Novartis Plans More Cuts And Consolidation
During an investor presentation the other day, Novartis execs spent considerable time not only discussing recent financial performance and pipeline progress, but also the many steps taken to save money. These include a raft of cuts across various divisions around the globe and, in the US, consolidating some operations, such as shifting some research from […]
Read More »Category : News
Deadly Drug Contamination Inevitable, FDA Tells U.S. Senate
Fatal drug contamination like a 2008 incident involving Baxter International Inc. (BAX)’s blood thinner Heparin that sickened and killed hundreds is inevitable unless the agency gets enhanced inspection and recall powers for non-U.S. factories, a top regulator said. Another crisis is “not a matter of if, it’s a matter of when,†Deborah Autor, the Food […]
Read More »Category : News
Most Protocols Are Amended During Clinical Trials
Nearly 60 percent of all protocols used in clinical trials for new drugs are amended during the trial, but one-third of those changes could have been avoided and saved countless dollars, according to an analysis by the Tufts Center for the Study of Drug Development. Specifically, the review found that completed protocols across all clinical […]
Read More »Category : News
Daiichi Unit Warned By FDA Over Manufacturing
Yet another unit of Daiichi Sankyo has elicited the wrath of the FDA. The agency issued a warning letter to its Luitpold Pharmaceuticals subsidiary for “significant†and repeated violations at a Long Island, New York, manufacturing plant. The facility was inspected last winter and was shut down for a month in April to address the […]
Read More »Category : News
Merck Is On The Defensive Over Gardasil, Again
These are trying times for the Merck c-suite. For the past week, their Gardasil vaccine has been in the news every day, but not for very good reasons. First, Texas Governor Rick Perry is attacked by his rivals for the Republican presidential nomination for accepting Merck donations leading up to his controversial decision to unilaterally […]
Read More »Category : News
J&J Pays $85M Fine Over Natrecor Marketing
The Scios unit of Johnson & Johnson Scios has agreed to pay an $85 million fine and pleaded guilty to a msidemeanor for misbranding the Natrecor acute heart failure drug. The drugmaker was accused of providing labeling that “lacked adequate directions for use†between 2001 and 2005. The move comes two years after prosecutors began […]
Read More »Category : News
FDA advisers wary of time limit on bone drugs
U.S. health advisers declined to suggest how long women should take a class of drugs used by millions to prevent bone fractures, but agreed the labels should be changed to reflect uncertainty about the risks and benefits of long-term use. The Food and Drug Administration had asked two of its advisory panels to recommend whether […]
Read More »Category : News
FDA cites Medtronic drug pump’s severe flaw
Federal health officials said Monday that an implantable drug pump that Medtronic Inc. recalled this year had a potentially life-threatening design problem. The pump, called the SynchroMed II, delivers drugs directly into the spinal fluid to treat chronic pain and spasticity. The problem relates to the formation of a film within the pump’s battery that […]
Read More »Category : News
FDA Reorganizes Its Office Of Cancer Drugs
The controversial FDA Office of Oncology Drug Products is being reorganized and renamed, although Richard Pazdur (see photo) remains in charge. The move comes amid increasing pressure on the agency to speed reviews and, in particular, cope with concerns over the application of the accelerated approval process (see this). And so the oncology office is […]
Read More »Category : News
Pradaxa Causes A Side Effect Flap In New Zealand
Three months after New Zealand’s pharmaceutical management agency agreed to place the new Pradaxa bloodthinner on its formuarly, the Boehringer Ingelheim drug is being linked to two deaths and reports of dozens of elderly patients suffering bleeds. And some doctors say the Pharmac agency may have put lives at risk by funding Pradaxa before more […]
Read More »Category : News
