Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Sanofi moves to buy Vicebio in a $1.15 billion deal, adding a Molecular Clamp platform and an RSV–hMPV combo vaccine to its respiratory arsenal

(IN BRIEF) Sanofi has agreed to acquire UK-based Vicebio for $1.15 billion upfront plus up to $450 million in milestones, with closing anticipated in Q4 2025. The deal adds an early-stage bivalent RSV/hMPV vaccine (VXB‑241, in Phase 1 for older adults) and … Read the full press release

Final FLAURA2 Results Confirm Survival Advantage of Tagrisso Plus Chemotherapy in Advanced EGFRm Lung Cancer

(IN BRIEF) Final overall survival results from AstraZeneca’s FLAURA2 Phase III trial confirm that combining Tagrisso with chemotherapy significantly improves survival for patients with first-line advanced EGFR-mutated NSCLC. The data reinforce Tagrisso as the foundational therapy in this setting, building … Read the full press release

Sanofi Finalizes Blueprint Medicines Deal Adding Ayvakit and Robust SM Pipeline

(IN BRIEF) Sanofi has completed its purchase of Blueprint Medicines, acquiring the approved systemic mastocytosis therapy Ayvakit/Ayvakyt (avapritinib), along with two pipeline candidates: elenestinib (a KIT D816V inhibitor in Phase 2/3 HARBOR, NCT04910685) and BLU‑808 (a wild‑type KIT inhibitor). The $129.00‑per‑share … Read the full press release

EIB Provides €20 Million to Solynta to Fund Disease‑Resistant True Potato Seed Technology

(IN BRIEF) The EIB has extended a €20 million venture debt facility to Solynta, a Dutch biotech firm specializing in true potato seeds, under the InvestEU initiative. This funding will accelerate Solynta’s hybrid breeding research, which replaces bulky, perishable tubers with … Read the full press release

Mukul Mehta to Succeed Harry Kirsch as Novartis CFO in March 2026 After Distinguished 22‑Year Career

(IN BRIEF) Novartis has appointed Mukul Mehta as CFO and Executive Committee member effective March 16, 2026. He will replace long‑time CFO Harry Kirsch, who retires on March 15, 2026, after 22 years at the company. Kirsch oversaw major strategic … Read the full press release

Boehringer Ingelheim and LEO Pharma Join Forces to Globalize SPEVIGO® Treatment for Generalized Pustular Psoriasis (GPP)

(IN BRIEF) Boehringer Ingelheim and LEO Pharma have agreed on a global license and transfer deal for SPEVIGO® (spesolimab), an antibody that blocks the IL‑36 receptor to treat generalized pustular psoriasis (GPP). LEO Pharma will assume worldwide commercialization and clinical development, harnessing … Read the full press release

Bayer and M2i Expand Exclusive Pheromone Gel Distribution to Asia-Pacific, Latin America and the US

(IN BRIEF) Bayer and M2i Group have extended their distribution partnership to cover Asia-Pacific, Latin America, and the United States, following a successful 2023 agreement in Europe and Africa. This exclusive deal will enable Bayer to market M2i’s pheromone gel … Read the full press release

Fresenius Kabi’s Portugal Plant Becomes First to Earn BSI Kitemark for AMR-Safe Ceftriaxone Production

(IN BRIEF) Fresenius Kabi’s Santiago de Besteiros plant in Portugal has secured BSI Kitemark™ Certification for Minimized Risk of AMR in its Ceftriaxone production, confirming compliance with the AMR Industry Alliance’s Antibiotic Manufacturing Standard. Key measures include stringent controls to … Read the full press release

EIB Provides €150 Million to Fuel Alfasigma’s 2025–2027 R&D in Specialty and Rare-Disease Medicines

(IN BRIEF) The EIB has extended a €150 million loan to Alfasigma to fund its R&D efforts from 2025 to 2027, targeting new drugs in gastroenterology, hepatology, vascular medicine, rheumatology, and rare diseases. The financing, endorsed by EIB Vice-President Gelsomina … Read the full press release

BARDA Invests Additional USD 39 Million to Accelerate Phase 3 Trials of Basilea’s Fosmanogepix and BAL2062

