Drugs in the Pipeline
La Jolla announced positive data from the ATHOS-3 study which evaluated LJPC-501 (angiotensin II) for the treatment of catecholamine resistant hypotension (CRH).
Valeant have re-submitted their NDA for latanoprostene bunod ophthalmic solution after receiving a Complete Response Letter from the FDA last summer.
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.
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.
The study achieved its primary endpoint, demonstrating that treatment with oral fusidic acid is non-inferior to oral linezolid.
AM-111 is currently under investigation in two Phase 3 trials for patients with severe to profound idiopathic sudden sensorineural hearing loss.
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.
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 is a next generation injectable analgesic specifically designed to deliver the pain-reducing potential of an opioid but with fewer associated adverse effects.
The primary endpoint was the reduction of annualized relapse rate (ARR) during the treatment period.
Ixmyelocel-T is an investigational autologous expanded multicellular therapy administered via transendocardial catheter-based injections.
The study met the pre-specified primary endpoints and showed that treatment with Carbavance is associated with an overall success rate of 98.4%.
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.
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).
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
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NEPHROLOGY & UROLOGY NEWS
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- Chronic Kidney Disease (CKD)
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- Cardiovascular Disease (CVD)
- Diabetic Nephropathy
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