Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

Sandoz Partners with Elawan Energy on 150 MW Spanish Solar Project to Power Nearly 90% of European Operations

(IN BRIEF) Sandoz has signed a 10-year virtual PPA with Elawan Energy to develop 150 MW of new solar capacity in Valladolid, Spain, expected to meet almost 90% of electricity demand for its European operations. This partnership is a key … Read the full press release

Novartis Phase III Trials Show Ianalumab Significantly Improves Outcomes in Sjögren’s Disease

(IN BRIEF) Novartis has reported landmark Phase III results showing that ianalumab significantly reduced disease activity in patients with Sjögren’s disease, meeting primary endpoints in both the NEPTUNUS-1 and NEPTUNUS-2 trials. The treatment, which combines B-cell depletion and BAFF-R inhibition, … Read the full press release

SCHOTT Pharma Sets New Standard with ISO-Compliant Ready-to-Use Polymer Cartridge for Biologics

IN BRIEF) SCHOTT Pharma has introduced the SCHOTT TOPPAC® cartridge, the first ready-to-use polymer cartridge to meet ISO dimensions, offering exceptional dimensional precision and broad device compatibility for injection systems such as pens. Made from COC and designed for sensitive … Read the full press release

WACKER and Gearbox Biosciences Unite to Launch Antibiotic-Free, High-Throughput pDNA Manufacturing Platform

(IN BRIEF) WACKER and Gearbox Biosciences have launched a partnership to co-develop advanced, antibiotic-free pDNA manufacturing techniques aimed at improving scalability, efficiency, and cost-effectiveness. Leveraging WACKER’s GMP biologics know-how and Gearbox’s Pop-Out-Plasmid® technology, the project will focus on streamlining workflows … Read the full press release

New Isotope Fingerprinting Technique Flags Counterfeit Medicines by Factory Origin

(IN BRIEF) A collaborative study by the University of Copenhagen and Stanford University has revealed that pharmaceuticals possess unique isotopic signatures—based on stable isotopes of carbon, hydrogen and oxygen—that correspond to their manufacturing conditions. By profiling these δ²H, δ¹³C and … Read the full press release

Sanofi Acquires Vigil Neuroscience to Advance VG-3927 Alzheimer’s Program and Expand Neurodegeneration Research

(IN BRIEF) Sanofi has finalized its takeover of Vigil Neuroscience for roughly $470 million, acquiring all outstanding shares at $8 each and issuing a $2-per-share CVR tied to VG-3927’s first commercial sale. This deal, following Sanofi’s June 2024 strategic investment, … Read the full press release

Almirall and Absci Advance AI Drug Discovery with Second Dermatology Target Selection

(IN BRIEF) Almirall and Absci have expanded their AI-based drug discovery collaboration by selecting a second dermatological target, following the initial success of AI-designed antibody leads against a difficult-to-drug protein. Their partnership, active since November 2023, leverages Absci’s Integrated Drug … Read the full press release

Fresenius Kabi Secures Global Rights to PB016 Vedolizumab Biosimilar from Polpharma Biologics

(IN BRIEF) Fresenius Kabi has licensed rights from Polpharma Biologics to commercialize the vedolizumab biosimilar candidate PB016 globally—except in the Middle East and North Africa—once approved. Vedolizumab treats Crohn’s disease and ulcerative colitis, and PB016 references Takeda’s Entyvio®. The transaction … Read the full press release

BioLabs|TUM: Munich’s New Biotech Launchpad Backed by TUM, BioLabs, and Lilly

(IN BRIEF) BioLabs | TUM is a new biotech incubator in Munich, created through a partnership between TUM Venture Labs, BioLabs, and Eli Lilly. Opening in early 2026 within an 1,800 m² refurbished building, the hub will host 15–20 early‑stage companies, providing fully equipped labs, … Read the full press release

Bayer Seeks EU Approval for Icafolin‑Methyl, Agriculture’s First New Herbicide Mode in 30 Years

