Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Novo Nordisk Hosts Capital Markets Day to Share Progress on Strategic Aspirations 2025

(IN BRIEF) Novo Nordisk is conducting a Capital Markets Day (CMD) to provide updates on its Strategic Aspirations 2025. The event will focus on various aspects, including corporate strategy, sustainability, research and development pipeline, and financial performance. Highlights include discussions … Read the full press release

Biotech Acceleration: Evotec and Claris Ventures Unite to Propel Portfolio Companies Forward

(IN BRIEF) Evotec and Claris Ventures have formed a strategic partnership to accelerate the progress of biotech ventures in Claris’s portfolio into clinical trials. This collaboration allows Claris’s portfolio companies, focused on biotech ventures nearing clinical trials, streamlined access to … Read the full press release

Novo Nordisk’s Semaglutide Shows Promise in Kidney Outcomes Trial FLOW

(IN BRIEF) Novo Nordisk has announced promising headline results from the kidney outcomes trial FLOW, which compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard care for people with type 2 diabetes and chronic kidney disease (CKD). … Read the full press release

What’s new in cancer care across Europe in early 2024 (1 Jan – 5 Mar 2024): Advancements, Innovations, Research, Awareness

(IN BRIEF) In early 2024, Europe’s medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for lung and breast cancer, and AstraZeneca’s Tagrisso for EGFR-mutated lung cancer. Diagnostic advancements … Read the full press release

EMA Validates Marketing Authorisation Applications for AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan in Lung and Breast Cancer Treatment

(IN BRIEF) The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for datopotamab deruxtecan (Dato-DXd), developed by AstraZeneca and Daiichi Sankyo, for the treatment of nonsquamous non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast … Read the full press release

Novartis Unveils Promising Results from SMART Study: Zolgensma’s Efficacy Confirmed in Older and Heavier SMA Patients

(IN BRIEF) Novartis has presented compelling data from the SMART study, reinforcing the clinical advantages of Zolgensma® (onasemnogene abeparvovec) in treating spinal muscular atrophy (SMA) patients weighing ≥ 8.5 kg to ≤ 21 kg, with a mean age of 4.69 … Read the full press release

Eckert & Ziegler’s GalliaPharm® Generator Powers Groundbreaking Cancer Diagnostic Trial in Japan

(IN BRIEF) Eckert & Ziegler, in collaboration with Novartis Pharma K.K., is expanding Ga-68 labeled diagnostics in Japan through a clinical trial approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Utilizing Eckert & Ziegler’s GalliaPharm® generator, the trial … 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

Revolutionizing Skincare: Evonik Invests in Jland Biotech to Launch Vegan Collagen

(IN BRIEF) Evonik has partnered with Jland Biotech to introduce vegan collagen for cosmetic and personal care applications. Through an investment from Evonik’s Venture Capital group, the collaboration aims to meet the rising demand for sustainable collagen solutions in skincare. … Read the full press release

Novo Nordisk Announces Annual General Meeting Date and Proposals for Board Re-election

(IN BRIEF) Novo Nordisk A/S has announced the date for its Annual General Meeting, scheduled for Thursday, March 21, 2024, at 14:00 CET. The meeting will be held partially electronically, allowing shareholders to participate either in person at Bella Center … Read the full press release

Evonik to Introduce New Class of rPEG Lipids for Enhanced Immunogenicity in Drug Delivery

(IN BRIEF) Evonik has partnered with the University of Mainz to commercialize a new class of polyethylene glycols (PEGs) called randomized polyethylene glycols (rPEGs). These rPEGs will be integrated into Evonik’s specialized lipid platform for drug delivery in nucleic acid-based … Read the full press release

AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan Moves Closer to Approval for Advanced NSCLC Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the FDA for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in patients who have undergone prior … Read the full press release

AstraZeneca’s Tagrisso Shows Promise in Phase III LAURA Trial for EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) demonstrates significant improvement in progression-free survival (PFS) for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) in the LAURA Phase III trial. The trial, led by Dr. Suresh Ramalingam, … Read the full press release

FDA Approves AstraZeneca’s Tagrisso Plus Chemotherapy for EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca’s Tagrisso receives FDA approval for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) following a Priority Review. The decision is based on FLAURA2 Phase III trial results demonstrating that Tagrisso plus … Read the full press release

Almirall Achieves Robust Growth in Dermatology Sector, Expands Pipeline with Licensing Agreement

(IN BRIEF) Almirall, a leading biopharmaceutical company specializing in medical dermatology, has reported its full-year 2023 financial results, showcasing a 4% year-on-year growth in net sales driven by the strong performance of its European Dermatology business. The company’s total EBITDA … Read the full press release

Almirall Secures Global Rights for Promising Dermatological Treatment, NN-8828, Targeting IL-21

(IN BRIEF) Almirall S.A., a leading pharmaceutical company specializing in medical dermatology, has finalized an exclusive license agreement with Novo Nordisk for the development and commercialization of NN-8828, an IL-21 blocking monoclonal antibody. This innovative treatment holds potential for various … Read the full press release

Dupixent® Receives Landmark Approval in Japan for Chronic Spontaneous Urticaria Treatment

(IN BRIEF) Japan’s Ministry of Health, Labor and Welfare (MHLW) has authorized the marketing and manufacturing of Dupixent® (dupilumab) for treating chronic spontaneous urticaria (CSU) in patients aged 12 years and older. This approval marks a significant milestone as Japan … Read the full press release

GSK Expands Respiratory Biologics Portfolio with Aiolos Bio Acquisition

(IN BRIEF) GSK plc has finalized the acquisition of Aiolos Bio, bolstering its respiratory biologics portfolio with AIO-001, a promising long-acting anti-TSLP monoclonal antibody for treating asthma. AIO-001, set to enter phase II clinical trials, targets severe asthma patients with … Read the full press release