Company Product Description Indication Status
Abbvie Inc., of North Chicago Rinvoq (upadacitinib) JAK inhibitor Moderate to severe atopic dermatitis Submitted marketing applications to the FDA and EMA
Agios Pharmaceuticals Inc., of Cambridge, Mass. Tibsovo (ivosidenib) Isocitrate dehydrogenase-1 inhibitor Relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-1 mutation Withdrew MAA after EMA's Committee for Medicinal Products for Human Use indicated data from the phase I study aren't sufficient to support approval; continuing two phase III studies
Astrazeneca plc, of Cambridge, U.K. Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) Long-acting muscarinic antagonist, long-acting beta2-agonist, inhaled corticosteroid Moderate to severe chronic obstructive pulmonary disease EMA's Committee for Medicinal Products for Human Use recommended approval of the drug for patients not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (LABA), or a combination of a LABA and a long-acting muscarinic antagonist
Astrazeneca plc, of Cambridge, U.K. Forxiga (dapagliflozin) SGLT2 inhibitor Symptomatic chronic heart failure with reduced ejection fraction EMA's Committee for Medicinal Products for Human Use recommended approval of the drug
Bristol Myers Squibb Co., of New York, and Exelixis Inc. of Alameda, Calif. Opdivo (nivolumab) and Cabometyx (cabozantinib) Anti-PD-1 monoclonal antibody and tyrosine kinase inhibitor Advanced renal cell carcinoma FDA accepted the supplemental BLA and NDA for use of the 2 drugs in combination and granted a priority review; PDUFA action date of Feb. 20, 2021
Dr. Reddy’s Laboratories Ltd., of Hyderabad, India Sputnik V Adenovirus-based vaccine COVID-19 prophylaxis Drug Control General of India granted approval to conduct an adaptive phase II/III study
Edesa Biotech Inc., of Toronto EB-05 Monoclonal antibody targeting Toll-like receptor 4 Hospitalized COVID-19 FDA approved starting the phase II portion of the phase II/III study; site initiation process has begun
Genentech Inc., of South San Francisco, a unit of Basel, Switzerland-based Roche Holding Venclexta (venetoclax) B-cell lymphoma-2 inhibitor Newly diagnosed acute myeloid leukemia FDA granted full approval for use of the drug plus azacitidine, or decitabine or low-dose cytarabine in adults 75 or older or adults with co-morbidities that preclude use of intensive induction chemotherapy
Gilead Sciences Inc., of Foster City, Calif. Veklury (remdesivir) Antiviral COVID-19 FDA reissued the emergency use authorization with a clarification that an alternate care site that meets certain criteria is considered an "inpatient hospital setting" as described in the scope of the authorization
Intellia Therapeutics Inc., of Cambridge, Mass. NTLA-2001  CRISPR-associated endonuclease Cas9 modulator; TTR gene modulator Transthyretin amyloidosis U.K. MHRA cleared CTA for phase I study in hereditary disease with polyneuropathy, expected to begin dosing by year-end 2020
Matinas Biopharma Holdings Inc., of Bedminster, N.J. MAT-2203 Encochleated formulation of the antifungal amphotericin B HIV-infected patients with cryptococcal meningitis Data and safety monitoring board of the Enact study completed review of data from the first cohort and recommended starting the second cohort of 40 active-treatment patients
Mereo Biopharma Group plc, of London Etigilimab Monoclonal antibody targeting TIGIT (T-cell immunoreceptor with Ig and ITIM domains) Various tumor types FDA cleared the IND for a phase Ib/II study; plans to start the 100-patient study testing etigilimab plus an anti-PD-1 therapy in the fourth quarter
Neurelis Inc., of San Diego Valtoco (diazepam nasal spray) Benzodiazepine Intermittent, stereotypic episodes of frequent seizure activity FDA granted an extended expiration for the drug
Octapharma AG, of Lachen, Switzerland Nuwiq (recombinant factor VIII) Cell line-derived recombinant FVIII Hemophilia A FDA approved updated prescribing information to include immunogenicity data from the Nuprotect study in previously untreated patients
Oncopeptides AB, of Stockholm OPD-5  Peptide-drug conjugate targeting aminopeptidases  Relapsed refractory multiple myeloma Submitted an IND to the FDA for a phase I study testing the safety and tolerability of OPD-5 as a myeloablative regimen followed by autologous stem cell transplantation
Prestige Biopharma Ltd., of Singapore PBP-1510 Monoclonal antibody targeting pancreatic adenocarcinoma up-regulated factor  Pancreatic cancer EMA Orphan Drug Commission granted a positive opinion for an orphan drug designation
Recce Pharma Ltd., of Sydney, Australia Recce-327 Broad-spectrum antibiotic Infected burn wounds Human Research Ethics Committee approved the start of a phase I/II study in Australia; study will initially enroll up to 30 patients, testing daily and 3-times-per-week treatment regimens
Versantis AG, of Zurich, Switzerland VS-01 Liposomal-based detoxification therapy Urea cycle disorders FDA granted rare pediatric disease designation

Notes

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