⇨ The pen­ny stock biotech Ma­teon Ther­a­peu­tics $MATN, for­mer­ly Ox­i­Gene, says it is scrap­ping a Phase II/III ovar­i­an can­cer study of CA4P in com­bi­na­tion with Avastin af­ter a re­cent fu­til­i­ty an­nounce­ment. The biotech says it will now shelve the drug and needs to ax 60% of its staff while se­nior ex­ecs take a 50% pay cut to pre­serve cap­i­tal as they shift fo­cus to an­oth­er ther­a­py in the pipeline.

⇨ Just a few days af­ter see­ing its stock price take a hit on J&J’s de­ci­sion to scrap a late-stage hep C cock­tail which it had con­tributed to, Medi­vir $MVIR got a boost from pos­i­tive top line da­ta for MIV-711 in pa­tients with mod­er­ate knee os­teoarthri­tis.

⇨ No­vo Nordisk says that reg­u­la­tors in Chi­na have OK’d the sale of its drug Tre­si­ba. The long-act­ing in­sulin can now be mar­ket­ed in what No­vo calls the biggest sin­gle di­a­betes mar­ket in the world.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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