Drug & Device Pipeline News

January 3, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Accutar Biotech	AC0176	Metastatic castration-resistant prostate cancer	IND approved by the FDA
Basilea Pharmaceutica	BAL0891	Advanced solid tumors	IND approved by the FDA
Editas Medicine	EDIT-301	Transfusion-dependent beta thalassemia	IND approved by the FDA
Glycomine	GLM101	Phosphomannomutase 2-congenital disorder of glycosylation (PMM2-CDG)	IND approved by the FDA
Lyell Immunopharma	LYL797	ROR1+ solid tumors	IND approved by the FDA
Rakuten	RM-1995 photoimmunotherapy	Advanced cutaneous squamous-cell carcinoma or head and neck squamous-cell carcinoma	IND approved by the FDA
Regor Therapeutics	RGT-419B	HER2-, HR+ breast cancer	Study May Proceed granted by the FDA
Sorrento Therapeutics	STI-1386	Relapsed or refractory solid tumors	IND approved by the FDA
Tryp Therapeutics	Synthetic psilocybin	Binge eating disorder	Study May Proceed granted by the FDA
Sedana Medical	Sedaconda (isoflurane)	Sedation of mechanically ventilated intensive care patients	IND approved by the FDA
I-Mab	Enoblituzumab in combination with Keytruda (pembrolizumab)	Solid tumors	IND approved by China’s regulatory authorities
IRLAB	Pirepemat	Parkinson's disease	Regulatory approval for a phase 2 trial granted by Sweden’s regulatory authorities
Trials Initiated
Bio-Thera	BAT6005	Advanced solid tumors	Initiation of phase 1 trial
Bio-Thera	BAT6026	Advanced solid tumors	Initiation of phase 1 trial
Immunolight	X-PACT Cancer Treatment system	Breast, melanoma, sarcoma and head and neck cancers	Initiation of phase 1 trial
Oramed Pharmaceuticals	Oral virus-like particle (VLP) COVID-19 vaccine	COVID-19 vaccine	Initiation of phase 1 trial in South Africa
Axcella	AXA1125	Long COVID/postCOVID-19 condition	Initiation of phase 2a trial
Alnylam	Lumasiran	Recurrent kidney stone disease and elevated urinary oxalate levels	Initiation of phase 2 trial
Fortress Biotech Helocyte	Triplex	Cytomegalovirus vaccine	Initiation of phase 2 trial
Jazz Pharmaceuticals	JZP150	Adults with post-traumatic stress disorder	Initiation of phase 2 trial
PharmAbcine	Olinvacimab plus Keytruda	Metastatic triple-negative breast cancer	Initiation of phase 2 trial in Australia
Aptinyx	NYX-783	Post-traumatic stress disorder	Initiation of phase 2b trial
ILiAD Biotechnologies	BPZE1	Live attenuated intranasal pertussis vaccine	Initiation of phase 2b trial
Saniona	Tesomet	Prader-Willi syndrome	Initiation of phase 2b trial
Daiichi Sankyo Astrazeneca	Enhertu (trastuzumab deruxtecan)	HER2-mutant unresectable, locally advanced or metastatic nonsquamous, nonsmall-cell lung cancer	Initiation of phase 3 trial
Eiger Biopharma	Peginterferon Lambda	Chronic hepatitis delta virus infection	Initiation of phase 3 trial
Kolon TissueGene	TG-C	Knee osteoarthritis	Initiation of phase 3 trials
Navidea	NAV3-33	Rheumatoid arthritis	Initiation of phase 3 trial
Novavax	NVX-CoV2373	COVID-19 vaccine with Matrix-M adjuvant	Initiation of phase 3 trial
Palatin Technologies	PL9643	Dry eye disease	Initiation of phase 3 trial
Approvals
Amgen AstraZeneca	Tezspire (tezepelumab-ekko)	Add-on maintenance treatment for patients >12 years with severe asthma	Approved by the FDA
Amgen	Otezla (apremilast)	Adults with plaque psoriasis across all severities	Approved by the FDA for expanded indication
argenx	Vyvgart (efgartigimod)	Generalized myasthenia gravis in adults with AChR antibody	Approved by the FDA
Calliditas Therapeutics	Tarpeyo (budesonide) delayed release capsules	Primary immunoglobulin A nephropathy	Accelerated approval granted by the FDA
Daiichi Sankyo American Regent	Injectafer (ferric carboxymaltose injection)	Pediatric patients with iron deficiency anemia	Approved by the FDA
Global Blood Therapeutics	Oxbryta (voxelotor)	Sickle cell disease in children ages four to 11 years	Approved by the FDA for expanded indication
Intra-Cellular Therapies	Caplyta (lumateperone)	Bipolar depression in adults	Approved by the FDA
Janssen Pharmaceuticals	Xarelto (rivaroxaban)	Prevention and treatment of venous thromboembolism in pediatrics	Approved by the FDA for new indications
LEO Pharma	Adbry (tralokinumab-ldrm)	Atopic dermatitis	Approved by the FDA
Novartis	Leqvio (inclisiran)	To lower low-density lipoprotein cholesterol	Approved by the FDA
Novartis	Cosentyx (secukinumab)	Active enthesitis-related arthritis in patients four years and older, and active psoriatic arthritis in patients two years and older	Approved by the FDA for expanded indication
Merck Ridgeback Biotherapeutics	Molnupiravir	Mild-to-moderate COVID-19 infections in adults who are at high risk of progression to severe disease	Emergency Use Authorization (EUA) granted by the FDA
Pfizer	Paxlovid (nirmatrelvir and ritonavir tablets)	High-risk adults and pediatric patients 12 years and older to treat COVID-19	EUA granted by the FDA
ViiV Healthcare	Apretude (cabotegravir extended-release injectable suspension)	Pre-exposure prophylaxis of HIV	Approved by the FDA
Edwards Lifesciences	Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent	Severe pulmonary regurgitation	Approved by the FDA
Sight Sciences	TearCare System	Meibomian gland dysfunction	Approved by the FDA
Telix Pharmaceuticals	Illuccix	Prostate cancer imaging	Approved by the FDA
Gilead Sciences	Veklury (remdesivir)	Adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19	Approved by the European Commission for expanded indication
Merck	Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine)	Vaccine for invasive disease and pneumonia caused by Streptococcus pneumoniae	Approved by the European Commission
Novavax	Nuvaxovid COVID-19 vaccine	COVID-19 vaccine	Conditional marketing authorization granted by the European Commission