Pur­due Phar­ma may soon be sign­ing off on a guilty plea and an $8 bil­lion-plus set­tle­ment to wrap up its con­tro­ver­sial role dis­trib­ut­ing Oxy­Con­tin.

The AP has the break­ing sto­ry this morn­ing.

Pur­due filed for bank­rupt­cy last year, along with In­sys and fol­lowed by Mallinck­rodt, as it nav­i­gat­ed its way through a bliz­zard of lit­i­ga­tion sur­round­ing Oxy, which trig­gered an epi­dem­ic of abuse around the coun­try.

Flag­ship Pi­o­neer­ing pipes new comms chief on board

Chris­tine Heenan

Flag­ship Pi­o­neer­ing has re­cruit­ed a new chief of com­mu­ni­ca­tions, and they’re bring­ing her in as a se­nior part­ner.

Chris­tine Heenan, pres­i­dent and founder of the Claren­don Group, was tapped for the post at the big biotech VC, which spe­cial­izes in spin­ning out am­bi­tious biotechs with grand vi­sions and the bank ac­count to back it up.

She’s be­ing brought on “to shape the or­ga­ni­za­tion’s glob­al brand strat­e­gy, com­mu­ni­ca­tions and ex­ter­nal af­fairs,” ac­cord­ing to Flag­ship. And she will re­port di­rect­ly to the head hon­cho him­self, Noubar Afeyan.

As­cen­t­age bur­nish­es can­cer drug prospects as Chi­nese reg­u­la­tors put olverem­bat­inib in the fast lane

As­cen­t­age Phar­ma has won a pri­or­i­ty re­view from Chi­nese reg­u­la­tors for its drug treat­ing chron­ic myeloid leukemia.

Yi­fan Zhai

The drug is olverem­bat­inib (or HQP1351), which the com­pa­ny de­scribes as the first third-gen­er­a­tion BCR-ABL in­hibitor in Chi­na.

Yi­fan Zhai, the CMO at As­cen­t­age Phar­ma, not­ed: “This pri­or­i­ty re­view grant­ed to olverem­bat­inib will help ex­pe­dite the ap­proval process, hope­ful­ly soon chang­ing the cur­rent treat­ment op­tions for pa­tients with CML in Chi­na who can­not be ef­fec­tive­ly treat­ed by cur­rent­ly avail­able TKIs. We hope olverem­bat­inib will soon be ap­proved to ben­e­fit more pa­tients.”

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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