The FDA in January asked zolpidem manufacturers, including NovaDel Pharma Inc and Swedish drugmaker Meda, to reduce recommended dosages on the drugs' labels. The FDA recommended doses of 5 mg for women and either 5 mg or 10 mg for men for immediate-release zolpidem products such as Sanofi's Ambien.
May 14- John Lechleiter, the longtime chief executive of Eli Lilly and Co, is recovering from successful surgery to repair a dilated aorta, the U.S. drugmaker said on Tuesday. Lechleiter is recovering and will be closely monitored by the medical staff over the next several days, "following his surgery on Monday, the Indianapolis company said in a statement.
*Ranbaxy says money set aside sufficient to cover costs. May 13- Indian generic drugmaker Ranbaxy Laboratories Ltd pleaded guilty on Monday to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the U.S. Department of Justice.
*Ranbaxy majority-owned by Japan's Daiichi Sankyo. May 13- Indian drugmaker Ranbaxy Laboratories Ltd pleaded guilty on Monday to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the U.S. Department of Justice.
MOUNTAIN VIEW, Calif.-- Obesity drug maker Vivus Inc. on Monday named two new directors to its board as it finds itself in a proxy fight. CEO of German drugmaker Boehringer Ingelheim from 2003 to 2011, and Plutzky has directed the vascular disease prevention program at Brigham and Women's Hospital in Boston since 1996..
NEW YORK-- Shares of Warner Chilcott PLC rose before Monday's opening bell on optimism that it will eventually reach a deal to combine with fellow drugmaker Actavis Inc..
DUBLIN, May 13- Irish drugmaker Elan Corporation has agreed a $1 billion royalties deal that could soothe concerns about its potentially risky acquisition strategy and fend off a takeover bid from Royalty Pharma.
Companies like Pfizer Inc and AstraZeneca have grown dependent on higher U.S. prices to generate profits as generic rivals to their best-selling medicines enter the world market, Europe's government-run health plans clamp down on spending and sales growth in emerging markets stutters.
District Judge Edward Korman in Brooklyn said he would give the FDA until May 13 to ask a federal appeals court in Manhattan to stay the order, which had been scheduled to take effect on Friday.
May 10- The U.S. Food and Drug Administration has approved a new drug to treat chronic obstructive pulmonary disease, a condition often associated with smoking that can include emphysema, chronic bronchitis, or both. The drug, Breo, is an inhaled treatment made by British drugmaker GlaxoSmithKline Plc and Theravance Inc of the United States.
May 9- A senior sales representative for Merck& Co has sued the drugmaker for more than $100 million, alleging it discriminates against female employees in terms of pay and advancement, particularly pregnant employees and women with children.
After approvals last year from the FDA for 39 novel medicines- a record only beaten in 1996- the healthy pace has continued into 2013.. And drugmakers are getting further help from a new FDA program to accelerate life-saving therapies designated as a "breakthrough," opening to door to earlier approval based on quicker studies, where clinical data is compelling.
*Bankers expect steady flow of $1 bln to $5 bln pharma deals. The stock valuations of companies like Regeneron Pharmaceuticals Inc, Gilead Sciences Inc, Celgene Corp and Biogen Idec Inc have skyrocketed in the past year or two alone, making it difficult for large pharmaceutical companies to buy them and leaving a trail of dead deals.
as the German generic drugmaker reports consensus-beating core earnings on strong sales in key growth markets Russia and Serbia.