Because FDA marketing clearance to sell a drug or device in the US remains the brass ring for medical manufacturers around the world, companies consistently invested in US trials in spite of rising costs. By 2016, however, more manufacturers were […]
Introducing SanaCurrents Introducing SanaCurrents, a research service for the serious and sophisticated biotech investor. Founder of SanaCurrents, Bill Langbein, finally brings his service to the mainstream to enable biotech investors to track catalysts through the lens of varying levels of […]
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Summary Recently disclosed court documents show that Sinovac Biotech’s (NASDAQ: SVA) CEO bribed a member of the Chinese Food and Drug Administration to assist its vaccine clinical trial and approval Bribery is a clear violation of Foreign Corrupt Practices Act […]
Shares of Repro Med (OOTC:REPR) are little changed following the company’s 2016 second quarter results. We view this as an encouraging sign that the market may finally be ready to shrug off the lingering issue of the FDA Warning letter that […]
One of the best performing stocks in our portfolio over the last couple years just gave away 50% of its peak gains about three weeks ago, after the Food & Drug Administration (FDA) issued a warning letter asking the company […]