Tag Archives: AstraZeneca

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

FDA Grants Priority Review for AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan for EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release

AstraZeneca’s Imfinzi Granted Priority Review by FDA for Groundbreaking Perioperative Immunotherapy in Bladder Cancer

(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has been granted Priority Review by the FDA for the treatment of muscle-invasive bladder cancer (MIBC), potentially becoming the first perioperative immunotherapy in this curative-intent setting. Supported by results from the NIAGARA Phase III trial, … Read the full press release

AstraZeneca’s Tagrisso Receives EU Recommendation as First Targeted Therapy for Unresectable EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the EU for treating adult patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) with EGFR mutations who have not experienced disease progression after platinum-based chemoradiation therapy. This … Read the full press release

Tezspire Shows Promise in Reducing Nasal Polyp Symptoms in Phase III Trial for Chronic Rhinosinusitis

(IN BRIEF) A Phase III trial of Tezspire (tezepelumab) by AstraZeneca and Amgen has shown significant benefits for patients with chronic rhinosinusitis with nasal polyps (CRSwNP), reducing both nasal polyp size and congestion compared to a placebo. The WAYPOINT trial … Read the full press release

AstraZeneca’s Fasenra Approved in EU for Treating Rare Vasculitis, Offering New Hope for EGPA Patients

(IN BRIEF) AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union as an add-on treatment for adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare and severe form of vasculitis. The approval follows positive results from the MANDARA Phase … Read the full press release

Wainzua Receives EU Recommendation for Treating Hereditary Amyloidosis, Offering New Monthly Self-Administered Option

(IN BRIEF) AstraZeneca and Ionis’ drug Wainzua (eplontersen) has been recommended for approval in the European Union for treating hereditary transthyretin-mediated amyloidosis (ATTRv-PN) in adults with stage 1 or 2 polyneuropathy. Based on the positive results from the NEURO-TTRansform Phase … Read the full press release

AstraZeneca Presents New Data at IDWeek 2024, Showcasing Progress in Respiratory Disease Prevention and Vaccine Innovation

(IN BRIEF) AstraZeneca presented significant advancements in the prevention of infectious diseases at IDWeek 2024, showcasing its dedication to addressing respiratory infections caused by RSV, hMPV, and COVID-19. The company revealed promising data across its portfolio, including Beyfortus, an antibody … Read the full press release

Enhertu by AstraZeneca and Daiichi Sankyo Approved in China as First HER2-Directed Therapy for Metastatic Lung Cancer

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China for the treatment of patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations who have previously undergone systemic … Read the full press release

Early Success: AstraZeneca’s Airsupra Proves Highly Effective in Reducing Severe Asthma Risks in Phase III Trial

(IN BRIEF) AstraZeneca’s inhaled rescue medication, Airsupra (albuterol/budesonide), has shown significant efficacy in reducing the risk of severe asthma exacerbations in patients with intermittent or mild persistent asthma, according to high-level results from the BATURA Phase IIIb trial. The trial … Read the full press release

AstraZeneca and Daiichi Sankyo’s Enhertu Receives Priority Review for HER2-Low and Ultralow Breast Cancer Patients Pre-Chemotherapy

(IN BRIEF) AstraZeneca and Daiichi Sankyo announced that their drug Enhertu (trastuzumab deruxtecan) has been granted Priority Review by the US FDA for treating patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer who have previously undergone endocrine therapy. … Read the full press release

FluMist Becomes First At-Home Self-Administered Flu Vaccine Approved by FDA

(IN BRIEF) FluMist, a needle-free nasal spray influenza vaccine, has been approved by the FDA for self-administration in the US, making it the first flu vaccine of its kind to be used at home. Adults up to 49 years old … Read the full press release

FDA Approves AstraZeneca’s Fasenra for Eosinophilic Granulomatosis with Polyangiitis, Offering New Hope for Patients

(IN BRIEF) AstraZeneca’s Fasenra (benralizumab) has been approved by the US FDA for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated vasculitis that can be fatal without treatment. The approval is based on results from the MANDARA … Read the full press release

AstraZeneca Pioneers Low-Impact Inhalers with Eco-Friendly Breztri Transition

(IN BRIEF) AstraZeneca has completed clinical studies to transition Breztri, its inhaled treatment for COPD, to a next-generation propellant with 99.9% lower Global Warming Potential. This change aligns with AstraZeneca’s commitment to reducing its environmental impact through its Ambition Zero … Read the full press release

AstraZeneca to Present Key Cancer Research Breakthroughs at WCLC and ESMO 2024

(IN BRIEF) AstraZeneca will present significant cancer research at the 2024 World Conference on Lung Cancer (WCLC) and the European Society for Medical Oncology (ESMO) Congress. Highlights include new data on the effectiveness of Imfinzi in bladder cancer, a novel … Read the full press release

Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu has received conditional approval in China for treating locally advanced or metastatic HER2-positive gastric cancer, following promising results from the DESTINY-Gastric06 trial. This marks the third approval for Enhertu in China in less … Read the full press release

AstraZeneca Unveils Groundbreaking Advances in Cancer Care at ASCO 2024

(IN BRIEF) AstraZeneca is set to revolutionize cancer care with a slew of groundbreaking data presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting. Over 100 abstracts will showcase 25 approved and potential new medicines, including two late-breaking … Read the full press release

AstraZeneca Completes Equity Investment in Cellectis for Cell and Gene Therapy Development

(IN BRIEF) AstraZeneca has finalized its equity investment with Cellectis, a clinical-stage biotechnology firm, following a successful research collaboration agreement announced in November 2023. This partnership aims to harness Cellectis’ gene editing technologies to design up to 10 novel cell … Read the full press release