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The Food and Drug Administration unveiled steps aimed at streamlining the approval process used for most medical devices and deferred decisions on the most contentious issues.
The FDA said Wednesday that it would ask the Institute of Medicine for input on seven proposals, including creation of a new class of devices that would require more data to win approval. Get the full story »
From MyNorthwest.com | A gastric bypass surgery kit made by Chicago-based Medline Inc. was put up for sale on Amazon.com for $264. “It was a mistake that it was on Amazon,” said Medline spokesman John Marks. “This is purely for hospital use by doctors and surgeons, and it is not for sale to consumers.” But that didn’t stop reviewers from having some fun with it.Get the full story>>
GlaxoSmithKline will record a legal charge of 2.2 billion pounds ($3.4 billion) for the fourth quarter, effectively wiping out its profit, as it settles further claims related to Avandia and sales practices.
The charge equates to an after-tax cost of 1.8 billion pounds, more than the 1.45 billion the drugmaker had been expected to make in net income in the three months to December, according to Thomson Reuters consensus forecasts. Get the full story »
The European Medicines Agency said Monday it was notified by Abbott Laboratories Limited of its decision to withdraw its application for a centralized marketing authorization for the medicine Ozespa, briakinumab, 100 mg solution for injection. Get the full story »
Johnson & Johnson recalled nearly 47 million units of over-the-counter medicines Friday, the latest in a string of quality-related product recalls.
J&J said the latest recall resulted from a thorough examination of manufacturing records that the company had undertaken in the wake of earlier recalls. J&J plans to continue reviewing practices at additional plants and signaled further recalls could result. Get the full story »
Bristol-Myers Squibb Co. and Sanofi-Aventis SA have recalled about 64 million tablets of hypertension drug Avalide because a manufacturing problem could affect the drug’s efficacy.
It is the second significant recall of Avalide in recent months. In September, Bristol and Sanofi recalled about 60 million tablets. Get the full story »
Abbott Laboratories this morning said it will hold off seeking U.S. approval of an experimental psoriasis treatment following feedback from federal regulators who have concerns about the drug.
Abbott would not disclose exactly what the concerns of the U.S. Food and Drug Administration are. The agency, however, has in recent years stepped up its scrutiny of the safety and efficacy of drugs and increasingly orders more study in clinical trials, particularly for safety risks to the heart.
The news hit the company’s stock. The price of Abbott’s shares lost 1 percent of their value or 49 cents, dipping to $46.88 in trading on the New York Stock Exchange. Get the full story »
The popular sleep drug Ambien can leave even the healthiest older people groggy and prone to stumbling, falling and confusion when they wake up, U.S. researchers reported on Thursday.
The drug, sold by Sanofi-Aventis under the brand name Ambien and known generically as zolpidem, appears to act broadly in the brain and has a numbing effect for at least half an hour after waking, the researchers reported in the Journal of the American Geriatric Society. Get the full story »
U.S. health regulators are requesting a limit on the amount of acetaminophen in prescription pain medicines to curb the risk of liver damage.
The move announced on Thursday aims to limit combination drugs such as the opioids Percocet and Vicodin to 325 milligrams of acetaminophen per pill and calls for them to carry a “black box” warning about potential liver failure. Get the full story »
Eli Lilly & Co failed to win support from a U.S. advisory panel Wednesday for what aims to be the first drug not made from pig enzymes to help certain pancreatic patients digest food. The drug was designed to compete with Abbott Labs’ drug Creon, among others. Get the full story »
Walgreen Co. wants more customers to fill 90-day prescriptions in its stores, a move it says will make it easier for patients to stick to their drug regimens and save millions of dollars in healthcare costs. Get the full story »
Indianapolis-based Eli Lilly and Co. will team with German drugmaker Boehringer Ingelheim to develop diabetes treatments, as the U.S. pharmaceutical company pushes to fill a looming revenue gap created by expiring patents for several key drugs. Get the full story »
Takeda Pharmaceutical Co. Ltd. said it has signed a deal to license Zinfandel Pharmaceuticals Inc.’s technology as a way to one day target and potentially treat Alzheimer’s disease with Takeda’s diabetes pill Actos. Get the full story »
Northbrook-based Idex Corp. will acquire Microfluidics International Corp., a maker of equipment used by pharmaceutical and chemical companies to make tiny materials, for about $14 million. Get the full story »
