Latest news with #Darmstadt
Yahoo
3 days ago
- Business
- Yahoo
China's Center for Drug Evaluation Accepts Merck KGaA, Darmstadt, Germany's Application for Marketing Authorization of Pimicotinib for Treatment of Tenosynovial Giant Cell Tumor
First global filing for potentially best-in-class TGCT treatment based on strong positive data from Phase 3 MANEUVER study Potential for pimicotinib to be first systemic TGCT therapy approved in China, following recent granting of Priority Review by CDE Additional applications planned in the US and other markets around the world Not intended for UK-based media DARMSTADT, Germany, June 10, 2025--(BUSINESS WIRE)--Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) officially accepted the company's application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with tenosynovial giant cell tumors (TGCT) requiring systemic treatment. The submission follows the granting of Priority Review to pimicotinib by the CDE in May for the treatment of patients with TGCT who require systemic therapy, which is expected to expedite the review process. Pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., also has been granted breakthrough therapy designation (BTD) by the NMPA. "With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country," said Hong Chow, Head of China and International, Healthcare business of Merck KGaA, Darmstadt, Germany. "Pimicotinib has demonstrated the ability to not only shrink tumors that affect their joints but also improve outcomes like mobility, pain and stiffness, highlighting its potential to be a best-in-class treatment for TGCT. In parallel, we are working to file a New Drug Application to the US Food and Drug Administration, with additional filings planned in other markets." TGCT is a locally aggressive and often recurring tumor of the joints that can cause high morbidity associated with swelling, pain, stiffness, and limited mobility of the affected joints, significantly impacting daily activities and quality of life in the primarily working-age population that it affects. If left untreated or in recurrent cases, TGCT can result in irreversible damage to the bone, joint and surrounding tissues. This highlights the need for well-tolerated and effective systemic treatments that can impact tumor growth while relieving the symptoms of the disease. The application is based on results from Part 1 of the global Phase 3 MANEUVER study, in which once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT, including improvements in active range of motion and physical function and reductions in stiffness and pain. The data were presented earlier this month at the 2025 ASCO Annual Meeting. About MANEUVERThe pivotal Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21). In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint is objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review in the intent-to-treat (ITT) population. Secondary endpoints include tumor volume score, active range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS). After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of dosing, results of which are expected in mid-2025. Patients who complete Part 2 may then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up. About Pimicotinib (ABSK021)Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib was recently granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with tenosynovial giant cell tumor (TGCT) who require systemic therapy. Pimicotinib has been granted breakthrough therapy designation (BTD) by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck KGaA, Darmstadt, Germany, holds worldwide commercialization rights for pimicotinib. Advancing the Future of Cancer CareAt Merck KGaA, Darmstadt, Germany, we strive every day to improve the futures of people living with cancer. Building on our 350-year global heritage as pharma pioneers, we are focusing our most promising science to target cancer's deepest vulnerabilities, pursuing differentiated molecules to strike cancer at its core. By developing new therapies that can help advance cancer care, we are determined to create a world where more cancer patients will become cancer survivors. Learn more at About Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck KGaA, Darmstadt, Germany, generated sales of € 21.2 billion in 65 countries. The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to to register for your online, change your selection or discontinue this service. View source version on Contacts Media Relations Phone: +1 (781) 427-4351 Investor Relations Phone: +49 6151 72-3321 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
BBC News
17-05-2025
- Entertainment
- BBC News
Eurovision 2025 Grand Final - How to watch on TV and BBC iPlayer and listen on Radio and BBC Sounds
