Company Product Description Indication Status
Allovir Inc., of Cambridge, Mass. Viralym-M (ALVR-105) Multivirus-specific T-cell therapy Prevention of BK virus, cytomegalovirus, human herpes virus-6, Epstein-Barr virus, adenovirus and JC virus EMA granted orphan drug designation
APR Applied Pharma Research SA, of Balerna, Switzerland APR-OD031 Extended-release amino acid mix Phenylketonuria FDA granted orphan designation
Arvelle Therapeutics GmbH, of Zug, Switzerland Cenobamate Voltage-gated sodium channel blocker Focal onset seizures in epilepsy EMA accepted marketing authorization application
Astrazeneca plc, of London Lokelma (sodium zirconium cyclosilicate) Potassium-removing medicine Hyperkalemia Approved for marketing by Japan Ministry of Health
Bristol Myers Squibb Co., of New York Zeposia (ozanimod)  Sphingosine 1-phosphate receptor modulator  Relapsing-remitting forms of multiple sclerosis Approved for marketing by FDA 
Innocoll Holdings Ltd., of Athlone, Ireland Xaracoll (bupivacaine hydrochloride collagen-matrix implant) Anesthetic Management of postsurgical pain after open inguinal hernia surgery FDA accepted the NDA resubmission and set PDUFA date of Aug. 26, 2020
Intercept Pharmaceuticals Inc., of New York Obeticholic acid Binds to farnesoid X receptor  Liver fibrosis due to nonalcoholic steatohepatitis FDA notified firm that, due to COVID-19 pandemic, it rescheduled advisory committee; originally set for April 22, 2020, the meeting is now tentatively scheduled for June 9, 2020; PDUFA date for the priority application remains June 26, 2020
Jazz Pharmaceuticals plc, of Dublin JZP-258 Oxybate product Excessive daytime sleepiness FDA accepted NDA for filing with priority review; seeks approval for use in patients 7 and older with narcolepsy
Orphan Technologies Ltd., of Rapperswil, Switzerland OT-58 Modified recombinant enzyme therapy Homocystinuria FDA granted rare pediatric disease designation
Pear Therapeutics Inc., of Boston  Somryst Digital therapeutic  Chronic insomnia FDA granted authorization for use in patients 22 and older
Recordati SpA, of Milan, Italy Osilodrostat Oral inhibitor of 11-beta-hydroxylase  Cushing’s syndrome Submitted NDA to Japan's Ministry of Health, Labor and Welfare
Relief Therapeutics Holding AG, of Zurich, and Neurorx Inc., of Wilmington, Del. RLF-100 (aviptadil)  Synthesized peptide Acute and moderate respiratory distress in COVID-19  Filed an IND with the FDA for a phase II trial 

Notes

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

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