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BrainStorm Cell Says FDA Meeting Provides Clear Path For Planned Phase 3b Trial Of NurOwn In ALS
(RTTNews) - BrainStorm Cell Therapeutics, Inc. (BCLI) announced Thursday the completion of a productive meeting with the U.S. Food and Drug Administration (FDA) to discuss NurOwn, its investigational treatment for amyotrophic lateral sclerosis (ALS).
The primary objective of the meeting was to discuss key considerations for a Special Protocol Assessment (SPA) for a planned Phase 3b registrational trial for NurOwn.
As an outcome of the meeting, BrainStorm will submit relevant documentation as outlined by the FDA to support the SPA.
The ultimate goal is to secure the FDA's agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application.
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BrainStorm Cell Therapeutics Promotes Stacy Lindborg To Work Alongside Chaim Lebovits As Co-CEO
Stem cell therapeutics developer BrainStorm Cell Therapeutics Inc. (BCLI) announced Wednesday the promotion of Stacy Lindborg to the role of Co-Chief Executive Officer. She will work alongside Chaim Lebovits, who is retaining his position as President and CEO.
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1347 days ago
U.S. Dollar Ticks Higher Amid Inflation Data Release, Expectations Of Reopening Of Strait Of Hormuz
The U.S. Dollar value inched higher as investors weighed today's inflation data that pushed the odds for a rate hike in the U.S. higher against reports of an upcoming meeting between the Gulf Cooperation Council nations and Iran to hasten the reopening of the Strait of Hormuz.
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18h 44min ago
TSX Climbs On Tech Rally, Looks Set To End 6-day Losing Streak
The S&P/TSX Composite Index rose 0.36% Friday to 35,634.50 as technology stocks surged 3.5%, contributing significantly to gains. Oil prices fell following International Energy Agency's downward global oil demand forecast revision.
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21h 0min ago
Swiss Market Ends Modestly Higher
The Switzerland stock market closed modestly higher on Friday, in line with markets across Europe, as a sharp drop in oil prices helped lift sentiment.
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21h 34min ago
European Markets Rise As Oil Prices Fall On IEA Demand Cut
European markets gained ground Friday after the International Energy Agency cut its global oil demand forecast, sending Brent crude futures down 3.5% to $103.50. The IEA now projects world oil demand will drop 2.5 million barrels per day this year versus its prior estimate of 1.6 million bpd.
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21h 57min ago
U.S. Consumer Sentiment Deteriorates Much More Than Expected In September
A report released by the University of Michigan on Friday showed consumer sentiment in the U.S. has deteriorated by much more than anticipated in the month of September. The University of Michigan said its consumer sentiment index slumped to 47.8 in September after tumbling to 51.7 in August. Economists had expected the index to edge down to 51.0.
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1 day ago
CPSC Recalls: 2.3 Mln Candy Bottles, Motorcycles, Dressers, Dual Fuel Ranges, Fire Spray Canisters
The U.S. Consumer Product safety Commission or CPSC has announced various recalls including more than 2.3 million sour crush candy bottles, motorcycles, six-drawer dressers, dual fuel ranges, hair dryer brushes, and fire spray canisters, among others. In most of the recalls, consumers are urged to immediately stop using the recalled product, and contact the respective firm for either a free repair
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1 day ago
U.S. Consumer Price Growth Matches Estimates, Core Prices Rise Slightly More Than Expected
A closely watched report released by the Labor Department on Friday showed consumer prices in the U.S. increased in line with economist estimates in the month of August, although core prices rose by slightly more than expected. The Labor Department said its consumer price index climbed by 0.4 percent in August after inching up by 0.1 percent in July.
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1 day ago
