Company Product Description Indication Status
Adamis Pharmaceuticals Corp., of San Diego Zimhi (naloxone injection) Opioid receptor antagonist Opioid overdose FDA issued complete response letter on NDA, with questions generally related to CMC
Aquestive Therapeutics Inc., of Warren, N.J. Exservan (riluzole) oral film Glutamate receptor antagonist; sodium channel inhibitor Amyotrophic lateral sclerosis FDA issued full approval in advance of PDUFA date
Cynata Therapeutics Ltd., of Melbourne, Australia Cymerus (CYP-002)
Mesenchymoangioblast-derived mesenchymal stem cell therapy
Critical limb ischemia Clinical trial authorization application for proposed phase II trial filed with U.K.'s MHRA
Genentech Inc., unit of Roche Holding AG, of Basel, Switzerland Risdiplam Survival motor neuron-2 splicing modifier Spinal muscular atrophy FDA accepted NDA and granted priority review, setting PDUFA date of May 24, 2020
Hutchison China Meditech Ltd. (Chi-Med), of Hong Kong Surufatinib Angio-immuno kinase inhibitor  Pancreatic neuroendocrine tumors FDA granted orphan drug designation
Inhibitor Therapeutics Inc., of Tampa, Fla. Suba-itraconazole Lanosterol-14 demethylase inhibitor Metastatic castrate-resistant prostate cancer IND application submitted to FDA for phase IIb trial evaluating drug in combination with docetaxel and prednisone
Innovation Pharmaceuticals Inc., of Beverly, Mass. Brilacidin Defensin peptidomimetic Oral mucositis FDA granted waiver eliminating need for study on prevention of severe oral mucositis in head and neck cancer in pediatric patients receiving chemoradiation, clearing way to focus development on target adult population
Intercept Pharmaceuticals Inc., of New York Obeticholic acid  Farnesoid X receptor agonist Fibrosis FDA accepted NDA under accelerated approval to treat fibrosis due to nonalcoholic steatohepatitis and granted priority review, setting PDUFA date of March 26, 2020
Revance Therapeutics Inc., of Newark, Calif. DaxibotulinumtoxinA injectable Acetylcholine receptor antagonist; Botulinum toxin A stimulator Glabellar (frown) lines BLA submitted to FDA
Seattle Genetics Inc., of Bothell, Wash. Adcetris (brentuximab vedotin) CD30 modulator; tubulin receptor antagonist Systemic anaplastic large-cell lymphoma; peripheral T-cell lymphoma-not otherwise specified; angioimmunoblastic T-cell lymphoma Health Canada approved supplemental new drug submission to expand use to the indications, in combination with cyclophosphamide, doxorubicin and prednisone chemotherapy, in previously untreated adults whose tumors express CD30
Tetra Bio-Pharma Inc., of Ottawa, Ontario Qixleef (PPP-001) Cannabinoid Pain FDA authorized advancement of previously discontinued 4-week phase II Plenitude trial of inhaled cannabis candidate in individuals with advanced cancer
Verastem Inc., of Boston Copiktra (duvelisib) Phosphoinositide-3 kinase delta/gamma inhibitor Chronic lymphocytic leukemia/small lymphocytic lymphoma; follicular lymphoma  MAA submitted to EMA for treatment of individuals with relapsed or refractory disease in both indications
Zogenix Inc., of Emeryville, Calif. Fintepla (ZX-008, fenfluramine oral solution) 5-HT 1d/2a/2c receptor modulator Dravet syndrome FDA accepted NDA filing for treatment of seizures associated with Dravet syndrome, granting priority review and setting PDUFA date of March 25, 2020

Notes

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

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