Protocols

Seres grabs $20M on PhIII microbiome launch; Gilead submits NDA; Alkermes begins Phase IIIb study

→  Seres $MCRB is taking another step forward in its comeback effort on a microbiome drug that rattled everyone in the field when it failed a mid-stage study. The biotech says that it has learned from its setback and has now started a study for patients with multiple recurrent C. difficile infection that it’s hoping will serve as the pivotal Phase III for SER-109. That move — the most advanced microbiome study in the gut research world — was worth a $20 million milestone payment from its partners at Nestlé Health Science.

→  Gilead has submitted an NDA for its HIV drug cocktail, which fared well in a recent Phase III study. The company has been racing with GSK to approve new therapies for HIV.

→ Alkermes announced the start of a Phase IIIb study on its drug for treatment-resistant Major Depressive Disorder. The company anticipates submitting an NDA at the end of this year. The drug has demonstrated mixed results in previous studies.

→  Helsinn has returned rights to elsiglutide, a drug designed to treat chemotherapy-induced diarrhea, to Zealand, ending the licensing agreement between the two companies. Zealand is evaluating the drug for further development.


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