→ Hus­tling as fast as it can, BeiGene $BGNE to­day of­fered an ear­ly look at ear­ly-stage da­ta for its PD-1 check­point part­nered with Cel­gene $CELG. The com­pa­ny says it got the ini­tial tu­mor re­spons­es it was look­ing for — with no dose-lim­it­ing tox­i­c­i­ty — as re­searchers pur­sue two reg­is­tra­tion stud­ies for BGB-A317 in urothe­lial can­cer and clas­si­cal Hodgkin lym­phoma. The Chi­na-based biotech has a slate of Phase III stud­ies in the pipeline.

→ Am­gen has struck a deal with Sim­cere to co-de­vel­op and com­mer­cial­ize its biosim­i­lars in Chi­na. Sim­cere’s pri­ma­ry role will be in the dis­tri­b­u­tion and com­mer­cial­iza­tion of the biosim­i­lars, which Am­gen has made a sig­nif­i­cant part of its port­fo­lio. These kinds of deals have grown in­creas­ing­ly com­mon over the past year as glob­al bio­phar­ma com­pa­nies po­si­tion them­selves in Chi­na with lo­cal part­ners. ”This col­lab­o­ra­tion will al­low both com­pa­nies to fur­ther pen­e­trate in­flam­ma­tion and on­col­o­gy mar­kets in Chi­na,” not­ed Sim­cere Pres­i­dent Hong­gang Feng.

→ BAR­DA has award­ed South San Fran­cis­co-based Achao­gen $12 mil­lion in com­mit­ted fund­ing for de­vel­op­ment of its an­tibac­te­r­i­al C-Scape. Achao­gen has a shot at up to $18 mil­lion in fund­ing un­der the con­tract.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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