Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Fresenius Medical Care Advances Precision Nephrology Through Hemodiafiltration and Artificial Intelligence Research

(IN BRIEF) Fresenius Medical Care will present multiple studies at ASN Kidney Week 2025, highlighting how hemodiafiltration (HDF) enhances clinical outcomes and how artificial intelligence is transforming kidney care. One of the featured oral presentations links HDF to a reduced … Read the full press release

New Distribution Agreement Between Brenntag and ArcticZymes Strengthens European Access to Advanced Enzymes for Biopharma Production

(IN BRIEF) Brenntag has signed an exclusive European distribution agreement with ArcticZymes AS for its line of salt-active nucleases—SAN HQ, SAN-HQ GMP, M-SAN HQ, and M-SAN HQ GMP—used in gene therapy, vaccine manufacturing, and bioprocessing. Signed during the CPHI fair … Read the full press release

BioNet Advances Pertussis Vaccine Agenda with EU-GMP Approval, Clinical Collaborations, and New Research Links

BioNet earns EU-GMP certification for its acellular pertussis vaccine, confirming compliance with EU manufacturing and quality standards. Inspection by Ireland’s HPRA supports EMA review of BioNet’s recombinant vaccine candidate VacPertagen. Partnerships expanding: MoU with Indonesia’s Bio Farma to accelerate TdaP … Read the full press release

European Commission Authorises AstraZeneca’s Koselugo for Adult Neurofibromatosis Type 1 Patients After Landmark KOMET Trial

(IN BRIEF) AstraZeneca’s Alexion has secured European Commission approval for Koselugo (selumetinib), the first targeted therapy available to adults with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PN). The approval is based on the KOMET Phase III trial, … Read the full press release

BioNet Achieves EU-GMP Certification for its Pertussis Vaccine

(IN BRIEF) BioNet has achieved European Union Good Manufacturing Practice (EU-GMP) certification, a key international standard that validates its facilities and processes for producing high-quality pharmaceuticals. This certification, granted after inspection by Ireland’s Health Products Regulatory Authority (HPRA), allows BioNet … Read the full press release

GSK Receives EMA Orphan Drug Designation for GSK’227 in Small-Cell Lung Cancer, Strengthening Its ADC Oncology Pipeline

(IN BRIEF) GSK announced that its B7-H3-targeted antibody-drug conjugate GSK5764227 (GSK’227) has been granted Orphan Drug Designation (ODD) by the European Medicines Agency (EMA) for the treatment of pulmonary neuroendocrine carcinoma, including small-cell lung cancer (SCLC). The designation is supported … Read the full press release

GSK Acquires Global License for Empirico’s Phase I siRNA Candidate EMP-012 Targeting Novel Inflammatory Pathway in COPD

(IN BRIEF) GSK has signed an exclusive global licensing agreement with Empirico Inc. for EMP-012, a first-in-class siRNA candidate currently in Phase I trials for chronic obstructive pulmonary disease (COPD). EMP-012 targets a distinct inflammatory pathway, offering potential therapeutic benefit … Read the full press release

Roche’s INShore Trial Shows Gazyva/Gazyvaro Significantly Improves Outcomes in Chronic Kidney Disease Compared With MMF

(IN BRIEF) Roche announced that its Phase III INShore trial evaluating Gazyva/Gazyvaro (obinutuzumab) in children and young adults with idiopathic nephrotic syndrome met its primary endpoint, showing superior sustained remission rates at one year compared to mycophenolate mofetil (MMF). The … Read the full press release

Novartis to Present Late-Breaking Phase III Data on Ianalumab and New CAR-T Insights at ACR 2025, Advancing Leadership in Autoimmune Disease Research

(IN BRIEF) Novartis will present new data from 27 abstracts at the 2025 American College of Rheumatology (ACR) Convergence, featuring late-breaking Phase III results from the NEPTUNUS-1 and NEPTUNUS-2 trials of ianalumab in Sjögren’s disease, which could become the first … Read the full press release

Novartis Advances RNA Medicine Strategy Through USD 12 Billion Acquisition of Avidity Biosciences and Its Late-Stage Neuromuscular Programs