The Eurovision Grand Final on Saturday 17 May sees 26 countries perform to be crowned the new Eurovision 2025 champion. Here's everything you need to know ahead of the big night... Eurovision 2025 on the BBC - Everything you need to know Watch Eurovision on BBC iPlayer and add to your Watchlist When is the Eurovision 2025 Grand Final? The Eurovision 2025 Grand Final is live from St Jakobshalle on iPlayer, BBC One, Radio 2 and BBC Sounds from 8pm on Saturday 16 May. Live Audio description and live signing is available on BBC iPlayer and the Red Button. Eurovision 2025 Presenters Hazel Brugger, Michelle Hunziker and Sandra Studer are your hosts for the Eurovision Song Contest 2025. All three present the Grand Final, while Hazel Brugger and Sandra Studer were also hosts for the Semi-Finals. Brugger is an award-winning stand-up comedian and presenter. Born in the USA, she grew up near Zurich and now lives in the Darmstadt region of Germany. Hunziker grew up in Ostermundigen near Bern and is one of Switzerland's best-known international personalities. Studer started her career in 1991 as Switzerland's Eurovision Song Contest participant. Performing with the stage name Sandra Simó, she secured 5th place with the song Canzone Per Te. Eurovision 2025 Grand Final Running Order Here's who you can expect to see on the Eurovision stage on Saturday night - and when! Norway | Kyle Alessandro – Lighter Luxembourg | Laura Thorn – La Poupée Monte Le Son Estonia | Tommy Cash – Espresso Macchiato Israel | Yuval Raphael – New Day Will Rise Lithuania | Katarsis – Tavo Akys Spain | Melody – ESA DIVA Ukraine | Ziferblat – Bird of Pray United Kingdom | Remember Monday – What The Hell Just Happened? Austria | JJ – Wasted Love Iceland | VÆB – RÓA Latvia | Tautumeitas – Bur Man Laimi Netherlands | Claude – C'est La Vie Finland | Erika Vikman – ICH KOMME Italy | Lucio Corsi | Volevo Essere Un Duro Poland | Justyna Steczkowska – GAJA Germany | Abor & Tynna – Baller Greece | Klavdia – Asteromáta Armenia | PARG – SURVIVOR Switzerland | Zoë Më – Voyage Malta | Miriana Conte – SERVING Portugal | NAPA – Deslocado Denmark | Sissal – Hallucination Sweden | KAJ – Bara Bada Bastu France | Louane – maman San Marino | Gabry Ponte – Tutta L'Italia Albania | Shkodra Elektronike – Zjerm UK Eurovision entry Remember Monday Remember Monday are representing the United Kingdom at the 69th Eurovision Song Contest in Basel, Switzerland in May 2025 with their song What The Hell Just Happened? Comprising of Charlotte, Holly and Lauren, Remember Monday are a trio of best friends, who have earned a reputation for their strong vocals and perfectly blended The Hell Just Happened? chronicles the aftermath of a fun night out with friends, it perfectly showcases the band's humour, relatability and their signature harmonies. The song, which is out now, is an upbeat pop track full of energy, excitement and drama. Remember Monday co-wrote the song with Billen Ted (Tom Hollings and Sam Brennan), Thomas Stengaard and Julie 'Kill J' Aagaard. More: Graham Norton and UK act Remember Monday talk drama and theatrics and tease Eurovision acts to watch out for UK Eurovision 2025 Commentators King of Eurovision, Graham Norton, returns to his role as BBC One commentator during the Grand Final of the world's biggest music competition on Saturday 17 May. Graham will oversee proceedings from the commentary box in the arena for audiences watching at home on iPlayer and BBC One while Scott Mills and Rylan will be guiding listeners through proceedings on BBC Radio 2 and BBC Sounds. Eurovision 2025 Presenters Due to unforeseen circumstances, unfortunately Ncuti Gatwa is no longer able to participate as Spokesperson during the Grand Final this weekend. However, we are delighted to confirm that BBC Radio 2's very own Friday night Kitchen Disco Diva Sophie Ellis-Bextor will be presenting the Jury result live from the UK. Sophie Ellis-Bextor says: 'I love Eurovision and it's a privilege to be part of 2025's Grand Final. What an honour it is to announce the UK's jury score on such a special show which always puts music front and centre. I am very much looking forward to delivering the iconic douze points from the United Kingdom!' Eurovision 2025 Voting The result of the 2025 Eurovision Song Contest will be determined by a combination of points from national juries and viewer votes in the participating countries, along with a separate Rest of The World vote. Each national jury is made up of a group of five music professionals in that country. After viewers have cast their votes, each national spokesperson from the 37 participating countries will present the points of their professional jury live to the world. After the presentation of the scores from the juries, the televoting points from all participating countries will be combined, providing one score for each song. These televoting results will then be announced by the hosts building towards a dramatic climax as the winner of Eurovision 2025 is announced. More details regarding the voting procedure and how you can get involved can be found at
BBC News
16-05-2025
- Entertainment
- BBC News
Eurovision 2025 Semi-Finals - How to watch on TV and BBC iPlayer and listen on Radio and BBC Sounds
The Eurovision Grand Final on Saturday 17 May sees 26 countries perform to be crowned the new Eurovision 2025 champion. Here's everything you need to know ahead of the big night... Eurovision 2025 on the BBC - Everything you need to know Watch Eurovision on BBC iPlayer and add to your Watchlist When is the Eurovision 2025 Grand Final? The Eurovision 2025 Grand Final is live from St Jakobshalle on iPlayer, BBC One, Radio 2 and BBC Sounds from 8pm on Saturday 16 May. Live Audio description and live signing is available on BBC iPlayer and the Red Button. Eurovision 2025 Presenters Hazel Brugger, Michelle Hunziker and Sandra Studer are your hosts for the Eurovision Song Contest 2025. All three present the Grand Final, while Hazel Brugger and Sandra Studer were also hosts for the Semi-Finals. Brugger is an award-winning stand-up comedian and presenter. Born in the USA, she grew up near Zurich and now