Amryt Pharma Says European Commission Oks Filsuvez For Dystrophic And Junctional EB

RTTNews | vor 1044 Tagen
Amryt Pharma Says European Commission Oks Filsuvez For Dystrophic And Junctional EB

(RTTNews) - Biopharmaceutical company Amryt Pharma plc (AMYT) announced the European Commission (EC) approval of Filsuvez in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.

EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market.

The centralized marketing authorization will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez in the EU provides a regulatory core dossier which may form the basis for future regulatory submissions in LATAM and the Middle East.

The EC approval of Filsuvez is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.

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Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

Biopharmaceutical company Amryt Pharma plc (AMYT) announced Friday that the company plans to submit a Formal Dispute Resolution Request (FDRR) for the company's New Drug Application (NDA) for Oleogel-S10 (Filsuvez), for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).
RTTNews | vor 1043 Tagen
Swiss Market Ends On Bright Note

Swiss Market Ends On Bright Note

The Switzerland market closed on a strong note on Friday, mirroring the trend in markets across Europe and elsewhere, as worries about trade tensions eased after China stated its willingness to hold talks with the U.S.
RTTNews | vor 1Std 8 Minuten
European Stocks Close On Buoyant Note

European Stocks Close On Buoyant Note

European stocks closed higher on Friday, with the major markets in the region posting strong gains, amid easing concerns about U.S-China trade relations, and on upbeat U.S. non-farm payroll data.
RTTNews | vor 1Std 29 Minuten
Canadian Market Up Firmly In Positive Territory

Canadian Market Up Firmly In Positive Territory

The Canadian market is up firmly in positive territory a little past noon on Friday, amid easing concerns about U.S.-China trade tensions following China expressing willingness to hold tariff talks with the United States. Data showing a much higher than expected increase in U.S. non-farm payroll growth in the month of April is also aiding sentiment.
RTTNews | vor 2Std 26 Minuten
U.S. Factory Orders Spike Slightly Less Than Expected In March

U.S. Factory Orders Spike Slightly Less Than Expected In March

The Commerce Department released a report on Friday showing a sharp increase by new orders for U.S. manufactured goods in the month of March. The report said factory orders spiked by 4.3 percent in March after rising by a downwardly revised 0.5 percent in February.
RTTNews | vor 4Std 24 Minuten
U.S. Employment Jumps By 177,000 Jobs In April, Much More Than Expected

U.S. Employment Jumps By 177,000 Jobs In April, Much More Than Expected

Job growth in the U.S. far exceeded economist estimates in the month of April, according to a closely watched report released by the Labor Department on Friday. The Labor Department said non-farm payroll employment shot up by 177,000 jobs in April compared to expectations for an increase of about 130,000 jobs.
RTTNews | vor 5Std 18 Minuten
Eurozone Inflation Remains Stable At 2.2%

Eurozone Inflation Remains Stable At 2.2%

Euro area annual inflation remained stable in April near the European Central Bank's 2 percent target, but the trade tariff uncertainty clouds the outlook. The harmonized index of consumer prices grew 2.2 percent on a yearly basis in April, the same pace of increase as seen in March, flash data from Eurostat showed on Friday. Prices were expected to climb at a slower pace of 2.1 percent.
RTTNews | vor 5Std 42 Minuten
Eurozone Manufacturing Activity Shrinks At Slower Pace

Eurozone Manufacturing Activity Shrinks At Slower Pace

Euro area factory activity contracted at a slower pace in April as production grew at the fastest pace in more than three years, final data of the purchasing managers' survey by S&P Global showed Friday. The HCOB manufacturing Purchasing Managers' Index rose to a 32-month high of 49.0 in April from 48.6 in March. The score was also above the flash estimate of 48.7.
RTTNews | vor 5Std 54 Minuten