Category: Biotechnology Industry News
Biotechnology industry news, updates, and press releases
Biopharmaceutical companies have the most complete and up-to-date information about the medicines that they research, develop and manufacture for use by patients. However, companies are often unable to proactively share valuable information about their medicines, especially for information that is not contained in the FDA-approved prescribing information (the package insert you often receive with a prescription), with physicians and other healthcare providers.
The new FDA draft guidance opens the door for companies to share truthful, scientifically accurate, and data-driven information with healthcare professionals to inform treatment decisions.
Whether it’s willful counterfeiting, sloppy manufacturing processes, or neglectful handing of drugs in the global supply chain, recent studies suggest the problem of weakened, adulterated, and fake drugs is a growing global issue with deadly consequences. In Africa, the lack of access to innovative drugs makes the population vulnerable to counterfeits and inefficacious copies of medicines that are much needed. This humanitarian crisis rests on policymakers’ steadfastness in each country to ensure the authenticity of the drug supply. Among the steps that should be taken is the restriction of the sale of drugs to pharmacies and hospitals and the prohibition of their sale through street vendors and open markets. There is also an urgent need for post-importation testing to ensure drugs actually contain their active ingredients in adequate strength before they are sold. These are necessary parts of a needed comprehensive approach to combating the importation of counterfeit, weakened, and adulterated drugs. Countries have it within their power to protect their populations, ensure the integrity of medications, and restore trust in their healthcare systems.
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.
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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.