Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis AstraZeneca’s inhaled anti-inflammatory rescue medication AIRSUPRA demonstrated significant benefit compared to albuterol WILMINGTON, Del. / Oct 07, 2024 / Business Wire / Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s AIRSUPRA ® (albuterol/budesonide) met the primary... Read More

Based on ECHO Phase III trial which demonstrated CALQUENCE combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy Submission to be reviewed under Project Orbis WILMINGTON, Del. / Oct 03, 2024 / Business Wire / AstraZeneca’s supplemental New Drug Application (sNDA) for CALQUENCE ® (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment... Read More

Based on DESTINY-Breast06 Phase III trial which demonstrated a statistically significant and clinically meaningful progression-free survival benefit for ENHERTU If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU will be the first HER2 directed therapy and ADC for patients prior to receiving chemotherapy for metastatic breast cancer ENHERTU also granted Breakthrough Therapy Designation in the US for this patient population... Read More

Based on LAURA Phase III trial results which showed TAGRISSO extended median progression-free survival by more than three years WILMINGTON, Del. / Sep 26, 2024 / Business Wire / AstraZeneca’s TAGRISSO ® (osimertinib) ​ has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed... Read More

Survival results for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in TROPION-Breast01 did not achieve statistical significance versus chemotherapy Trial previously met the dual primary endpoint of progression-free survival WILMINGTON, Del. / Sep 23, 2024 / Business Wire / High-level results from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) compared to investigator’s choice of... Read More

Only influenza vaccine approved for self- or caregiver-administration at home, expanding options for influenza protection WILMINGTON, Del. / Sep 20, 2024 / Business Wire / FLUMIST ® has been approved in the US as the only self-administered influenza vaccine. FLUMIST, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years... Read More

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids WILMINGTON, Del. / Sep 18, 2024 / Business Wire / AstraZeneca’s FASENRA ® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 1 EGPA is a rare, immune-mediated vasculitis that can... Read More

Longest survival follow-up ever reported for a Phase III immunotherapy trial in this setting WILMINGTON, Del. / Sep 16, 2024 / Business Wire / Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) plus IMJUDO ® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who... Read More

First immunotherapy regimen before and after surgery to demonstrate statistically significant and clinically meaningful overall survival improvement in this setting WILMINGTON, Del. / Sep 15, 2024 / Business Wire / Positive results from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the... Read More

AstraZeneca and Daiichi Sankyo’s ENHERTU achieved 61.6% progression-free survival rate at one year in patients with active or stable brain metastases in DESTINY-Breast12 Largest prospective trial of ENHERTU in this patient population WILMINGTON, Del. / Sep 13, 2024 / Business Wire / Results from the DESTINY-Breast12 Phase IIIb/IV trial showed that ENHERTU ® (fam-trastuzumab deruxtecan-nxki) demonstrated substantial overall... Read More

TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population Presidential Symposium for NeoCOAST-2 demonstrates potential for datopotamab deruxtecan plus IMFINZI ® (durvalumab) and chemotherapy in neoadjuvant early-stage non-small cell lung cancer WILMINGTON, Del. / Sep 09, 2024 /... Read More

AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan demonstrated meaningfully greater magnitude of progression-free survival benefit in patients with this biomarker AstraZeneca and Roche Tissue Diagnostics are collaborating to co-develop and commercialize the TROP2-QCS biomarker companion diagnostic WILMINGTON, Del. / Sep 08, 2024 / Business Wire / Results from an exploratory analysis of the TROPION-Lung01 Phase III... Read More

Presidential Symposium will demonstrate how proprietary computational pathology biomarker for TROP2 enhances patient selection and potentially predicts patient outcomes in advanced lung cancer Presidential Symposium for NIAGARA will highlight practice-changing impact of a perioperative IMFINZI ® (durvalumab)-based regimen in bladder cancer WILMINGTON, Del. / Sep 03, 2024 / Business Wire / AstraZeneca advances its ambition to... Read More

