Tag Archives: treatment

Ultomiris Receives FDA Approval as First Long-Acting Treatment for AQP4 Ab+ NMOSD, Redefining Patient Care

(IN BRIEF) Ultomiris (ravulizumab-cwvz) has gained approval from the FDA as the inaugural long-acting C5 complement inhibitor for treating adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The approval, based on the CHAMPION-NMOSD Phase III trial’s … Read the full press release

Boehringer Ingelheim and Sosei Heptares Forge Global Collaboration to Pioneer Precision Treatment for Schizophrenia

(IN BRIEF) Boehringer Ingelheim and Sosei Group Corporation (Sosei Heptares) have unveiled a global collaboration and exclusive option-to-license agreement aimed at advancing the development and commercialization of Sosei Heptares’ portfolio of first-in-class GPR52 agonists. The focus of this collaboration lies … Read the full press release

Voydeya Recommended for EU Marketing Authorization as PNH Treatment Add-On

(IN BRIEF) Voydeya (danicopan), a first-in-class oral Factor D inhibitor, has been recommended for marketing authorization in the European Union (EU) as an add-on to ravulizumab or eculizumab for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience residual haemolytic … Read the full press release

GSK’s Gepotidacin Shows Promise as Gonorrhoea Treatment: Positive Results from EAGLE-1 Trial

(IN BRIEF) GSK plc has announced positive headline results from the pivotal EAGLE-1 phase III trial for gepotidacin, an oral antibiotic aimed at treating uncomplicated urogenital gonorrhoea in adolescents and adults. The trial demonstrated gepotidacin’s non-inferiority compared to the current … Read the full press release

Boehringer Ingelheim’s Survodutide Shows Promising Results as Potential Best-in-Class Treatment for MASH in Phase II Trial

(IN BRIEF) Boehringer Ingelheim has reported compelling results from its Phase II trial of Survodutide, a novel glucagon/GLP-1 receptor dual agonist, indicating its potential to become a leading treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH). In the trial, up to 83.0% … Read the full press release

Acoramidis Shows Positive Results in Japanese Trial for Treating Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

(IN BRIEF) In a Phase III trial conducted in Japan, acoramidis, an investigational treatment for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), demonstrated promising high-level results consistent with the global BridgeBio Pharma, Inc. ATTRibute-CM Phase III trial. The trial in Japan aimed to … Read the full press release

GUSTO Trial Aims to Revolutionize Bladder Cancer Treatment with Genetic Tailoring

(IN BRIEF) A groundbreaking trial called GUSTO, led jointly by the University of Southampton, Sheffield Teaching Hospitals NHS Foundation Trust, and the University of Leeds, has been launched to potentially revolutionize bladder cancer treatment by matching therapies to the genetic … Read the full press release

Groundbreaking Treatment Tezepelumab Offers Hope to Severe Asthma Patients

(IN BRIEF) Researchers at the University of Leicester have developed a groundbreaking treatment for severe asthma using the monoclonal antibody tezepelumab. This monthly injection targets thymic stromal lymphopoietin (TSLP), a substance associated with inflammation in the airways of severe asthma … Read the full press release

ViiV Healthcare Receives Chinese Approval for Long-Acting HIV Treatment Vocabria and Rekambys

(IN BRIEF) ViiV Healthcare has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir) in combination with Rekambys (rilpivirine), marking the first complete long-acting HIV-1 injectable treatment in China. This approval allows people living with HIV in … Read the full press release

GSK’s ViiV Healthcare to Share Latest Advances in HIV Treatment and Prevention at EACS 2023

(IN BRIEF) ViiV Healthcare, a global specialist HIV company, will present 23 abstracts at the 19th Annual European AIDS Conference (EACS 2023). These abstracts will cover various aspects of HIV treatment and prevention, including real-world data on long-acting and 2-drug … Read the full press release

GSK’s Jemperli Receives Positive CHMP Opinion for Frontline Treatment of Advanced Endometrial Cancer with Chemotherapy

(IN BRIEF) GSK has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Jemperli (dostarlimab) in combination with chemotherapy as a frontline treatment for adult … Read the full press release

Alexion to Present Data Reinforcing Effectiveness of Ultomiris and Soliris in Treating Rare Neurological Disorder at ECTRIMS-ACTRIMS Meeting

(IN BRIEF) Alexion, a subsidiary of AstraZeneca Rare Disease, is set to present new data at the 9th Joint Meeting of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple … Read the full press release

Roche’s OCREVUS Subcutaneous Injection Shows Promise in Phase III Study for Multiple Sclerosis Treatment

