Tag Archives: AstraZeneca

AstraZeneca Secures FDA Approval for Koselugo to Treat Adults with NF1 Plexiform Neurofibromas Following Positive Phase III KOMET Results

(IN BRIEF) AstraZeneca’s Alexion division has received FDA approval for Koselugo (selumetinib) to treat adults with NF1 who have symptomatic, inoperable plexiform neurofibromas. The decision is based on strong results from the Phase III KOMET trial, which showed a 20% … Read the full press release

SAP and Snowflake Partner to Unify Business and AI Data Clouds, Empowering Enterprises with Seamless Data Intelligence

(IN BRIEF) SAP SE and Snowflake have joined forces to integrate SAP Business Data Cloud with Snowflake’s AI Data Cloud, enabling enterprises to access and utilize semantically rich data seamlessly across both platforms. The collaboration introduces the SAP Snowflake solution … 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

Europe’s RNA Immunotherapy Enters a New Phase: Trials Scale Up, Deals Consolidate, and Regulators Move

Europe’s RNA immunotherapy sector is gaining speed with new in vivo CAR-T and mRNA vaccine trials. Germany approved the region’s first in vivo CAR-T study, marking regulatory progress. The UK’s Cancer Vaccine Launch Pad advances personalised mRNA cancer vaccine trials … Read the full press release

AstraZeneca Reports Positive Phase III Bax24 Results, Reinforcing Baxdrostat’s Potential as a Novel Treatment for Hard-to-Control Hypertension

(IN BRIEF) AstraZeneca reported positive Phase III Bax24 trial results showing that baxdrostat achieved a significant and clinically meaningful reduction in 24-hour ambulatory systolic blood pressure in patients with treatment-resistant hypertension. The once-daily oral therapy was well tolerated and maintained … Read the full press release

AstraZeneca and Daiichi Sankyo’s Enhertu-based regimen shows 44% risk reduction and over three-year PFS in HER2-positive metastatic breast cancer

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu plus pertuzumab has been accepted for Priority Review by the FDA for the first-line treatment of HER2-positive metastatic breast cancer. The application is supported by data from the … Read the full press release

Alfa Laval brings global industry and academia together in Lund for ESS Innovation Day 2025 on neutron science applications

(IN BRIEF) Alfa Laval is hosting ESS Innovation Day 2025 on 19 August in Lund, Sweden, an event that unites research directors from leading companies and universities to explore how neutron science from the European Spallation Source (ESS) can help … 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

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

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

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

Sanofi Begins Early Global Distribution of Beyfortus to Strengthen RSV Protection for 2025–2026 Season

(IN BRIEF) Sanofi has launched early global shipments of Beyfortus (nirsevimab) in anticipation of the 2025–2026 RSV season, enabling healthcare providers to begin immunizations well before the typical onset of infections in November. In collaboration with AstraZeneca, Sanofi has significantly … Read the full press release

AstraZeneca’s Calquence Combination Therapy Approved for Untreated CLL in Europe Following Positive AMPLIFY Phase III Results

(IN BRIEF) AstraZeneca’s Calquence, in combination with venetoclax, with or without obinutuzumab, has been approved by the European Commission for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). The approval follows the positive results from the … Read the full press release

AstraZeneca’s Imfinzi Plus BCG Induction and Maintenance Therapy Significantly Improves Disease-Free Survival in High-Risk Non-Muscle-Invasive Bladder Cancer

(IN BRIEF) The POTOMAC Phase III trial results show that adding Imfinzi to standard BCG induction and maintenance therapy improves disease-free survival (DFS) for patients with high-risk non-muscle-invasive bladder cancer (NMIBC). The combination demonstrated significant benefits over BCG alone, with … Read the full press release

AstraZeneca’s Breztri Aerosphere Shows Positive Phase III Results for Uncontrolled Asthma Treatment

(IN BRIEF) Positive results from the Phase III KALOS and LOGOS trials show that AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) significantly improves lung function in patients with uncontrolled asthma, compared to dual-combination ICS/LABA therapy. The trials demonstrate the potential of Breztri … Read the full press release

AstraZeneca Unveils Breakthrough Data on Vaccines and Antibody Therapies for Infections

(IN BRIEF) At ESCMID Global 2025 in Vienna, AstraZeneca will present a comprehensive data package from its Vaccines & Immune Therapies portfolio, featuring 13 abstracts across oral and poster presentations. The Company aims to demonstrate its progress in developing innovative … Read the full press release

MATTERHORN Trial Shows Perioperative Immunotherapy Significantly Enhances Survival in Gastric and GEJ Cancer Patients

(IN BRIEF) The MATTERHORN Phase III trial has demonstrated that a perioperative regimen combining AstraZeneca’s Imfinzi (durvalumab) with FLOT chemotherapy significantly improves event-free survival in patients with resectable gastric and gastroesophageal junction cancers compared to standard chemotherapy alone. Interim findings … Read the full press release

Patients as Partners® Europe Launches the 9th Annual Event with 2025 Keynotes, Featured Speakers and Topics

(IN BRIEF) The Conference Forum has announced the 9th annual Patients as Partners® Europe event, scheduled for May 20-21, 2025, at the Royal National Hotel in London. This event offers a platform for pharma R&D and patient advocacy to discuss … Read the full press release

AstraZeneca’s Imfinzi Recommended for EU Approval as Breakthrough Treatment for Limited-Stage Small Cell Lung Cancer

(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval as a monotherapy to treat limited-stage small cell lung cancer (LS-SCLC) in patients whose disease … Read the full press release

AstraZeneca’s Calquence Gains U.S. Approval for First-Line Treatment of Mantle Cell Lymphoma, Following Positive Phase III Results

(IN BRIEF) AstraZeneca’s Calquence (acalabrutinib) has been approved by the U.S. FDA for the first-line treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval is based on … Read the full press release