Latest news with #Angulo
Yahoo
28-05-2025
- Business
- Yahoo
Scynexis resumes dosing in Phase III MARIO study after lengthy delay
Scynexis has resumed dosing of its vaginal yeast infection drug Brexafemme (ibrexafungerp) in a Phase III trial after a 19-month clinical hold by the US Food and Drug Administration (FDA). The resumption of dosing in the MARIO study (NCT05178862) comes after the FDA lifted the clinical hold last month, originally in place due to concerns about cross-contamination. Scynexis said the investigational sites were reactivated a few days ago, as per a 28 May press release. The issue was highlighted after a review from GSK, which signed a licensing deal for the drug with Scynexis in 2023. The British big pharma noted that the manufacturing site for Brexafemme also produced a non-antibiotic beta-lactam substance. This drug, which can cause allergic reactions in some patients, has been the subject of an FDA draft guidance that details the separation of manufacturing processes for these compounds. In September 2023, Scynexis issued a voluntary recall of Brexafemme, an FDA-approved treatment for vulvovaginal candidiasis (VVC), due to the potential for cross-contamination. Scynexis said the study has resumed following the manufacture of new clinical supplies at another site. The Phase III MARIO study is investigating oral Brexafemme as a potential step-down antifungal therapy following intravenous (IV) echinocandin for invasive candidiasis, a potentially life-threatening infection. The trial has enrolled around 25% of its 220-patient target. 'We are pleased to announce the dosing of the first new patient in the Phase III MARIO study following the lifting of the clinical hold by the FDA in April,' said Scynexis CEO David Angulo. 'The rapid resumption of patient enrolment, just a few days after the investigational sites were reactivated in the study, reflects the eagerness of the scientific community to have new treatment options for this life-threatening infection.' MARIO being back on track comes amid a saga between Scynexis and GSK, with the companies pointing fingers at each other with regard to trial duties. During its Q1 earnings report, Scynexis said that GSK had tried to terminate the study, with Angulo affirming plans to move forward with Brexafemme in this new indication. There used to be substantial cash on the line. The partnership in 2023 included not just a $90m upfront payment, but up to $503m in milestone payments. However, after the commercial delays, millstone payments were cut in a revised deal in December 2023. Approval-based milestones were slashed from $70m to $49m, whilst commercial counterparts were halved from $115m to a potential $57.5m. Milestone payments based on sales were also downwardly revised. By dosing the first new patient, Scynexis believes it has now triggered a $10m payment, with another $20m to arrive by the six-month anniversary of dosing. 'As previously disclosed, there is a disagreement between Scynexis and GSK regarding the resumption of the MARIO Study and GSK's responsibility for paying these milestones. Scynexis is working to resolve the disagreement,' Scynexis said in a statement. GSK did not immediately respond to Clinical Trials Arena's request for comment. Scynexis reported $3.7m in revenue for 2024, which primarily consisted of the licence agreement with GSK. Brexafemme generated sales of $5m in 2022 before the recall. GlobalData's Pharma Intelligence Center forecasts global sales of $139m by 2031, a valuation that hinges on the outcome of the MARIO study and a subsequent label expansion. GlobalData is the parent company of Clinical Trials Arena. "Scynexis resumes dosing in Phase III MARIO study after lengthy delay" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
28-05-2025
- General
- Yahoo
🚨Jesús Angulo ruled out of the Mexico squad
This article was translated into English by Artificial Intelligence. You can read the original version in 🇪🇸 here. The Mexican National Team suffered a significant loss this Tuesday, as Jesús Angulo, defender for Tigres, will not be able to play in the friendlies against Switzerland and Turkey due to an injury. In a statement, the Tricolor detailed that the player experienced discomfort since joining the team, and after undergoing an MRI, a meniscopathy in the lateral meniscus of the right knee was diagnosed, along with a chondral injury. 🗒️ Jesús Angulo, jugador de @TigresOficial, causa baja de la convocatoria de nuestra Selección por lesió deseamos una pronta y completa recuperación. 🙌#PorMéxicoTodo — Selección Nacional (@miseleccionmx) May 28, 2025 Due to this situation, Tigres requested Angulo's return so that he can be directly evaluated by the club's medical staff. So far, it has not been announced who will take Angulo's place in Javier 'Vasco' Aguirre's call-up, which had already caused a stir with names like Guillermo Ochoa, Mateo Chávez, and the return of Hirving 'Chucky' Lozano. 📸 Luiza Moraes - 2025 Getty Images
Yahoo
28-05-2025
- General
- Yahoo
🚨Jesús Angulo ruled out of the Mexico squad
