TGR

Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma

Retrieved on: 
Wednesday, February 21, 2024
Orbis, Classification, PFS, European Commission, EMA, Traffic barrier, Progression-free survival, Confidence interval, Committee, Enzyme, MAA, Research and development, ASCO, Malignancy, Physician, FDA, PDUFA, Society, Glioma, TGR, Microsoft Access, Safety, INDIGO, Prognosis, Civil service commission, HR, CHMP, SNO, IDH, Patient, Medicine, BIRC, Public, Disease, Diagnosis, Mutation, Development, NDA, Priority review, Pharmaceutical industry

BOSTON and SURESNES, France, Feb. 21, 2024 /PRNewswire/ -- Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while the European Commission approval is anticipated in the second half of 2024.

Key Points: 
  • This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma.
  • If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers.
  • "In the realm of glioma treatment, innovation has been stagnant for nearly a quarter-century, posing challenges for patients who, post-surgery, may opt to defer treatment due to concerns around potential toxic side effects.
  • "This promising outcome brings hope to patients grappling with IDH-mutant diffuse gliomas, offering a potential breakthrough for those eagerly awaiting a new therapeutic option."

2024 GENESIS INVITATIONAL RETURNS TO THE RIVIERA COUNTRY CLUB AS PGA TOUR SIGNATURE EVENT

Retrieved on: 
Thursday, February 15, 2024
Bang & Olufsen, Los Angeles Open, Student, G70, Run, Golf, United States Soccer Federation, Genesis G80, Price action trading, TGR Foundation, Sport, Spectator, TGR, FedEx, Players, Electrification, PGA, STEAM, Pin, Athlete, Music, Partnership, Video game

Tournament commences February 15, 2024, at The Riviera Country Club in Pacific Palisades, Calif.

Key Points: 
  • Tournament commences February 15, 2024, at The Riviera Country Club in Pacific Palisades, Calif.
    PACIFIC PALISADES, Calif., Feb. 15, 2024 /PRNewswire/ -- Genesis enters its eighth consecutive year of partnership with the PGA TOUR, TGR Live, and TGR Foundation, title sponsoring the 2024 Genesis Invitational hosted by Tiger Woods at The Riviera Country Club.
  • "The Genesis Invitational represents a celebration of golf that brings together fans and athletes, providing them with an immersive experience based on Genesis' distinctly Korean values of elevated hospitality."
  • Tournament host Tiger Woods will make his 2024 PGA TOUR debut at The Genesis Invitational.
  • The Genesis Invitational was elevated once again this year as one of the eight PGA TOUR Signature Events for 2024.

Dakar Rookies Shine for TOYOTA GAZOO Racing

Retrieved on: 
Monday, January 22, 2024
History, Villiers, Toyota, Overalls, GTC, Puncture, Toyota Hilux, NRC, Toyota Gazoo Racing, Dust, Round 1, Dakar Rally, TGR

Toyota City, Japan, Jan 22, 2024 - (JCN Newswire) - The 2024 edition of the Dakar Rally brought mixed results for TOYOTA GAZOO Racing, but while some of the team's big names found the going particularly tough, it was the two rookie drivers who made their presence count.

Key Points: 
  • Toyota City, Japan, Jan 22, 2024 - (JCN Newswire) - The 2024 edition of the Dakar Rally brought mixed results for TOYOTA GAZOO Racing, but while some of the team's big names found the going particularly tough, it was the two rookie drivers who made their presence count.
  • This underscores TOYOTA GAZOO Racing South Africa (TGRSA)'s commitment to the development of motorsport in South Africa and proves that emerging talents have a clear path from the Junior Academy, through to SupaCup and GTC, and on to rally-raid racing, with the Dakar Rally as the ultimate goal.
  • This year, the TGR team fielded two rookies, in the form of Guy Botterill and Saood Variawa.
  • The two rookies were supported by veteran Dakar racer Giniel de Villiers and his co-driver, Dennis Murphy.

TOYOTA GAZOO Racing launches 2024 WRC challenge at iconic opener

Retrieved on: 
Friday, January 19, 2024
Power Stage, Team, Leg, Digne-les-Bains, Classification, Calendar, Season, WRC, Pressure, Monte Carlo Rally, FIA, WRC2, Principality, Ice, ERACE, Table tennis rubber, Special edition, Jan Solans, Snow, Col, Rallying, Motivation, TGR, Casino

Toyota City, Japan, Jan 19, 2024 - (JCN Newswire) - TOYOTA GAZOO Racing World Rally Team will target a successful start to the 2024 FIA World Rally Championship at the famous Rallye Monte-Carlo on January 25-28.