(IN BRIEF) Bayer has filed for EU approval of icafolin‑methyl, its first new herbicide mode of action in over 30 years, after earlier submissions in Brazil, the U.S., and Canada. With peak sales estimated at €750 million, icafolin‑methyl is slated for … Read the full press release

Basilea Launches FORWARD‑IM Phase 3 Trial of Fosmanogepix in Invasive Mold Infections

(IN BRIEF) Basilea Pharmaceutica has initiated FORWARD‑IM, a global Phase 3 trial evaluating fosmanogepix in adults with invasive mold infections. Building on positive Phase 1 and Phase 2 results—and following the FAST‑IC Phase 3 candidemia trial—this open‑label study will randomize about 160 patients to … Read the full press release

FDA Grants Priority Review to Imfinzi for First‑Ever Perioperative Immunotherapy in Resectable Gastric and GEJ Cancer

(IN BRIEF) The FDA has accepted AstraZeneca’s sBLA for Imfinzi as a perioperative immunotherapy regimen in resectable early‑stage and locally advanced gastric and GEJ cancers, granting Priority Review with a decision expected in Q4 2025. The application leverages MATTERHORN Phase III data … Read the full press release

Trontinemab Brainshuttle Study Achieves 91 Percent Amyloid Clearance and Sets Stage for 2025 Phase III Rollout

(IN BRIEF) Roche’s ongoing Phase Ib/IIa Brainshuttle™ AD study of trontinemab shows that 91 percent of participants reach amyloid PET negativity, with ARIA‑E rates under 5 percent. The company has outlined Phase III TRONTIER 1 and 2 trials in early symptomatic Alzheimer’s for 2025, plus a planned … Read the full press release

GSK and Hengrui Pharma Sign Strategic $12 Billion Deal to Advance Up to 12 Innovative Therapeutics

(IN BRIEF) GSK has entered into a multi-programme development and licensing agreement with Hengrui Pharma to advance up to 12 innovative therapies, including HRS-9821, a potentially best-in-class PDE3/4 inhibitor currently in clinical trials for COPD. The deal includes $500 million … Read the full press release

EMA Recommends Approval of Pfizer-BioNTech’s LP.8.1 COVID-19 Vaccine for Broad Use in EU

(IN BRIEF) Pfizer and BioNTech have received a positive recommendation from the EMA’s CHMP for their LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY® LP.8.1, for individuals aged six months and older. This updated vaccine offers improved immune protection against prevalent SARS-CoV-2 subvariants, … Read the full press release

EMA Supports AstraZeneca’s Eco-Friendly Trixeo Aerosphere for COPD with Ultra-Low Emission Propellant

(IN BRIEF) AstraZeneca’s Trixeo Aerosphere has received a positive opinion from the EMA’s CHMP for use with a new propellant that offers a 99.9% reduction in Global Warming Potential compared to traditional formulations. Trixeo becomes the first pressurised metered-dose inhaler … Read the full press release

CHMP Recommends Expanding Novo Nordisk’s Alhemo® Access to Broader Haemophilia Population Without Inhibitors

(IN BRIEF) Novo Nordisk has received a positive opinion from the European Medicines Agency’s CHMP recommending label expansion for Alhemo® (concizumab) to include adolescents and adults with haemophilia A and B without inhibitors. Backed by robust data from the explorer8 … Read the full press release

Sanofi Gains EU Approval for Sarclisa in First-Line Treatment of Transplant-Eligible Multiple Myeloma

(IN BRIEF) Sanofi has secured European Commission approval for Sarclisa in combination with VRd as an induction treatment for newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant. The decision was based on part one of the GMMG-HD7 … Read the full press release

European Commission approves Conexxence and Bomyntra denosumab biosimilars from Fresenius Kabi for all reference indications, boosting access and the #FutureFresenius Biopharma agenda

(IN BRIEF) The European Commission has approved Fresenius Kabi’s denosumab biosimilars, Conexxence® and Bomyntra®, for all uses of the originator product. These include osteoporosis treatment for postmenopausal women and at-risk men, mitigation of treatment-related bone loss, prevention of skeletal complications … Read the full press release

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