Based on AEGEAN Phase III trial results which showed IMFINZI-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone WILMINGTON, Del. / Aug 16, 2024 / Business Wire / AstraZeneca’s IMFINZI ® (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC)... Read More

Based on ADRIATIC Phase III trial which demonstrated statistically significant and clinically meaningful overall survival and progression-free survival benefit WILMINGTON, Del. / Aug 15, 2024 / Business Wire / AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI ® (durvalumab), based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer... Read More

Favorable trend in overall survival was also observed WILMINGTON, Del. / Jul 29, 2024 / Business Wire / Positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of AstraZeneca’s CALQUENCE ® (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival... Read More

Strong underlying growth supports FY 2024 guidance upgrade, with both Total Revenue and Core EPS now expected to increase by a mid teens percentage at CER 1 CAMBRIDGE, United Kingdom / Jul 25, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary H1 2024 % Change Q2 2024 % Change $m Actual CER $m Actual CER - Product Sales 24,629 15 18 12,452 14 18 - Alliance Revenue 939 50 50 482 42 42 - Collaboration Revenue 49 (78)... Read More

First immunotherapy regimen before and after surgery to extend survival in bladder cancer WILMINGTON, Del. / Jun 25, 2024 / Business Wire / Positive high-level results from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key... Read More

Approval based on DUO-E trial results, which showed IMFINZI reduced the risk of disease progression or death by 58% vs. chemotherapy WILMINGTON, Del. / Jun 17, 2024 / Business Wire / AstraZeneca’s IMFINZI ® (durvalumab) in combination with carboplatin and paclitaxel followed by IMFINZI monotherapy has been approved in the US as treatment for adult patients with primary advanced or recurrent endometrial cancer that is... Read More

First and only BTK inhibitor to demonstrate favorable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting WILMINGTON, Del. / Jun 16, 2024 / Business Wire / Positive results from the ECHO Phase III trial showed AstraZeneca’s CALQUENCE ® (acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in progression-free... Read More

US patients aged 10 years and older can now benefit from FARXIGA for type-2 diabetes Approval based on results from T2NOW, one of the largest pediatric type-2 diabetes Phase III trials to date WILMINGTON, Del. / Jun 12, 2024 / Business Wire / AstraZeneca’s FARXIGA ® (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged... Read More

Decision based on LAURA Phase III trial results which extended median progression-free survival by more than three years TAGRISSO also granted Breakthrough Therapy Designation in US in this setting WILMINGTON, Del. / Jun 10, 2024 / Business Wire / AstraZeneca’s supplemental New Drug Application (sNDA) for TAGRISSO ® (osimertinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with... Read More

ROCKVILLE, Md. , June 6 , 2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, exclusively focused on the development and potential commercialization of highly differentiated immunotherapies for the treatment of cancer, today announced the appointment of Dr. Phillip Dennis as Chief Medical Officer. Dr. Dennis, who will join I-Mab effective June 17, 2024 , will lead the Company's... Read More

​​ ​ First and only EGFR inhibitor and targeted treatment to show benefit in Stage III setting, extending progression-free survival by more than three years WILMINGTON, Del. / Jun 02, 2024 / Business Wire / Positive results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO ® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for... Read More

57% of patients treated with IMFINZI were alive at three years in ADRIATIC Phase III trial WILMINGTON, Del. / Jun 02, 2024 / Business Wire / Positive results from the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) ​ demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to placebo... Read More

DESTINY-Breast06 results show AstraZeneca and Daiichi Sankyo’s ENHERTU is the first HER2-directed medicine and ADC to demonstrate clinically meaningful benefit for patients in this setting Additionally, data from DESTINY-Breast03 and DESTINY-Breast07 trials in HER2-positive metastatic breast cancer reinforce ENHERTU as standard of care in 2nd-line setting and highlight potential in 1st-line setting WILMINGTON, Del. / Jun 02,... Read More

In the overall trial population, survival results numerically favoured AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan but did not reach statistical significance TROPION-Lung01 previously met the dual primary endpoint of progression-free survival in the overall trial population Results support applications currently under review by regulatory authorities globally including in the US and EU This announcement contains... Read More

