Abbvie Inc., of North Chicago, and Genentech, of South San Francisco, a unit of the Roche Group

Venclexta (venetoclax)

Oral Bcl-2 inhibitor

Acute myeloid leukemia

Received accelerated approval from FDA for use in combination with azacitidine, decitabine or low-dose cytarabine in newly diagnosed AML in adults who are 75 or older, or who have co-morbidities that preclude use of intensive induction chemotherapy

Infant Bacterial Therapeutics AB, of Stockholm


Lactobacillus reuteri probiotic

Necrotizing enterocolitis

Phase III trial start delayed to first half of 2019 because company is modifying protocol based on FDA guidance to increase chances of success

Pfizer Inc., of New York

Daurismo (glasdegib)

Oral smoothened receptor and hedgehog pathway inhibitor

Acute myeloid leukemia

Approved by FDA under priority review for use with low-dose cytarabine in newly diagnosed patients, ages 75 or older or who have other co-morbidities that may preclude intensive chemotherapy

Synthetic Biologics Inc., of Rockville, Md.

SYN-004 (ribaxamase)

Oral beta-lactamase

Clostridium difficile infection

Following FDA meeting, said single phase III trial may be sufficient for approval for prevention of antibiotic-mediated CDI; seeking financing via a strategic partnership to support trial start


For more information about individual companies and/or products, see Cortellis.


No Comments