Company Product Description Indication Status
Emmaus Life Sciences Inc., of Torrance, Calif. Xyndari L-glutamine oral powder Sickle cell disease EMA issued scientific advice regarding the clinical development pathway
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa. INO-3107 DNA plasmid vaccine Recurrent respiratory papillomatosis FDA granted orphan drug designation
Melt Pharmaceuticals Inc., of Boston MELT-100 (midazolam + ketamine, sublingual) Benzodiazepine receptor agonist; NMDA receptor antagonist Pain FDA cleared IND to begin phase I pharmacokinetics study, with data expected in fourth quarter of 2020; drug advancing through 505(b)(2) regulatory pathway to provide sedation and analgesia for individuals undergoing cataract surgery
Merck & Co. Inc., of Kenilworth, N.J. MK-6482 HIF-2-alpha inhibitor Renal cell carcinoma FDA granted breakthrough therapy designation for treatment of Von Hippel-Lindau (VHL) disease-associated RCC with certain nonmetastatic tumors and of VHL disease
Novartis AG, of Basel, Switzerland Piqray (alpelisib) Phosphoinositide-3 kinase alpha inhibitor Breast cancer European Commission approved in combination with fulvestrant to treat men and postmenopausal women with HR+/HER2- locally advanced or metastatic disease with PIK3CA mutation after disease progression following endocrine therapy 
Regulus Therapeutics Inc., of La Jolla, Calif. RGLS-4326  Anti-miR-17 antisense oligonucleotide inhibitor  Autosomal dominant polycystic kidney disease FDA granted orphan drug designation
Relief Therapeutics Holding AG, of Geneva, and Neurorx Inc., of Radnor, Pa. RLF-100 (aviptadil)  VIP receptor agonist COVID-19-related respiratory failure FDA granted expanded access protocol to those ineligible for enrollment in clinical trial, including pregnant women, who exhausted approved therapies
Ridgeback Biotherapeutics LP, of Miami Ansuvimab (mAb-114) Monoclonal antibody Ebola FDA accepted BLA, granting priority review 
Roche Holding AG, of Basel, Switzerland Ventana HER2 Dual ISH DNA Probe Cocktail assay Companion diagnostic Breast cancer Approved by FDA for use in Herceptin (trastuzumab) therapy for detecting HER2 biomarker in breast cancer
Scynexis Inc., of Jersey City, N.J. Ibrexafungerp 1,3 beta glucan synthase inhibitor Vulvovaginal candidiasis infection Pre-NDA meetings with FDA completed; based on feedback, regulatory package considered sufficient for submission and filing expected in fourth quarter of 2020
Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel Ajovy (fremanezumab) CGRP receptor antagonist Migraine Licensee Otsuka Pharmaceutical Co. Ltd. submitted NDA for preventive treatment to Japan PMDA

Notes

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

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