PUMA

PUMA Reveals Global Partnership With HYROX

Retrieved on: 
måndag, juni 3, 2024

Global sports company PUMA, has announced a worldwide partnership with HYROX , the world series of fitness racing.

Key Points: 
  • Global sports company PUMA, has announced a worldwide partnership with HYROX , the world series of fitness racing.
  • View the full release here: https://www.businesswire.com/news/home/20240603109731/en/
    Global sports company PUMA has announced a worldwide partnership with HYROX, the world series of fitness racing.
  • The global partnership will see PUMA develop a full range of HYROX apparel, utilising its innovative Cloudspun technology that features dryCELL moisture-wicking properties.
  • PUMA will physically activate its global partnership rights at all HYROX events throughout the season until 2027.

Procedural advice on paediatric applications

Retrieved on: 
måndag, juni 3, 2024

Procedural advice on paediatric applications

Key Points: 
    • 9 Human Medicines Division Procedural advice on paediatric applications Guidance for applicants 1 1 To be consulted together with the IRIS guide for applicants.
    • Placing paediatric medicines on the market ......................................................... 15 Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • Regulation (EC) No 1901/2006 (the 'Paediatric Regulation') lays down obligations, rewards and incentives for the development and placing on the market of medicines for use in children.
    • Where results of paediatric studies are submitted, applicants should include in the clinical overview a rationale supporting the proposed changes to the Product Information.
    • Further information can be found in the Procedural Advice document on ?applications for PIPs, Waivers and Modifications.
    • However, the following types of application are exempted from the application of the above requirements: Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • Objectives The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007.
    • Its main impact was the establishment of the Paediatric Committee (PDCO), which is responsible for coordinating the Agency's work on medicines for children.
    • For pre-submission interactions: Send a question to the European Medicines Agency Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • for modification of a paediatric investigation plan) it is suggested to record all successive name changes in the document.? Invented name: The trade name of a medicine.
    • In general paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population, where appropriate, before marketing authorisation applications are submitted.
    • It is often referred to as full waiver as it is related the age range covering all paediatric subsets.
    • During the second PDCO discussion, either a request for modification (RfM) or PDCO opinion is adopted: Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • Opinion According to Article 25(1) of the Paediatric Regulation (Regulation (EC) No 1901/2006), within ten days of its receipt, the Agency shall transmit the opinion of the Paediatric Committee to the applicant.
    • The following documents should be uploaded into ?Documents from applicant? in addition to the IRIS application for the related initial PIP: ? Detailed grounds for re-examination in a Word document Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • EMA decision According to Article 25(5) of the Paediatric Regulation (Regulation (EC) No 1901/2006), the Agency issues its decision within 10 days of the Paediatric Committee's definitive opinion.
    • The following documents should be uploaded into ?Documents from applicant? in addition to the IRIS application for Discontinuation of paediatric development: Procedural advice on paediatric applications EMA/672643/2017 Rev.
    • See also: Deadlines for placing paediatric medicines on the market Procedural advice on paediatric applications EMA/672643/2017 Rev.

Puma Exploration Inc. to Participate in THE Mining Investment Event of the North, Canada's Only Tier I Global Mining Investment Conference

Retrieved on: 
onsdag, maj 29, 2024

Management invites shareholders and interested parties to book a meeting to learn more about Puma and our flagship Williams Brook Gold Project in northern New Brunswick.

Key Points: 
  • Management invites shareholders and interested parties to book a meeting to learn more about Puma and our flagship Williams Brook Gold Project in northern New Brunswick.
  • Throughout the three-day conference, Puma representatives will be available in the Mi3 Lounge to meet with investors.
  • Please book a meeting with Mia Boiridy , Head of Investor Relations for Puma Exploration.
  • Since 2021, with less than C$15 M of exploration investment, Puma has made multiple gold discoveries at the Williams Brook property and believes it hosts an extensive orogenic gold system.

Vyluma Announces Marketing Authorization Application Validation for the European Union

Retrieved on: 
onsdag, maj 29, 2024

BRIDGEWATER, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company dedicated to advancing novel ophthalmic solutions for refractive errors, announced today that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for its lead compound, NVK002.

Key Points: 
  • BRIDGEWATER, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company dedicated to advancing novel ophthalmic solutions for refractive errors, announced today that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for its lead compound, NVK002.
  • The application is confirmed to be eligible for a Paediatric Use Marketing Authorisation (PUMA), providing 10 years of data exclusivity and marketing protection upon product approval.
  • “This acceptance represents an important and key milestone for our Company, as NVK002 has now been submitted for regulatory review across our three most key global markets: the U.S., China, and the European Union,” stated Raul A. Trillo, MD, MBA, President, and Chief Commercial Officer of Vyluma.
  • “Our steadfast commitment to delivering an innovative pharmaceutical option for pediatric myopia underscores our dedication to improving children’s vision worldwide.”
    The regulatory application of NVK002 is supported by previously reported safety and efficacy data from the multi-center, placebo-controlled, Phase III CHAMP (Childhood Atropine Myopia Progression) clinical study which evaluated the safety and efficacy of the product in children aged three years and older.

EQS-News: PUMA delivers Q1 results fully in line with expectations

Retrieved on: 
fredag, maj 10, 2024

The launch of our first brand campaign in a decade was an important first step and the first results came in above our expectations.

