Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

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


(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

BioNTech and DualityBio Initiate Phase 3 Trial for HER2-Targeting ADC in Metastatic Breast Cancer

(IN BRIEF) BioNTech and Duality Biologics have announced the commencement of a pivotal Phase 3 trial for BNT323/DB-1303, a next-generation antibody-drug conjugate (ADC) targeting the Human Epidermal Growth Factor Receptor 2 (HER2) in metastatic breast cancer. The trial will enroll … Read the full press release

Japan Approves Voydeya (danicopan), an Innovative Treatment for Paroxysmal Nocturnal Haemoglobinuria (PNH)

(IN BRIEF) The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Voydeya (danicopan), a groundbreaking oral Factor D inhibitor, for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Voydeya is indicated in Japan for use in combination … Read the full press release

Basilea’s Antifungal Cresemba Sales in Latin America Trigger Milestone Payment from Partner Knight Therapeutics

(IN BRIEF) Basilea Pharmaceutica Ltd (SIX: BSLN) has announced that its partner Knight Therapeutics Inc. (TSX: GUD) exceeded the sales threshold for the antifungal Cresemba (isavuconazole) in Latin America in 2023, triggering the first sales milestone payment for the region. … Read the full press release

Boehringer Ingelheim Awarded ‘Global Top Employer’ for Fourth Consecutive Year, Recognized for Employee Development and Wellbeing Focus

(IN BRIEF) Boehringer Ingelheim has been honored by the Top Employers Institute with a “Global Top Employer” certification for the fourth consecutive year, distinguishing it as one of only 17 globally certified companies. The recognition is attributed to the company’s … Read the full press release

EQT Life Sciences and Gimv Lead €30M Series C Round for Onera Health to Advance Sleep Diagnostics

(IN BRIEF) Onera Health, a leader in sleep diagnostic and monitoring solutions, has successfully completed a €30 million ($32 million) Series C financing round. The funding was led by EQT Life Sciences and co-led by Gimv, with participation from existing … Read the full press release

Empa Researchers Develop Nanoparticle Soldering for Minimally Invasive Surgery

(IN BRIEF) Empa researchers have developed an innovative technique using nanoparticles for soldering wounds, potentially revolutionizing wound closure methods. This groundbreaking approach offers precise temperature control and can be applied in minimally invasive surgery. The nanoparticles enable gentle laser soldering, … Read the full press release

Basilea Pharmaceutica Acquires Novel Antibiotics Program Targeting Multidrug-Resistant Gram-Negative Bacteria

(IN BRIEF) Basilea Pharmaceutica Ltd (SIX: BSLN), a biopharmaceutical company specializing in severe bacterial and fungal infection treatments, has announced an asset purchase agreement with Spexis AG (SIX: SPEX) for a preclinical antibiotics program aimed at combating Gram-negative bacteria, including … Read the full press release

Evonik Honored with Cefic Responsible Care® Award for Sustainable Biosurfactants

(IN BRIEF) Evonik has been awarded the Responsible Care® Award by the European Chemical Industry Council (Cefic) in the “Safe and Sustainable Chemicals” category for its innovative glycolipid biosurfactants platform. The company’s glycolipid biosurfactants, developed using biotechnology, are recognized for … Read the full press release

Accenture Ventures Invests in QuantHealth to Accelerate AI-Powered Clinical Trial Design

(IN BRIEF) Accenture has announced a strategic investment through Accenture Ventures in QuantHealth, an AI-powered clinical trial design company specializing in cloud-based simulations for pharmaceutical and biotech companies. Using AI technology trained on extensive patient data and clinical trial information, … Read the full press release

Global Life Sciences M&A Surges to $191 Billion in 2023, Driven by Big Pharma’s Big Deals

(IN BRIEF) The global life sciences industry has witnessed a resurgence in mergers and acquisitions (M&A) activity, with investments totaling $191 billion by December 10, 2023, compared to $142 billion in 2022. Although the number of completed deals decreased, the … Read the full press release

