Shares of Shire PLC (ADR) (NASDAQ:SHPG) ended Tuesday session in green amid volatile trading. The shares closed up +2.22points or 1.15% at $194.59 with 906.90 million shares getting traded. Post opening the session at $191.56, the shares hit an intraday low of $191.56 and an intraday high of $194.68 and the price vacillated in this range throughout the day. The company has a market cap of $59.00 Billion and the numbers of outstanding shares have been calculated to be 906.90 million shares.
Shire PLC (ADR) (SHPG) on Aug. 29, 2016 announced that Xiidra™ (lifitegrast ophthalmic solution) 5%, a twice-daily prescription eye drop indicated for the treatment of both the signs and symptoms of dry eye disease, is now available by prescription in the United States. An estimated 16 million adults in the U.S. are diagnosed with dry eye, a disease associated with inflammation that may eventually lead to damage to the surface of the eye. An eye care professional can diagnose dry eye disease based on signs and symptoms and determine management options, which could include the use of a prescription treatment. The U.S. Food and Drug Administration (FDA) approved Xiidra on July 11, 2016.
“Shire worked rapidly to bring Xiidra to market following the approval of this new treatment – a first-in-its-class medication and the first prescription treatment to be approved for both the signs and symptoms of dry eye disease,” said Perry Sternberg, Head, U.S. Commercial. “We have a full range of modern, educational access programs to support the millions of patients across the U.S. living with dry eye disease. This delivers on our commitment to showing up differently in ophthalmics.”
“As the number of people presenting with the signs and symptoms of dry eye disease increases, the availability of a new prescription treatment option for this condition is an exciting development,” Eric D. Donnenfeld, M.D., FAAO, National Medical Director, TLC Laser Eye Centers. “We now have a new prescription eye drop that is specifically indicated for the signs and symptoms of dry eye disease, an often common eye condition that may be progressive.”
Shares of Amgen, Inc. (NASDAQ:AMGN) ended Tuesday session in green amid volatile trading. The shares closed up +1.07 points or 0.63% at $170.84 with 784.36 million shares getting traded. Post opening the session at $169.85, the shares hit an intraday low of $169.39 and an intraday high of $171.77 and the price vacillated in this range throughout the day. The company has a market cap of $127.58 million and the numbers of outstanding shares have been calculated to be 748.36 million shares.
Amgen, Inc. (AMGN) on Sept. 1, 2016 announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials.
The approval is based on results from the Phase 1/2 ‘205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of BLINCYTO in pediatric patients with relapsed or refractory B-cell precursor ALL.