Drugs in the Pipeline

Cerebral Edema Treatment Gains Orphan Drug Status

Cerebral Edema Treatment Gains Orphan Drug Status

Remedy announced that their investigational treatment for severe cerebral edema in patients with acute ischemic stroke, Cirara, has been granted Orphan Drug Designation.

Oral Therapy for Uterine Fibroids Demonstrates Efficacy in Study

Oral Therapy for Uterine Fibroids Demonstrates Efficacy in Study

Allergan and Gedeon Richter announced positive results from the second Phase 3 trial of ulipristal acetate, evaluating its efficacy and safety for the treatment of abnormal bleeding due to uterine fibroids in women.

Novel Cephalosporin Demonstrates Superiority in Complicated UTI

Novel Cephalosporin Demonstrates Superiority in Complicated UTI

Shionogi has announced positive results from the APEKs-cUTI* study which evaluated their novel antibiotic, cefiderocol (S-649266), for the treatment of patients with serious complicated urinary tract infection (cUTI) by Gram-negative bacteria.

Cinvanti NDA Submitted for CINV Prevention

Cinvanti NDA Submitted for CINV Prevention

Heron Therapeutics announced the submission of the New Drug Application (NDA) for Cinvanti (HTX-019) to the Food and Drug Administration (FDA) for the prevention of chemotherapy-induced nausea and vomiting (CINV).

FDA Accepts BLA for Trastuzumab Biosimilar

FDA Accepts BLA for Trastuzumab Biosimilar

Mylan announced that the Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for their biosimilar to trastuzumab, MYL-1401O

Female Sexual Disorder Drug Appears Effective in Two Phase 3 Studies

Female Sexual Disorder Drug Appears Effective in Two Phase 3 Studies

AMAG pharmaceuticals and Palatin Technologies have entered into an agreement for the exclusive North American rights to develop and commercialize Rekynda (bremelanotide), an investigational drug to treat hypoactive sexual desire disorder (HSDD).

Viralym-C Granted Fast Track Status for Refractory CMV Infection

Viralym-C Granted Fast Track Status for Refractory CMV Infection

ViraCyte announced that the FDA has granted Fast Track designation to its T cell immunotherapy, Viralym-C, for the treatment of refractory cytomegalovirus (CMV) infections in patients following a stem cell transplant.

Fixed-Dose Pan-Genotypic HCV Regimen Shows Promise at Week 8

Fixed-Dose Pan-Genotypic HCV Regimen Shows Promise at Week 8

AbbVie announced positive data from its Phase 3 study of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis.

Tecentriq Granted Priority Review for mUC Indication

Tecentriq Granted Priority Review for mUC Indication

Genentech announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab)

Soliris Application Seeks Ultra-Rare Neuromuscular Disease Indication

Soliris Application Seeks Ultra-Rare Neuromuscular Disease Indication

Alexion has submitted a marketing application to the Food and Drug Administration (FDA) to extend the indication for Soliris (eculizumab) to be a treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

Life-Threatening Blood Disorder Treatment Gets Orphan Drug Status

Life-Threatening Blood Disorder Treatment Gets Orphan Drug Status

Alexion has announced that the Food and Drug Administration (FDA) has granted orphan drug designation to ALXN1210, their candidate treatment for paroxysmal nocturnal hemoglobinuria (PNH).

FDA Review Underway for Eptacog Beta in Hemophilia

FDA Review Underway for Eptacog Beta in Hemophilia

LFB S.A. announced that the FDA has accepted for review the Biologic License Application (BLA) of its recombinant Coagulation Factor VIIa (eptacog beta, activated) for the potential treatment of congenital hemophilia A or B in adolescents and adults with inhibitors.

Potential Treatment for Levodopa-Induced Dyskinesia Under Review

Potential Treatment for Levodopa-Induced Dyskinesia Under Review

The FDA has accepted for review the New Drug Application (NDA) for ADS-5102 (amantadine extended-release capsules; Adamas) for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease.

Stargardt Disease Drug Candidate Receives Orphan Drug Status

Stargardt Disease Drug Candidate Receives Orphan Drug Status

Acucela has announced that the Food and Drug Administration (FDA) has granted orphan drug designation to their candidate, emixustat (emixustat hydrochloride), for the treatment of Stargardt disease.

Gene Therapy Fast Tracked for Rare Congenital Skin Disorder

Gene Therapy Fast Tracked for Rare Congenital Skin Disorder

Fibrocell Science announced that the Food and Drug Administration (FDA) has granted Fast Track designation to FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).