Company Product Description Indication Status
Biophytis SA, of Paris Sarconeos (BIO-101) Proto-oncogene Mas agonist Acute respiratory failure associated with COVID-19 Received approval from the U.K. Medicines and Healthcare Products Regulatory Agency to start the study
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) Monoclonal antibody targeting PD-1 Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy FDA approved the expanded indication
CNS Pharmaceuticals Inc., of Houston Berubicin Anthracycline that interferes with topoisomerase II Malignant gliomas FDA granted orphan drug designation
Diffusion Pharmaceuticals Inc., of Charlottesville, Va. TSC (trans sodium crocetinate) Oxygenation-enhancing product COVID-19 Submitted CTA to Romanian National Agency for Medicines and Medical Devices for a phase Ia/Ib trial in hospitalized COVID-19 patients displaying severe respiratory symptoms and low oxygen levels; assuming approval, 24-patient phase Ia portion set to start by end of second quarter of 2020
Eyegate Pharmaceuticals Inc., of Waltham, Mass. Ocular Bandage Gel Modified form of natural polymer hyaluronic acid Wound repair post photorefractive keratectomy and for dry eye with punctate epitheliopathies Received feedback from FDA regarding requested packaging for eye drop; agency has provided path forward using the multi-dose preservative-free bottle, requesting some additional tests prior to fully approving bottle for use; tests expected to be completed in second half of 2020
Genequantum Healthcare (Suzhou) Co. Ltd., of Suzhou, China GQ-1001 Site-specific antibody-drug conjugate  HER2-positive solid tumors Received U.S. IND approval
Inmune Bio Inc., of La Jolla, Calif. Inkmune Therapy designed to prime NK cells High-risk myelodysplastic syndrome U.K.’s Medicines and Healthcare products Regulatory Agency cleared start of phase I trial; study expected to begin in second half of 2020
Intelgenx Corp., of Saint Laurent, Quebec Rizaport Versafilm Rizatriptan oral disintegrating film Acute migraine Obtained clarity from FDA during type A meeting to discuss March 27, 2020, complete response letter, regarding CMC information required for resubmission of NDA
Lannett Co. Inc., of Philadelphia Insulin glargine biosimilar Long-acting insulin Diabetes  FDA provided feedback during type II meeting; company plans 351(k) biosimilar application filed in 2022
Leo Pharma A/S, of Ballerup, Denmark Tralokinumab Fully human monoclonal antibody targeting interleukin-13 cytokine Moderate to severe atopic dermatitis EMA validated marketing authorization application
Mylan NV, of Hertfordshire, U.K. Semglee Long-acting insulin Diabetes Approved by FDA to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus; approved as BLA under section 351(a) of Public Health Service Act and can be a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product
Novartis AG, of Basel, Switzerland Beovu (brolucizumab) Single-chain antibody fragment Wet age-related macular degeneration FDA approved label update to include additional safety information regarding retinal vasculitis and retinal vascular occlusion under “Warnings and Precautions”; update also specifies that those adverse reactions are part of a spectrum of intraocular inflammation rates from phase III Hawk and Harrier trials
Pfizer Inc., of New York Nyvepria (pegfilgrastim-apgf) Biosimilar to G-CSF therapy Neulasta Febrile neutropenia Approved by FDA for use to decrease incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive cancer drugs associated with a clinically significant incidence of febrile neutropenia; company expects drug to be available to patients later in 2020

Notes

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

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