Drug & Device Pipeline News

March 13, 2023

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Estrella Biopharma	EB103	Relapsed/refractory B-cell non-Hodgkin lymphoma	IND for a phase 1/2 trial approved by the FDA
Vertex Pharmaceuticals	VX-264	Type 1 diabetes	IND for a phase 1/2 trial approved by the FDA
SciSparc	SCI-110	Tourette syndrome	IND for a phase 2b trial approved by Israel’s regulatory authority
Trials Initiated
Bio-Thera Solutions	BAT8010	Advanced solid tumors	Initiation of a phase 1 trial
Enthera Pharmaceuticals	Ent001	Inflammatory bowel disease and type 1 diabetes	Initiation of a phase 1 trial
Molecure	OATD-02	Advanced and/or metastatic solid tumors	Initiation of a phase 1 trial
Ribon Therapeutics	RBN-3143	Moderate-to-severe atopic dermatitis	Initiation of a phase 1 trial
Trevena	TRV045	Epilepsy and other central nervous system disorders	Initiation of a phase 1 trial
BerGenBio	Bemcentinib	Non-small cell lung cancer patients harboring STK11 mutations	Initiation of a phase 1b/2a trial
Areteia Therapeutics	Dexpramipexole	Severe eosinophilic asthma	Initiation of two phase 3 trials
DBV Technologies	Modified Viaskin Peanut 250 μg patch (DBV712)	Peanut allergy	Initiation of a phase 3 trial
Approvals
Eli Lilly	Verzenio (abemaciclib)	HR+, HER2-, node-positive, high-risk early breast cancer	Approved by the FDA for expanded indication
Merck	Intramuscular M-M-RII, VARIVAX and ProQuad vaccines	Measles, mumps, rubella and varicella infection	Approved by the FDA for new route of administration
Neuromod Devices	Lenire	Tinnitus	Approved by the FDA