Company

Product

Description

Indication

Status

Astrazeneca plc, of Cambridge, U.K.

Imfinzi (durvalumab)

Monoclonal antibody targeting PD-L1

Stage III non-small-cell lung cancer

FDA approved the inclusion of overall survival data from the phase III Pacific study in the drug's label

Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn.

Nurtec (riluzole) (BHV-0223)

Sublingual tablet formulation

Amyotrophic lateral sclerosis

FDA issued a complete response letter for the 505(b)2 application, citing concerns about the active pharmaceutical ingredient that was manufactured by Apotex Pharmachem India Pvt Ltd. between 2014 to 2016 and used in the bioequivalence study in 2017

Cstone Pharmaceuticals Co. Ltd., of Suzhou, China

Tibsovo (ivosidenib)

Targets mutant isocitrate dehydrogenase-1

Relapsed or refractory acute myeloid leukemia with an IDH1 mutation

China National Medical Products Administration approved a phase I bridging registrational study

Exopharm Ltd., of Melbourne, Australia

Plexaris

Autologous exosomes from blood platelets

Wound healing

Melbourne Health Human Research Ethics Committee approved the 42-day phase I study measuring safety, wound closure and scar formation

Genkyotex SA, of Archamps, France

Setanaxib (GKT-831)

NADPH oxidase (NOX) inhibitor

Primary biliary cholangitis

World Health Organization recommended setanaxib as the international nonproprietary name and adopted naxib as the stem for NOX inhibitors

Invagen Pharmaceuticals Inc., of New York, a subsidiary of Cipla Ltd., of Mumbai, India

Pregabalin 

Generic of Lyrica (Pfizer Inc.)

Neuropathic pain, postherpetic neuralgia, partial onset seizures and fibromyalgia

FDA gave final approval for the abbreviated NDA

Orphazyme A/S, of Copenhagen

Arimoclomol

Amplifies the production of heat-shock proteins

Niemann-Pick disease type C

Following a meeting with the FDA, the company remains on track to submit an NDA in the first half of 2020

Vanda Pharmaceuticals Inc., of Washington

Hetlioz (tasimelteon)

Agonist of melatonin MT1 and MT2 receptors

Jet lag disorder

FDA indicated that the supplemental NDA has deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time; PDUFA date is Aug. 16, 2019

Vertex Pharmaceuticals Inc., of Boston

VX-445 (elexacaftor), tezacaftor and ivacaftor

CFTR modulator/stimulator

Cystic fibrosis

Company submitted the NDA to the FDA with a request for a priority review


Notes

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

 

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