|Drug Approvals Expected to Rise as Trump Pledges to Speed Up Approval Process: Latest Reports on MannKind and Keryx|
Accesswire AccesswireFebruary 1, 2017Comment
NEW YORK, NY / ACCESSWIRE / February 1, 2017 / The Biotech Industry has outperformed the broader markets in 2017, despite all the criticism drug makers have been facing. The iShares NASDAQ Biotechnology Index ETF gained 2.84 percent to close at 278.07, up 4.78 percent year-to-date, while the SPDR S&P Biotech ETF spiked 4.14 percent to close at 64.90, up 9.65 percent year-to-date. In comparison, the Dow Jones Industrial Average and the S&P 500 Index have posted gains of 0.51 percent and 1.79 percent, respectively, so far this year. The Biotech Industry received a boost Tuesday after President Trump stated he would loosen drug regulations and push for a faster drug approval process.
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"We're also gonna be streamlining the process so that, from your standpoint, when you have a drug, you can actually get it approved if it works instead of waiting for many, many years," President Trump said. "The U.S. drug companies have produced extraordinary results for our country, but the pricing has been astronomical for our country."
The U.S. Food and Drug Administration (FDA) approved just 22 new drugs in 2016, less than half of the 45 new drugs approved in 2015, according to Reuters. The number of drugs approved last year was the lowest number of approvals since 2010.
Keryx Biopharmaceuticals (NASDAQ: KERX)
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Keryx Biopharmaceuticals' shares jumped 8.71 percent to close at $4.99 a share Tuesday. The stock traded between $4.47 and $5.05 on volume of 2.27 million shares traded. Keryx is a commercial stage company focused on bringing innovative medicines to people with renal disease. On January 12th, the company announced the publication of results from its pivotal Phase 3 study evaluating ferric citrate for iron deficiency anemia (IDA) in non-dialysis-dependent chronic kidney disease (NDD-CKD) in the online issue of the Journal of the American Society of Nephrology (JASN).
"The results shown in this pivotal study demonstrated that ferric citrate, if approved for this indication, could provide an important new treatment option for people living with chronic kidney disease and iron deficiency anemia who are not on dialysis," said Steven Fishbane, M.D., chief of nephrology for North Shore University Hospital and Long Island Jewish Medical Center.Re: $10.00+ in sight. sNDA filed and it is much bigger market the current infant ...
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| Reply to SpecGuru - Msg #2626 - 02/02/2017 15:04|
$10.00+ in sight. sNDA filed and it is much bigger market the current infant stage of Auryxia. Really...Re: BIG NEWS!! Harmony, Wellcare, Staywell, they all have put Auryxia on PDL and...