Company Product Description Indication Status
ADC Therapeutics SA, of Lausanne, Switzerland Camidanlumab tesirine IL-2 receptor alpha subunit inhibitor Hodgkin lymphoma FDA lifted partial hold on pivotal phase II study in individuals with relapsed or refractory disease who failed 3 prior lines of therapy
Adial Pharmaceuticals Inc., of Charlottesville, Va. AD-04 (repurposed ondansetron) 5-HT 3 receptor antagonist Alcohol use disorder Regulators in Sweden and Estonia cleared initiation of sites in pivotal phase III Onward trial in people with target genotypes related to serotonin transporter and receptor genes
Ascendis Pharma A/S, of Copenhagen Transcon hGH (lonapegsomatropin) Growth hormone ligand Growth hormone deficiency EMA's pediatric committee issued positive opinion on agreement with proposed pediatric investigation plan to treat individuals from 6 months to <18 years of age; MAA submission on track for third quarter of 2020, with no additional studies required
CSL Behring LLC, of Hattersheim, Germany Idelvion (albutrepenonacog alfa) Coagulation factor modulator; factor IX agonist
Factor IX deficiency
EMA updated routine prophylaxis regimen, approving 21-day dosing intervals for adults with hemophilia B
Daiichi Sankyo Co. Ltd., of Tokyo Trastuzumab deruxtecan ERBB2 tyrosine kinase receptor inhibitor; topoisomerase I inhibitor HER2-positive breast cancer EMA validated MAA to treat adults with unresectable or metastatic disease who received 2 or more prior anti-HER2 regimens; EMA's CHMP to review under accelerated assessment
Esperare Foundation, of Geneva ER-004 Ectodysplasin A ligand X linked hypohidrotic ectodermal dysplasia FDA granted breakthrough therapy designation for prenatal treatment
Gilead Sciences Inc., of Foster City, Calif. Veklury (remdesivir) COVID-19 nonstructural protein 8 modulator; COVID-19 replicase polyprotein 1ab inhibitor COVID-19 infection European Commission granted conditional marketing authorization to treat people 12 and older and weighing at least 40 kg who have pneumonia requiring supplemental oxygen
Medivir AB, of Stockholm MIV-818 (liver-targeted troxacitabine prodrug) DNA polymerase inhibitor Hepatocellular carcinoma European Commission granted orphan medicinal product designation
Mesoblast Ltd., of Melbourne, Australia Remestemcel-L Allogeneic mesenchymal stem cell therapy COVID-19-related multisystem inflammatory syndrome Expanded access protocol initiated in U.S. for compassionate use in infected children 2 months to 17 years with cardiovascular and other MIS-C complications
Mylan NV, of Hertfordshire, U.K. Remdesivir lyophilized powder for injection (Desrem) COVID-19 nonstructural protein 8 modulator; COVID-19 replicase polyprotein 1ab inhibitor COVID-19 infection Drug Controller General of India approved formulation of 100 mg/vial, under license from Gilead Sciences Inc. for restricted emergency use in India under accelerated approval to treat suspected or laboratory confirmed infection in adults and children hospitalized with severe disease
Napo Pharmaceuticals Inc., wholly owned subsidiary of Jaguar Health Inc., of San Francisco Mytesi (crofelemer) Calcium activated chloride channel inhibitor Diarrhea IND filing to FDA completed for planned indication of prophylaxis and symptomatic relief for cancer therapy‑related condition in adults
Sinovac Biotech Ltd., of Beijing Coronavac Adjuvant inactivated vaccine COVID-19 infection Brazil's Anvisa granted approval for pivotal phase III trial sponsored by Instituto Butantan; enrollment expected to begin in July 2020
Viiv Healthcare Ltd., of London Rukobia (fostemsavir) HIV-1 attachment inhibitor HIV-1 infection FDA approved drug in combination with other antiretroviral therapies to treat heavily treatment-experienced adults with multidrug-resistant infection who are failing current regimen due to resistance, intolerance or safety considerations

Notes

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

No Comments