Drugs in the Pipeline

Drug for Catecholamine Resistant Hypotension Shows Promise in Phase 3 Study

Drug for Catecholamine Resistant Hypotension Shows Promise in Phase 3 Study

La Jolla announced positive data from the ATHOS-3 study which evaluated LJPC-501 (angiotensin II) for the treatment of catecholamine resistant hypotension (CRH).

NDA Re-Submitted for Novel Glaucoma Drug

NDA Re-Submitted for Novel Glaucoma Drug

Valeant have re-submitted their NDA for latanoprostene bunod ophthalmic solution after receiving a Complete Response Letter from the FDA last summer.

Lurasidone Effective in Phase 3 Pediatric Bipolar Depression Study

Lurasidone Effective in Phase 3 Pediatric Bipolar Depression Study

Sunovion announced that its Phase 3 study of Latuda (lurasidone HCI) in children aged 10 to 17 years with bipolar depression met its primary and secondary endpoints.

Dsuvia for Acute Pain Under FDA Review

Dsuvia for Acute Pain Under FDA Review

The FDA has accepted for review the New Drug Application (NDA) for Dsuvia (sufentanil sublingual tablet; AcelRx) for the treatment of moderate-to-severe acute pain in a medically supervised setting.

Fusidic Acid Looks Promising as Oral Therapy for ABSSSI

Fusidic Acid Looks Promising as Oral Therapy for ABSSSI

The study achieved its primary endpoint, demonstrating that treatment with oral fusidic acid is non-inferior to oral linezolid.

FDA Grants Fast Track Status to Novel Therapy for Hearing Loss

FDA Grants Fast Track Status to Novel Therapy for Hearing Loss

AM-111 is currently under investigation in two Phase 3 trials for patients with severe to profound idiopathic sudden sensorineural hearing loss.

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