→ Sunovion Phar­ma­ceu­ti­cals has post­ed pos­i­tive top-line da­ta from their Phase III study for OFF episodes of Parkin­son’s dis­ease. Ac­cord­ing to re­searchers apo­mor­phine hit the pri­ma­ry: a sta­tis­ti­cal­ly sig­nif­i­cant mean re­duc­tion in the Move­ment Dis­or­der So­ci­ety Uni­fied Parkin­son’s Dis­ease Rat­ing Scale (MDS-UP­DRS) Part III score. They added that the drug al­so scored on a key sec­ondary. Sunovion now plans to hus­tle the drug to the FDA soon, which may well set up a con­fronta­tion with a ri­val drug from the strug­gling Acor­da $ACOR, now ru­mored to be on the sales block.

→ The EMA may be shut­ting the door to Puma Biotech­nol­o­gy’s ner­a­tinib, but that hasn’t stopped the com­pa­ny $PBYI from try­ing to com­mer­cial­ize the drug (al­so known as Ner­l­ynx) out­side the US. Is­rael’s Medi­son Phar­ma is the newest part­ner of the Los An­ge­les-based biotech, hav­ing inked an ex­clu­sive li­cens­ing deal to seek reg­u­la­to­ry ap­proval for and com­mer­cial­ize the breast can­cer treat­ment. Medi­son ex­ecs say they ex­pect to re­ceive ap­proval from the Is­raeli Min­istry of Health in 2019.

→ En­tera Bio, the Jerusalem-based com­pa­ny that spe­cial­izes in oral de­liv­ery of in­jecta­bles, has post­poned the $55 mil­lion IPO that it pro­posed ear­li­er this month. It had planned to of­fer 5 mil­lion shares at a price range of $10 to $12, list­ing as $EN­TX.

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 That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled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