This article was translated into English by Artificial Intelligence. You can read the original version in 🇪🇸 here. The Mexican National Team suffered a significant loss this Tuesday, as Jesús Angulo, defender for Tigres, will not be able to play in the friendlies against Switzerland and Turkey due to an injury. Advertisement In a statement, the Tricolor detailed that the player experienced discomfort since joining the team, and after undergoing an MRI, a meniscopathy in the lateral meniscus of the right knee was diagnosed, along with a chondral injury. Due to this situation, Tigres requested Angulo's return so that he can be directly evaluated by the club's medical staff. So far, it has not been announced who will take Angulo's place in Javier 'Vasco' Aguirre's call-up, which had already caused a stir with names like Guillermo Ochoa, Mateo Chávez, and the return of Hirving 'Chucky' Lozano. 📸 Luiza Moraes - 2025 Getty Images
Hans India
20-05-2025
- Sport
- Hans India
Independiente, San Lorenzo reach last-four stage in Argentine title race
Buenos Aires: A second-half strike by Colombian defender Alvaro Angulo fired Independiente to a 1-0 away victory over Boca Juniors in the quarterfinals of Argentina's Primera Division Apertura tournament on Monday. Angulo broke the deadlock just after the hour at La Bombonera when he intercepted Carlos Palacios' clearance and darted into the box before thumping a left-footed drive into the far corner. Independiente controlled the match thereafter to set up a home semifinal clash against Huracán, reports Xinhua. "We knew that tonight we could make our fans immensely happy, and we gave our all to ensure that would happen," defender Kevin Lomonaco said after the match. "We have to enjoy this victory, and then we'll focus on trying to advance further." In Monday's other quarterfinal, Gaston Hernandez struck the decisive spot kick as San Lorenzo overcame hosts Argentinos Juniors 8-7 on penalties. Andres Vombergar had given the visitors a 69th-minute lead at Estadio Diego Armando Maradona, but Tomas Molina forced the match into a penalty shootout by heading home in the 95th minute. Both sides converted their first seven spot kicks before San Lorenzo goalkeeper Orlando Gill dived to his right to deny Maximiliano Romero with Argentinos Juniors' eighth attempt. Hernandez then sparked wild celebrations as he calmly slotted his shot into the top-right corner to set up a semifinal duel against the winner of Tuesday's clash between River Plate and Platense, which progressed to the last eight by overcoming Racing Club 1-0. River Plate advanced to the quarterfinals with a 3-0 home victory over Barracas Central. "To be one of four semifinalists in a competition like this is a significant achievement," San Lorenzo manager Miguel Russo said. "We are convinced that we can do it." The Apertura or "Opening" tournament of the Primera Division is half of Argentina's split-season format, which was reintroduced in 2025 after its last implementation in 2012. It runs from January to June and is followed by the Clausura or "Closing" tournament from July to December.
CNA
20-05-2025
- Sport
- CNA
Independiente beat Boca 1-0 to reach Apertura semi-finals
BUENOS AIRES :Independiente beat hosts Boca Juniors 1-0 in the quarter-finals of the Argentine Apertura tournament on Monday thanks to a second-half strike by defender Alvaro Angulo. Independiente, who will play Huracan for a spot in the final, struggled in the first half but came alive in the second with Angulo sealing the victory with a superb finish just after the hour-mark at La Bombonera. As Boca looked to make a quick break from an Independiente corner, the Colombian intercepted the ball and raced back into the box before slipping inside defender Ayrton Costa and firing high over the goalkeeper's head. Angulo had said before the game that he would score against Boca and was happy to deliver on that promise. "A promise is meant to be kept, right?" he told TNT Sports. "A beautiful goal (I heard) from my teammates, I didn't get to see it clearly in my own excitement." Boca had a goal ruled out for offside in the 15th minute and squandered a golden opportunity towards the end of the first half when Miguel Merentiel's whipped cross found Carlos Palacios all alone in front of goal but he somehow missed the tap-in. The introduction of Ander Herrera and Edinson Cavani in the second half did little to turn the tide for Boca as frustrated fans made their discontent clear. "There's a lot of pain... we had two top players from the bench but we couldn't pull it off," interim Boca coach Mariano Herron told reporters. Herron had replaced the sacked Fernando Gago last month and doubt surrounds his future after Boca failed to reach the final. "About the matches I coached, I take responsibility," he added. "I don't know if it's a failure, but I didn't achieve my objectives, which was to reach the June 1 final." Boca next face Atletico Tucuman in the Copa Argentina before starting their Club World Cup campaign in the United States. San Lorenzo also secured a semi-final spot after beating Argentinos Juniors 8-7 on penalties following a 1-1 draw on Monday. They will face the winner of the quarter-final between River Plate and Platense on Tuesday.
