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Gilead Sciences said it should be able to meet international demand for remdesivir in October, thanks to improvements in its own processes and an expanded manufacturing network. Read More
The agency said it is taking urgent steps to protect consumers from products that, “without approval, clearance or authorization by the FDA, claim to mitigate, prevent, treat, diagnose or cure COVID-19.” Read More
Novavax signed a licensing agreement with the Serum Institute of India yesterday to commercialize the drugmaker’s COVID-19 vaccine candidate in low- and middle-income countries, as well as in India. Read More
Pfizer’s CEO Albert Bourla said that it is “highly likely” that the ongoing phase 3 trial of its mRNA-based COVID-19 vaccine candidate, BNT162, will show in October whether the vaccine is safe and effective — and said the company plans to seek the FDA’s approval the same month if the data support it. Read More
AstraZeneca (AZ) has reached an agreement with China’s Kangtai Biologics to help develop and manufacture its promising coronavirus candidate AZD1222, the first deal the British drugmaker has forged for its experimental vaccine in China. Read More
The NIH’s National Institutes of Allergy and Infectious Diseases (NIAID) has launched a phase 3 trial of Gilead Sciences’ remdesivir with Merck’s anti-inflammatory drug Rebif (interferon-beta-1a) for the treatment of hospitalized COVID-19 patients. Read More
As concerns mount over the FDA coming under undue pressure to approve a COVID-19 vaccine, FDA Commissioner Stephen Hahn said again yesterday that the agency won’t take any shortcuts. Read More
In a move that’s likely to shake up the entire U.S. drug supply chain, President Trump signed an executive order yesterday directing the federal government to buy “essential drugs” from domestic companies. Read More
Almost three dozen state attorneys general have called on the federal government to bypass Gilead Sciences’ remdesivir patents and begin producing the COVID-19 treatment. Read More