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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MyoKardia (NASDAQ:MYOK), a leading precision cardiovascular medicine company, reported good data during 2015-16 on its drug, mavacamten, to treat hypertrophic cardiomyopathy (HCM), a condition that reduces the rate of heart contractions because of the thickening of surrounding heart muscles. Mavacamten, […]
Dynavax’s (NASDAQ:DVAX) BLA application for its Hepatitis B vaccine first received a complete response letter from the FDA in 2013 and then experienced further regulatory delays between 2015-2016. Some of the FDA requests involved the vaccine’s overall immunogenicity data, while […]
California-based company Zogenix (NASDAQ:ZGNX) observed the drug fenfluramine, which had problematic side effects in obesity, and demonstrated it could work to prevent seizures. At a time when GW Pharmaceuticals (GWPH) and Insys Therapeutics (INSY) were advancing cannabidiol (CBD)-based drugs to […]