Structural Heart Disease

Structural heart diseases include any issues preventing normal cardiovascular function due to damage or alteration to the anatomical components of the heart. This is caused by aging, advanced atherosclerosis, calcification, tissue degeneration, congenital heart defects and heart failure. The most commonly treated areas are the heart valves, in particular the mitral and aortic valves. These can be replaced through open heart surgery or using cath lab-based transcatheter valves or repairs to eliminate regurgitation due to faulty valve leaflets. This includes transcatheter aortic valve replacement (TAVR). Other common procedures include left atrial appendage (LAA) occlusion and closing congenital holes in the heart, such as PFO and ASD. A growing area includes transcatheter mitral repair or replacement and transcatheter tricuspid valve repair and replacement.

As Avandia regulatory fate looms, firm predicts sales drop

Drug sales of rosiglitazone (Avandia, GlaxoSmithKline) will most likely decrease despite a majority vote by FDA advisers July 15 to keep the drug on the U.S. market, albeit, with added warnings or restrictions, according to market research firm Datamonitor.

Novartis posts strong Q2, CV unit comes up big

Novartis Pharmaceuticals has released its financial results for 2010 second quarter, which ended June 30, recording an increase in net sales and net income.

Takeda defends Actos, in light of FDA committee meeting

After two days of FDA advisory committee meetings focused on reviewing the cardiovascular safety of rosiglitazone (Avandia), Takeda Pharmaceuticals North America has underscored its position that pioglitazone HCI (Actos) offers an established safety profile regarding the risk of cardiovascular events in people living with type 2 diabetes.

GSK reportedly settles 10,000 Avandia liability claims for $460M

GlaxoSmithKline (GSK) has reportedly made an offer of $460 million to settle approximately 10,000 product liability suits over its diabetes drug rosiglitazone (Avandia), while the company is simultaneously defending the fate of the controversial pill at an FDA panel committee meeting.

FDA committee may decide fate of Avandia

As controversy continues to surround GlaxoSmithKline and its diabetes drug rosiglitazone (Avandia), the FDA has released hundreds of pages of briefing documents in preparation of today's FDA committee meetings that will answer questions and hope to settle the ongoing debate whether Avandia does more harm than good.

Merck to shut down 16 sites, shed 15% of employees

In a mission to reduce spending and reach its target savings goals of $3.5 billion in 2012, Merck will shut down operations at eight research and eight manufacturing sites, depleting almost 15 percent of its workforce.

Health Affairs: Modifying generic med substitution laws could slash almost $100M

With patent expiries for major name brand pharmaceutical drugsLipitor (atorvastatin; Pfizer), Plavix (clopidogrel; Sanofi-Aventis/Bristol-Myers Squibb) and Zyprexa (olanzapine; Eli Lilly)on the horizon, switching to generic drug forms could save $100 million in Medicaid coverage costs. However, strict state generic substitution laws often require prior consent or step therapy approaches and make switching to generic brands difficult and costly, according to the results of a study published in the July edition of Health Affairs.

Report Sanofi-Aventis may be looking to ink $20B pharma deal

Various outlets, including business information group Datamonitor, have speculated that Sanofi-Aventis may be looking to acquire a U.S.-based pharmaceutical company for a reported $20 billion.

Around the web

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

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