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

RTTNews | vor 1184 Tagen
Amryt Pharma To Submit Formal Dispute Resolution Request For Oleogel-S10 NDA

(RTTNews) - 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).

EB is a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma and for which there are no approved treatment options in the US.

Amryt recently had a Type A meeting with the US Food and Drug Administration (FDA) to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt's NDA for Oleogel-S10.

Following this meeting, Amryt plans to proceed to the Formal Dispute Resolution pathway in the FDA's Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level.

read more
Swiss Market Ends Higher For 2nd Straight Session

Swiss Market Ends Higher For 2nd Straight Session

The Switzerland market opened on a slightly weak note on Friday, but recovered swiftly and then kept edging higher to eventually end the day's session on a firm note.
RTTNews | vor 17Std 59 Minuten
Major European Markets Close Slightly Weak

Major European Markets Close Slightly Weak

The major European markets closed slightly down on Friday as investors assessed recent moves of the central banks and weighed the potential impact of tariffs. A bit of profit taking also contributed to the market's weak close.
RTTNews | vor 18Std 24 Minuten
TSX Marches On, Hits Fresh Record High; Materials Stocks Rally

TSX Marches On, Hits Fresh Record High; Materials Stocks Rally

The Canadian market is up firmly in positive territory a little past noon on Friday, extending recent gains, thanks largely to strong buying in the materials sector. Energy stocks are struggling for support due to weak oil prices. The mood remains fairly bullish amid expectations the Bank of Canada and the Federal Reserve will announce further easing this year to boost growth.
RTTNews | vor 19Std 29 Minuten
Bank Of Japan Holds Rate Steady; Plans To Lower ETF Holdings

Bank Of Japan Holds Rate Steady; Plans To Lower ETF Holdings

The Japanese central bank left its key interest rate unchanged on Friday, as expected, but surprised markets with a decision to reduce the holdings of its massive stock of exchange-traded funds, suggesting that the monetary policy normalization is underway. The Bank of Japan policy board, led by Governor Kazuo Ueda, voted 7-2 to hold the uncollateralized overnight call rate at around 0.5 percen
RTTNews | vor 22Std 25 Minuten
Bay Street Likely To Open On Subdued Note

Bay Street Likely To Open On Subdued Note

Canadian shares may open on a somewhat subdued note on Friday with investors reacting to retail sales data, and looking to take some profits following recent gains.
RTTNews | vor 23Std 9 Minuten