Company Product Description Indication Status
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) NMDA receptor antagonist COVID-19 Received no objection letter from Health Canada for phase IIb/III trial; same study protocol being prepared for submission to U.S. and Australian regulators
Amylyx Pharmaceuticals Inc., of Cambridge, Mass. AMX-0035 Targets mitochondrial and endoplasmic reticulum dependent neuronal degeneration pathways  Amyotrophic lateral sclerosis EMA’s Committee for Orphan Medicinal Products recommended orphan designation 
ANI Pharmaceuticals Inc., of Baudette, Minn. Cortrophin Gel Repository corticotropin injection USP Undisclosed Received a refuse-to-file letter from FDA regarding its supplemental NDA
Azurrx Biopharma Inc., of New York MS-1819 Recombinant lipase enzyme Cystic fibrosis Received approval to conduct phase II Option trial in patients with exocrine pancreatic insufficiency
Beyondspring Inc., of New York Plinabulin Immune and stem cell modulator Chemotherapy-induced neutropenia Following discussions with FDA, company formally changed primary endpoint of Study 106 phase III trial to be the rate of prevention of grade 4 neutropenia in combination with G-CSF vs. G-CSF alone; previous endpoint had been duration of severe (grade 4) neutropenia
Capricor Inc., of Los Angeles CAP-1002 Allogeneic cardiac cell therapy COVID-19 Following a review of available data, FDA approved expanded access protocol to treat up to 20 additional patients 
Chimerix Inc., of Durham, N.C. Brincidofovir Antiviral Smallpox Received clearance from FDA for rolling NDA seeking approval for use as medical countermeasure
Erytech Pharma SA, of Lyon, France Eryaspase L-asparaginase encapsulated inside donor-derived red blood cells Metastatic pancreatic cancer FDA granted fast track designation for use as second-line treatment
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Anti-PD-1 antibody All approved indications FDA approved additional recommended dosage of 400 mg every 6 weeks across all adult indications, including monotherapy and combination therapy; approved under accelerated pathway based on pharmacokinetic data, relationship of exposure to efficacy and relationship of exposure to safety
Neuraptive Therapeutics Inc., of Philadelphia NTX-001 Drug-device combination Peripheral nerve injuries FDA cleared IND for testing in patients with acute single transected PNI
Novartis AG, of Basel, Switzerland Cosentyx (secukinumab) Inhibits IL-17A Active non-radiographic axial spondyloarthritis Approved by European Commission
Ortho Dermatologics, a unit of Bausch Health Cos. Inc., of Laval, Quebec Jublia (efinaconazole) topical solution 10% Antifungal Onychomycosis FDA approved a supplemental NDA extending the age range to children 6 and older
Remegen Ltd., of Yantai, China RC-48 (disitamab vedotin) Anti-HER2 antibody-drug conjugate HER2-positive metastatic or unresectable urothelial cancer FDA cleared the IND for a phase II trial 

Notes

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

No Comments