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STAT+: Tracking the FDA expert review of Replimune’s melanoma treatment
Welcome to STAT’s live blog of a meeting, convened by the Food and Drug Administration, to review Replimune’s experimental treatment for melanoma.
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee is meeting Thursday to evaluate whether the biotech company has collected sufficient data to support the accelerated approval of RP1, an engineered viral immunotherapy for melanoma. The agency tends to follow the recommendations of its expert panels but is not bound by them.
The vote will be seen by some as a signal of how the FDA, under new leadership, weighs potential benefits and risks when it comes to investigational drugs. RP1 was rejected in April, under former FDA leaders Marty Makary and Vinay Prasad. Investors have interpreted the FDA’s decision to hold an advisory committee meeting about the drug as a sign of new lenience. But STAT has reported that earlier resistance to RP1 was based on the views of the FDA’s career staff, not leadership.
Welcome to STAT’s live blog of a meeting, convened by the Food and Drug Administration, to review Replimune’s experimental treatment for melanoma.
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee is meeting Thursday to evaluate whether the biotech company has collected sufficient data to support the accelerated approval of RP1, an engineered viral immunotherapy for melanoma. The agency tends to follow the recommendations of its expert panels but is not bound by them.
The vote will be seen by some as a signal of how the FDA, under new leadership, weighs potential benefits and risks when it comes to investigational drugs. RP1 was rejected in April, under former FDA leaders Marty Makary and Vinay Prasad. Investors have interpreted the FDA’s decision to hold an advisory committee meeting about the drug as a sign of new lenience. But STAT has reported that earlier resistance to RP1 was based on the views of the FDA’s career staff, not leadership.
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Key Senate panel backs Trump’s picks for CDC, pandemic preparedness
WASHINGTON — The Senate health committee approved two Trump administration nominees for key health roles Thursday, including the director of the Centers for Disease Control and Prevention and a pandemic preparedness leader, after an earlier vote was delayed.
The vote on Erica Schwartz for CDC director was approved by all Republicans and by Tim Kaine (D-Va.), with other Democrats opposed. Sean Kaufman won support from all Republicans to be assistant secretary for preparedness and response, and all Democrats were opposed.
WASHINGTON — The Senate health committee approved two Trump administration nominees for key health roles Thursday, including the director of the Centers for Disease Control and Prevention and a pandemic preparedness leader, after an earlier vote was delayed.
The vote on Erica Schwartz for CDC director was approved by all Republicans and by Tim Kaine (D-Va.), with other Democrats opposed. Sean Kaufman won support from all Republicans to be assistant secretary for preparedness and response, and all Democrats were opposed.
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Judge denies states’ motion to postpone Medicaid work requirement
BOSTON — In an order issued Thursday, a federal judge denied 26 states’ request to postpone the implementation of Medicaid work requirements announced in June.
The case, which was filed by 26 states, seeks to alter a piece of one of President Trump’s biggest legislative priorities. The suit is focused on the implementation of a work requirement for people who receive Medicaid, the details of which were issued in June with the target of implementing the changes by Jan. 1. But states must also communicate with Medicaid recipients by Aug. 31 regarding how the changes may affect those enrollees.
BOSTON — In an order issued Thursday, a federal judge denied 26 states’ request to postpone the implementation of Medicaid work requirements announced in June.
The case, which was filed by 26 states, seeks to alter a piece of one of President Trump’s biggest legislative priorities. The suit is focused on the implementation of a work requirement for people who receive Medicaid, the details of which were issued in June with the target of implementing the changes by Jan. 1. But states must also communicate with Medicaid recipients by Aug. 31 regarding how the changes may affect those enrollees.
With Enhertu and Datroway hitting their peak revenue and rivals flowing into the antibody-drug conjugate space, Jefferies cuts expectations for Daiichi Sankyo.
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
Key Senate panel backs Trump’s picks for CDC, pandemic preparedness
Judge denies states’ motion to postpone Medicaid work requirement
Daiichi’s pipeline falls behind rivals as cash flow nears peak: analysts
Latigo Reports Positive Phase IIb Data for Non-Opioid Acute Pain Candidate
J&J secures right to take the helm in up to $925M Sail CAR T pact
Ebola outbreak nears milestone, but vaccine is close
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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