As Covid-19 nears its in­evitable, slow-to-de­vel­op endgame, the na­tions of the world are look­ing to speed the pan­dem­ic’s end while prepar­ing for what comes next. A high­ly-tout­ed plan from CEPI to tur­bocharge pan­dem­ic R&D has earned the first of what it hopes will be sig­nif­i­cant fund­ing to take that ini­tia­tive for­ward.

With CEPI’s an­nu­al Glob­al Pan­dem­ic Pre­pared­ness Sum­mit just days away, the gov­ern­ments of the UK and Japan have pledged more than half a bil­lion dol­lars to the in­ter­na­tion­al ini­tia­tive as part of a five-year plan to end Covid-19 and pre­pare for fu­ture pan­demics.

CEPI’s am­bi­tious plan — dubbed the 100 Days Mis­sion — aims to speed the de­vel­op­ment of vac­cines and ther­a­peu­tics to 100 days for emerg­ing dis­eases. En­dorsed by the G7 and G20, the ini­tia­tive is look­ing to raise $3.5 bil­lion by the end of the sum­mit in ear­ly March.

For its part, the Japan­ese gov­ern­ment pledged $300 mil­lion to the ini­tia­tive, re­it­er­at­ing its sup­port for the in­ter­na­tion­al R&D strat­e­gy. In a state­ment, the gov­ern­ment said:

Japan will strength­en its co­op­er­a­tion with CEPI to re­spond to the cur­rent pan­dem­ic and pre­pare for fu­ture pan­demics. The con­tri­bu­tion to CEPI has great sig­nif­i­cance in ad­dress­ing the com­mon hu­man is­sue of pan­demics and can al­so help to fur­ther pro­mote Japan’s own vac­cine de­vel­op­ment and pro­duc­tion.

Mean­while, the UK pledged rough­ly $214 mil­lion to the mis­sion. The na­tion has raised around $370 mil­lion for the or­ga­ni­za­tion since 2018.

CEPI CEO Richard Hatch­ett had this to say about the pledges in a state­ment:

This fund­ing comes at a crit­i­cal mo­ment, al­low­ing CEPI to pur­sue our am­bi­tious pro­gram to de­vel­op ‘vari­ant proof’ vac­cines against Covid-19 and oth­er be­ta­coro­n­avirus­es as well as pur­sue our life-sav­ing work de­vel­op­ing vac­cines against the next Dis­ease X and known vi­ral threats such as Las­sa Fever, Ni­pah and Chikun­gun­ya.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.