Additional clinical and real-world data from the industry’s largest amyloidosis pipeline will advance understanding of underlying mechanisms of disease and unmet needs WILMINGTON, Del. / May 23, 2024 / Business Wire / AstraZeneca and Alexion, AstraZeneca Rare Disease, will showcase 14 studies, including real-world evidence (RWE), from their portfolio and pipeline of investigational amyloidosis therapies at the International... Read More

Back-to-back plenary presentations from LAURA and ADRIATIC Phase III trials reinforce the potential of TAGRISSO ® (osimertinib) and IMFINZI ® (durvalumab) in early lung cancer settings​ DESTINY-Breast06 data underscore potential of ENHERTU ® (fam-trastuzumab deruxtecan-nxki) earlier in HR-positive, HER2-low breast cancer treatment, and in a broader population including HER2-ultralow WILMINGTON, Del. / May 22, 2024 / Business... Read More

Launch of 20 new medicines expected by 2030 Significant growth from existing oncology, biopharmaceuticals and rare disease portfolios Investing in disruptive innovation that will shape the future of medicine and drive long-term growth Decoupling carbon emissions from revenue growth CAMBRIDGE, England / May 21, 2024 / Business Wire / Today AstraZeneca revealed its bold ambition to deliver $80 billion in Total Revenue by 2030,... Read More

Late-breaking results from the Phase IIa COURSE trial provide insight into TEZSPIRE’s impact on COPD exacerbations in patients with a broad range of eosinophil levels WILMINGTON, Del. / May 19, 2024 / Business Wire / The Phase IIa COURSE trial was a proof-of-concept study in people with moderate to very severe chronic obstructive pulmonary disease (COPD) with a broad range of blood eosinophil counts (BEC) and irrespective of... Read More

First BTK inhibitor to show favorable trend in overall survival vs. standard-of-care chemoimmunotherapy in this setting WILMINGTON, Del. / May 02, 2024 / Business Wire / Positive high-level results from an interim analysis of the ECHO Phase III trial showed AstraZeneca’s CALQUENCE ® (acalabrutinib) in combination with standard-of-care chemoimmunotherapy, bendamustine and rituximab, demonstrated a statistically significant... Read More

New data for TEZSPIRE and BREZTRI demonstrate AstraZeneca’s innovation and commitment to transform care in COPD WILMINGTON, Del. / May 01, 2024 / Business Wire / AstraZeneca will showcase new clinical and real-world data across its leading inhaled, biologic and early science respiratory portfolio at the American Thoracic Society (ATS) International Conference, in San Diego, CA from May 17 - 22, 2024. The company will present... Read More

ENHERTU demonstrated statistically significant and clinically meaningful improvement in progression-free survival in HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy in DESTINY-Breast06 Phase III trial AstraZeneca and Daiichi Sankyo’s ENHERTU also demonstrated a clinically meaningful progression-free survival improvement in patients with HER2-ultralow expression WILMINGTON, Del.... Read More

Very strong revenue and EPS growth in the first quarter coupled with exciting pipeline delivery CAMBRIDGE, United Kingdom / Apr 25, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary Q1 2024 % Change $m Actual CER 1 - Product Sales 12,177 15 18 - Alliance Revenue 457 59 59 - Collaboration Revenue 45 66 66 Total Revenue 12,679 17 19 Reported EPS $1.41 21 30 Core 2 EPS $2.06 7 13 Financial performance for Q1 2024... Read More

Longest survival follow-up ever reported for immunotherapy treatment in this setting WILMINGTON, Del. / Apr 16, 2024 / Business Wire / Updated exploratory results from the TOPAZ-1 Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) in combination with standard-of-care chemotherapy demonstrated a clinically meaningful long-term overall survival (OS) benefit at three years for patients with advanced biliary tract... Read More

