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Russia has approved the world’s first coronavirus vaccine, President Vladimir Putin announced Tuesday, prompting widespread concerns about the vaccine’s safety as it is only entering a late-stage clinical trial this week. Read More
In a final guidance released yesterday, the FDA explains how and when drug sponsors should notify the agency about products that they plan to withdraw from the market or that will not be offered for sale. Read More
Genentech has set a maximum yearly price of $340,000 for its recently approved spinal muscular atrophy drug Evrysdi (risdiplam), making the medicine notably less expensive than the other two SMA treatments on the market. Read More
The U.S. government’s $765 million loan to Eastman Kodak for a generic drug ingredient manufacturing facility aimed at reducing U.S. dependence on imports is on hold as federal investigators look into allegations of wrongdoing at the company. Read More
The World Health Organization (WHO) will need $100 billion to pay for COVID-19 vaccines but it has only received commitments for 10 percent of that amount, according to the organization’s Director General Tedros Adhanom Ghebreyesus. Read More
China-based CanSino Biologics is preparing a phase 3 trial of its COVID-19 vaccine in Saudi Arabia, the country’s Ministry of Health has announced. Read More
Gilead Sciences announced yesterday that it has filed a new drug application (NDA) with the FDA, seeking approval for remdesivir for the treatment of COVID-19 patients. Read More