Analysis: Entering the age of the $1 million medicine

An operator installs a chromatography column to purify the gene therapy drug Glybera at Dutch biotech company uniQure in AmsterdamLONDON (Reuters) – 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. …

Number of new drugs picks up in Europe and U.S.

LONDON (Reuters) – The number of new medicines approved or pending approval is on the rise on both sides of the Atlantic, painting an encouraging picture for the global drugs industry as it emerges from a wave of patent expiries. European regulators said on Tuesday that they expect an increase in new drug applications to about 54 in 2013. In the United States, a total of 34 new drugs have been approved for sale so far in 2012 – the highest level in eight years. …

Shire’s ADHD amphetamine wins British backing

LONDON (Reuters) – Shire’s hyperactivity treatment Vyvanse will be available in Europe within months after Britain’s drugs regulator backed the amphetamine-based stimulant used to treat millions of U.S. students. The drug, lisdexamfetamine dimesylate, has a slow-release action that activates the amphetamine ingredient over the course of a day, helping levels of alertness and concentration in children with ADHD (attention deficit hyperactivity disorder). It was assessed under the European Union’s decentralized approvals procedure, led by Britain’s medicines watchdog. …

Disability expected to rise as more premature babies survive

LONDON (Reuters) – Little progress has been made in improving the long-term health of extremely premature babies, and with pre-term births on the rise across Europe, rates of serious disability are likely to increase, doctors said on Wednesday. A decade of advances in medicine mean more babies born at between 22 and 26 weeks gestation manage to survive, but rates of severe health complications remain as high as they were in 1995, according to research by neonatal specialists in Britain. …

Basic hygiene at risk in debt-stricken Greek hospitals

Doctors examine patients at a medical centre of the Greek delegation of the Doctors of the World in AthensLONDON (Reuters) – Greek hospitals are in such dire straits that staff are failing to keep up basic disease controls such as using gloves and gowns, threatening a rise in multidrug-resistant infections, according to Europe's top health official. Greece already has one of the worst problems in Europe with hospital-acquired infections, and disease experts fear this is being made worse by an economic crisis that has cut health care staffing levels and hurt standards of care. …

Obama says not able to overhaul tax system, entitlements in two weeks: Bloomberg TV

WASHINGTON (Reuters) – President Barack Obama said on Tuesday there is not enough time this year to come up with an overhaul of the U.S. tax system and entitlement programs as Republicans want as a condition for an agreement to avoid the fiscal cliff. Obama told Bloomberg Television that despite weaknesses in Europe and Asia, he believes the U.S. economy is “poised to take off. …

Actelion says lung drug macitentan submitted in Europe

ZURICH (Reuters) – Actelion has submitted heart and lung drug macitentan to European health regulators, the second major step for the drug the Swiss group is positioning as a viable successor to its current top seller. “The European Medicines Agency will now start the formal review process,” Actelion said on Thursday. It plans to sell the drug under the brand name Opsumit. Actelion, which submitted the treatment to the U.S. health regulator a month ago, issued data last month showing macitentan prolonged overall survival by more than a third in a clinical trial. …

Analysis links psoriasis, diabetes

NEW YORK (Reuters Health) – A new review of more than two dozen studies adds support to the link between the chronic skin disease psoriasis and diabetes. In studies from the United States, Europe, the Middle East and elsewhere, participants with psoriasis had anywhere from an equal risk to an almost four-fold higher risk of developing diabetes than those without the skin condition. According to the National Institutes of Health, more than three percent of adults in the U.S. have psoriasis, which is characterized by itchy, painful plaques on the skin. …

Intuitive Surgical procedure growth disappoints

(Reuters) – Intuitive Surgical Inc on Tuesday lowered its full-year forecast for procedure growth after posting a disappointing growth rate of 22 percent for surgeries using its high-priced da Vinci robots in the third quarter. Intuitive’s shares dropped more than 4 percent after it reported its third quarter results. The company said it now expects 2012 procedure growth of 24 percent, down from its prior view of 25 percent to 27 percent. Intuitive said the slower growth was due to spending constraints in Europe and a slowdown in U.S. …

Watson gets U.S. approval to buy Actavis, with conditions

WASHINGTON (Reuters) – Watson Pharmaceuticals has won U.S. antitrust approval to buy Swiss peer Actavis Inc on the condition that it sell a number of their current and future products to two other companies, the Federal Trade Commission said on Monday. The $5.9 billion deal won approval in Europe on October 5. New Jersey-based Watson is one of the world’s biggest suppliers of generic drugs. The FTC said it would require the two companies to sell the rights and assets of 18 drugs to Sandoz International and Par Pharmaceuticals. …

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