Drugs in the Pipeline
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
Data from the Phase 3 PRIMA study suggests that Privigen may help decrease weakness and loss of motor function in people with CIDP.
The FDA has granted Fast Track designation to the investigational drug AXS-05 (Axsome Therapeutics) for patients with treatment resistant depression (TRD).
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.
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.
Zosano has announced positive results from their Phase 3 clinical trial of M207, the companies lead candidate for the treatment of migraine attacks.
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.
Renal and Urology News Articles
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NEPHROLOGY & UROLOGY NEWS
- Acute Kidney Injury (AKI)
- Chronic Kidney Disease (CKD)
- Contrast Nephropathy
- Cardiovascular Disease (CVD)
- Diabetic Nephropathy
- End-stage Renal Disease (ESRD)
- Lupus Nephritis
- Peritoneal Dialysis
- Secondary Hyperparathyroidism (SHPT)