(IN BRIEF) Basilea Pharmaceutica has secured an extra USD 39 million from BARDA under its Other Transaction Agreement, bringing potential non-dilutive funding to USD 268 million over 12 years. This new tranche will finance the ongoing phase 3 trial of … Read the full press release

Boehringer Ingelheim Launches Phase II Trial of Oral BI 1815368 to Treat Diabetic Macular Edema

(IN BRIEF) Boehringer Ingelheim has initiated the THULITE Phase II trial (NCT06962839) to assess BI 1815368, a novel oral agent for diabetic macular edema (DME). Affecting more than 21 million people globally, DME is typically managed by frequent eye injections, … Read the full press release

Aortic Aneurysms: EU-funded Pandora Project Brings In-Silico Modelling to Aid Surgeons

A European collaboration developing predictive tools to personalise aortic surgery, enhance prosthesis selection, and support clinical decision-making (IN BRIEF) PANDORA is an EU-funded collaboration uniting LivGemini, RBF Morph, INSA and UnivREN—alongside Rennes University Hospital—to create patient-specific “digital twins” of the … Read the full press release

Imfinzi Regimen Cuts Recurrence Risk by a Third and Boosts Two-Year Survival in Bladder Cancer

(IN BRIEF) The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) combined with gemcitabine and cisplatin as neoadjuvant therapy, followed by Imfinzi adjuvant monotherapy, for adults with resectable muscle-invasive bladder cancer. This approval is anchored in NIAGARA Phase III trial data … Read the full press release

Roche Announces Retirement of pRED Head Hans Clevers and Communications Leader Barbara Schädler

(IN BRIEF) Roche has revealed that Dr. Hans Clevers, Head of Pharma Research and Early Development and board member since 2019, will retire from his pRED role at the end of August, though he will continue leading the Institute of … Read the full press release

FDA Grants Orphan Status to Sanofi’s Riliprubart for Preventing and Treating Transplant Rejection

(IN BRIEF) The FDA has awarded orphan drug designation to Sanofi’s riliprubart for the treatment of antibody-mediated rejection in solid organ transplants, highlighting the therapy’s potential in an area lacking approved options. Riliprubart, a humanized IgG4 antibody targeting activated C1s … Read the full press release

Roche Reports Zero Treatment-Requiring Bleeds with NXT007 in Phase I/II Haemophilia A Study

(IN BRIEF) Roche presented positive phase I/II data for NXT007, its Chugai-engineered bispecific antibody for haemophilia A, at the 2025 ISTH Congress. In the NXTAGE study’s highest-dose cohorts (B-3 and B-4), none of the 30 participants experienced bleeds requiring treatment, … Read the full press release

GSK Submits Linerixibat for European Approval to Treat Debilitating PBC Pruritus

(IN BRIEF) GSK’s marketing authorisation application for linerixibat, an investigational ileal bile acid transporter inhibitor, has been accepted for review by the European Medicines Agency. The submission is supported by GLISTEN Phase III trial data showing that linerixibat rapidly and … Read the full press release

EMA Committee Recommends Approval of Sarclisa-VRd Induction in Newly Diagnosed Multiple Myeloma Patients Eligible for Transplant

(IN BRIEF) The CHMP has recommended EU approval of Sarclisa alongside VRd for transplant-eligible NDMM, based on GMMG-HD7 trial results showing superior MRD negativity and PFS compared to VRd alone. This potential label extension would mark Sarclisa’s fourth EU approval … Read the full press release

Neoclease Wins Merck’s 2025 Biotech Grant for AI-Powered Gene Therapies Targeting Parkinson’s and Genetic Disorders

(IN BRIEF) Merck has awarded its 2025 North American Advance Biotech Grant to Neoclease, a Boston-based startup developing AI-designed gene-editing therapies for Parkinson’s disease and other monogenic disorders. Neoclease will benefit from Merck’s technologies, contract testing, regulatory guidance, and hands-on … Read the full press release

University of Copenhagen Develops CRISPR-Based Method to Identify Hereditary Cancer Risk Before Symptoms Appear

(IN BRIEF) The University of Copenhagen, in collaboration with Rigshospitalet, has introduced a clinically validated gene-editing method to identify harmful inherited mutations that raise cancer risk. Developed at the university’s Biotech Research and Innovation Center, the CRISPR-Select technique allows scientists … Read the full press release