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 […]
Forbes.com 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 […]
They say the modern biotechnology industry was born 30 years ago this year, with the founding of Genentech in April 1976. Now, in its 20th anniversary edition report called Beyond Borders 2006, Ernst & Young sets out an in-depth analysis and key trends for the biotechnology sector with a timeline charting the industrys evolution. The […]
The European Commission has given Sandoz, the generic division of Novartis, approval for the sale of a generic version of a human growth hormone, making it the first generic of a biotechnology drug authorized for sale in Europe. The approved drug, Omnitrope®, is based on Pfizer’s Genotropin, a treatment for abnormal growth and growth hormone […]
I just returned from the BIO 2006 conference in Chicago. It was a fantastic meeting with lots of excitement in the biotech arena. Almost every U.S. state had a booth and lots of governors and state officials were in attendance. With sponsorships going for over $200K, there were big bucks being splashed around – including […]
The European Medicines Agency (EMEA) published a set of five final guidelines on similar biological medicinal products. They are intended to give guidance to industry in the development of this new type of applications for marketing authorisation. They give guidance on quality, non-clinical and clinical issues. The product class specific annexes to the guideline on […]
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Editor-in-Chief Barista Stephen Jenei is a patent attorney and Owner of Jenei LLC. When not serving up patent chat over a steaming cup of java, he's handling a diverse intellectual property practice in the biotechnology, pharmaceutical and chemical fields. More info @ Jenei LLC
