Drugs in the Pipeline

Fast Track Designation Granted to Novel Gastroparesis Therapy

Fast Track Designation Granted to Novel Gastroparesis Therapy

Theravance announced that the Food and Drug Administration (FDA) has granted Fast Track designation to to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis.

T2DM Drug Semaglutide Gets Closer to Approval with NDA Submission

T2DM Drug Semaglutide Gets Closer to Approval with NDA Submission

Novo Nordisk has announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for semaglutide, for the treatment of adults with type 2 diabetes.

FDA Accepts Keytruda sBLA for Hodgkin Lymphoma Indication

FDA Accepts Keytruda sBLA for Hodgkin Lymphoma Indication

Merck announced that the Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review.

Drug to Prevent S. aureus Pneumonia Gets Fast Track Designation

Drug to Prevent S. aureus Pneumonia Gets Fast Track Designation

Arsanis has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to ASN100, a novel combination of two fully human monoclonal antibodies to potentially prevent Staphylococcus aureus pneumonia.

DS-8201 Fast-Tracked for HER2+ Metastatic Breast Cancer

DS-8201 Fast-Tracked for HER2+ Metastatic Breast Cancer

Daiichi Sankyo announced that the Food and Drug Administration (FDA) has granted Fast Track designation for DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).

Significant Seizure Reduction with Pregabalin in Pediatric Study

Significant Seizure Reduction with Pregabalin in Pediatric Study

Pfizer announced positive Phase 3 study data that evaluated Lyrica (pregabalin) capsules and oral solution as adjunctive therapy for pediatric epilepsy patients aged 4-16 years with partial onset seizures.

Pediatric Crohn's Disease Therapy Granted Orphan Drug Designation

Pediatric Crohn's Disease Therapy Granted Orphan Drug Designation

AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066) for the investigational treatment of Crohn's disease in pediatric patients.

Priority Review Given to Metastatic Merkel Cell Carcinoma Agent

Priority Review Given to Metastatic Merkel Cell Carcinoma Agent

Merck and Pfizer announced that the Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for avelumab to treat metastatic Merkel cell carcinoma.

Promising Results for Breast Cancer Drug Biosimilar

Promising Results for Breast Cancer Drug Biosimilar

Pfizer announced positive results from the REFLECTIONS B3271002 study that compared the safety and efficacy of Herceptin (trastuzumab; Genentech) and PF-05280014, a potential biosimilar to Herceptin.

FDA to Review Abilify Maintena for Bipolar I Disorder

FDA to Review Abilify Maintena for Bipolar I Disorder

Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena (aripiprazole extended-release) for the maintenance treatment of bipolar I disorder in adults.

Biosimilar Candidate Effective in Phase 3 Psoriasis Trial

Biosimilar Candidate Effective in Phase 3 Psoriasis Trial

Momenta has announced their adalimumab biosimilar candidate, M923, has met its Phase 3 primary endpoint of at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment.

Results Released for Investigational Uveitis Therapy

Results Released for Investigational Uveitis Therapy

Santen has announced positive results from two Phase 3 trials of sirolimus intravitreal injection 440µg (Opsiria) for patients with non-infectious uveitis of the posterior segment.

Rare Liver Disorder Therapy Designated Orphan Drug

Rare Liver Disorder Therapy Designated Orphan Drug

PhaseRx announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for PRX-OTC for the treatment of ornithine transcarbamylase deficiency (OTCD).

Novel Opioid Therapy Emits Blue Dye as Abuse Indicator

Novel Opioid Therapy Emits Blue Dye as Abuse Indicator

Intellipharmaceutics has filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) for Rexista, a formulation of extended-release oxycodone hydrochloride with abuse-deterrent properties.

Results for Solanezumab in Mild Dementia of Alzheimer's Disease Announced

Results for Solanezumab in Mild Dementia of Alzheimer's Disease Announced

Eli Lilly announced that solanezumab did not meet the primary endpoint in the Phase 3 EXPEDITION3 clinical trial in patients with mild dementia due to Alzheimer's disease.