Company

Product

Description

Indication

Status

Amgen Canada, of Mississauga, Ontario

Evenity (romosozumab)

Monoclonal antibody targeting sclerostin

Postmenopausal women at high risk for fracture

Health Canada approved the drug for sale

Astrazeneca Canada, of Mississauga, Ontario

Calquence (acalabrutinib)

Bruton's tyrosine kinase inhibitor

Second-line mantle cell lymphoma

Health Canada approved the drug for sale

Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia

Scenesse (afamelanotide)

Melanocortin-1 receptor agonist

Erythropoietic protoporphyria

Approved by FDA to increase pain-free light exposure in adults with history of phototoxic reactions

Gilead Sciences Inc., of Foster City, Calif.

Filgotinib

JAK1 inhibitor

Rheumatoid arthritis

NDA submitted to the Japanese Ministry of Health, Labor and Welfare

Intarcia Therapeutics Inc., of Boston

ITCA-650 (exenatide implant)

Long-acting glucagon-like peptide-1 receptor agonist

Type 2 diabetes mellitus

FDA accepted the resubmitted NDA as a class 2 response; PDUFA date of March 9, 2020

Matinas Biopharma Holdings Inc., of Bedminster, N.J.

MAT-2203

Oral formulation of the antifungal amphotericin B

Cryptococcosis

FDA granted orphan drug designation

Novartis AG, of Basel, Switzerland

Beovu (brolucizumab)

Monoclonal antibody targeting VEGF

Wet age-related macular degeneration

FDA approved the drug

Octapharma USA, of Hoboken, N.J.

Wilate

Human plasma-derived, sterile, purified, double virus inactivated von Willebrand factor/coagulation factor VIII complex

Hemophilia A

Approved by FDA for routine prophylaxis to reduce frequency of bleeding episodes and on-demand treatment and control of bleeding episodes

Vast Therapeutics Inc., of Durham, N.C.

BIOC-11

Delivers nitric oxide via macromolecules

Chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis

FDA designated the drug a qualified infectious disease product

Vivus Inc., of Campbell, Calif.

Qsymia (phentermine and topiramate)

Enhances satiety

Obesity

European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway and Poland accepted the MAA on a decentralized basis; Sweden is acting as the lead concerned member state; marketing authorizations, if approved, are expected in the second half of 2020

Notes

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

 

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