Additional indication for pediatric patients with severe eosinophilic asthma WILMINGTON, Del. / Apr 11, 2024 / Business Wire / AstraZeneca’s FASENRA ® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype. 1 FASENRA was first approved in 2017 as an add-on maintenance for the treatment of severe... Read More

Based on three Phase II trials of AstraZeneca and Daiichi Sankyo’s ENHERTU which showed clinically meaningful responses across a broad range of tumors ENHERTU now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers WILMINGTON, Del. / Apr 05, 2024 / Business Wire / AstraZenec a and Daiichi Sankyo's ENHERTU ® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the... Read More

First and only immunotherapy to demonstrate survival benefit in this setting in a global Phase III trial WILMINGTON, Del. / Apr 05, 2024 / Business Wire / Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS)... Read More

Application based on results from the TROPION-Breast01 phase 3 trial Additional BLA under review in the U.S. for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan for patients with advanced nonsquamous non-small cell lung cancer TOKYO & BASKING RIDGE, N.J. / Apr 02, 2024 / Business Wire / Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan... Read More

Approval of first-in-class, oral, Factor D inhibitor based on results from pivotal ALPHA Phase III trial WILMINGTON, Del. / Apr 01, 2024 / Business Wire / VOYDEYA™ (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). 1 VOYDEYA is a first-in-class, oral, Factor D inhibitor developed as... Read More

First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+ NMOSD the potential to live relapse-free Unprecedented relapse risk reduction observed in CHAMPION-NMOSD trial underscores how ULTOMIRIS may redefine patient journey for rare neurological disease WILMINGTON, Del. / Mar 25, 2024 / Business Wire / ULTOMIRIS ® (ravulizumab-cwvz) has been approved in the United States (US) as the first and only... Read More

Includes actinium-based clinical-stage radioconjugate targeting PSMA for prostate cancer, pipeline of radioconjugates and state-of-the-art R&D and manufacturing facilities WILMINGTON, Del. / Mar 19, 2024 / Business Wire / AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The acquisition marks... Read More

Expanded savings programs build on company’s longstanding commitment to addressing barriers to access and affordability for patients WILMINGTON, Del. / Mar 18, 2024 / Business Wire / AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.* Expanding the savings programs will help make its inhalers... Read More

THARROS is the first-ever prospective trial to investigate the potential of an inhaled triple therapy to reduce cardiopulmonary events, a key driver of mortality, in COPD First patients dosed in ATHLOS Phase III trial assessing impact of BREZTRI on integrated cardiopulmonary parameters associated with health status and survival in patients with COPD WILMINGTON, Del. / Mar 13, 2024 / Business Wire / AstraZeneca today... Read More

In recognition of Rare Disease Day on February 29 , Alexion welcomes people across the country to join the international colourUp4RARE challenge and learn more about the impact of rare diseases on an estimated three million Canadian families MISSISSAUGA, ON , Feb. 26, 2024 /CNW/ - Alexion Pharma Canada Corp. , AstraZeneca's Rare Disease group, is marking Rare Disease Day on February 29 by launching colourUp4RARE . The... Read More

FASENRA enabled patients to taper off oral corticosteroids while preventing relapses WILMINGTON, Del. / Feb 23, 2024 / Business Wire / Positive results from the MANDARA Phase III trial for FASENRA ® (benralizumab) in patients with EGPA were published in the New England Journal of Medicine today, 1 as the first head-to-head trial of biologics in patients with EGPA, 2 and the first to demonstrate that more than half of... Read More

Application based on results from the TROPION-Lung01 Phase III trial If approved, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan may be the first TROP2-directed antibody drug conjugate for patients with lung cancer WILMINGTON, Del. / Feb 19, 2024 / Business Wire / AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment... Read More

First EGFR inhibitor and targeted treatment to demonstrate progression-free survival benefit in Stage III setting WILMINGTON, Del. / Feb 19, 2024 / Business Wire / Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO ® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage... Read More

Application based on results from the TROPION-Lung01 phase 3 trial If approved, Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan may be the first TROP2 directed antibody drug conjugate for patients with lung cancer TOKYO & BASKING RIDGE, N.J. / Feb 19, 2024 / Business Wire / Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has... Read More

