FDA approval news from FierceHealthcare
News
Cephalon settlement requires physician payments to be disclosed
Drugmaker Cephalon has agreed to pay $444 million to bring state and federal investigations of its sales and marketing practices to a close. As part of its settlement, Cephalon has agreed to plead... Read more...
ALSO NOTED: FDA sending fewer warning letters;IL law would limit what hospitals can charge uninsured patients; and much more...
> It looks like the FDA is sending out a lot fewer warning letters to potential violators of late. Officials say they're just changing emphasis, but critics suggest that th agency is slacking off.... Read more...
Personalized cancer treatment on the rise, cutting drug spend
If research presented at this year's annual meeting of the American Society of Clinical Oncology is any indication, the time could arrive sooner than expected for "personalized medicine," in which... Read more...
SPOTLIGHT: Terminal patients not entitled to unapproved drugs
The Supreme Court has ruled that terminally ill patients have no constitutional right to gain access to experimental drugs which haven't yet won FDA approval. Advocates had argued that the FDA was... Read more...
ALSO NOTED: Health IT not likely to shift much in '08; HHS recommends better health data privacy protections; and much more...
> Despite the volume of political dialog on the subject, it seems unlike that there will be big changes in the U.S. health IT infrastructure this year. Read more...
Researcher challenges FDA approval process
A high-profile researcher has issued what is now one of many public challenges to the manner in which the FDA speeds approval of certain drugs. Researcher Dr. Clifford J. Rosen is concerned, in... Read more...
Pediatric stent-maker faces FDA investigation
A company that makes coronary stents and catheters for pediatric use is facing an investigation by the FDA and federal prosecutors, who contend that it promoted non-approved stents for use in children. They say device maker NuMed sold more than 30 stents to the DuPont Hospital for Children in Wilmington, Del., but didn't file for FDA approval prior to selling the stents as agency regs require. If the FDA investigation moves forward, NuMed ultimately could be banned from selling the …
... Read more...Health plan association backs monitoring agency
How often do you see the insurance industry petition the government to set up another federal agency? Well, in this case, this most unlikely of events has actually occurred. America's Health Insurance Plans (AHIP), the association representing health insurers, has asked Congress to create an agency dedicated to comparing the effectiveness of existing medical treatments, drugs and devices with new ones. (It would be intriguing to see whether some doctors' instincts are correct that snazzy …
... Read more...Cyberonics denies backdating charges
Cyberonics, a Houston-based maker of a controversial medical device for the treatment of depression says charges that it backdated stock options are "inaccurate and without merit." In a research note last week, SunTrust Robinson Humphrey analyst Amit Hazan questioned the timing of grants the company made to executives around the time the company won FDA approval for its Vagus Nerve Stimulation system. Hazan writes that the Cyberonics board approved options for three key executives dated …
... Read more...J&J wins approval for Lonsys
Johnson & Johnson won FDA approval for a medical device designed to deliver painkillers to hospitalized patients at the touch of a button. The Ionsys system delivers the opiod painkiller fentanyl cutaneously through a patch into the bloodstream. The company says the technology has built-in safeguards designed to prevent abuse.
- read this Wall Street Journal article (sub. req.)
