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Merck is expanding further into the biotech sector by acquiring Rockville, Md., biopharma company OncoImmune for $425 million, netting in the process an investigational drug that has shown promise as a treatment for hospitalized COVID-19 patients. Read More
UK regulators are reviewing the latest data on the Pfizer/BioNTech COVID-19 vaccine candidate and aim to decide on an approval “in the shortest time possible, without compromising the thoroughness of our review,” the agency’s top official said yesterday. Read More
Regeneron has won Emergency Use Authorization (EUA) from the FDA for its investigational antibody cocktail for the treatment of patients with mild-to-moderate COVID-19 symptoms at high risk of severe disease progression or hospitalization — and an initial 30,000 doses are expected to ship today. Read More
AstraZeneca’s (AZ) and the University of Oxford’s COVID-19 vaccine candidate — which has been shown to be 90 percent effective at a one-and-a-half-dose level — could be a godsend for low- and middle-income nations due to its relative ease of distribution, high manufacturing capacity and the not-for-profit price the drugmaker has vowed to offer developing countries “in perpetuity.” Read More
Pfizer has released promising results from a global phase 3 trial of its non-small cell lung cancer (NSCLC) investigational treatment, Lorbrena (lorlatinib). Read More
The FDA will analyze initial promotional materials from drug companies within five business days of receiving them to see if they qualify for priority “core launch” review, said Susannah O’Donnell, leader of the review team in the agency’s Office of Prescription Drug Promotion (OPDP) in a Friday update on the program. Read More
The FDA has granted an Emergency Use Authorization (EUA) for Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead Sciences’ antiviral Veklury (remdesivir) for treatment of COVID-19 patients needing supplemental oxygen. Read More
The World Health Organization (WHO) released revised guidance on Gilead Sciences’ antiviral Veklury (remdesivir) after an expert panel review of multiple trials found no evidence for the drug’s effectiveness in treating COVID-19. Read More
The Trump administration on Friday rolled out a pair of final rules meant to reduce high U.S. drug prices, including the “most favored nations” strategy strongly opposed by the pharma industry, possibly marking the president’s last significant actions on drug pricing. Read More