*AbbVie, InterMune say they defending business secrets. The decision leaves in limbo a high-profile fight that has pitched the European Medicines Agency, Europe's equivalent of the U.S. Food and Drug Administration, against AbbVie and InterMune.» Read More
*Bid at 27 pct premium to Algeta's last close. *Bayer, Algeta jointly develop prostate cancer drug. OSLO, Nov 26- German pharmaceutical group Bayer has offered to buy Norway's Algeta, its partner for a new prostrate cancer treatment, for $2.4 billion, a 27 percent premium to the stock's last close, Algeta said on Tuesday.
These data do not confirm the signal of increased risk of heart attacks that was found in an analysis of previous clinical trials first reported in 2007, the FDA said in a statement. "GSK welcomes the decision of the FDA and appreciates the agency's robust review of the science with regard to Avandia," Glaxo said in an emailed statement.
These data do not confirm the signal of increased risk of heart attacks that was found in an analysis of previous clinical trials first reported in 2007, the FDA said in a statement. GlaxoSmithKline could not immediately be reached to comment on the FDA decision.
The FDA had requested an additional trial. "The interim analysis of the Light study clearly achieved the goal set by the FDA," Chief Executive Michael Narachi said in a statement. Vivus Inc and Arena Pharmaceuticals Inc already have their obesity pills approved by the FDA.
MUMBAI, Nov 25- Lupin Ltd, India's No. 4 drug maker by revenue, may come from the land of cheap generics but it is betting on high-margin branded drugs in the United States to drive growth.
Nov 22- The U.S. Food and Drug Administration said on Friday it has approved a vaccine made by GlaxoSmithKline Plc for use in the event of an H5N1 bird flu epidemic. The vaccine, Pandemrix, will be added to the national stockpile and will not be available for commercial use, the FDA said.
WASHINGTON-- The Food and Drug Administration said Friday it expanded approval of a Bayer drug to treat patients with thyroid cancer. Now the FDA has approved the drug to treat cancerous growth of the thyroid gland, which is located in the neck.
Shares of troubled drugmaker Amarin fell again Friday after the Food and Drug Administration refused to reconsider a recent decision that casts doubt on the future of the company's lead product.
LONDON, Nov 22- European regulators have recommended approval of a new drug from Gilead Sciences to treat hepatitis C and an HIV medicine from GlaxoSmithKline, both of which are expected to be major sellers.
WASHINGTON-- Specialty drugmaker Celgene Corp. said Friday a panel of European Union medical experts issued a positive review of its drug Abraxane for patients with late-stage pancreatic cancer. The U.S. Food and Drug Administration approved Celgene's drug for late-stage pancreatic cancer in September.
*Ontario ban could be imitated by other provinces. Pharmacy companies saw the private-label drugs as a way to reduce the impact of Ontario regulations designed to lower the cost of generic drugs. The Ontario rules have weighed on the earnings of the drugstore chains, including Shoppers Drug Mart Corp, a principal appellant in this case.
WASHINGTON-- Shares of Biogen Idec jumped to an all-time high Friday morning after the company said European regulators have determined its new multiple sclerosis is a novel drug, granting it 10 years of market exclusivity in the European Union.
Jim Cramer explains what to watch ahead of the open including the biotech index and the "sleeping giant" Gilead Science.
ZURICH, Nov 22- Swiss drugmaker Novartis offered a sweetener to investors on Friday by starting a $5 billion share buyback programme, but shied away from announcing any radical surgery to its structure.
The panel recommended that the U.S. Food and Drug Administration approve the drug, Vimizim, which is made by BioMarin Pharmaceutical Inc. The FDA is not obliged to follow the recommendations of its advisory panels but typically does so.
New York- based JLL will merge the DSM business with that of Toronto- based drug maker Patheon Inc, forming a joint venture boasting some $2 billion in annual sales that the companies said on Tuesday will be a leader in manufacturing medicines for pharmaceutical companies.
NEW YORK, Nov 19- PharMEDium Services LLC, a venture capital-backed provider of pharmacy compounding services to hospitals, is in discussions to sell itself for close to $1 billion, according to people familiar with the matter.
AMSTERDAM, Nov 19- Dutch food and chemicals group DSM said on Tuesday it was spinning off its pharmaceuticals division in a $2.6 billion deal with private equity firm JLL, pushing DSM's shares up more than 3 percent. JLL is the majority shareholder in contract drug maker Patheon.
WASHINGTON, Nov 18- The U.S. Senate on Monday approved a bill designed to prevent the type of quality control problems that led last year to a deadly outbreak of fungal meningitis traced to a tainted pharmaceutical mixed by a Massachusetts pharmacy. Some pharmacies may choose not to register with the FDA.
WASHINGTON, Nov 18- The U.S. Senate easily approved a bill on Monday that will give the Food and Drug Administration greater authority to regulate companies that compound sterile drugs and ship them across state lines.