A1M Pharma AB, of Lund, Sweden

Rosgard

Based on endogenous protein alpha-1-microglobulin

Kidney injury

Resubmitted application to Swedish regulators for a phase I trial in healthy volunteers, expected to start in the fourth quarter; drug showed protective effect against kidney injuries in connection with oxidative stress in preclinical studies

Adverum Biotechnologies Inc., of Menlo Park, Calif.

ADVM-022

Gene therapy

Wet age-related macular degeneration

FDA granted fast track designation

Asterias Biotherapeutics Inc., of Fremont, Calif.

OPC-1

Oligodendrocyte progenitor cell population derived from human embryonic stem cells

Subacute motor complete cervical spinal cord injuries

FDA accepted request to meet to discuss proposed next steps; type B meeting request is in accordance with regenerative medicine advanced therapy designation

Mylan NV, of Hertfordshire, U.K., and Fujifilm Kyowa Kirin Biologics Co. Ltd., of Tokyo

Hulio (FKB-327)

Biosimilar to Humira (adalimumab)

Indications for which Humira is approved

European Commission granted marketing authorization for all indications

Pfizer Inc., of New York

PF-06482077

20-valent pneumococcal conjugate vaccine

Prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes

FDA granted breakthrough therapy designation for use in adults, 18 and older

Pierre Fabre SA, of Castres, France, and Array Biopharma Inc., of Boulder, Colo.

Braftovi (encorafenib) and Mektovi (binimetinib)

BRAF inhibitor and MEK inhibitor

Unresectable or metastatic melanoma

Combination approved by the European Commission for use in adults with a BRAFV600 mutation, as detected by a validated test

Shire plc, of Dublin

Takhzyro (lanadelumab injection)

Plasma kallikrein-inhibiting monoclonal antibody

Prevention of attacks of hereditary angioedema

Approved by Health Canada for routine prevention of HAE attacks in adolescents and adults, 12 and older

Therapeuticsmd Inc., of Boca Raton, Fla.

Annovera (segesterone acetate and ethinyl estradiol vaginal system)

Hormone-releasing system

Contraceptive

FDA granted marketing exclusivity as a new chemical entity, which comes with five years of exclusivity from the time of FDA approval

Tetraphase Pharmaceuticals Inc., of Watertown, Mass.

Xerava (eravacycline)

Fluorocycline antibacterial

Complicated intra-abdominal infections

European Commission granted marketing authorization for use in adults; phased commercial launch expected in first half of 2019

Notes

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