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The new FDA draft guidance opens the door for companies to share truthful, scientifically accurate, and data-driven information with healthcare professionals to inform treatment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.
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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