Key Points: 
  • Toyota City, Japan, Jan 19, 2024 - (JCN Newswire) - TOYOTA GAZOO Racing World Rally Team will target a successful start to the 2024 FIA World Rally Championship at the famous Rallye Monte-Carlo on January 25-28.
  • While the technical regulations remain stable, a radical change has been made to the WRC points system for 2024, aimed at enhancing the sporting spectacle on the final day of rallies.
  • Rallye Monte-Carlo is one of the trickiest rallies in terms of the conditions with difficult tyre choices, but we're up for the challenge."
  • Follow TOYOTA GAZOO Racing WRT:

Toyota: Evolved GR Yaris Makes World Premiere

Retrieved on: 
Friday, January 12, 2024
Tokyo Auto Salon, Toyota GR Yaris, TGR, Yaris, Super Taikyu Series, Akio Toyoda, 4WD, Rally Championship, Instrumentation

Toyota City, Japan, Jan 12, 2024 - (JCN Newswire) - TOYOTA GAZOO Racing (TGR) held the world premiere today of its evolved GR Yaris at Tokyo Auto Salon 2024*1.

Key Points: 
  • Toyota City, Japan, Jan 12, 2024 - (JCN Newswire) - TOYOTA GAZOO Racing (TGR) held the world premiere today of its evolved GR Yaris at Tokyo Auto Salon 2024*1.
  • Sales in Japan of the new GR Yaris are scheduled to start this spring through Toyota vehicle dealers nationwide.
  • The evolved GR Yaris (Japanese market specifications, prototype)
    TGR has continued to compete in various motorsports following the debut of the GR Yaris.
  • TGR intends to continue competing in races using the GR Yaris and evolving it with input from various drivers.

Jack's Bay Announces a Partnership with Latitude Builders

Retrieved on: 
Monday, January 8, 2024
Pink, TGR, PALM, Multimedia, Tiger Woods, Crump, Builder, Atlantic Club, Pink House, Jack's Bay, Foot

PALM BEACH GARDENS, Fla.and ELEUTHERA, Bahamas, Jan. 8, 2024 /PRNewswire-PRWeb/ -- Jack's Bay, a 1,200-acre private club community on the island of Eleuthera in The Bahamas, anchored by both an 18-hole Nicklaus Heritage™ championship course and a 10-hole Tiger Woods and TGR short course, today announces the launch and formation of Latitude Builders, the club's in-house builder and construction management partner. This collaborative effort between United States and Bahamian-based Island Builders and Jack's Bay Club will have a direct economic impact in Eleuthera creating 55-60 jobs for the area.

Key Points: 
  • Latitude Builders, a collaboration between Jack's Bay and Abaco-based Island Builders, will oversee in-house building and construction management in the community.
  • This collaborative effort between United States and Bahamian-based Island Builders and Jack's Bay Club will have a direct economic impact in Eleuthera creating 55-60 jobs for the area.
  • "We're confident Jack's Bay owners will work with us for the results, but they'll continue engaging Latitude for future projects because they enjoy our detailed process and the experience of working with our expert team," says Blue Crump, chief executive officer of Latitude Builders.
  • Whether Jack's Bay owners work directly with Latitude Builders for building their home, or their own builder, Latitude will provide full-service construction management to ensure compliance and the highest standards of quality.

TOYOTA GAZOO Racing and Lexus to Exhibit at Tokyo Auto Salon 2024

Retrieved on: 
Tuesday, December 26, 2023
TGR, Super Taikyu Series, WEC, AE86, Super GT, Toyota, SUPER, Makuhari Messe, Tokyo Auto Salon, Rally Championship, CP, FIA, Motorsport, Akio Toyoda, Carbon, WRC

Toyota City, Japan, Dec 26, 2023 - (JCN Newswire) - TOYOTA GAZOO Racing (TGR) and Lexus plan to exhibit at Tokyo Auto Salon 2024*1 to be held at Makuhari Messe (in Chiba City, Japan) for three days from January 12 to 14, 2024.

