Company Product Description Indication Status
Abbvie Inc., of North Chicago Botox (onabotulinumtoxinA) Acetylcholine receptor antagonist; p130Cas associated protein inhibitor Bladder muscle overactivity associated with neurologic condition FDA approved for treating pediatric patients 5 and older who have inadequate response to or are intolerant of anticholinergic medication
Adaptive Phage Therapeutics Inc., of Gaithersburg, Md. Phagebank Phage therapy Prosthetic joint infections FDA cleared IND for phase I/II trial in the first half of 2021
AIM Immunotech Inc., of Ocala, Fla. Ampligen (rintatolimod) Ribonuclease stimulator; 2,5-oligoadenylate synthetase stimulator; TLR-3 agonist; polymerase cofactor VP35 inhibitor Pancreatic cancer  Dutch Health and Youth Care Inspectorate approved treatment for 6 patients as part of a new follow-up early access program 
Astrazeneca plc, of Cambridge, U.K., and Oxford University AZD-1222 COVID-19 spike glycoprotein modulator COVID-19 South Korean regulators approved vaccine for use in all adults, though use included a precautionary warning about inoculating adults older than 65
Eli Lilly and Co., of Indianapolis Bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) COVID-19 spike glycoprotein modulator and COVID-19 spike glycoprotein inhibitor COVID-19 FDA granted emergency use authorization for combo in treating mild to moderate COVID-19 patients, 12 and older, who are at high risk for progressing to severe COVID-19 and/or hospitalization
I-Mab Biopharma Co. Ltd., of Shanghai TJ-210/MOR-210 Monoclonal antibody directed against complement factor C5a receptor 1 Advanced solid tumors China’s NMPA cleared the IND for a phase I trial
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Anti-PD-1 antibody Triple-negative breast cancer FDA advisory committee voted unanimously to recommend deferral of decision on supplemental BLA seeking use in patients with high-risk, early stage disease
Panbela Therapeutics Inc., of Minneapolis SBP-101 Polyamine analogue Metastatic pancreatic ductal adenocarcinoma Independent data safety monitoring board recommending holding administration of SBP-101 pending further investigation of visual disturbance adverse events
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany COVID-19 vaccine mRNA vaccine COVID-19 Pfizer said it withdrew its application for emergency use authorization in India
Russian Direct Investment Fund, of Moscow Sputnik V COVID-19 spike glycoprotein modulator COVID-19 Vaccine approved by National Health Regulatory Authority of the Kingdom of Bahrain
Sanifit SA, of Palma, Spain SNF-472 Calcium metabolism modulator Peripheral arterial disease FDA granted orphan designation for use in treating PAD patients with end-stage kidney disease
Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Libtayo (cemiplimab-rwlc) Anti-PD-1 antibody Basal cell carcinoma Received full FDA approval in locally advanced BCC and accelerated approval in metastatic BCC
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Darvadstrocel  Stem cell modulator; vulnerary agent; anti-inflammatory Crohn’s disease Submitted application to Japanese regulators seeking approval to treat complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease
Vico Therapeutics BV, of Leiden, the Netherlands VO-659 Antisense oligonucleotide Spinocerebellar ataxia European Commission granted orphan designation

Notes

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