Current medical news and unique business news for anyone who cares about healthcare.
Drug companies & FDA reach user fee agreement. The drug industry and the FDA have reached an agreement on a five-year plan to increase drug approval fees paid to the agency under the Prescription Drug User Fee Act by about 6 percent. Also in the agreement is a the addition of an extra 60 days to the FDA’s 10-month time line for approving new drugs (or six months for priority drugs). Congress needs to approve the agreement by next year, when the current user fee act expires.
The negotiations appear to have been quite smooth, in contrast to the debate going on between medical device industry any the FDA over that approval process. Meanwhile, the generics drug industry is also in talks with the FDA over a similar system for generic drugs.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Sanofi lands generic Lipitor deal. French drugmaker Sanofi will be able to develop a generic version of Pfizer’s best-selling cholesterol drug Lipitor, possibly even before its patent expires in May 2012.
Med-tech may not fare well in BRIC. The push for med-tech companies to invest and push work overseas into emerging markets may not pay off like some had originally thought, according to Goldman Sachs analysts, who predicted flat 7.9 percent growth in Brazil, Russia, India and China through 2012.
Questioning clinical trials. A new study in the Annals of Surgery questions the validity of clinical trials for cancer drugs, as researched examined eight years of cancer patients’ records to determine who participates in clinical trials. Only .64 percent of cancer patients enrolled in trials, and those who did were mostly under 65, white, and in early stages of cancer.
Implantable medical devices for cancer. In medical device news, two separate groups of researchers are working on implantable oxygen generators that work in different ways to treat cancer.
