The U.S. Food and Drug Administration has approved Novartis AG’s Omnitrope hormone in what could mark a sea change in the stance taken by the FDA on generic biotechnology drugs. This precedent setting event marks the first follow-on version of a previously approved recombinant biotechnology drug in the U.S. Earlier, a federal judge ordered the […]

The World Health Organization (WHO) said it would look at whether the international drug patent system prevents developing countries from obtaining needed medicines, vaccines and diagnostic tests. The 192 WHO members agreed at an annual meeting in Geneva to launch an intergovernmental group to look for gaps in medical research and development, and draw up […]

The Boston Globe recently ran an article that nanotechnology is about to be the next big thing in bioscience. Although nanotechnology has had a lot of ups and downs in its enthusiam in the marketplace, it’s still remains mostly a laboratory study subject. Now, nanotech seems staged to make huge leaps in medical treatment, so […]

Roche has received European Commission approval for Herceptin (trastuzumab) for patients with early-stage HER2-positive breast cancer following surgery and chemotherapy. HER2-positive breast cancer affects approximately 20% to 30% of women with breast cancer and has a higher likelihood of relapse. The fast approval was based on results from the international HERA (HERceptin Adjuvant) study which […] reports that Merck is close to obtaining approval for a vaccine against common viruses that lead to cervical cancer. An FDA advisory committee voted 13-0 to approve Merck’s Gardasil, a vaccine that protects against four types of sexually transmitted viruses– two of which are believed to be responsible for about 70% of cervical cancer […]

The World Health Organization (WHO) is calling on all medical studies that test treatments on humans to be registered, in order to make research more transparent and enhance the public’s trust in science. Currently, the registration of clinical trials – scientific studies carried out in human participants – is voluntary. As a result, negative results […]

Kevin Heller over at Tech Law Advisor provides a special showcase this week for Blawg Review #58. The presentation provides everything from must-reads to classifieds. I was especially interested in Midwifery Miscellaneous by the Mommy Blogger. After using a midwife to help with the birth of our three children, our midwives’ practice is now closing […]

Earlier, the Baristas had a post from Patent Baristas featured in the newly launched BlawgWorld 2006: Capital of Big Ideas, an eBook sampler of 51 of the most influential law blogs (blawgs). BlawgWorld is published by TechnoLawyer, a publisher of various e-mail newsletters for the legal marketplace. The Barista article, “Misconduct (and Not Just Scientific) […]