ZURICH - 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.
WASHINGTON - 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.
NEW YORK - 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.
LONDON - 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.
FRANKFURT - 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.
CHICAGO - 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.
NEW YORK - 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.
- 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.
CARACAS - 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.