Drugs in the Pipeline

Drugs in the Pipeline

Rare Inherited Liver Disorder Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to DCR-PH1 for the treatment of primary hyperoxaluria type 1 (PH1).

Priority Status Granted for Combination Genotype 4 HCV Therapy

The Food and Drug Administration (FDA) has accepted AbbVie's NDA and granted priority review to its all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/R) with ribavirin (RBV) for the treatment of adults with GT4 hepatitis C virus (HCV) infection.

Single Dalvance Dose As Effective for ABSSSI in Phase 3 Trial

Actavis announced results for its Phase 3 DUR001-303 study of single dose Dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).

Priority Review Granted for Pradaxa Reversal Agent

The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab (Boehringer Ingelheim) to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.

FDA Designates Cantrixil Orphan Drug for Ovarian Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Cantrixil (TRXE-002; CanTx Inc.) for ovarian cancer.

Investigational Malignant Melanoma Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to SRX-1177 (SolaranRx) for the treatment of stage IIB to IV malignant melanoma.

Lonafarnib Fast Tracked for Hepatitis Delta Virus Infection

The FDA has granted Fast Track designation to lonafarnib (Eiger BioPharmaceuticals) in combination with ritonavir for treatment of hepatitis delta virus (HDV) infection.

FDA Agrees to Review Adcetris for Post-Transplant Consolidation Therapy

The FDA has accepted for filing the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin; Seattle Genetics) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression.

sBLA Submitted for Additional Keytruda Indication

Merck announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC).

Biotin for Progressive Multiple Sclerosis: New Phase 3 Trial Data

MedDay announced results from its Phase 3 MS-SPI clinical trial with MD1003, a highly concentrated pharmaceutical-grade biotin for the treatment of progressive multiple sclerosis.