Pseudo-controversy continues to rage over whether foods from plants and animals genetically engineered with the newest molecular techniques should have to be labeled as such. The battles, fought in the media, state legislatures, referendum issues, and in federal courts, have been largely fomented and funded by the organic agriculture and food industries. All but one of the proposals to require labeling in the United States have failed, and that exception is being challenged in a federal court . In spite of these failures and the fact that mandatory labeling fails every test –scientific, economic, legal and common-sense–the true believers soldier on.
The regenerative medicine space is one that is set to explode with considerable innovation and profitability for shrewd biotechnologists. I had the opportunity to speak with Michael West, PhD., CEO of BioTime (BTX) and found a man passionate about rege…
Cannabis, commonly known as marijuana, weed or pot, is a natural product derived from the Cannabis sativa plant. It has been used medicinally for thousands of years. Recent legislation allowing the use of medical marijuana in over 23 US states has spurred interest in developing pharmaceutical-derived Cannabis products to treat a variety of clinical indications ranging from pain relief to epilepsy. Many products are in late stage clinical development in the US and elsewhere. This article reviews the medicinal properties of Cannabis and describes pharmaceutical-derived Cannabis products that are currently being developed for theUS market.
I am putting in a lot of miles on behalf of international regulatory fraternity.
Like Johnny Cash said, “I’ve been everywhere” — or at least it seems that way. Recently I’ve visited with government health officials in China (both PRC and ROC), the Philippines, Malaysia, Egypt, Algeria, Saudi Arabia, Jordan, the United Arab Emirates, Kuwait, Russia, Brazil, Colombia, South Africa, Indonesia, Kenya, and many other points in-between. And the only thing that’s grown more than my frequent flyer miles is my respect and admiration for those over-worked and under-appreciated civil servants toiling on the front lines of medicines regulation. It’s a global fraternity of dedicated (and generally under-paid) healthcare and health policy professionals devoted to ensuring timely access to innovative medicines and quality generics drugs. But, just as in similar Western agencies (USFDA, EMA, Health Canada, etc.), “doing the right thing” is often a battle of evolving regulatory science, tight resources, competing priorities … and politics.
Venture capitalists (VCs) aim at trade sales as a preferred exit-strategy for biotechnology companies they invest in. Therefore, VCs pay close attention to the wishes of larger (bio)pharmaceutical acquirers. In this paper we explore VCs’ behavior and strategies by analyzing the technology fields and therapeutic areas in which they are invested most and which yield the highest returns by means of trade sales. The data show that VCs are by far most invested in oncology and this is also an area in which relatively high returns are realized. Regarding other areas, VCs could balance their average investment valuations more in correspondence with what acquirers are willing to pay. In addition, VCs have formidable insight in the types of technologies that do well and they seem to employ a strategy focused on both short-term and long-term success. They are investing most in small molecule drugs and protein/peptide therapeutics, which both yield high returns, followed by DNA/RNA technologies which underlie the possibilities of personalized medicine. We conclude that Venture Capitalists act as technological gatekeepers because they are predicting long-term cure and care macro-trends.
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After dominating the world tea market since last 170 years, today India became the fourth largest tea exporter. The state Assam, located in the Northeastern end of the country contributes almost 50% of the India’s total tea production and Small tea growers of Assam (STGs) produces around 30% of its total annual production and contributes almost 12% of India’s annual production. Though the use of harmful pesticides and fertilizers by the STGs of Assam is still not recognized and controversial in the state, but it is observed that STGs of Assam hardly follows standard scientific techniques for handling such chemicals. Therefore, maintenance of sound health of STGs and environmental safety is a necessary issue. But, till date no such awareness program was found to be initiated scientifically to teach them about those safety measures. Therefore, there is a great need for immediate implementation of such kind of scientific solutions, basically for storing (micro level) of these harmful chemicals and also for grass root level safety campaign by scientific communities of India including other competent Agencies.
The field of bioinformatics is flourishing, and strong growth is only projected to continue. Like any cutting edge technology, bioinformatics requires an integrated IP strategy involving patent, trade secret, and copyright laws. The patent system in particular can be a powerful protection for commercializing bioinformatics inventions as long as a corresponding patent application meets certain patent law standards. Recently, the most rapidly evolving of these patent law standards—patent eligibility—came to a crescendo last year when the Supreme Court in Alice v. CLS Bank introduced a two-step test for determining whether computer-implemented inventions are patent-eligible. Since then, other courts and the USPTO have applied the test on inventions implemented on a computer and/or using the Internet with fact-dependent results. Here, we discuss how these decisions relate to bioinformatics inventions. We then analyze bioinformatics patents that have recently issued post-Alice. While the law remains relatively underdeveloped, it becomes clear that relying on a general purpose computer to perform routine or conventional steps in a claim will not infuse patent-eligibility into a claim. However, bioinformatics inventions remain patentable, especially when the patent prosecution team properly and persuasively presents the technical improvements and commercial embodiments.