This week’s headlines include, the biggest biotech trends of 2012, a recap of FDA drug approvals last year, stem Cell Therapy hits FDA evaluation, Abbott spins off AbbVie, and new Gene Therapy will cost $1 million.
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U.S. regulators approved 39 new drugs in 2012, the most in 16 years, suggesting that pharmaceutical makers are poised for growth after losing billions of dollars in recent years to generic drug makers because of patent expirations. There were eight approvals in December alone, including a new treatment from Johnson & Johnson called Sirturo for drug-resistant tuberculosis approved on Monday, the first new TB drug in decades. The pharmaceutical sector badly needs a pick-up in productivity as companies try to refill their medicine chests after heavy losses to generic manufacturers, which have benefited from a string of patent expirations that peaked in 2012. When generics go on the market at a lower cost, sales of name brand drugs plummet. The tally of 39 new drugs and biological products approved by the Food and Drug Administration compares with 30 in 2011 and just 21 in 2010. At least 10 of the drugs had fast track status in 2012, which enabled them to be reviewed more quickly.
If you like this story, please see our blog titled “The Number of FDA Drug Approvals for the 2012 Fiscal Year Remains High”
Celltex’s venture raises some of the most vexing, emotional issues in the business of medicine. Stem cells hold enormous promise, but promise isn’t proof, and anecdotal evidence isn’t science. Small companies often can’t do the research required by the FDA and make money at the same time. Some patients will pay to be part of an experiment, but many doctors and regulators don’t think they should. In Texas the science of stem cells has collided with a governor’s ambitions, a businessman’s optimism, a doctor’s faith, and patients’ hopes.
If you like this story, please see our blog titled “How Stem Cells Can Play a Major Role in Developing New Therapeutics”
The Western world’s first drug to fix faulty genes promises to transform the lives of patients with an ultra-rare disease that clogs their blood with fat. The only snag is the price. The Gene Therapy for lipoprotein lipase deficiency (LPLD), a hereditary disorder that raises the risk of potentially lethal inflammation of the pancreas, is likely to cost more than $1 million per patient when it goes on sale in Europe this summer. Rare or so-called orphan diseases are winning unprecedented attention from drug developers. More than a quarter of the 39 new medicines approved in the United States last year were designated for such conditions.
If you like this story, please see our blog titled “Best Selling Biologics for 2011 – CHO Still the Top Manufacturing Choice”
Abbott Laboratories today spun off its branded biopharmaceutical operations into AbbVie, an $18 billion-a-year business focused on building a broad portfolio anchored by what had been Abbott’s top-selling drug, the anti-TNF biologic Humira. Humira is likely to account for about half of AbbVie’s total sales, having generated nearly $6.6 billion during the first three quarters of 2012, up 14% from about $5.8 billion in Q1 through Q3 of 2011. For all of 2011, the drug racked up $7.9 billion in sales, up 21% from $6.5 billion in 2010. Earlier this year, Abbott said its scientific experience with Humira served as a strong foundation for continuing research in immunology—R&D that AbbVie is expected to continue since the spinoff’s portfolio includes several immunology and virology drugs. In addition to Humira, AbbVie’s pipeline includes Synagis, the respiratory drug developed by MedImmune; as well as Lupron, Creon, Synthroid, Kaletra, Norvir, Zemplar, and AndroGel.
If you like this story, please see our blog titled “Innovative Products Featured at the ASCB Conference – Part I”