→ Am­gen caught a break to­day on its block­buster fran­chise drug Neu­las­ta. The FDA has re­ject­ed an ap­pli­ca­tion from Bio­con and My­lan for a knock­off of the bi­o­log­ic af­ter cit­ing man­u­fac­tur­ing is­sues at the In­di­an com­pa­ny that need to be re­solved. No­var­tis was re­cent­ly hand­ed a CRL for its biosim­i­lar of Neu­las­ta as well, con­serv­ing a multi­bil­lion-dol­lar mar­ket for Am­gen. Bio­con, though, says it doesn’t ex­pect a de­lay in its com­mer­cial launch plans.

Jeff Hat­field Cred­it: Pur­due Uni­ver­si­ty

→ Jeff Hat­field is be­ing giv­en the lead­ing role at Zaf­gen, which is mak­ing a come­back bid af­ter its lead drug proved un­safe. Hat­field, com­ing off his role as CEO of Vi­tae, which was sold to Al­ler­gan, will take the helm as Tom Hugh­es moves in­to a new role as chief sci­en­tif­ic of­fi­cer. Hugh­es is al­so re­tain­ing the pres­i­dent’s ti­tle in the shift at Zaf­gen. Hugh­es says he’s hap­py with the change-up, not­ing: “We are ramp­ing up our clin­i­cal ac­tiv­i­ties with ZGN-1061 now in Phase 2, and have two pre­clin­i­cal can­di­dates that are ad­vanc­ing to­ward the clin­ic. We al­so have ex­cit­ing new in­sights in­to the MetAP2 path­way that war­rant an in­creased com­mit­ment to ad­vance our un­der­stand­ing of its ther­a­peu­tic po­ten­tial and de­vel­op new drugs lever­ag­ing its im­pact.”

→ Ex-JP­Mor­gan ex­ec and new­ly mint­ed ven­ture ex­ec Stephen Beren­son is join­ing the board at Mod­er­na, where Flag­ship chief Noubar Afeyan is chair­man of the board. Beren­son joined Flag­ship as an ex­ec­u­tive part­ner last sum­mer af­ter wrap­ping a stint as vice chair­man of in­vest­ment bank­ing.

→ Cel­gene’s slow and steady en­try in­to neu­rode­gen­er­a­tion R&D is pro­gress­ing nice­ly. Af­ter the “suc­cess­ful” com­ple­tion of a screen­ing pro­gram, Evotec is pick­ing up a $5 mil­lion mile­stone for its neu­rode­gen­er­a­tion work for Cel­gene.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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