Approval based on FLAURA2 results which showed TAGRISSO plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care WILMINGTON, Del. / Feb 16, 2024 / Business Wire / AstraZeneca’s TAGRISSO ® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm)... Read More

Strong growth and pipeline momentum with three new medicines approved since the third quarter CAMBRIDGE, United Kingdom / Feb 08, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary FY 2023 Q4 2023 % Change % Change $m Actual CER 1 $m Actual CER - Product Sales 43,789 2 4 11,323 5 5 - Alliance Revenue 2 1,428 89 89 424 69 67 - Collaboration Revenue 2 594 (1 ) (1 ) 277 75 74 Total Revenue 45,811 3 6 12,024 7 8 Total... Read More

New facility in Rockville, Maryland will focus on manufacturing for critical cancer trials and launch of its commercial cell therapy platforms WILMINGTON, Del. / Feb 06, 2024 / Business Wire / AstraZeneca is investing $300 million in a state-of-the-art facility in Rockville, MD to launch its life-saving cell therapy platforms... Read More

NEW YORK and SHANGHAI, China, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Yiviva, a clinical-stage, platform biotechnology company developing systems biology medicines to treat aging-related diseases, signed a memorandum of understanding (MOU) with AstraZeneca China to establish a research and development collaboration at AstraZeneca’s... Read More

If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU will potentially be the first HER2-directed treatment and antibody drug conjugate to receive a tumor-agnostic indication Application based on results from DESTINY-PanTumor02 trial and supported by additional ENHERTU data Submission to be reviewed under FDA Real-Time Oncology Review and Project Orbis WILMINGTON, Del. / Jan 29, 2024 / Business Wire / AstraZeneca and Daiichi... Read More

Adults living with asthma now have an approved rescue treatment designed to treat both symptoms and inflammation to help prevent asthma attacks WILMINGTON, Del. / Jan 22, 2024 / Business Wire / AstraZeneca announces AIRSUPRA ® (albuterol/budesonide), is now commercially available in the US by prescription. AIRSUPRA received... Read More

EMERALD-1 is first global Phase III trial to show improved clinical outcome for systemic therapy in combination with TACE in this setting WILMINGTON, Del. / Jan 19, 2024 / Business Wire / Positive results from the EMERALD-1 Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint... Read More

HOLON, Israel , Jan. 8, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that Compugen is entitled to receive a $10 million milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN), after the first patient was dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig. Rilvegostomig is a PD-1/TIGIT... Read More

Includes clinical-stage autologous BCMA/CD19 CAR-T therapy targeting haematologic malignancies and autoimmune diseases, and proprietary cell therapy manufacturing platform WILMINGTON, Del. / Dec 26, 2023 / Business Wire / AstraZeneca has entered into a definitive agreement to acquire Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company developing innovative cell therapies... Read More

US FDA approval based on NEURO-TTRansform Phase III results showing WAINUA demonstrated consistent and sustained benefit improving neuropathy impairment and quality of life Additional regulatory reviews underway in rest of world WILMINGTON, Del. / Dec 21, 2023 / Business Wire / AstraZeneca and Ionis’ WAINUA ™ (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary... Read More

Building on expertise in RSV prevention, acquisition will accelerate ambition to deliver portfolio of protective interventions to address high unmet needs in infectious diseases WILMINGTON, Del. / Dec 12, 2023 / Business Wire / AstraZeneca has entered into a definitive agreement to acquire Icosavax, Inc. (NASDAQ: ICVX), a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential... Read More

Data demonstrated effective control of intravascular and extravascular hemolysis through 48 weeks Results showed increase in mean hemoglobin levels were maintained through 48 weeks WILMINGTON, Del. / Dec 10, 2023 / Business Wire / Positive results from the 24-week and long-term extension (LTE) period of the pivotal ALPHA Phase... Read More

