Company Product Description Indication Status
Amarin Corp. plc, of Dublin Vazkepa (icosapent ethyl) Apolipoprotein B antagonist; phospholipase A2 inhibitor Cardiovascular disease EMA’s Committee for Medicinal Products for Human Use recommended approval for use in reducing risk of cardiovascular events in patients at high cardiovascular risk
Arvelle Therapeutics GmbH, of Zug, Switzerland Ontozry (cenobamate) Sodium channel inhibitor Focal onset seizures EMA’s Committee for Medicinal Products for Human Use recommended approval for use as adjunctive treatment in patients with focal onset seizures, with or without secondary generalization, in adults with epilepsy who have not been adequately controlled despite history of treatment with at least 2 antiepileptic products
Ascentage Pharma Group International, of Suzhou, China, and Rockville, Md. APG-2575 Bcl-2 inhibitor Follicular lymphoma FDA granted orphan drug designation
Bellicum Pharmaceuticals Inc., of Houston BPX-601 GoCAR-T candidate Previously treated metastatic pancreatic or prostate cancer FDA lifted the clinical hold on the phase I/II trial evaluating BPX-601 and rimiducid
Biogen, of Cambridge, Mass., and Eisai Co., Ltd., of Tokyo, Japan Aducanumab Monoclonal antibody targeting amyloid beta Alzheimer’s disease FDA extended the review period by 3 months for the BLA; the updated PDUFA action date is June 7, 2021
Gan & Lee Pharmaceuticals Co. Ltd., of Beijing GLR-2007 Cyclin-dependent kinase 4/6 inhibitor Glioblastoma FDA granted fast track designation 
Incyte Corp., of Wilmington, Del. Pemigatinib Oral inhibitor of FGFR isoforms 1, 2 and 3  Cholangiocarcinoma EMA’s Committee for Medicinal Products for Human Use recommended conditional authorization for use in treating adults with unresectable locally advanced or metastatic disease with FGFR2 fusion or rearrangement that is relapsed or refractory, after at least 1 line of systemic therapy
Karyopharm Therapeutics Inc., of Newton, Mass. Nexpovio (selinexor) Exportin 1 inhibitor Refractory multiple myeloma EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the conditional approval in combination with dexamethasone for the treatment of adult patients who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody
Mabxience SA, of Lugano, Switzerland Alymsys (bevacizumab) Biosimilar to VEGF inhibitor Avastin Carcinoma of the colon or rectum, breast cancer, non-small-cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix EMA’s Committee for Medicinal Products for Human Use recommended approval
Novartis AG, of Basel, Switzerland Kesimpta (ofatumumab) B-cell therapy Relapsing forms of multiple sclerosis EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for use in adults with active disease defined by clinical or imaging features
Novo Nordisk A/S, of Bagsvaerd, Denmark Sogroya (somapacitan) Weekly human growth hormone therapy Growth hormone deficiency  EMA’s Committee for Medicinal Products for Human Use recommended approval for use in adults
Pfizer Inc., of New York, and Biontech SE, Mainz, Germany Comirnaty mRNA vaccine COVID-19 EMA’s Committee for Medicinal Products for Human Use updated product information to clarify interval between first and second dose, now recommending administration of second dose 3 weeks after first dose; previously, product information stated interval should be at least 21 days
Roche Holding AG, of Basel, Switzerland Tecentriq (atezolizumab) Anti-PD-L1 inhibitor Advanced or metastatic urothelial cancer European application seeking use in combination with platinum-based therapy in patients who had not been treated before was withdrawn
Russian Direct Investment Fund, of Moscow Sputnik V Adenoviral vector-based vaccine COVID-19 prophylaxis Authorized in the Republic of Guinea under the emergency use authorization procedure
Stada Arzneimittel AG, of Bad Vilbel, Germany Oyavas (bevacizumab) Biosimilar of VEGF inhibitor Avastin Carcinoma of the colon or rectum, breast cancer, non-small-cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix EMA’s Committee for Medicinal Products for Human Use recommended approval
Tetra Bio-Pharma Inc., of Ottawa Qixleef Cannabinoid-based candidate Cancer pain FDA cleared the IND application, allowing the clinical trial to commence
Vertex Pharmaceuticals Inc., of Boston VX-880 Stem cell-derived, fully differentiated pancreatic islet cell therapy Type 1 diabetes FDA cleared the IND, enabling the company to proceed with initiating a phase I/II trial

Notes

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