Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

EQT Life Sciences Portfolio Company Amolyt Pharma Acquired by Alexion, AstraZeneca Rare Diseases for $1.05 Billion

(IN BRIEF) EQT Life Sciences announces the acquisition of its portfolio company, Amolyt Pharma, by Alexion, AstraZeneca Rare Diseases, for a total deal value of $1.05 billion. This acquisition underscores Amolyt’s significant advancements in developing novel treatments for rare endocrine … Read the full press release

Evonik Vland Biotech Launches Joint Venture to Enhance Animal Gut Health Solutions

(IN BRIEF) The joint venture, Evonik Vland Biotech, established by Evonik China and Shandong Vland Biotech, officially commenced operations in Binzhou, China, aiming to bolster the market presence of probiotics for livestock gut health in the Greater China region while … Read the full press release

Evonik’s EUDRAGIT® Polymers: Pioneering Pharmaceutical Innovation for 70 Years

(IN BRIEF) Evonik’s EUDRAGIT® polymers, renowned coatings for pharmaceuticals, celebrate 70 years of revolutionizing drug delivery. With over 23,000 patents and 10,000 scientific publications, these methacrylate polymers have become industry standards, employed in formulations for modified drug release across 80 … Read the full press release

Tubulis Secures €128 Million Series B2 Financing to Advance Novel ADC Pipeline for Cancer Treatment

(IN BRIEF) Tubulis has closed an oversubscribed €128 million ($138.8 million) Series B2 financing round, co-led by EQT Life Sciences and Nextech Invest Ltd, with participation from new and existing investors including Frazier Life Sciences and Deep Track Capital. The … Read the full press release

Health Canada Authorizes Probiotic Strain CLEPIUS™ for Alleviating Digestive Discomfort and Stress

(IN BRIEF) Health Canada has approved functional claims for Novonesis’ probiotic strain CLEPIUS™, acknowledging its efficacy in alleviating symptoms of irritable bowel syndrome (IBS) and improving quality of life in adults. The authorization encompasses a range of benefits, including relief … Read the full press release

Patients as Partners® Europe Announces the Launch of 8th Annual Meeting with 2024 Keynotes and Topics

(IN BRIEF) The Conference Forum announced the launch of the 8th annual Patients as Partners® Europe meeting, scheduled for May 14-15, 2024, at Plaisterers’ Hall in London, England. This event brings together pharma R&D and patient advocacy to discuss patient … Read the full press release

Breakthrough Study Shows Amlitelimab’s Long-lasting Effectiveness in Atopic Dermatitis Treatment

(IN BRIEF) In a groundbreaking Phase 2b study, amlitelimab demonstrates remarkable potential in maintaining treatment response for patients with moderate to severe atopic dermatitis (AD). Presented at the American Academy of Dermatology (AAD) 2024 Conference, the study reveals sustained improvement … 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

Continuity and Strategy: Fresenius Management SE Proactively Extends CFO Sara Hennicken’s Mandate

(IN BRIEF) Fresenius Management SE has extended Sara Hennicken’s term as Chief Financial Officer (CFO) until 2027, two years earlier than planned, to ensure continuity in advancing the #FutureFresenius strategy. Hennicken, who joined Fresenius in 2019, has been instrumental in … Read the full press release

FDA Gives Nod to Fresenius Kabi’s Tyenne®: A Dual-Format Tocilizumab Biosimilar Advancement

(IN BRIEF) Fresenius Kabi announces FDA approval of Tyenne® (tocilizumab-aazg), the first tocilizumab biosimilar offering both IV and subcutaneous formulations. This marks a significant milestone in the company’s growth strategy (#FutureFresenius) and expands treatment options for inflammatory, autoimmune diseases, and … Read the full press release

GSK Reports Positive Results from DREAMM-8 Phase III Trial of Blenrep in Multiple Myeloma Treatment

(IN BRIEF) GSK has announced encouraging findings from the interim analysis of the DREAMM-8 phase III trial evaluating Blenrep (belantamab mafodotin) in combination with pomalidomide plus dexamethasone (PomDex) compared to the standard of care, bortezomib plus PomDex, for relapsed or … Read the full press release

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

AI IN JAN 2024 ACROSS EUROPE: THE LATEST IN AI (ARTIFICIAL INTELLIGENCE) RESEARCH, DEPLOYMENTS, DEVELOPMENTS, DEALS, ETC.

(IN BRIEF) From Bonn to Bilbao, Europe’s AI scene is buzzing with innovation. Major players like Deutsche Telekom, Ericsson, and Volkswagen are pushing boundaries through groundbreaking partnerships and integrations. Projects like NextGen are personalizing therapies using AI, while collaborations between … Read the full press release

GSK’s Bepirovirsen Receives FDA Fast Track Designation for Chronic Hepatitis B Treatment

(IN BRIEF) GSK plc has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) targeting chronic hepatitis B (CHB). The Fast Track designation aims to expedite the development … 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

Novonesis: The New Force in Biosolutions Created by Novozymes and Chr. Hansen Merger

(IN BRIEF) Novonesis, the merger of Novozymes and Chr. Hansen, is now officially completed, solidifying its position as a global leader in biosolutions. With over 10,000 employees worldwide and expertise spanning 30 industries, Novonesis aims to provide biosolutions that benefit … Read the full press release

GSK’s Omjjara Receives EU Approval for Myelofibrosis Treatment

(IN BRIEF) GSK has received marketing authorization from the European Commission for Omjjara (momelotinib), an oral inhibitor targeting JAK1/JAK2 and activin A receptor type 1 (ACVR1). Omjjara is the first approved treatment in the EU for disease-related splenomegaly (enlarged spleen) … Read the full press release

GSK Seeks Regulatory Approval to Extend RSV Vaccination to At-Risk Adults Aged 50-59

(IN BRIEF) GSK has submitted a regulatory application to the European Medicines Agency (EMA) to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. The … Read the full press release

Leadership Changes Announced in Merck Family Board Elections

(IN BRIEF) E. Merck KG, representing the Merck family’s interests in Merck KGaA, has disclosed the results of its regular board elections. Johannes Baillou, with 30 years of board experience at E. Merck KG, has been elected as Chairman of … Read the full press release

Merck Launches Digital Hub in Singapore to Drive Healthcare and Semiconductor Innovation

(IN BRIEF) Merck, a leading science and technology company, has inaugurated the Merck Digital Hub in Singapore, its first digital hub outside of the US and Europe. Supported by the Singapore Economic Development Board (EDB), the hub aims to accelerate … Read the full press release

Sanofi’s Dupixent Receives FDA Approval for Pediatric Eosinophilic Esophagitis (EoE) Treatment

(IN BRIEF) The U.S. Food and Drug Administration (FDA) has granted approval for Dupixent® (dupilumab) to treat pediatric patients aged 1 to 11 years, weighing at least 15 kg, who suffer from eosinophilic esophagitis (EoE). Dupixent is now the first … Read the full press release