EC | Jotup

Akebia’s Vafseo (vadadustat) Poised to Make Waves for GSK’s Jesduvroq and FibroGen/Astellas’ Evrenzo

Retrieved on:

Thursday, July 20, 2023

While several agents within the class have found success globally, the U.S. struggled to get even just one approval across the finish line.

Key Points:

While several agents within the class have found success globally, the U.S. struggled to get even just one approval across the finish line.
However, Jesduvroq’s approval did come with a black box warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
At the same time, their perceptions of ESAs as a treatment for renal anemia in dialysis patients have become increasingly favorable.
Assuming approval, Akebia’s launch of vadadustat will also be covered once commercially available and benchmarked against Jesduvroq at a similar time post-launch.

ECGI's 8-Bit Cannabis Expands Distribution to 65 Stores, Up 225% Since March

Retrieved on:

Wednesday, July 19, 2023

Growth, Intellectual property, Acquisition, EC, SKU, 8-bit computing, OTC, Drug

ECGI's 8-Bit Cannabis Expands Distribution to 65 Stores, Up 225% Since March

Key Points:

ECGI's 8-Bit Cannabis Expands Distribution to 65 Stores, Up 225% Since March
Specifically, the 8-bit cannabis brand has expanded its active distribution footprint from twenty (20) cannabis stores to sixty-five (65) cannabis stores since the end of March, representing a 225% increase in distribution footprint in less than four months.
EC's primary asset is its 8-bit branded cannabis products line.
"We are excited about the prospect of wrapping up this acquisition with a finalized definitive agreement over coming weeks," stated Danny Wong, CEO of ECGI.
"8-bit has continued to expand as a brand, catching fire with distributors and end-market consumers in the California cannabis products space since the signing of our Binding Agreement in March.

European $6+ Bn Natural Cosmetics Market Outlook to 2028: Sustainable and Ethical Beauty Trends Shaping the Market - ResearchAndMarkets.com

Retrieved on:

Monday, July 17, 2023

Cosmetics, Retail, Growth, Skin, Health, Beauty, EC, COSMOS, Regulation of pesticides in the European Union, Dietary supplement

The demand for natural cosmetics continues to rise, with consumers seeking products that align with their values of health and sustainability.

Key Points:

The demand for natural cosmetics continues to rise, with consumers seeking products that align with their values of health and sustainability.
There is a growing demand for natural cosmetics that clearly communicate their ingredient lists, highlighting natural and organic ingredients.
Natural cosmetics, with their focus on organic and natural ingredients, cruelty-free practises, and eco-friendly packaging, appeal to these values.
Natural cosmetics often emphasise sustainable sourcing, eco-friendly manufacturing processes, and recyclable or biodegradable packaging, making them attractive options for environmentally conscious consumers.

eDreams ODIGEO Heightens Measures to Protect Consumers Hit by Travel Disruptions

Retrieved on:

Monday, July 17, 2023

eDreams ODIGEO, one of the world’s largest online travel companies, today revealed a comprehensive set of proactive measures implemented across the Company to protect consumers.

Key Points:

eDreams ODIGEO, one of the world’s largest online travel companies, today revealed a comprehensive set of proactive measures implemented across the Company to protect consumers.
As a result, eDreams ODIGEO has decided to discontinue the sale of tickets for 15 airlines that have consistently breached their refund obligations to consumers.
This enabled eDreams ODIGEO to provide resolutions to over 6.4 million travellers hit by airline and airport disruptions since March 2020.
As advocates for our customers, we recognise the crucial role that online travel agencies like eDreams ODIGEO play in representing consumers' interests before key industry stakeholders.

Highlights - Presentation by the EC of the greening transport package - Committee on Transport and Tourism

Retrieved on:

Friday, July 14, 2023

Commission, Committee, Transport, Tourism, Efficiency, European Green Deal, EC, European Parliament Committee on Transport and Tourism, Teahouse, EU, Greening

Presentation by the EC of the greening transport package

Key Points:

Presentation by the EC of the greening transport package
14-07-2023 - 09:49
On 19 July, the Committee on Transport and Tourism will discuss the Greening freight package.
Members will examine the new proposal from the Commission, which aims to make freight transport more efficient and sustainable,
by improving rail infrastructure management, providing stronger incentives for low-emission lorries, and offering better information on freight transport greenhouse gas emissions.
The aim is to increase efficiency within the sector, helping it to contribute to significant cuts in transport emissions by 2050, as set out in the European Green Deal, while allowing the EU single market to continue growing.
The debate will take place on Wednesday afternoon 19 July 2023 in room ANTALL 4Q2 from where it will be webstreamed
The debate will take place on Wednesday afternoon 19 July 2023 in room ANTALL 4Q2 from where it will be webstreamed

Microsoft and Activision: the big questions that will decide whether the US$68 billion deal goes ahead

Retrieved on:

Friday, July 14, 2023

Microsoft’s proposed US$68 billion (£52 billion) acquisition of video game maker Activision Blizzard should be allowed to go ahead, according to a US federal judge.

Key Points:

Microsoft’s proposed US$68 billion (£52 billion) acquisition of video game maker Activision Blizzard should be allowed to go ahead, according to a US federal judge.
Yet US competition authority the Federal Trade Commission (FTC) has taken the rare step of appealing the decision.