(IN BRIEF) Novartis announced a definitive agreement to acquire Avidity Biosciences for USD 12 billion in cash, in a move that strengthens its neuroscience franchise and accelerates its xRNA therapeutic strategy. The acquisition brings Avidity’s late-stage programs in myotonic dystrophy … Read the full press release

Evotec Receives US$ 25 Million Milestone Payment from Bristol Myers Squibb for Progress in Neurodegenerative Disease Partnership

(IN BRIEF) Evotec SE announced it has received a US$ 25 million payment from Bristol Myers Squibb, marking progress in their joint neuroscience partnership focused on neurodegenerative diseases. The milestone payment will further advance the companies’ preclinical pipeline and research … Read the full press release

Strategic Collaboration Between Symrise and Cellibre to Drive Next-Generation Sustainable Ingredient Manufacturing

(IN BRIEF) Symrise has made a strategic equity investment in U.S.-based biotech firm Cellibre to drive innovation in sustainable biomanufacturing. The collaboration will accelerate the commercialization of natural flavor ingredients and cosmetic bioactives produced through precision fermentation. By combining Symrise’s … Read the full press release

Efdoralprin Alfa Meets All Endpoints in Sanofi’s Phase 2 Study, Paving Way for First Recombinant Therapy in AATD

(IN BRIEF) Sanofi’s investigational therapy efdoralprin alfa met all primary and key secondary endpoints in the Phase 2 ElevAATe study for alpha-1 antitrypsin deficiency emphysema, demonstrating superior efficacy compared to standard plasma-derived therapy. The results highlight its potential as the … Read the full press release

New Report Supported by Bayer Highlights Urgent Need for Allergy-Friendly Schools and Evidence-Based Treatment for Children

(IN BRIEF) A new expert-led publication in the European Medical Journal, supported by Bayer, highlights the growing global burden of allergic rhinitis (hay fever) among children. Affecting 20% of children worldwide, the condition is linked to reduced academic performance, poor … Read the full press release

SCHOTT Pharma debuts world’s first 5.5 ml prefillable staked-needle glass syringe, paving the way for next-generation biologic therapies at home

(IN BRIEF) SCHOTT Pharma has launched the industry’s first 5.5 ml prefillable staked-needle glass syringe, expanding its syriQ BioPure® platform to support biologic therapies designed for home administration. The syringe integrates seamlessly with Ypsomed’s YpsoMate® 5.5 ml autoinjector and Datwyler’s … Read the full press release

New RAMPART trial results show combination immunotherapy significantly improves disease-free survival in kidney cancer patients after surgery

(IN BRIEF) The Phase III RAMPART trial has demonstrated that combining the immunotherapy drugs durvalumab and tremelimumab after surgery significantly improves disease-free survival in patients with early-stage renal cell carcinoma (RCC). Led by the Medical Research Council Clinical Trials Unit … Read the full press release

New monarchE trial data shows long-term survival gains for high-risk early breast cancer patients receiving abemaciclib with hormone therapy

(IN BRIEF) Long-term data from the international monarchE trial has confirmed that patients with HR+ and HER2- node-positive high-risk early breast cancer achieve better survival outcomes when treated with the targeted therapy abemaciclib in combination with standard hormone therapy. Presented … Read the full press release

The Institute of Cancer Research highlights the vital role of statistics in shaping cancer breakthroughs for World Statistics Day 2025

(IN BRIEF) In recognition of World Statistics Day 2025, The Institute of Cancer Research (ICR), London, is spotlighting the essential role of statisticians in advancing cancer research through reliable, transparent, and responsible data analysis. The event, themed “Quality statistics and … Read the full press release

Cancer incidence increasing across age groups as ICR study identifies shared global risk patterns

(IN BRIEF) A new global analysis by The Institute of Cancer Research (ICR), London, has found that cancer incidence is rising in both younger and older adults, disputing the idea that the global increase is limited to those under 50. … Read the full press release

EDAP TMS Secures €36 Million Credit Facility from the European Investment Bank to Accelerate Global Growth and Innovation

(IN BRIEF) EDAP TMS SA has secured a €36 million credit facility from the European Investment Bank (EIB), supported by the European Commission’s InvestEU guarantee, to boost the global expansion of its Focal One® Robotic HIFU platform and fund new … Read the full press release