Tag Archives: AstraZeneca

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

Positive Results from DESTINY-Breast06 Trial: Enhertu Shows Promise in HER2-Low and HER2-Ultralow Breast Cancer Patients

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu, a HER2-directed antibody drug conjugate (ADC), has demonstrated significant progress in treating HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. The high-level results from the DESTINY-Breast06 Phase … Read the full press release

AstraZeneca’s Truqap Receives EU Recommendation for ER-Positive Breast Cancer Treatment

(IN BRIEF) AstraZeneca’s Truqap, in combination with Faslodex, has received a positive recommendation from the European Medicines Agency (EMA) for treating estrogen receptor-positive, HER2‑negative locally advanced or metastatic breast cancer with specific genetic alterations. The recommendation follows promising results from … Read the full press release

AstraZeneca’s IMPACT CKD Model Forecasts Alarming Rise in Chronic Kidney Disease by 2032

(IN BRIEF) AstraZeneca’s IMPACT CKD model predicts a significant increase in chronic kidney disease (CKD) across eight countries, with up to 16.5% of the population affected by 2032, including a substantial rise in advanced-stage cases. Presented at the 2024 ISN … Read the full press release

AstraZeneca’s Imfinzi Shows Promising Results in Phase III Trial for Small Cell Lung Cancer

(IN BRIEF) AstraZeneca announces positive outcomes from the ADRIATIC Phase III trial, revealing that its immunotherapy drug Imfinzi (durvalumab) demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS) among patients with limited-stage small cell lung cancer (LS-SCLC) … Read the full press release

AstraZeneca and Daiichi Sankyo’s BLA for Datopotamab Deruxtecan Accepted by FDA for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been acknowledged by the US FDA for treating adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior systemic … Read the full press release

AstraZeneca and Sanofi’s Beyfortus Receives Approval in Japan for Prophylaxis against Respiratory Syncytial Virus

(IN BRIEF) AstraZeneca and Sanofi celebrate the approval of Beyfortus (nirsevimab) in Japan by the Ministry of Health, Labour, and Welfare for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in neonates, infants, and children entering … Read the full press release

AstraZeneca’s Truqap Gets Green Light in Japan for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca announces the approval of Truqap (capivasertib) in combination with Faslodex (fulvestrant) by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for treating adult patients with unresectable or recurrent hormone receptor-positive, HER2-negative breast cancer. The approval, based … Read the full press release

Ultomiris Receives FDA Approval as First Long-Acting Treatment for AQP4 Ab+ NMOSD, Redefining Patient Care

(IN BRIEF) Ultomiris (ravulizumab-cwvz) has gained approval from the FDA as the inaugural long-acting C5 complement inhibitor for treating adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The approval, based on the CHAMPION-NMOSD Phase III trial’s … Read the full press release

Patients as Partners® Europe Announces the Launch of 8th Annual Meeting with 2024 Keynotes and Topics

(IN BRIEF) The Conference Forum announced the launch of the 8th annual Patients as Partners® Europe meeting, scheduled for May 14-15, 2024, at Plaisterers’ Hall in London, England. This event brings together pharma R&D and patient advocacy to discuss patient … Read the full press release

What’s new in cancer care across Europe in early 2024 (1 Jan – 5 Mar 2024): Advancements, Innovations, Research, Awareness

(IN BRIEF) In early 2024, Europe’s medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for lung and breast cancer, and AstraZeneca’s Tagrisso for EGFR-mutated lung cancer. Diagnostic advancements … Read the full press release

EMA Validates Marketing Authorisation Applications for AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan in Lung and Breast Cancer Treatment

(IN BRIEF) The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for datopotamab deruxtecan (Dato-DXd), developed by AstraZeneca and Daiichi Sankyo, for the treatment of nonsquamous non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast … Read the full press release

Voydeya Recommended for EU Marketing Authorization as PNH Treatment Add-On

(IN BRIEF) Voydeya (danicopan), a first-in-class oral Factor D inhibitor, has been recommended for marketing authorization in the European Union (EU) as an add-on to ravulizumab or eculizumab for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience residual haemolytic … Read the full press release

AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan Moves Closer to Approval for Advanced NSCLC Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the FDA for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in patients who have undergone prior … Read the full press release

AstraZeneca’s Tagrisso Shows Promise in Phase III LAURA Trial for EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) demonstrates significant improvement in progression-free survival (PFS) for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) in the LAURA Phase III trial. The trial, led by Dr. Suresh Ramalingam, … Read the full press release

FDA Approves AstraZeneca’s Tagrisso Plus Chemotherapy for EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca’s Tagrisso receives FDA approval for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) following a Priority Review. The decision is based on FLAURA2 Phase III trial results demonstrating that Tagrisso plus … Read the full press release

Acoramidis Shows Positive Results in Japanese Trial for Treating Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

(IN BRIEF) In a Phase III trial conducted in Japan, acoramidis, an investigational treatment for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), demonstrated promising high-level results consistent with the global BridgeBio Pharma, Inc. ATTRibute-CM Phase III trial. The trial in Japan aimed to … Read the full press release

Japan Approves Voydeya (danicopan), an Innovative Treatment for Paroxysmal Nocturnal Haemoglobinuria (PNH)

(IN BRIEF) The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Voydeya (danicopan), a groundbreaking oral Factor D inhibitor, for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Voydeya is indicated in Japan for use in combination … Read the full press release

AstraZeneca Advances in Cell Therapy with Acquisition of Gracell Biotechnologies

(IN BRIEF) AstraZeneca has announced its definitive agreement to acquire Gracell Biotechnologies Inc. (NASDAQ: GRCL), a global biopharmaceutical company specializing in cell therapies for cancer and autoimmune diseases. This strategic move aims to bolster AstraZeneca’s presence in the field of … Read the full press release

AstraZeneca Showcases Hematology Advancements and Calquence’s Long-Term Efficacy at ASH Annual Meeting

(IN BRIEF) AstraZeneca is set to unveil promising data at the 65th American Society of Hematology (ASH) Annual Meeting, highlighting its expanding hematology pipeline and the enduring effectiveness of Calquence in treating chronic lymphocytic leukemia (CLL). The presentation includes six-year … Read the full press release

AstraZeneca Launches Evinova: Pioneering Digital Health Solutions for Global Healthcare Advancement

(IN BRIEF) AstraZeneca has introduced Evinova, a groundbreaking venture poised to become a leader in digital health solutions, catering to the needs of healthcare professionals, regulators, and patients. Backed by AstraZeneca and strategically collaborating with Parexel and Fortrea, Evinova is … Read the full press release

AstraZeneca’s Truqap Receives US FDA Approval for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has gained approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer possessing specific … Read the full press release

AstraZeneca’s Imfinzi Combination Therapy Shows Promise in Phase III Trial for Liver Cancer Treatment

(IN BRIEF) AstraZeneca has reported positive high-level results from the EMERALD-1 Phase III trial, demonstrating that its drug Imfinzi (durvalumab), in combination with transarterial chemoembolisation (TACE) and bevacizumab, significantly improves progression-free survival (PFS) in patients with hepatocellular carcinoma (HCC) eligible … Read the full press release

AstraZeneca Secures Exclusive License for ECC5004, Promising Oral GLP-1RA for Cardiometabolic Conditions

(IN BRIEF) AstraZeneca and Eccogene have signed an exclusive license agreement for ECC5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) designed for the treatment of obesity, type-2 diabetes, and other cardiometabolic conditions. Initial results from the Phase … Read the full press release

AstraZeneca Teams Up with Cellectis to Accelerate Gene Therapy Development

(IN BRIEF) AstraZeneca has entered into a collaboration and investment agreement with biotech firm Cellectis to fast-track the development of cutting-edge therapeutics in areas such as oncology, immunology, and rare diseases. This partnership will leverage Cellectis’ gene editing technologies and … Read the full press release

AstraZeneca’s FluMist Nasal Spray Moves Closer to FDA Approval for Self-Administration

(IN BRIEF) AstraZeneca’s Supplemental Biologics License Application (sBLA) seeking approval for a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray flu vaccine, has been accepted for review by the US Food and Drug Administration (FDA). If approved, … Read the full press release