Protocols

Novartis’ ‘breakthrough’ AML drug gets accelerated FDA review; Ocular surges on positive PhIII eye study

Novartis will get a quick decision from the FDA on its application for PKC412 (midostaurin), its FLT3 drug for acute myeloid leukemia. The agency is providing a priority review for the application. Phase III overall survival data included a 23% reduction in the risk of death, compared to a placebo. And the numbers also paved the way to a breakthrough drug designation, which set the stage for an accelerated decision. A priority review clips four months off the process at the FDA, reducing the deadline to 6 months from acceptance.

Shares of Bedford, MA-based Ocular Therapeutix $OCUL surged 20% Monday morning after the biotech announced positive top-line results for the two Phase III primary endpoints on Dextenza, in development for the treatment of post-surgical ocular inflammation and pain.

Pfizer has signed up to collaborate with scientists at the NCI on a slate of top cancer drug prospects. The partners will explore OX40 (CD134), (also known as PF-04518600); and utomilumab, targeting 4-1BB (CD137), (also known as PF-05082566); as well as avelumab, the anti-PD-L1 IgG1 monoclonal antibody. They’ll undertake a slate of preclinical and clinical studies looking at the drugs as monotherapies as well as in combo trials for multiple cancer types.

The UK’s Stallergenes Greer (Paris:STAGR) will collaborate with the Sean N. Parker Center for Allergy and Asthma Research at Stanford University to on potential biomarkers of allergy immunotherapy efficacy.

Motif Bio’s proposed microIPO is getting smaller. The biotech $MTFB upsized the number of shares being sold to 2.9 million while cutting the price from $12.36 to $8.38, which would be worth a reduced $24 million. The biotech is developing antibiotics.


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RAPS Regulatory Convergence 2017