Key Points: 
  • The launch of our first brand campaign in a decade was an important first step and the first results came in above our expectations.
  • This resulted in an increased DTC share of 23.5% (Q1 2023: 21.3%), in line with expectations.
  • Consequently, net income decreased by 25.5% to € 87.3 million (Q1 2023: € 117.3 million) and earnings per share amounted to € 0.58 (Q1 2023: € 0.78).
  • In line with our expectations, the year 2024 has started with geopolitical and macroeconomic challenges as well as currency volatility.

Puma Launches 2024 Exploration Program at Jonpol Gold

Retrieved on: 
onsdag, maj 8, 2024

RIMOUSKI, Quebec, May 08, 2024 (GLOBE NEWSWIRE) -- Puma Exploration Inc. (TSXV: PUMA, OTCQB: PUMXF) (the "Company" or "Puma") is pleased to launch its 2024 exploration program at its 100%-owned Jonpol Gold property located 8 km east of its Williams Brook property in Northern New Brunswick.

Key Points: 
  • RIMOUSKI, Quebec, May 08, 2024 (GLOBE NEWSWIRE) -- Puma Exploration Inc. (TSXV: PUMA, OTCQB: PUMXF) (the "Company" or "Puma") is pleased to launch its 2024 exploration program at its 100%-owned Jonpol Gold property located 8 km east of its Williams Brook property in Northern New Brunswick.
  • A focused exploration program will be deployed this summer at the Jonpol Gold property and its new expansion (see Figure 1) to advance the Company’s understanding of the sizeable orogenic gold system at play in the region and identify additional potential gold deposits.
  • The 2024 summer program at Jonpol aims to investigate and revisit gold showings found by previous operators using Puma's proven exploration strategy.
  • Puma has not done any field work on those gold showings since the acquisition of the property in 2019.

DN Solutions, a Global Leader in Machine Tools, Joins MacTech KSA 2024 in Saudi Arabia

Retrieved on: 
tisdag, april 30, 2024

SEOUL, South Korea, April 30, 2024 /PRNewswire/ -- DN Solutions, a global leader in machine tools, showcases its top-tier product at MacTech KSA 2024, a machine tool exhibition held in Saudi Arabia.

Key Points: 
  • SEOUL, South Korea, April 30, 2024 /PRNewswire/ -- DN Solutions, a global leader in machine tools, showcases its top-tier product at MacTech KSA 2024, a machine tool exhibition held in Saudi Arabia.
  • This year, MacTech KSA 2024 marks its inaugural edition at the Riyadh International Convention and Exhibition Center in Riyadh, Saudi Arabia, running from April 30 to May 2.
  • DN Solutions is confident that by showcasing its high-end products at MacTech KSA 2024, it will fortify its brand presence and seize fresh sales opportunities.
  • With MacTech KSA 2024, our objective is to bolster our brand presence in Saudi Arabia and solidify our standing as a global leader in the machine tools industry, actively meeting the evolving demands of the Middle East."

CARBIOS celebrates the groundbreaking of its PET biorecycling plant, a world first, with its partners

Retrieved on: 
fredag, april 26, 2024

PET, the second most widely used plastic in the world, is mainly manufactured from oil.

Key Points: 
  • PET, the second most widely used plastic in the world, is mainly manufactured from oil.
  • Thanks to CARBIOS’ enzymatic biorecycling technology, PET will no longer be made from oil, but from its own waste.
  • »
    Emmanuel Ladent, CEO, CARBIOS : “At CARBIOS, we have turned a vision into reality with the groundbreaking of the world's first PET biorecycling plant.
  • CARBIOS continues its mission by collaborating with strategic partners around the world and embarking on a promising commercial and international deployment.

Puma Exploration Launches Drone High-Resolution Magnetic Survey at Williams Brook

Retrieved on: 
torsdag, april 25, 2024

RIMOUSKI, Quebec, April 25, 2024 (GLOBE NEWSWIRE) -- Puma Exploration Inc. (TSXV: PUMA, OTCQB: PUMXF) (the "Company" or "Puma") has launched a high-resolution magnetic survey at its 100%-owned Williams Brook property (Figure 1) in Northern New Brunswick.

Key Points: 
  • RIMOUSKI, Quebec, April 25, 2024 (GLOBE NEWSWIRE) -- Puma Exploration Inc. (TSXV: PUMA, OTCQB: PUMXF) (the "Company" or "Puma") has launched a high-resolution magnetic survey at its 100%-owned Williams Brook property (Figure 1) in Northern New Brunswick.
  • Vision 4k Inc. has been contracted to fly a 372-line-kilometre survey at 35-metre spacing, covering an area of about 12 square kilometres.
  • The survey will help map the lithology and structural features that control gold mineralization at the Lynx Gold Zone and translate that data to its extension along the Lynx Gold Trend.
  • The detailed overprint of lithological contacts and additional structural features along the Lynx Gold Trend will identify additional exploration and drilling targets.

CARBIOS celebrates the groundbreaking of its PET biorecycling plant, a world first, with its partners

Retrieved on: 
torsdag, april 25, 2024

PET, the second most widely used plastic in the world, is mainly manufactured from oil.

Key Points: 
  • PET, the second most widely used plastic in the world, is mainly manufactured from oil.
  • Thanks to CARBIOS’ enzymatic biorecycling technology, PET will no longer be made from oil, but from its own waste.
  • »
    Emmanuel Ladent, CEO, CARBIOS : “At CARBIOS, we have turned a vision into reality with the groundbreaking of the world's first PET biorecycling plant.
  • CARBIOS continues its mission by collaborating with strategic partners around the world and embarking on a promising commercial and international deployment.