• No­var­tis nev­er has tried to ex­plain why the FDA has re­ject­ed its biosim­i­lar of Am­gen’s Neu­las­ta. And it’s be­ing equal­ly ret­i­cent about its de­ci­sion to yank its ap­pli­ca­tion in Eu­rope. The “ap­pli­ca­tion for a mar­ket­ing au­tho­riza­tion for Ziox­ten­zo (peg­fil­gras­tim) has been with­drawn,” the EMA not­ed to­day. “Ziox­ten­zo was de­vel­oped as a biosim­i­lar med­i­cine to treat neu­trope­nia in can­cer pa­tients.” No­var­tis loves to high­light its R&D progress, but set­backs are dealt with silent­ly. The EMA, though, did ex­plain that the biosim­i­lar ap­peared to be un­ap­prov­able.  “One con­cern was that study re­sults were not able to show that the con­cen­tra­tions of peg­fil­gras­tim in blood were the same af­ter tak­ing Ziox­ten­zo and Neu­las­ta. The oth­er con­cern was the lack of a cer­tifi­cate of Good Man­u­fac­tur­ing Prac­tice (GMP) for the med­i­cine’s man­u­fac­tur­ing site. An in­spec­tion of the site will there­fore be need­ed be­fore the med­i­cine can be ap­proved.”

• The GT­JA In­vest­ment Group has led a $39 mil­lion round for Mab­works Biotech, a Chi­nese com­pa­ny that’s been work­ing on a cock­tail for Ebo­la. Har­vest Cap­i­tal Man­age­ment, Me­fund Cap­i­tal and E-Town Bio­med­ical Park al­so par­tic­i­pat­ed in the round for the Bei­jing based an­ti­body de­vel­op­er.

• Pfiz­er says that its Phase II study of a new C diff vac­cine, passed muster in a Phase II tri­al, set­ting up a late-stage study set to launch in the first half of this year. “We are very en­cour­aged by these in­ter­im im­muno­genic­i­ty and safe­ty re­sults demon­strat­ing ro­bust in­creas­es in vac­cine-elicit­ed neu­tral­iz­ing an­ti­bod­ies to both tox­ins, that we be­lieve could pro­vide pro­tec­tion against C. dif­fi­cile dis­ease,” said Kathrin Jansen, Ph.D., se­nior vice pres­i­dent and head of Vac­cine Re­search and De­vel­op­ment for Pfiz­er.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.