Drugs in the Pipeline

Combination Biologic Granted Breakthrough Status for High Grade Glioma

Combination Biologic Granted Breakthrough Status for High Grade Glioma

The Breakthrough Therapy designation was supported by safety, efficacy (durable, complete or partial tumor shrinkage) and patient survival data from three Phase 1 studies involving 126 patients with recurrent brain cancer.

Dextenza NDA Resubmission Accepted for Post-Surgical Ocular Pain

Dextenza NDA Resubmission Accepted for Post-Surgical Ocular Pain

The NDA for Dextenza was resubmitted in January 2017 following a Complete Response Letter that was issued in July 2016 due to concerns with deficiencies in manufacturing processes and controls.

Oliceridine as Effective as Morphine in Phase 3 Studies of Acute Post-Op Pain

Oliceridine as Effective as Morphine in Phase 3 Studies of Acute Post-Op Pain

Oliceridine is a next generation injectable analgesic specifically designed to deliver the pain-reducing potential of an opioid but with fewer associated adverse effects.

Novel Oral MS Drug Effective, Safe in Phase 3 Study

Novel Oral MS Drug Effective, Safe in Phase 3 Study

The primary endpoint was the reduction of annualized relapse rate (ARR) during the treatment period.

Unique Therapy for Advanced Heart Failure Granted Fast Track Status

Unique Therapy for Advanced Heart Failure Granted Fast Track Status

Ixmyelocel-T is an investigational autologous expanded multicellular therapy administered via transendocardial catheter-based injections.

Carbavance Gets Priority Review for Complicated UTI

Carbavance Gets Priority Review for Complicated UTI

The study met the pre-specified primary endpoints and showed that treatment with Carbavance is associated with an overall success rate of 98.4%.

FDA Grants Priority Review to Antibody-Drug Conjugate for ALL

FDA Grants Priority Review to Antibody-Drug Conjugate for ALL

The BLA submission is based on positive data from the INO-VATE 1022 study, a Phase 3 trial evaluating inotuzumab ozogamicin vs. standard of care chemotherapy in 326 adults with relapsed or refractory B-cell ALL.

FDA to Review Potential Neulasta Biosimilar

FDA to Review Potential Neulasta Biosimilar

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MYL-1401H (Mylan and Biocon), a proposed biosimilar candidate to Amgen's Neulasta (pegfilgrastim).

Doravirine Demonstrates Non-Inferiority in Phase 3 HIV Study

Doravirine Demonstrates Non-Inferiority in Phase 3 HIV Study

Merck announced positive results from the pivotal Phase 3 study of doravirine (MK-1439), evaluating its efficacy and safety for the treatment of HIV-1 infection.vvvv

FDA to Review New Indication for Privigen

FDA to Review New Indication for Privigen

Data from the Phase 3 PRIMA study suggests that Privigen may help decrease weakness and loss of motor function in people with CIDP.

FDA Fast Tracks Novel Combo Drug for Treatment Resistant Depression

FDA Fast Tracks Novel Combo Drug for Treatment Resistant Depression

The FDA has granted Fast Track designation to the investigational drug AXS-05 (Axsome Therapeutics) for patients with treatment resistant depression (TRD).

Two-Drug HIV Combo as Effective as Three-, Four-Drug Regimen in Phase 3 Studies

Two-Drug HIV Combo as Effective as Three-, Four-Drug Regimen in Phase 3 Studies

Janssen announced positive data from the SWORD Clinical Trial Program of the two-drug regimen dolutegravir (ViiV Healthcare) and rilpivirine (Janssen) for the maintenance treatment of HIV-1 infection in patients who have already achieved viral suppression.

Rescue Tx for Post-Op Nausea/Vomiting Effective in Pivotal Trial

Rescue Tx for Post-Op Nausea/Vomiting Effective in Pivotal Trial

Acacia has announced positive results from its final pivotal Phase 3 study investigating BAREMSIS (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea and vomiting (PONV), despite having received prior antiemetic prophylaxis.

Positive Results Announced for Novel Microneedle Migraine Patch

Positive Results Announced for Novel Microneedle Migraine Patch

Zosano has announced positive results from their Phase 3 clinical trial of M207, the companies lead candidate for the treatment of migraine attacks.

Inhaled Levodopa Shows Promise for OFF Periods in PD Patients

Inhaled Levodopa Shows Promise for OFF Periods in PD Patients

Acorda Therapeutics announced statistically significant results from the Phase 3 study of CVT-301, an investigational inhaled formulation of levodopa, for the treatment of OFF periods in patients with Parkinson's disease (PD) on an oral carbidopa/levodopa regimen.