proprietary buccal insulin spray product presented at CODHy Congress

Glenmark Generics, Konec ordered to stop marketing unapproved nitroglycerin tablets

Genentech submits ACTEMRA sBLA to FDA

IDSA calls for global commitment to develop 10 new antibiotics by 2020

EU-India free-trade negotiations could limit access to affordable, generic drugs, advocacy group says

Women on oral contraceptive pills live longer

Gardasil vaccine may protect women from post-surgical recurrence of cervical cancer

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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