Transforming FDA LogoAccording to an Associated Press report, some members of Congress are upset that FDA has increased spending on bonus payments to retain certain employees, especially reviewers. Well, too bad. There's a reason why these bonuses are needed. Without them, the agency would be severely lacking in expertise. The private sector offers much better pay than the public sector, which means reviewers and other personnel are always at risk of crossing over to work for industry. It also means the top scientists and engineers coming out of school aren't exactly chomping at the bit to work for the agency, either. If Congress...
July 17th, 2007
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FDA yesterday approved the first molecular diagnostic test that can detect the spread of breast cancer to the lymph nodes. If breast cancer cells are found in the lymph nodes, that's a strong indicator that the cancer has spread there and the patient's treatment should be changed. The GeneSearch BLN Assay, made by Veridex (Warren, NJ), a Johnson & Johnson company, produces results in 40 minutes and is faster and more accurate than existing tests.
July 17th, 2007
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Boston Scientific agreed to pay $195 million to settle a class-action suit against Guidant, which it now owns, over faulty implantable heart devices. Guidant allegedly knew about the defects but did not bring them to light in a timely manner. The settlement covers the largest class action, which was to be heard in Minnesota, reports the Boston Globe. The class action consolidated 1500 suits by 4000 people. Other suits are still pending. One might argue that Boston Scientific got off easy: It had set aside more than $700 million for legal fees and potential settlements. This case represents why risk management is more than just talk. Guidant ignored a basic fundamental of risk management: The problems that require immediate corrective action are the ones that occur the most frequently and/or pose the most danger to patients. Guidant downplayed the seriousness of the...
July 16th, 2007
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Reading an item on Ogan Gurel's Life Sciences Daily blog about the Stryker-Corin hip-resurfacing partnership, I was inspired to post something I've been thinking about for a while: "I believe that in the future, the device industry will start to look like the pharma industry as far as partnerships go -- at least for Class III products. The clinical-study requirements for Class III devices and combination products are getting so extensive, stringent, and complex that start-ups, even ones with a decent amount of venture capital, won't be able to fund them anymore. That will lead to more of the licensing/milestone arrangements that we see in the pharma industry. That is, the small company invents the product and the big company funds the research and gets marketing rights,...
July 13th, 2007
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Boston Scientific and Alfred Mann, founder of Advanced Bionics, a neurostimulation company sold to Boston Scientific in 2004, face off in court today over the firm's wish to oust Mann from his old company, reports the Boston Globe. As part of the sale agreement, Mann stayed on as head of the new Boston Scientific division, and shared control over it with the company. But things quickly went wrong, as Advanced Bionics ran into quality problems and Boston Scientific moved to dump Mann. Last year, the firm told Mann and his right-hand man to resign or they would be forced out. Mann then sued the company, and in April, a judge agreed with him, finding Boston Scientific acted in bad faith and issuing an injunction preventing his ouster. Today, an appellate court hears the company's appeal. At the root of this is poor contract negotiation. It's not...
July 13th, 2007
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Abbott and GE have scrapped a deal that would have sent Abbott's diagnostic businesses to GE for $8 billion. The firms could not agree on final terms, reports Reuters News. Abbott, like Bayer before it, wants to sell its diagnostics business because it doesn't have the growth potential that its pharmaceutical business does. But if GE won't buy it, who will? Siemens is reeling from the fallout over a bribery scandal. Most other diagnostics companies aren't big enough to even contemplate such a deal.
July 12th, 2007
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Transforming FDA LogoThe House yesterday read more >>
July 12th, 2007
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Plaintiff lawyers have indicated that Boston Scientific is engaging them in settlement talks regarding lawsuits over malfunctioning implantable cardioverter-defibrillators and pacemakers, the Star Tribune of Minneapolis reports. Boston Scientific inherited the liability when it bought Guidant. The company is not talking, but a spokeswoman for the plaintiffs said that "the parties are discussing the best way to proceed with these cases." It is believed that Wall Street might look favorably on a settlement, as it would allow the firm to better focus on operational issues.
July 11th, 2007
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Today's New York Times has a lengthy piece on the Myomo e100, read more >>
July 10th, 2007
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Medtronic has launched two innovative defibrillators that are the first of their kind in Japan. Both of the devices wirelessly transmit information to doctors and can be programmed wirelessly upon initial implantation. The defibrillators also deliver electrical shock without a delay (the pacing can happen while charging the capacitor), which could provide safer and less painful anti-tachycardia pacing. Their final novel feature is a diagnostic function that helps doctors monitor fluid build up in the lungs. The fluid status technology can indicate the early warning signs of deteriorating heart failure.
July 9th, 2007
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