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Researchers have developed an implantable sensor that measures blood sugar continuously and transmits the information without wires — a milestone, they said, in diabetes treatment.
The device worked in one pig for more than a year and in another for nearly 10 months with no trouble, said a report in the journal Science Translational Medicine. Get the full story »
In the wake of health reform’s passage, Hospira Inc. will begin testing an experimental cheaper version of a popular anemia treatment in the first phase of a U.S. clinical trial.
A path for the Food and Drug Administration to approval “biosimilar” or biogeneric drugs was a part of health reform legislation passed by Congress and signed into law four months ago by President Barack Obama. Biotech brands are available only outside the U.S. but the law will enable biosimilars here in the coming years. Get the full story »
From Bloomberg News | Only devising a test protocol stands in the way of a version of Pfizer’s Viagra being used to treat a rare lung disorder in children. A Food and Drug Administration panel will meet Thursday to discuss it.
The Food and Drug Administration should better explain its reasons whenever it requires additional safeguards for risky drugs, a pharmaceutical industry group said Monday.
That recommendation is one of dozens expected this week at a public meeting on the FDA’s risk evaluation and mitigation strategies, or REMS, a set of tools to protect consumers from drugs with potentially serious side effects. Get the full story »
Medical product giant Baxter International Inc. reported second quarter profit dropped 9 percent on declining sales in its biosciences unit and from the costs of a settlement with the financially troubled Greek government.
Baxter, which makes blood therapies and medication delivery devices, said net income fell to $535 million, or 90 cents a share, from $587 million, or 96 cents a share. Revenues rose 2 percent to $3.19 billion. Get the full story »
Abbott Laboratories reported flat second-quarter earnings thanks to charges related to research and legal expenses and costs of its flurry of acquisitions in the last year. The North Chicago-based medical product giant reported earnings of $1.29 billion, or 83 cents a share in the period ended June 30. That compares with $1.28 billion, or 83 cents in the second quarter of 2009. Get the full story »
The U.S. Food and Drug Administration has warned Abbott Laboratories’ diabetes care unit about manufacturing problems at its Alameda, California plant, a letter released Tuesday said.
In a letter dated July 2, FDA said its inspectors found Abbott’s Freestyle and Navigator blood glucose monitoring products were adulturated and not conforming with codes for good quality system manufacturing practices. Get the full story »
The Food and Drug Administration questioned the benefit of using Roche Holding AG’s top-selling cancer drug, Avastin, in breast cancer.
The agency said the magnitude of an improvement seen among women being treated with chemotherapy drugs plus Avastin compared with women being given chemotherapy alone “is not clinically meaningful.” The agency also said there were more serious side effects such as bleeding seen among women being given Avastin. Get the full story »
U.S. health advisers said GlaxoSmithKline Plc’s diabetes drug Avandia should be allowed to stay on the market in some form, easing a threat of further litigation that could have followed a ban.
Twenty of the 33-member panel of outside experts convened by the Food and Drug Administration voted for various options that would allow Avandia to stay on the market despite concerns over associated heart risks. Get the full story »
Walgreen Co. on Wednesday raised its quarterly dividend 27 percent to 17.5 cents a share, topping its compound annual dividend growth rate of 24 percent in the past six years. Last year, the drugstore chain raised its dividend 22 percent and set a long-term dividend payout target of 30 percent to 35 percent of net earnings. Get the full story »
The California Supreme Court has breathed new life into a massive antitrust lawsuit filed by pharmacies against 18 of the country’s largest drugmakers. The pharmacies accuse the drugmakers of conspiring to artificially inflate prices by restricting importation of their drugs made overseas and stifling generic competition.
The U.S. Food and Drug Administration today said Baxter International Inc. needs to take several steps designed to follow through on a recall of its Colleague infusion pumps including providing customers with a “a refund, a replacement pump, or lease termination.” Get the full story »
Pharmaceutical Research and Manufacturers of America, which includes Abbott Laboratories and Takeda Pharmaceuticals as members, said Tuesday that John Castellani will become the drug lobby’s president and chief executive, effective Sept. 1.
Castellani, who replaces the retiring Billy Tauzin, comes to PhRMA after nearly a decade as president and CEO of Business Roundtable, an association of corporate executives. Get the full story »
GlaxoSmithKline Plc insisted its diabetes pill Avandia was safe as U.S. advisers began a two-day meeting to consider whether the medicine is too dangerous to stay on the market.
The scientific experts assembled by the Food and Drug Administration are sorting through sharply conflicting data on whether Avandia causes heart attacks. Get the full story »
Johnson & Johnson said Monday it plans to bolster its lineup of stroke-prevention products by buying Micrus Endovascular Corp. for about $480 million, marking the latest deal in a neurovascular-device market that appears to be heating up.
J&J’s planned purchase of San Jose, Calif.-based Micrus comes weeks after rival Covidien PLC announced plans to buy ev3 Corp. , a Micrus rival, for $2.6 billion. Leerink Swann analyst Rick Wise said the Covidien-ev3 combination may have spurred on J&J amid a trend of focusing more on bundled portfolios of products. Get the full story »
