Company Product Description Indication Status
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (repurposed ifenprodil)  NMDA receptor antagonist COVID-19 infection IND application submitted to FDA for phase IIb/III study
Amivas (USA) LLC, of Frederick, Md. Intravenous artesunate Artemisinin derivative Severe malaria Approved by FDA for use in adult and pediatric patients
Anivive Lifesciences Inc., of Long Beach, Calif.  GC-376 Protease inhibitor COVID-19 infection Pre-IND request filed with FDA for human trial with repurposed veterinary drug
Astellas Pharma Inc., of Tokyo Vesicare LS (solifenacin) Muscarinic M3 receptor antagonist Neurogenic detrusor overactivity  FDA approved oral suspension formulation to treat form of bladder dysfunction related to neurological impairment in children 2 and older
Azitra Inc., of Branford, Conn. ATR-12 Strain of Staphylococcus epidermidis engineered to express therapeutic levels of LEKTI protein Netherton syndrome FDA granted rare pediatric disease designation
Beyond Air Inc., of Garden City, N.Y. Lungfit Inhaled nitric oxide COVID-19 Health Canada approved use for a study in hospitalized patients diagnosed with COVID-19
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) plus Yervoy (ipilimumab) PD-1-targeting antibody plus CTLA4-targeting antibody Metastatic or recurrent non-small-cell lung cancer Approved by FDA for use in combination with 2 cycles of platinum-doublet chemotherapy for first-line treatment of adults whose disease has no EGFR or ALK genomic tumor aberrations; therapy is approved for patients with squamous or nonsquamous disease and regardless of PD-L1 expression; application reviewed under FDA’s real-time oncology review pilot program
Bristol Myers Squibb Co., of New York Zeposia (ozanimod) S1P receptor modulator Relapsing-remitting multiple sclerosis Approved by European Commission for use in adults with active disease as defined as clinical or imaging features
Diffusion Pharmaceuticals Inc., of Charlottesville, Va. TSC Trans sodium crocetinate COVID-19 Received accelerated response from FDA regarding pre-IND meeting request seeking guidance for proposed development of TSC in patients displaying severe respiratory symptoms and low oxygen levels; FDA recommended study employ a double-blinded, controlled, randomized design to address wide variability in standard of care and also recommended incorporating, where available, the drug remdesivir, which has been newly approved for emergency use; FDA agreed with the safety and oxygenation marker endpoints proposed by the company for early trials and suggested a range of potential functional outcomes which might be used as primary endpoints in possible later-stage trials supporting approval
Fresenius Kabi AG, of Bad Homburg, Germany MSB-11455 Pegfilgrastim biosimilar to Neulasta Neutropenia FDA accepted the BLA for review
Glaxosmithkline plc, of London Nucala (mepolizumab) Monoclonal antibody targeting IL-5 Hypereosinophilic syndrome FDA granted priority review for the application seeking approval
Immunitybio Inc., of Culver City, Calif. Nogapendekin alfa inbakicept IL-15 drug COVID-19 FDA authorized use of drug to treat patients prior to onset of severe disease
Intelgenx Corp., of Saint Laurent, Quebec Rizaport Versafilm Oral thin-film formulation of 5-HT1 receptor agonist Acute migraine FDA granted request for type A meeting  to obtain clarification on resubmitted NDA; application received complete response letter March 27, 2020; type A meeting set for June 10, 2020
Microbion Corp., of Bozeman, Mont. Pravibismane  Inhaled delivery of BisEDT antimicrobial suspension Pulmonary infections in cystic fibrosis FDA granted orphan designation
Protara Therapeutics Inc., of New York Intravenous choline chloride Phospholipid substrate replacement therapy Intestinal failure-associated liver disease FDA granted fast track designation
Radius Health Inc., of Waltham, Mass., and Teijin Pharma Ltd., of Tokyo Abaloparatide-SC Parathyroid hormone receptor 1 agonist Osteoporosis NDA filed in Japan to treat men and women at high risk of fractures
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Sanofi SA, of Paris Dupixent (dupilumab) Monoclonal antibody targeting IL-4 and IL-13 Moderate to severe atopic dermatitis FDA approved use in children, ages 6 to 11, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not available
Regenerx Biopharmaceuticals Inc., of Rockville, Md. Thymosin beta 4 Promotes corneal would healing and modulates inflammatory mediator Tissue protection and repair Posted information on its website that FDA reclassified thymosin beta 4 from a drug to a biologic
Relmada Therapeutics Inc., of New York REL-1017 (dextromethadone) Non-competitive N-methyl-D-aspartate receptor antagonist Major depressive disorder Completed end-of-phase II meeting with FDA on development program for use as adjunctive treatment; company can proceed into phase III, which will consist of 2 studies set to start in the fourth quarter of 2020
Sorrento Therapeutics Inc., of San Diego STI-6129 CD38-targeting antibody-drug conjugate Advanced relapsed and/or refractory systemic amyloid light chain amyloidosis FDA cleared IND for a phase I study

Notes

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

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