(IN BRIEF) Roche has announced positive late-breaking data from the Phase III OCARINA II study, which demonstrates the effectiveness of OCREVUS as a twice-yearly, 10-minute subcutaneous injection for patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS). The … Read the full press release

Merck’s Evobrutinib Shows Long-Term Efficacy and Improved Quality of Life in Multiple Sclerosis Patients, Revealing Potential RMS Treatment Advancements

(IN BRIEF) Merck has presented new data on evobrutinib, an investigational BTK inhibitor, at the 9th Joint ECTRIMS-ACTRIMS congress. The data from an ongoing Phase II open-label extension study of evobrutinib in patients with relapsing multiple sclerosis (RMS) show sustained … Read the full press release

Sanofi’s ALTUVIIIO Granted Marketing Authorization in Japan for Hemophilia A Treatment

(IN BRIEF) The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for ALTUVIIIO, a novel factor VIII replacement therapy used to control bleeding in patients with hemophilia A. ALTUVIIIO, also known as efanesoctocog alfa, stands out … Read the full press release

Internet-Delivered Cognitive Behavioral Therapy Offers Cost-Effective Alternative for Depression and Anxiety Treatment, Study Finds

(IN BRIEF) A study conducted by the University of York, in collaboration with ieso Digital Health Ltd and Dorset HealthCare University NHS Trust, has found that internet-delivered cognitive behavioral therapy (CBT) offers greater cost-effectiveness and comparable clinical effectiveness compared to … Read the full press release

Switzerland’s First Proton Radiotherapy for Oesophageal Cancer Conducted in Landmark Clinical Trial

(IN BRIEF) The Paul Scherrer Institute (PSI) has administered proton radiotherapy to a 67-year-old patient with oesophageal cancer, marking the first time this treatment has been used in Switzerland for such a case. The treatment is part of a collaborative … Read the full press release

Multi-Omics Research Reveals Surprising Protein’s Role in Prostate Cancer Treatment Resistance

(IN BRIEF) Simon Linder, a PhD candidate, conducted multi-omics research to understand how tumor cells adapt to hormonal therapies in prostate cancer. Prostate cancer is hormone-dependent, and although hormonal therapy is initially effective, cancer cells eventually become resistant to it. … Read the full press release

AstraZeneca showcases potential of Imfinzi-based treatment for early-stage lung cancer

(IN BRIEF) AstraZeneca will showcase new data from its industry-leading Oncology pipeline and portfolio at the American Association for Cancer Research Annual Meeting. A total of 70 presentations will be given, including a plenary presentation on the AEGEAN Phase III … Read the full press release

Researchers discover new approach to treating brain hemorrhage with protein therapy

(IN BRIEF) Researchers from the Brain Repair laboratory at the University of Helsinki have investigated whether a protein called cerebral dopamine neurotrophic factor (CDNF) has potential as a treatment for intracerebral haemorrhage, a condition where bleeding into brain tissue causes … Read the full press release

Roche on Tecentriq’s US FDA Priority Review grant: New treatment options are urgently needed in early-stage non-small cell lung cancer

Application is being reviewed under the US FDA’s Real-Time Oncology Review pilot programme Based on results of the Phase III IMpower010 study, presented at ASCO, that showed adjuvant Tecentriq improved disease-free survival by more than one-third in PD-L1-positive early-stage lung cancer, compared with … Read the full press release

Roche’s Tecentriq in combination with Avastin receives FDA Breakthrough Therapy Designation as initial treatment for advanced or metastatic hepatocellular carcinoma

BASEL, 18-Jul-2018 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as an initial (first-line) treatment for people with advanced … Read the full press release

UK signs the European X-Ray Free-Electron Laser (XFEL) convention

The UK has today (Monday 19 March) signed the European X-Ray Free-Electron Laser (XFEL) convention in Berlin, Germany. UK signs agreement to work with other countries to create new medical treatments using a powerful laser super-strength laser acts like a microscope … Read the full press release

U.S. FDA designated Basilea Pharmaceutica’s isavuconazole as Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis

Basel, Switzerland, 11-12-2013 — /EuropaWire/ — Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis. QIDP status provides priority review and … Read the full press release

European Medicines Agency: Concerns have been raised in the media about certain stem cell therapy treatments

23-4-2013 — /europawire.eu/ — These sorts of new techniques potentially offer exciting possibilities to patients for the treatment of a range of difficult or previously untreatable conditions. Like all treatments, these techniques also come with benefits and risks. Specific rules were introduced … Read the full press release