AstraZeneca reported that its Covid-19 vaccine was 79% effective at preventing severe infection and 100% effective at preventing hospitalization. The company expects to file a submission seeking FDA emergency use authorization in coming weeks.
Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.
A review published in JAMA found that bills introduced into the House and Senate don’t go nearly as far as existing drug pricing regulations other countries. The researchers listed eight key lessons from six nations.
The drug, AZD7442, is designed to potentially provide at least six months of protection from Covid-19. The trial, which is funded by federal defense and health authorities in the U.S., is enrolling up to 48 healthy volunteers in the U.K. AstraZeneca’s double-antibody approach is similar… Read More »AstraZeneca starts Phase I study of long-acting double-antibody cocktail for Covid-19
KaNDy’s lead product candidate, NT-814, is a non-hormonal treatment for symptoms of menopause. The drug completed Phase IIb testing and is slated to start Phase III testing next year.
Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.
The companies will share development and commercialization of DS-1062 in solid tumors. They already have a similar deal in place, the $6.9 billion agreement signed last year for another ADC, the HER2-positive breast cancer drug Enhertu.
The company said that patients receiving the drug, SNG001, had a 79% lower risk of requiring ventilation or dying compared with those on placebo, sending the company’s stock soaring more than 400%, but it did not clarify what that meant in terms of patient numbers.
The company announced the publication of interim data from the Phase I/II study of a vaccine it is developing with the University of Oxford. The news comes the week after Moderna announced the publication of data for its vaccine.
A joint report by cybersecurity agencies in the U.K. and Canada, endorsed by their U.S. counterparts, states that the hacker group Cozy Bear had been targeting organizations involved with Covid-19 vaccine development efforts.
The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.
The FDA’s Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug’s first-in-class potential, the briefing document for the meeting raised concerns about eye toxicity and questions about its risk-benefit profile.
ViiV’s twice-monthly injected PrEP drug superior in HIV prevention to Gilead daily pill, analysis shows
The company said Tuesday that a final analysis of its Phase IIb/III study of cabotegravir showed greater efficacy in HIV prevention than Gilead’s Truvada. The study, among men and transgender women who have sex with men, was stopped in May following an interim analysis.