SEATTLE , Nov. 30, 2023 /PRNewswire/ -- Presage Biosciences , a pioneering translational oncology company whose mission is to use CIVO and spatial molecular profiling to understand the complexity of drug response in the tumor microenvironment (TME), has entered into an agreement with AstraZeneca (LSE/STO/Nasdaq: AZN), a global biopharmaceutical company. According to the agreement, Presage's platform will be used by... Read More

CALQUENCE six-year follow-up data reinforce long-term benefit in chronic lymphocytic leukemia, and data across multiple hematology assets showcase breadth of promising early pipeline New, longer-term data from ALPHA Phase III trial will further show potential of danicopan to address clinically significant extravascular hemolysis and maintain disease control, allowing paroxysmal nocturnal hemoglobinuria patients to continue... Read More

Evinova will operate as a separate health-tech business within AstraZeneca Evinova’s globally-scaled digital health solutions are evidence-led, science-based and human experience-driven to serve clinical trial sponsors, clinical research organisations (CROs), clinical trial site care teams and patients First strategic collaborations with globally-leading CROs Parexel and Fortrea enable Evinova’s digital health solutions to... Read More

First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients with specific biomarker alterations (PIK3CA, AKT1 or PTEN) Approval based on CAPItello-291 results which showed this combination reduced the risk of disease progression or death by 50% vs. fulvestrant alone in the biomarker-altered population WILMINGTON, Del. / Nov 17, 2023 / Business Wire / AstraZeneca’s TRUQAP™ (capivasertib) in... Read More

First global Phase III trial to show improved clinical outcome for systemic therapy in combination with transarterial chemoembolization (TACE) in this setting WILMINGTON, Del. / Nov 09, 2023 / Business Wire / Positive high-level results from the EMERALD-1 Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) in combination with transarterial chemoembolization (TACE) and bevacizumab demonstrated a statistically... Read More

52.5% reduction with high-dose and 47.7% reduction with low-dose combination compared to baseline, and an acceptable tolerability profile Novel investigational drug leverages SGLT2 inhibition and high selectivity ET A receptor antagonism with potential to deliver step-change efficacy and acceptable fluid retention Plans for Phase III start underway WILMINGTON, Del. / Nov 03, 2023 / Business Wire / Combination of zibotentan... Read More

Ultomiris transforms the treatment landscape for AQP4 Ab+ NMOSD patients, with potential to eliminate relapses and improve outcomes MISSISSAUGA, ON , Nov. 1, 2023 /CNW/ - Ultomiris (ravulizumab) has been approved by Health Canada as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). 1... Read More

Potential to be the first and only self-administered flu vaccine WILMINGTON, Del. / Oct 24, 2023 / Business Wire / AstraZeneca’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal), a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA). If approved, FLUMIST... Read More

The LOI is a critical step in ensuring patients living with PNH or aHUS have public access to Ultomiris, the first and only long-acting C5 complement inhibitor MISSISSAUGA, ON , Oct. 24, 2023 /CNW/ - Alexion Pharma Canada Corp., AstraZeneca's Rare Disease group, has entered into a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) for Ultomiris (ravulizumab) for the treatment of adult patients with... Read More

AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan reduced the risk of disease progression or death by 25% in overall population and by 37% in patients with non-squamous tumors Datopotamab deruxtecan is the first antibody drug conjugate to demonstrate statistically significant improvement in PFS over docetaxel in this setting of high unmet need WILMINGTON, Del. / Oct 23, 2023 / Business Wire / Positive results from the... Read More

AstraZeneca and Daiichi Sankyo’s ENHERTU showed a median progression-free survival of 6.9 months and median overall survival of 13.4 months in the overall trial population Results reaffirm potential role of ENHERTU as a tumor-agnostic therapy for previously treated patients with HER2-expressing solid tumors and support ongoing discussions with global regulatory authorities WILMINGTON, Del. / Oct 23, 2023 / Business Wire /... Read More

AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan reduced the risk of disease progression or death by 37%, providing a 2-month median PFS benefit, and was well tolerated in post-endocrine therapy setting WILMINGTON, Del. / Oct 23, 2023 / Business Wire / Positive results from the pivotal TROPION-Breast01 Phase III trial showed that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically... Read More

AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan plus IMFINZI showed a confirmed objective response rate of 79% Two ongoing Phase III trials are evaluating datopotamab deruxtecan in patients with triple-negative breast cancer WILMINGTON, Del. / Oct 22, 2023 / Business Wire / Updated results from the BEGONIA Phase Ib/II trial for the cohort of patients treated with datopotamab deruxtecan (Dato-DXd) plus IMFINZI ®... Read More

IMFINZI reduced the risk of disease progression or death by 29% vs. chemotherapy First Phase III trial to demonstrate clinical benefit of immunotherapy plus PARP inhibition in advanced or recurrent endometrial cancer WILMINGTON, Del. / Oct 21, 2023 / Business Wire / Positive results from the primary analysis of the DUO-E Phase III trial showed that IMFINZI ® (durvalumab) plus platinum-based chemotherapy, followed by either... Read More

59% of these patients treated with TAGRISSO plus chemotherapy had complete brain tumor responses in FLAURA2 Phase III trial WILMINGTON, Del. / Oct 21, 2023 / Business Wire / Results from a prespecified exploratory analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO ® (osimertinib) with the addition of chemotherapy demonstrated a 42% improvement in central nervous system (CNS) progression-free survival... Read More

Trial will continue to assess primary endpoint of event-free survival WILMINGTON, Del. / Oct 20, 2023 / Business Wire / Positive results from a planned interim analysis of the MATTERHORN Phase III trial showed treatment with AstraZeneca's IMFINZI ® (durvalumab) in combination with standard-of-care FLOT neoadjuvant chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel given before surgery) demonstrated a... Read More

Decision based on FLAURA2 Phase III trial results which extended median progression-free survival by nearly 9 months versus standard of care WILMINGTON, Del. / Oct 16, 2023 / Business Wire / AstraZeneca’s supplemental New Drug Application (sNDA) for TAGRISSO ® (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or... Read More

R&D Postdoctoral Challenge is a ground-breaking initiative fostering collaboration, innovation and global diversity WILMINGTON, Del. / Oct 12, 2023 / Business Wire / AstraZeneca announced today eight winners of the 2023 R&D Postdoctoral Challenge and agreed to fund their postdoctoral positions at one of the Company’s strategic R&D centres in either Cambridge, UK, Gaithersburg or Boston, US or Gothenburg, Sweden. The R&D... Read More

Two highly anticipated Presidential Symposia for TROPION-Lung01 and TROPION-Breast01 will unveil the significance of datopotamab deruxtecan in lung and breast cancers FLAURA2 data reinforce TAGRISSO ® (osimertinib) as the backbone therapy in EGFR-mutated lung cancer and underscore its added benefit of treating brain metastases DUO-E results for IMFINZI ® (durvalumab) plus LYNPARZA ® (olaparib) will show the benefit of... Read More

As part of the Foundation’s 30th anniversary, grants demonstrate its expanded focus on health equity WILMINGTON, Del. / Oct 10, 2023 / Business Wire / As the AstraZeneca Foundation celebrates its 30th anniversary, the organization has awarded 12 nonprofit organizations $2,170,318 in grants across eight US states and Washington, D.C., for innovative approaches to address healthcare disparities at the community level, a... Read More

First Phase III results in breast cancer for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan Plans for global regulatory submissions underway WILMINGTON, Del. / Sep 22, 2023 / Business Wire / Positive high-level results from the TROPION-Breast01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of... Read More

15-year agreement with Future Biogas will provide 100 GWh of green gas (biomethane) annually, equivalent to meet the heat demands of over 8,000 homes Initiative will provide additional renewable capacity to the national gas grid, representing the UK's first fully commercial biomethane system Significant boost to energy... Read More

First head-to-head trial of biologics in EGPA, comparing a single monthly injection of FASENRA to three injections per month of mepolizumab WILMINGTON, Del. / Sep 11, 2023 / Business Wire / Positive high-level results from the MANDARA Phase III trial showed AstraZeneca’s FASENRA (benralizumab) met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with... Read More

