UK-based AI-as­sist­ed R&D biotech Syn­thace just wrapped up a Se­ries C round, bring­ing in $35 mil­lion.

Per a com­pa­ny state­ment this morn­ing, the in­vest­ment will fu­el com­mer­cial and go-to-mar­ket (GTM) growth as Syn­thace con­tin­ues to ex­pand across the At­lantic in­to the US. This in­cludes plans to ex­pand its lead­er­ship team by bring­ing in new VPs of mar­ket­ing and sales to join US-based Guy Levy-Yurista, Syn­thace’s CEO.

“To max­i­mize im­pact, we need to ex­pand ac­cess and reach to cus­tomers across the globe—at scale. This in­vest­ment serves as a strong vote of con­fi­dence from world-class in­vestors in the bio­phar­ma­ceu­ti­cal and in­no­va­tion tech­nol­o­gy in­dus­tries,” said Levy-Yurista in a state­ment.

In­vestors in­clud­ed Hori­zon Ven­tures and Sofinno­va Part­ners.

US biotech De­ka rais­es $20M in Se­ries A

Mary­land-based De­ka Bio­sciences closed a $20 mil­lion Se­ries A round, with the as­sis­tance of Leaps by Bay­er and Lu­mi­na Ven­tures along­side oth­er in­vestors.

De­ka, a pre­ci­sion med­i­cine biotech pri­or­i­tiz­ing can­cer and an­ti-in­flam­ma­to­ry dis­eases, has been fo­cus­ing on en­gi­neered pro­teins and cy­tokine-based ther­a­pies it calls “Di­akines.”

The in­vest­ment will en­able De­ka to ad­vance re­search, hire new peo­ple and fur­ther ex­pand the de­vel­op­ment of its plat­form. The biotech is al­so hop­ing to use the fund­ing to help push its lead on­col­o­gy pro­gram past the IND stage and in­to Phase I tri­als.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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.