Government
AstraZeneca’s Phase III COVID-19 vaccine study in the United States is being further delayed due to the U.S. FDA wanting to take a more thorough look at information related to the trial.
PF-06939926 is currently being evaluated to determine the safety and efficacy of this gene therapy in boys with DMD.
The trial was initially placed on hold in November 2019 due to safety concerns.
Catalyst Pharmaceuticals is reeling this morning after a federal judge dismissed the company’s lawsuit against the U.S. Food and Drug Administration regarding the approval of a rival drug for a rare autoimmune disease from New Jersey-based Jacobus Pharmaceutical.
California Gov. Gavin Newsom signed Senate Bill 852 into law on Monday, paving the way for California to manufacture cheaper versions of insulin and other drugs that have been in short supply in recent years.
More than one month after the government of Russia announced it approved the world’s first vaccine for COVID-19, it announced it will share preliminary data from the first six weeks of the ongoing Phase III study.
One month after the government inked a $750 million contract with Abbott for its new, point-of-care COVID-19 test, President Trump said they will be soon be distributed across the country to double the number of tests being performed in the United States.
The new approval makes it the first FDA-approved therapy in over a decade to treat HES and the third indication for the therapy overall.
On Face the Nation, Gottlieb said hospitalization rates in the United States for COVID-19 had been in a state of decline, but those numbers are now rising, which goes hand in hand with an increase in infection rates.
Pennsylvania-based Inovio said the regulatory agency has additional questions about the Phase II/III trial regarding the vaccine candidate itself, known as INO-4800, as well as the company’s Cellectra 2000 delivery device.
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