Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

AstraZeneca and Sanofi’s Beyfortus Receives Approval in Japan for Prophylaxis against Respiratory Syncytial Virus

(IN BRIEF) AstraZeneca and Sanofi celebrate the approval of Beyfortus (nirsevimab) in Japan by the Ministry of Health, Labour, and Welfare for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in neonates, infants, and children entering … Read the full press release

AstraZeneca’s Truqap Gets Green Light in Japan for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca announces the approval of Truqap (capivasertib) in combination with Faslodex (fulvestrant) by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for treating adult patients with unresectable or recurrent hormone receptor-positive, HER2-negative breast cancer. The approval, based … Read the full press release

Merck Expands M LabTM Collaboration Center in Shanghai, Enhancing Biopharmaceutical Capabilities

(IN BRIEF) Merck, a prominent science and technology company, announces a €14 million expansion of its M LabTM Collaboration Center in Shanghai, bolstering its support for the biopharmaceutical industry in China. The expansion includes new facilities such as a biology … Read the full press release

Mubadala Acquires KELIX bio, Expanding Access to Life-Saving Pharmaceuticals in Emerging Markets

(IN BRIEF) DPI, BII, and the EBRD have reached a binding agreement to fully exit their investment in KELIX bio, a pan-African biopharmaceutical platform, through its acquisition by Mubadala Investment Company. Founded in 2020, KELIX bio has rapidly grown to … Read the full press release

Novo Nordisk Acquires Cardior Pharmaceuticals in Billion-Euro Deal, Pioneering RNA Therapies for Heart Diseases

(IN BRIEF) EQT Life Sciences proudly announces Novo Nordisk’s acquisition of Cardior Pharmaceuticals, valuing the biopharmaceutical company at up to EUR 1.025 billion. Based in Hannover, Germany, Cardior specializes in RNA-based therapeutics for cardiovascular diseases, focusing initially on heart failure. … Read the full press release

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

Novartis’ Fabhalta Receives Positive CHMP Opinion for PNH Treatment: A Potential Game-Changer

(IN BRIEF) Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorization for Fabhalta® (iptacopan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who … Read the full press release

Evotec-Backed Breakpoint Therapeutics Nominates Breakthrough Cancer Treatment Candidate BTX-011 for Clinical Development

(IN BRIEF) Breakpoint Therapeutics GmbH, a company focused on developing drugs targeting the DNA Damage Response (DDR), has nominated its first preclinical development candidate, BTX-011, an inhibitor of polymerase theta (Pol θ / POLQ), for the treatment of solid tumors. … Read the full press release

Evonik Receives Second Consecutive Asia-Pacific Bioprocessing Excellence Award for Cell Culture Solutions

(IN BRIEF) Evonik has been honored with the Asia-Pacific Bioprocessing Excellence Award (ABEA) for the second consecutive year, specifically in the category of Best New Bioprocessing Supplier Award: Upstream Processing, for its Cell Culture Solutions portfolio. As a crucial component … Read the full press release

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