Reuters Health News Summary

GSK sees little prospect of U.S. generic Advair in 2016

After relying for years on its top-selling lung drug Advair, GlaxoSmithKline is now braced for the worst in the form of cheap generics - but not just yet. Chief Executive Andrew Witty said on Wednesday that the chances of cheap copies of its highly profitable inhaled medicine reaching the world's biggest market in 2016 were "vanishingly small".

Under pressure, FDA to hold public meeting on off-label use

The U.S. Food and Drug Administration will hold a public meeting this summer to address drug company concern that restrictions on what they can say about off-label use of drugs violate their First Amendment right to free speech. The meeting, announced last month by FDA chief counsel Elizabeth Dickinson, comes as a bill known as 21st Century Cures, designed to speed new drugs to market, is moving through Congress. Language in the bill is adding pressure on the agency to relax its guidelines.

Siegfried buys BASF drug ingredient businesses for $306 million

German chemicals group BASF has agreed to sell parts of its pharmaceutical ingredients business to Swiss drug contract manufacturer Siegfried Holding for 270 million euros ($306 million), including assumed debt. "Siegfried will reach the critical size to play a leading role in the supplier market as a recognized partner for the pharmaceutical industry," said Siegfried Chief Executive Rudolf Hanko.

Venezuela says probing drugmakers for improper use of hard currency

Venezuela is investigating whether drug companies including Germany's Merck KGaA and Bayer AG have improperly profited from subsidized foreign exchange amid growing medicine shortages, the country's health minister said. Those firms have received a favorable exchange rate through Venezuela's currency controls to produce or import price-controlled medication to treat chronic ailments such as thyroid conditions, Health Minister Henry Ventura said in an interview late on Tuesday.

Safety switches may redeem potent CAR T cancer therapies

New therapies that clinical data show can eliminate blood cancers such as leukemia and lymphoma in 40 percent to 90 percent of patients may have to be genetically modified to include a switch that shields healthy cells from attack. The therapies could generate tens of billions of dollars in annual sales for drugmakers including Kite Pharma and Juno Therapeutics Inc, once they are approved.

Despite U.S. efforts, bird flu thought to spread between farms

Poultry veterinarians in Minnesota believe an outbreak of avian flu has spread between farms, indicating the implementation of a U.S. strategy to contain the deadly bird disease failed in at least some cases. Wild birds are thought to be carriers of the flu virus, which can be tracked onto poultry farms by people or trucks that come into contact with contaminated feces. It may also be carried into barns by wind blowing in contaminated dirt or dust.

J&J to consult ethicists on requests for experimental drugs

Johnson & Johnson will become the first pharmaceutical company to formally seek advice from outside medical ethicists on "compassionate use" requests, in which desperate patients ask drugmakers to let them take an experimental medication, the company announced on Thursday. The ethicists' recommendations will be advisory, with J&J making the decision.

Roche says FDA grants breakthrough therapy designation for venetoclax

Swiss drugmaker Roche said on Thursday the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for venetoclax for the treatment of people who have relapsed or refractory chronic lymphocytic leukemia with a genetic abnormality. "We are pleased that the FDA has granted venetoclax breakthrough therapy designation and hope this regulatory pathway will help us bring venetoclax to people with this difficult-to-treat disease soon," Roche Chief Medical Officer and Head of Global Clinical Development Sandra Horning said in a statement.

EU drugs agency tightens rules on experts moving to industry jobs

Europe's medicines regulator said on Wednesday it would restrict experts and committee members who intend to work for a pharmaceutical company from participating in the evaluation of medicines, in a move to reduce conflict of interests. The European Medicines Agency (EMA) updated its "revolving door" rules on the declaration of interests, including a revised guide on how to complete its declaration form. (http://bit.ly/1EPMmU7)

Safety switches may redeem potent CAR T cancer therapies

New therapies that clinical data show can eliminate blood cancers such as leukemia and lymphoma in 40 percent to 90 percent of patients may have to be genetically modified to include a switch that shields healthy cells from attack. The therapies could generate tens of billions of dollars in annual sales for drugmakers including Kite Pharma and Juno Therapeutics Inc, once they are approved.