Key Points: 
  • Toyota City, Japan, Dec 26, 2023 - (JCN Newswire) - TOYOTA GAZOO Racing (TGR) and Lexus plan to exhibit at Tokyo Auto Salon 2024*1 to be held at Makuhari Messe (in Chiba City, Japan) for three days from January 12 to 14, 2024.
  • Displays are to be held under the banner of "Getting more passionate about cars with car lovers", and Toyota Motor Corporation Chairman Akio Toyoda, a.k.a.
  • The TGR and Lexus displays are to feature vehicles and parts under such themes as "Beloved cars", "Customization", and "Motorsports".
  • During the event, TGR and Lexus also plan to hold talk sessions featuring racing drivers and development engineers, as well as demo runs.

TOYOTA GAZOO Racing Presents new-look cars for WRC and WEC in 2024

Retrieved on: 
Tuesday, December 12, 2023
GR010, WEC, Hatred, TGR, Formula One, WRC, FIA, The Great Gazoo

Toyota City, Japan, Dec 12, 2023 - (JCN Newswire) - TOYOTA GAZOO Racing (TGR) has unveiled the new livery for the cars that will compete in the FIA World Rally Championship and FIA World Endurance Championship in the 2024 season.

Key Points: 
  • Toyota City, Japan, Dec 12, 2023 - (JCN Newswire) - TOYOTA GAZOO Racing (TGR) has unveiled the new livery for the cars that will compete in the FIA World Rally Championship and FIA World Endurance Championship in the 2024 season.
  • There are two concepts for the all-new matt black livery for the GR YARIS Rally1 HYBRID and the GR010 HYBRID, which compete in the respective FIA World Championships.
  • The other one is the "Prototype" which represents making ever-better motorsports-bred cars and to keep evolving.
  • The new livery will be used not only in the WRC and the WEC, but also in other competitions in which TOYOTA GAZOO Racing participates.

Dream 1-2-3 finish at home for TOYOTA GAZOO Racing

Retrieved on: 
Monday, November 20, 2023
Culture, TGR, Toyota Stadium, Aichi Prefecture, Rally Japan, WRC, Central Europe Rally

Toyota City, Japan, Nov 20, 2023 - (JCN Newswire) - TOYOTA GAZOO Racing World Rally Team has scored a dream 1-2-3 finish on home roads at Rally Japan to complete a season of success in style, Elfyn Evans claiming victory ahead of Sebastien Ogier and Kalle Rovanpera.

Key Points: 
  • Toyota City, Japan, Nov 20, 2023 - (JCN Newswire) - TOYOTA GAZOO Racing World Rally Team has scored a dream 1-2-3 finish on home roads at Rally Japan to complete a season of success in style, Elfyn Evans claiming victory ahead of Sebastien Ogier and Kalle Rovanpera.
  • He recovered to fifth overall by the finish, just 20s away from fourth.
  • The most impressive thing was that we were able to use Toyota Stadium as one of the special stages.
  • "This is a really fantastic way for us to end the season, with a 1-2-3 finish at home in Japan.

New Analyses from Pivotal Phase 3 INDIGO Study Reinforce Vorasidenib's Potential to Change the Treatment Paradigm for IDH-Mutant Diffuse Glioma

Retrieved on: 
Saturday, November 18, 2023
NDA, Glioma, Safety, TGR, Food, European Medicines Agency, Astrocytoma, Dana–Farber Cancer Institute, Progression-free survival, IDH2, Aes, Clinical trial, EMA, Data, Patient, Abstract, PFS, FDA, INDIGO, Division, Pembrolizumab, Merck, Neoplasm, IDH, IDH1, Growth, Merck & Co., Quality of life, Society, SNO, HIV disease progression rates, Medical imaging, Pharmaceutical industry, Laboratoires Servier

BOSTON, Nov. 18, 2023 /PRNewswire/ -- New data from Servier's clinical development program for vorasidenib in IDH-mutant diffuse glioma, presented at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO) in Vancouver, Canada, showed that vorasidenib reduced tumor growth as measured by a blinded independent radiology committee. Additional data from the INDIGO study being presented at SNO include health-related quality of life data, indicating patients receiving vorasidenib experience preservation of quality of life, stable neurocognitive function, and seizure control, as well as translational data demonstrating vorasidenib's efficacy across IDH-mutant diffuse gliomas with various additional mutations.

Key Points: 
  • We are honored and excited at the prospect of ushering in a new era of targeted treatment options for patients living with this devastating disease."
  • The safety lead-in was conducted to determine the recommended combination dose for the recently initiated perioperative phase of the study.
  • In this phase, approximately 60 patients will be randomized to the combination treatment, vorasidenib 40 mg once-daily alone, or no treatment prior to surgery.
  • KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.