Merck KGaA Partners with Inspirna to Advance Novel Therapy for RAS-mutated Colorectal Cancer

(IN BRIEF) Merck KGaA, Darmstadt, Germany, has entered into a licensing agreement with Inspirna, Inc. for ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, and SLC6A8-targeting follow-on compounds, currently under Phase II evaluation for the second-line … Read the full press release

Novo Nordisk Initiates Groundbreaking Collaborations for Innovative Obesity and MASH Treatments

(IN BRIEF) Novo Nordisk has announced separate research collaborations with Omega Therapeutics and Cellarity Inc. to explore innovative treatment approaches for obesity and MASH (Metabolic Associated Fatty Liver Disease). The collaboration with Omega aims to develop an epigenomic controller to … Read the full press release

QIAGEN Expands Presence in Middle East with New Riyadh HQ, MoU with Saudi Ministry of Health, and Oman TB Screening Initiative

(IN BRIEF) QIAGEN, a leading provider of molecular diagnostics and life sciences solutions, is significantly expanding its operations in the Middle East region. In early 2024, the company will open its regional headquarters in Riyadh, Saudi Arabia, to strengthen its … Read the full press release

AstraZeneca Advances in Cell Therapy with Acquisition of Gracell Biotechnologies

(IN BRIEF) AstraZeneca has announced its definitive agreement to acquire Gracell Biotechnologies Inc. (NASDAQ: GRCL), a global biopharmaceutical company specializing in cell therapies for cancer and autoimmune diseases. This strategic move aims to bolster AstraZeneca’s presence in the field of … Read the full press release

Sanofi Ceases Development of Tusamitamab Ravtansine for NSCLC after Trial Misses Primary Endpoint

(IN BRIEF) Sanofi has announced the discontinuation of the global clinical development program for tusamitamab ravtansine, following an interim analysis of the Phase 3 CARMEN-LC03 trial. The trial assessed tusamitamab ravtansine as a monotherapy in previously treated metastatic non-squamous non-small … Read the full press release

Cancer Treatment Advances: FDA Recognizes Breakthrough Potential of BNT323/DB-1303 for Endometrial Cancer

(IN BRIEF) BioNTech and Duality Biologics have received Breakthrough Therapy designation from the FDA for their antibody-drug conjugate (ADC) candidate, BNT323/DB-1303. The designation is for the treatment of advanced endometrial cancer in patients who have progressed following immune checkpoint inhibitor … Read the full press release

Roche’s Xolair Nears FDA Approval for Reducing Allergic Reactions to Multiple Foods

(IN BRIEF) Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) under Priority Review. The sBLA is for the reduction of allergic reactions, including anaphylaxis, caused by … Read the full press release

Almirall S.A. to Participate in 42nd Annual J.P. Morgan Healthcare Conference

(IN BRIEF) Almirall S.A., a global pharmaceutical company specializing in medical dermatology, has confirmed its involvement in the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, taking place from January 8th to 11th, 2024. Carlos Gallardo, Chairman and CEO … Read the full press release

BioNTech Inaugurates mRNA Vaccine Manufacturing Site in Rwanda, Aims to Boost Vaccine Equity in Africa

(IN BRIEF) BioNTech has achieved a significant milestone in expanding mRNA vaccine manufacturing in Africa with the inauguration of its Kigali site, which includes the first manufacturing unit known as BioNTainer. This move is part of BioNTech’s broader efforts to … Read the full press release

GSK’s Dostarlimab Shows Positive Results in Endometrial Cancer Trial

(IN BRIEF) GSK plc has announced positive results from Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial, evaluating the use of Jemperli (dostarlimab) in combination with standard chemotherapy and as maintenance therapy for patients with primary advanced or recurrent endometrial … Read the full press release

EMA and HMAs Announce 2028 Workplan to Harness Artificial Intelligence in Medicines Regulation

(IN BRIEF) The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMAs) have jointly released a comprehensive Artificial Intelligence (AI) workplan outlining their collaborative strategy through 2028. This initiative aims to maximize the benefits of AI for stakeholders … Read the full press release