Category Archives: Pharma & Biotech

Pharma & Biotech Press Releases & News distributed via EuropaWire

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

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