Roche Suffers Setback as Lung Drug Gets Mixed Result in Trial
The late-stage trials for astegolimab — the medicine being developed to treat chronic obstructive pulmonary disease, or COPD — offered contrasting results, according to a statement on Monday.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Santhera Secures Agreement with GEN for the Distribution of AGAMREE® (Vamorolone) in Türkiye
Pratteln, Switzerland, 13 August, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the signing of an exclusive agreement with Gen İlaç ve Sağlık Ürünleri San. ve Tic. A.Ş. (GEN) for the distribution and promotion of AGAMREE® (vamorolone) in Türkiye for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. Supply and sales by GEN are expected to start in the first half of 2026, initially on a named patient basis, followed by commercial sales. Santhera has received a small upfront payment and, as per previous agreements, will receive an ongoing percentage of net sales. Dario Eklund, Chief Executive Officer of Santhera, said: 'As leaders in the Turkish specialty pharmaceuticals market, GEN were a natural choice for Santhera as we looked for a high-quality distribution partner. We look forward to working closely in the run up to launching in the country in 2026, to provide access to the many DMD patients lacking suitable treatment options.' Abidin Gülmüş, Chairman/CEO of GEN, added: 'The potential for AGAMREE is clear, and we are determined to ensure this DMD therapy reaches patients in Türkiye without delay. We understand the rare disease market deeply, use our longtime experience on neuromuscular diseases and look forward to partnering with Santhera in the months and years ahead.' About AGAMREE® (vamorolone) AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. Moreover, it is not a substrate for the 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues [1-4]. This mechanism has shown the potential to 'dissociate' efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD [1-4]. In the pivotal VISION-DMD study, AGAMREE met the primary endpoint Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile [1, 4]. The most commonly reported side effects were cushingoid features, vomiting, weight increase and irritability. Side effects were generally of mild to moderate severity. Currently available data show that AGAMREE, unlike corticosteroids, has no restriction of growth [5] and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers [6]. ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. References:[1] Dang UJ et al. (2024) Neurology 2024;102:e208112. Link.[2] Guglieri M et al (2022). JAMA Neurol. 2022;79(10):1005-1014. doi:10.1001/jamaneurol.2022.2480. Link. [3] Liu X et al (2020). Proc Natl Acad Sci USA 117:24285-24293[4] Heier CR et al (2019). Life Science Alliance DOI: 10.26508[5] Ward et al., WMS 2022, FP.27 - Poster 71. Link.[6] Hasham et al., MDA 2022 Poster presentation. Link. About SantheraSanthera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular diseases with high unmet medical need. The Company has an exclusive license from ReveraGen for all indications worldwide to AGAMREE® (vamorolone), a dissociative steroid with novel mode of action, which was investigated in a pivotal study in patients with Duchenne muscular dystrophy (DMD) as an alternative to standard corticosteroids. AGAMREE for the treatment of DMD is approved in the U.S. by the Food and Drug Administration (FDA), in the EU by the European Medicines Agency (EMA), in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), in China by the National Medical Products Administration (NMPA) and Hong Kong by the Department of Health (DoH). Santhera has out-licensed rights to AGAMREE for North America to Catalyst Pharmaceuticals and for China and certain countries in Southeast Asia to Sperogenix Therapeutics. For further information, please visit AGAMREE® is a trademark of Santhera Pharmaceuticals. About GENGen İlaç ve Sağlık Ürünleri San. Ve Tic. A.Ş. (BIST: is Türkiye's leading specialty pharmaceutical company, focused on developing innovative therapies across multiple therapeutic areas including neurological and neuromuscular disorders (DMD, SMA, etc) since 1998. GEN manufactures high-quality, competitive products at its GMP-certified facility and pursues original drug development through two dedicated R&D centers and investments. For further information, please visit For further information please contact: SantheraCatherine Isted, Chief Financial Officer: IR@ ICR Healthcare Santhera@ GEN Deniz Karagulle, Chief Commercial Officer Bulutay Gunes, Sr. Head of Corporate Brand Ali Ketencioglu, Investor Relations Manager Disclaimer / Forward-looking statements This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements. # # # Attachment 250813 - Santhera Gen Ilac Turkey Distribution Agreement
Yahoo
5 hours ago
- Yahoo
Driving theory test to include CPR first aid questions
People sitting their driving theory test will soon need to swot up on life-saving cardiopulmonary resuscitation (CPR) skills, the UK's Driver and Vehicle Standards Agency (DVSA) has decided. All road users are being encouraged to learn the basics and know how to use a defibrillator in an emergency. It's hoped the questions, which will be added to the car and motorcycle theory test in early 2026, could prevent avoidable deaths. Drivers are often first on the scene when someone suffers a cardiac arrest, says the DVSA. Adding the information into the official learning materials means that the 2.4 million learner drivers who take their theory test each year will have a better understanding of the skills to use in an emergency, it says. Learning materials have already been updated with the new content, including questions such as "Who can use a public access defibrillator?" - the answer being "everyone". A defibrillator gives a jolt of energy to the heart, which can help get it beating normally. The devices are designed to be user-friendly, with clear instructions. If CPR is given and a defibrillator used within the first minutes of collapse, survival rates could be as high as 70%, evidence suggests. Without it, fewer than one in 10 survive. If someone is unconscious and not breathing normally, call 999 and start CPR straight away. This can be "hands-only" CPR to deliver timely chest compressions to get blood pumping. One of the new theory test questions is about the correct depth to push down. To carry out a chest compression, the NHS advises: kneel next to the person and place the heel of your hand on the breastbone at the centre of their chest. Place the palm of your other hand on top of the hand that's on their chest and interlock your fingers position yourself so your shoulders are directly above your hands using your body weight (not just your arms), press straight down by 5 to 6cm (2 to 2.5 inches) on their chest keeping your hands on their chest, release the compression and allow their chest to return to its original position repeat these compressions at a rate of 100 to 120 times a minute until an ambulance arrives or for as long as you can James Cant, chief executive of Resuscitation Council UK, said: "We're delighted to be working with the DVSA and other partners to introduce CPR and defibrillator awareness into the driving theory test. "By embedding these life-saving skills into such a widely taken assessment, we can help ensure that more people, from all communities, gain the knowledge and confidence to act during a cardiac arrest." 10,000 extra driving tests a month to clear backlog
Yahoo
5 hours ago
- Yahoo
DVSA announces major change to driving theory test from early 2026
The Driver and Vehicle Standards Agency (DVSA) has announced that learner drivers will start to see an update to the driving theory test from next year. Within the theory test, they will be quizzed on their CPR skills and how to use a defibrillator. The DVSA, which oversees driving tests in Britain, said motorists are often 'first on the scene' when someone suffers a cardiac arrest. Adding questions on CPR and defibrillators to the theory test from early next year means candidates will 'have a better understanding of the skills to use in an emergency', it added. DVSA to make change to theory driving test content More than 40,000 people in the UK suffer an out-of-hospital cardiac arrest each year, with fewer than one in 10 surviving. Research has found survival rates can be as high as 70% if CPR is given and a defibrillator is used within three to five minutes of collapse. DVSA chief driving examiner, Mark Winn, said: 'Part of being a safe and responsible driver is knowing what to do in an emergency – how to step in and make a real, life-saving difference. 'Learning CPR and how to use a defibrillator is a very simple skill, and adding this into the official learning resource is a great way for DVSA to support the drive to raise awareness.' The push for the change was led by Professor Len Nokes, chair of the Save a Life Cymru scheme, whose 24-year-old daughter Claire died in 2017 from complications following a cardiac arrest. He said: 'When Claire, my daughter, had her cardiac arrest, some knowledge of CPR might have made a difference. 'I don't want any other family to go through this experience. 'All of us in this partnership hope that by making CPR and how to use a defibrillator part of the theory test, we will be able to significantly increase the number of people who have this life-saving awareness.' James Cant, chief executive of charity Resuscitation Council UK, said: 'By embedding these life-saving skills into such a widely-taken assessment, we can help ensure that more people, from all communities, gain the knowledge and confidence to act during a cardiac arrest.' What does a driving theory test mean for learner drivers? Learners must pass the theory driving test before booking a practical test. Theory test candidates must get at least 43 out of 50 multiple-choice questions correct, covering areas such as road signs, traffic laws, vehicle safety and first aid. 10 obscure driving laws you may not know They must also pass a hazard perception video test with the theory examination. More than two million theory tests are taken each year, with a pass rate of about 45%. What is a defibrillator? The British Heart Foundation (BHF) explained: 'A defibrillator is a device that gives a jolt of energy to the heart. It helps get the heart beating again when someone is in cardiac arrest and their heart has stopped. 'You might also hear it being called a defib, a PAD (public access defibrillator) or an AED (automated external defibrillator).' The BHF added: 'Anyone can use a defibrillator. You do not need training. Once you turn it on, it will give clear step-by-step voice instructions. Recommended reading: Drivers over 70 face driving bans in UK under new rules shake-up Drivers warned new speed cameras can fine them for more than just speeding 'Safe' drivers warned of 'dangerous' mistake on UK motorways 'Many defibrillators also have visual prompts and images showing how to use it. 'The device checks the person's heart rhythm and will only tell you to give them a shock if it's needed. You cannot shock yourself or someone else accidentally.' What to do if someone is in cardiac arrest The BHF has shared some advice for what to do if you see someone in cardiac arrest: 'If someone is in cardiac arrest, call 999 and start CPR. If you're on your own, do not interrupt CPR to go and find a defibrillator. 'If it's possible, send someone else to find one. When you call 999, the operator can tell you if there's a public access defibrillator nearby.'
