Amryt provides EMA regulatory update for Oleogel-S10

Amryt (NASDAQ:AMYT) announces that the EMA plans to seek external independent Epidermolysis Bullosa (EB) specific expertise and advice on the assessment of Oleogel-S10 for the treatment of the cutaneous manifestations of Junctional and Dystrophic EB, a rare and distressing genetic skin disorder with currently no approved treatment. Given the rarity...

Blueprint Medicines' Ayvakyt wins positive CHMP opinion for systemic mastocytosis

Blueprint Medicines (NASDAQ:BPMC) announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending to expand the current indication for AYVAKYT (avapritinib) to include monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN) or mast cell leukemia (MCL), after at least one systemic therapy.

EC formally authorizes Pfizer's COVID antiviral pill Paxlovid

The European Commission today authorized Pfizer's (PFE +1.0%) COVID-19 antiviral pill Paxlovid. The move follows the recommendation of authorization from a panel of European Medicines Agency ("EMA") advisors. The Commission is still weighing authorization of Merck's (MRK -0.1%) COVID antiviral, molnupiravir. However, the EMA's advisory panel previously recommended approval.

UK arms exports delayed ‘for up to six months’ due to Brexit

UK arms manufacturers have been hit by long delays in attempts to export weapons overseas because of Brexit red tape, a leading trade body has told MPs.The Engineering and Machinery Alliance (EMA) said some firms are “waiting for up to six months” for government licences to export into the EU – despite the target time for approval being two weeks. Jack Semple, director of policy at the alliance, told MPs on the international trade committee that the industry blames the Export Control Joint Unit (ECJU) for failing to anticipate time-consuming Brexit red tape. “The ECJU’s target for granting or rejecting license...

EMA's Advisory Committee Recommends Approval Of Bristol-Myers' Breyanzi In Lymphoma

TODAY ONLY! For only $7, you can get 2 winning options trade alerts every month! Click Here to See Trade Ideas! (Risk-free with a 14 day refund guarantee) The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Bristol-Myers Squibb Co BMY Breyanzi (lisocabtagene maraleucel; liso-cel) for lymphoma settings.

Slovenia: How to watch the EMA FRES 2022 final

It started with a month of daily online duels back in December. Now, Slovenia’s EMA Freš 2022 process comes to a close with tonight’s final. Out of the original 24 newcomers, just 14 remain in the quest to win a spot in the main EMA shows. Only four will make it.

Activated PI3Kdelta Syndrome (APDS) - Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report - 2020 To 2030

Pharming Group N.V. announces that a positive decision has been made by the European Medicines Agency (EMA) on the Paediatric Investigation Plan (PIP) for leniolisib, a phosphoinositide 3-kinase (PI3K) inhibitor, currently in development for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS). Source:- Pharming Group N.V. According to a...

It Feels Like the Bulls Threw Open the Doors and No One Attended

Imagine you held a party, and nobody showed up, states Ian Murphy of The S&P 500 (SPX), Nasdaq (NDX) and Russell 2000 (RUT) are all trading at their -3ATR lines on a daily chart and failed to rally after Monday’s reversal bar, it feels like the bulls threw open the doors and no one attended.

Why NetOps-SecOps Collaboration Must be Part of Your Business Strategy

IT organizations have always needed to evolve to meet the demands of everyday life. In recent years, it has become apparent that the next evolution is collaboration between network operations (NetOps) and security operations (SecOps). According to the recent EMA white paper “NetSecOps: Aligning Networking and Security Teams to Ensure Digital Transformation,” more than 75 percent of network and security teams have increased their level of collaboration in recent years. This is due to increased digital transformation, rapid growth in work-from-home operations, and data center automation, among other factors.

Is this a stock market crash? A look at the indices

It’s always worth keeping an eye on the indices. They are the bellwether for the markets – whenever the Dow plunges or hits new highs then we always hear about it. However, there is also a disconnect between the indices and the overall market. One thing that I...

EU to create pan-European cyber incident coordination framework

The European Systemic Risk Board (ESRB) proposed a new systemic cyber incident coordination framework that would allow EU relevant authorities to coordinate better when responding to major cross-border cyber incidents impacting the Union's financial sector. ESRB is an independent EU body established in 2010 that oversees the European Union's financial...