Aptose Biosciences Inc., of San Diego

CG-806

Oral pan-FLT3/pan-BTK multi-cluster kinase inhibitor

Chronic lymphocytic leukemia; non-Hodgkin lymphoma

FDA granted IND allowance for initiation of phase I open-label dose-escalation study and associated expansions

Astrazeneca plc, of Cambridge, U.K.

Forxiga (dapagliflozin)

Oral SGLT2 inhibitor

Insulin dependent diabetes

EC approved for use in type 1 diabetes as an adjunct to insulin in patients with a BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy

Biosyent Inc., of Toronto

N/A

N/A

N/A

Health Canada said company will receive a Notice of Deficiency with respect to its new drug submissions of two cardiovascular products for which company has exclusive distribution rights in Canada

Bone Biologics Corp., of Burlington, Mass.

NB-1

NELL-1 recombinant protein freeze dried onto DBX (demineralized bone putty)

Degenerative disc disease

Received human research ethics committee approval on March 20 for first center of a multicenter pilot clinical trial to evaluate NB-1 (NELL-1/DBX) in 30 patients in Australia

Excellthera Inc., of Montreal, Quebec

ECT-001

Expanded allogeneic umbilical cord-derived CD34+ hematopoietic stem cells

Leukemia; myelodysplasia

FDA and Health Canada have given the company clearance to proceed with phase II studies in the U.S. and Canada

Mesoblast Ltd. of New York and Melbourne and JCR Pharmaceuticals Co. Ltd. of Ashiya, Japan

Temcell (remestemcel-L)

Allogeneic cell-based product

Epidermolysis bullosa

JCR filed to extend marketing approval of Temcell for use in patients with EB

Oasmia Pharmaceutical AB, of Uppsala, Sweden

Apealea (paclitaxel, XR-17 encapsulated)

Cremophor- and albumin-free formulation of paclitaxel combined with XR-17

Ovarian cancer

EMA adopted a positive opinion recommending approval of a type II variation application to add efficacy data to the Apealea product information

Race Oncology Ltd., of Melbourne

Bisantrene

Telomerase inhibitor

Acute myelogenous leukemia

Filed IND for bisantrene which, if approved, would allow company to run registrational phase III trial

Slayback Pharma LLC, of Princeton, N.J.

Hydroxyprogesterone caproate

Progestin

Premature labor

Received ANDA approval from FDA for drug it said is therapeutically equivalent to AMAG Pharmaceuticals Inc.'s Makena (hydroxyprogesterone caproate)

Notes

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