lives in the Darmstadt region of Germany. Hunziker grew up in Ostermundigen near Bern and is one of Switzerland's best-known international personalities. Studer started her career in 1991 as Switzerland's Eurovision Song Contest participant. Performing with the stage name Sandra Simó, she secured 5th place with the song Canzone Per Te. Eurovision 2025 Grand Final Running Order Here's who you can expect to see on the Eurovision stage on Saturday night - and when! Norway | Kyle Alessandro – Lighter Luxembourg | Laura Thorn – La Poupée Monte Le Son Estonia | Tommy Cash – Espresso Macchiato Israel | Yuval Raphael – New Day Will Rise Lithuania | Katarsis – Tavo Akys Spain | Melody – ESA DIVA Ukraine | Ziferblat – Bird of Pray United Kingdom | Remember Monday – What The Hell Just Happened? Austria | JJ – Wasted Love Iceland | VÆB – RÓA Latvia | Tautumeitas – Bur Man Laimi Netherlands | Claude – C'est La Vie Finland | Erika Vikman – ICH KOMME Italy | Lucio Corsi | Volevo Essere Un Duro Poland | Justyna Steczkowska – GAJA Germany | Abor & Tynna – Baller Greece | Klavdia – Asteromáta Armenia | PARG – SURVIVOR Switzerland | Zoë Më – Voyage Malta | Miriana Conte – SERVING Portugal | NAPA – Deslocado Denmark | Sissal – Hallucination Sweden | KAJ – Bara Bada Bastu France | Louane – maman San Marino | Gabry Ponte – Tutta L'Italia Albania | Shkodra Elektronike – Zjerm UK Eurovision entry Remember Monday Remember Monday are representing the United Kingdom at the 69th Eurovision Song Contest in Basel, Switzerland in May 2025 with their song What The Hell Just Happened? Comprising of Charlotte, Holly and Lauren, Remember Monday are a trio of best friends, who have earned a reputation for their strong vocals and perfectly blended The Hell Just Happened? chronicles the aftermath of a fun night out with friends, it perfectly showcases the band's humour, relatability and their signature harmonies. The song, which is out now, is an upbeat pop track full of energy, excitement and drama. Remember Monday co-wrote the song with Billen Ted (Tom Hollings and Sam Brennan), Thomas Stengaard and Julie 'Kill J' Aagaard. More: Graham Norton and UK act Remember Monday talk drama and theatrics and tease Eurovision acts to watch out for UK Eurovision 2025 Commentators King of Eurovision, Graham Norton, returns to his role as BBC One commentator during the Grand Final of the world's biggest music competition on Saturday 17 May. Graham will oversee proceedings from the commentary box in the arena for audiences watching at home on iPlayer and BBC One while Scott Mills and Rylan will be guiding listeners through proceedings on BBC Radio 2 and BBC Sounds. Eurovision 2025 Presenters Due to unforeseen circumstances, unfortunately Ncuti Gatwa is no longer able to participate as Spokesperson during the Grand Final this weekend. However, we are delighted to confirm that BBC Radio 2's very own Friday night Kitchen Disco Diva Sophie Ellis-Bextor will be presenting the Jury result live from the UK. Sophie Ellis-Bextor says: 'I love Eurovision and it's a privilege to be part of 2025's Grand Final. What an honour it is to announce the UK's jury score on such a special show which always puts music front and centre. I am very much looking forward to delivering the iconic douze points from the United Kingdom!' Eurovision 2025 Voting The result of the 2025 Eurovision Song Contest will be determined by a combination of points from national juries and viewer votes in the participating countries, along with a separate Rest of The World vote. Each national jury is made up of a group of five music professionals in that country. After viewers have cast their votes, each national spokesperson from the 37 participating countries will present the points of their professional jury live to the world. After the presentation of the scores from the juries, the televoting points from all participating countries will be combined, providing one score for each song. These televoting results will then be announced by the hosts building towards a dramatic climax as the winner of Eurovision 2025 is announced. More details regarding the voting procedure and how you can get involved can be found at
BBC News
20-03-2025
- Sport
- BBC News
Farmers stumble but top European Cricket League
Jersey champions Farmers lost two of their three matches on Thursday but still all but secured qualification to the knockout stages of the European Cricket League in second, Farmers' day got off to a positive start as they chased down Darmstadt's score of 89-5 to beat them by nine wickets, scoring 91-1 in 4.1 were then beaten by seven wickets by fourth-placed Skanderborg, whose 86-3 score in 4.5 overs was enough to overcome a total of day in the sunshine ended when second bottom Voorburg managed to reach 66-3 in 4.5 overs after a modest total of 65-6 by Farmers. Julius Sumerauer led the way for Farmers against Darmstadt scoring 46 runs, and Zak Tribe was the highest scorer in the loss to Skanderborg, with defeat by Dutch side Voorburg was undoubtably the shock of the afternoon, as Farmers seemed well on course for victory after bowling out Cedric de Lange and Carl Mumba in quick 18-year-old bowler Toby Britton bowled five wides in the final over allowing Voorburg to get over the things stand, Farmers stay top of the European Cricket League with 14 points from six games, with other teams in the table still yet to complete all their fixtures following bad weather on Monday and Tuesday.
