Earnings reports, pipeline updates and regulatory news were overshadowed by the run-up to the Presidential election and the surprise win of Donald Trump. In fact, the biotech sector responded favorably to Trump’s victory on hopes that there will be fewer drug pricing headwinds considering Trump was not as vocal as Hillary Clinton about rising drug prices and excessive price hikes. Trump’s pro-business stand is also expected to benefit the sector.
Recap of the Week’s Most Important Stories
Gilead HBV Drug Gains FDA Approval: Gilead GILD, which is facing a slowdown in hepatitis C virus (HCV) franchise sales, gained FDA approval for Vemlidy (tenofovir alafenamide, TAF), a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Approval comes with a boxed warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of HBV. With HBV being an under-treated disease that affects up to 2.2 million in the U.S., Vemlidy provides patients with a new treatment option.
Vemlidy also got a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency.