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6/24/2019

HHS Secretary Alex Azar said the agency sent to the White House for review a proposal that would align prices paid by Medicare for certain drugs with those paid in other countries. The international pricing index was proposed in October by President Donald Trump as part of the administration's broader efforts to lower prescription drug prices.

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The Hill
6/24/2019

The CMS has released new guidance for state Medicaid programs, covering eligibility determinations and spending integrity after the Office of Inspector General found inconsistent compliance with standards. The agency warned states to expect audits of their managed care financing and eligibility determination programs, and CMS Administrator Seema Verma said the steps are part of "a strategic approach to managing improper payments, risks, and fraud as well as developing effective program integrity controls to ensure that government services aid their intended purposes."

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Administrator Seema Verma
6/24/2019

The supplemental new drug application for the use of Ocular Therapeutix's Dextenza, or dexamethasone ophthalmic insert, as a treatment of ocular inflammation after opthalmic surgery has been approved by the FDA. The decision was backed by late-stage trials in which more patients experienced no pain eight days after treatment with Dextenza and demonstrated a statistically significant lack of anterior chamber cells versus the vehicle group 14 days after treatment.

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eMPR
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FDA, Dextenza, dexamethasone
6/24/2019

Dicerna Pharmaceuticals unveiled updated results from an ongoing early-stage trial assessing the safety, efficacy and tolerability of its experimental drug DCR-PHXC in patients with type 1 or type 2 primary hyperoxaluria. The data, which showed patients experiencing substantial 24-hour reductions in urinary oxalate levels after administration of a single-dose of DCR-PHXC, were presented during the Oxalosis & Hyperoxaluria Foundation International Hyperoxaluria Workshop.

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Seeking Alpha
6/24/2019

The FDA has approved Allergan's supplemental biologics application for Botox as a treatment for children two to 17 years old with upper limb spasticity.

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Botox, Allergan, FDA
6/24/2019

Data shows that AstraZeneca's Lokelma, or sodium zirconium cyclosilicate, was effective in treating patients with end-stage renal disease who have hyperkalemia and are undergoing hemodialysis. Findings were presented at the 56th Congress of the European Renal Association-European Dialysis and Transplant Association and were also published in the Journal of the American Society of Nephrology.

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hyperkalemia, ESRD, Lokelma
6/24/2019

Hookipa Pharma will fund a clinical trial for its investigational vaccine HB-101 for the prevention of cytomegalovirus infections in patients who undergo kidney transplants. The University of Cincinnati Medical Center will serve as one of an estimated 40 international test sites that will enroll a total of 150 transplant patients.

6/24/2019

The Crop Life Pakistan Association exhibited the benefits of biotechnology through the performance of maize hybrids in the field and highlighted its importance in cultivation during a value assessment trial.

6/24/2019

The FDA has released around 6 million previously undisclosed reports of medical device-related adverse events that were filed by manufacturers from 1999 to April 2019 under the Alternative Summary Reporting (ASR) program. AdvaMed expressed support for the agency's move, with spokesman Jim Jeffries saying that "while the ASR information was not accessible in FDA's MAUDE database, the agency had access to all this information and used that data in its analysis to determine the risk profile of the devices subject to ASR."

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FDA, AdvaMed
6/24/2019

AdvaMed has welcomed Jessica Lenard as its vice president for government affairs. Lenard formerly served as director of federal government relations at the Tennessee Valley Authority.