Cloud gaming

Microsoft owns the Xbox gaming console and makes games like Minecraft and Age of Empires.
Cloud streaming is viewed by many as the future of gaming.
So far, however, cloud gaming has struggled to take hold with consumers.
Yet as a whole, the segment is expected to keep grinding upwards, capturing 6.2% of gaming in 2027 compared to 3.8% today, with revenues rising from US$4.3 billion to US$18.7 billion.

Regulatory differences

The European Commission (EC) was among those that cleared the deal with conditions.
These related to ensuring Activision games wouldn’t be restricted to Microsoft’s cloud gaming services but could be played on any platform.
The UK and US competition authorities both view cloud gaming as a “distinct market” that needs to be protected from a large technology incumbent.
Earlier this year I submitted a report to the CMA titled Cloud Gaming Is Not A Distinct Market.

What next

The terms of the deal stipulate that Microsoft must consummate the merger by July 18, or pay Activision US$3 billion in termination fees.
Yet blocking the way are the FTC appeal and the CMA in the UK.
The CMA signalled it was willing to negotiate with Microsoft after the US ruling, but has since tempered any expectations of a quick resolution.

How the Recent FDA & EMA Regulations are Helping Advance and Enhance Electronic Clinical Outcome Assessments (eCOA/ePRO), Upcoming Webinar Hosted by Xtalks

Retrieved on:

Tuesday, July 11, 2023

Science, US Food Sovereignty Alliance, American Opportunity Tax Credit, European Medicines Agency, MBA, Holocene, Doctor of Philosophy, Clario Tech, EMA, Ethics, MD, Risk, Master of Science, FDA, EC, Consultant, Food, Pharmaceutical industry, Vaccine

TORONTO, July 11, 2023 /PRNewswire-PRWeb/ -- In an effort to help advance and enhance electronic clinical outcome assessments (eCOA/ePRO), four esteemed professionals from the Clario's eCOA Science team will be conducting a free webinar on recent FDA & EMA regulations.

Key Points:

In this free webinar, learn how the recent FDA & EMA regulations are helping advance and enhance electronic clinical outcome assessments (eCOA/ePRO).
Attendees will gain an understanding how these new guidances have the potential to enhance and accelerate the use of eCOA/ePRO in clinical trials.
TORONTO, July 11, 2023 /PRNewswire-PRWeb/ -- In an effort to help advance and enhance electronic clinical outcome assessments (eCOA/ePRO), four esteemed professionals from the Clario's eCOA Science team will be conducting a free webinar on recent FDA & EMA regulations.
The live webinar , "How the Recent FDA & EMA Regulations are Helping Advance and Enhance Electronic Clinical Outcome Assessments (eCOA/ePRO)," is scheduled for Wednesday, July 26, 2023, at 11am EDT (4pm BST/UK).

Akari Therapeutics Receives Positive Opinion on Orphan Drug Designation from the European Medicines Agency for Nomacopan for Treatment in Hematopoietic Stem Cell Transplantation

Retrieved on:

Thursday, July 6, 2023

Civil service commission, European Medicines Agency, COMP, Committee, EMA, Patient, Akari, Mortality, Therapy, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Hematopoietic stem cell transplantation, Food, European Commission, Pharmaceutical industry

The application included nomacopan clinical data from the treatment of patients with pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

Key Points:

The application included nomacopan clinical data from the treatment of patients with pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).
Typically, the European Commission (EC) grants orphan drug designation 30 days after a positive opinion is issued.
The EMA designates orphan drug status for medicines treating rare, life-threatening, or chronically debilitating diseases that meet certain criteria.
The EMA orphan drug designation, if granted, will be an important addition to the Rare Pediatric Disease, Orphan Drug, and Fast Track designations already granted to nomacopan in pediatric HSCT-TMA by the U.S. Food and Drug Administration.

Highlights - SANT: Hearing on 'Medicine shortages' - Subcommittee on Public Health

Retrieved on:

Monday, July 3, 2023

EC, Urinary tract infection, Member, Hearing, Medical device, EU

SANT: Hearing on 'Medicine shortages'

Key Points:

SANT: Hearing on 'Medicine shortages'
03-07-2023 - 17:19
During the hearing of 13 July, Members of the SANT subcommittee will hear and hold an exchange of views with a number of experts.
Medicine shortages have been a persistent public health problem in recent times, and the situation in the EU has been dramatically exacerbated by geopolitical events and trends, such as the war in Ukraine, the energy crisis and high inflation rates.
Furthermore, the recent massive increase in respiratory infections has also led to a higher demand for antibiotics.
During its hearing, SANT subcommittee will hold debate on the role of the EC and Member States regarding any necessary action to restore pharmaceutical sovereignty in Europe and local pharmaceutical production, with particular attention to the priority given to essential and strategic medicines.

Dalata Hotel Group PLC: Total Voting Rights

Retrieved on:

Monday, July 3, 2023

Dalata Hotel Group, EC, Medical device, Security (finance)

In conformity with Regulation 20 of the Transparency (Directive 2004/109/EC) Regulations 2007, Dalata Hotel Group plc announces that:

Key Points:

In conformity with Regulation 20 of the Transparency (Directive 2004/109/EC) Regulations 2007, Dalata Hotel Group plc announces that:
As of 3 July 2023, Dalata Hotel Group plc’s share capital consists of 223,433,968 Ordinary Shares of nominal value €0.01 each.
Dalata Hotel Group plc does not hold any Ordinary Shares in treasury.
Therefore, the total number of voting rights in Dalata Hotel Group plc is 223,433,968.
The above figure may be used by shareholders as a denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Dalata Hotel Group plc under the Transparency (Directive 2004/109/EC) Regulations 2007.