Combination reduced the risk of disease progression by 38% versus TAGRISSO monotherapy, the current 1st-line global standard of care WILMINGTON, Del. / Sep 11, 2023 / Business Wire / Positive results from the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO ® (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS),... Read More

AstraZeneca and Daiichi Sankyo’s ENHERTU showed objective response rates of 49% and 56% with 5.4mg/kg and 6.4mg/kg doses respectively in primary analysis ENHERTU provided a median progression-free survival of 9.9 months at 5.4mg/kg dose and 15.4 months at 6.4mg/kg dose with a median duration of response of 16.8 months seen at the 5.4mg/kg dose and not reached at the 6.4mg/kg dose Favorable safety profile confirms 5.4mg/kg as... Read More

Company files legal challenge to protect timely access to medicines for orphan indications in the US WILMINGTON, Del. / Aug 25, 2023 / Business Wire / To help protect access to medicines for cancer and rare disease patients, AstraZeneca today has filed a legal challenge to critical aspects of the drug price negotiation provisions of the Inflation Reduction Act (IRA). The drug price negotiation provisions of the IRA run... Read More

FLAURA2 data reinforce TAGRISSO ® as backbone therapy for EGFR-mutated advanced lung cancer in combination with chemotherapy; granted Breakthrough Therapy Designation in the US Further results for ENHERTU ® , IMFINZI ® and datopotamab deruxtecan showcase strength of diverse ADC and IO portfolios to address unmet needs WILMINGTON, Del. / Aug 16, 2023 / Business Wire / AstraZeneca advances its robust lung cancer portfolio and... Read More

Data support ongoing discussions with global health authorities WILMINGTON, Del. / Jul 27, 2023 / Business Wire / High-level results from the primary analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed ENHERTU ® (fam-trastuzumab deruxtecan-nxki) demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients across multiple HER2-expressing advanced... Read More

First Phase III results for AstraZeneca and Daiichi Sankyo’s TROP2-directed antibody drug conjugate demonstrated statistically significant improvement in progression-free survival vs. standard chemotherapy in previously treated locally advanced or metastatic disease Trial will continue to assess the dual primary endpoint of overall survival WILMINGTON, Del. / Jul 03, 2023 / Business Wire / Positive high-level results from... Read More

Longest survival follow-up reported to date for a Phase III trial in this setting WILMINGTON, Del. / Jun 29, 2023 / Business Wire / Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) plus IMJUDO ® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at four years for patients with unresectable hepatocellular carcinoma (HCC) who had not... Read More

Expansion of AZ Forest programme raises commitment to plant 200 million trees across six continents by 2030 New reforestation projects in Brazil, India, Vietnam, Ghana and Rwanda in addition to existing projects including in Australia and Indonesia CAMBRIDGE, United Kingdom / Jun 28, 2023 / Business Wire / AstraZeneca has announced a $400 million investment in its global AZ Forest programme, raising its commitment to plant... Read More

Decision based on CAPItello-291 Phase III trial results which showed the combination reduced the risk of disease progression or death by 40% vs. FASLODEX alone Potential first-in-class AKT inhibitor being reviewed under Project Orbis WILMINGTON, Del. / Jun 12, 2023 / Business Wire / AstraZeneca’s New Drug Application (NDA) for capivasertib in combination with FASLODEX ® (fulvestrant) has been accepted and granted Priority... Read More

In previously untreated patients, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan plus pembrolizumab with or without platinum chemotherapy demonstrated objective response rates of 57% and 50%, respectively, with a disease control rate of 91% across cohorts Three ongoing pivotal trials are evaluating datopotamab deruxtecan and immune checkpoint inhibitor combinations in 1st-line non-small cell lung cancer WILMINGTON,... Read More

AstraZeneca and Daiichi Sankyo’s ENHERTU showed an objective response rate of 37.1% in the overall population of the DESTINY-PanTumor02 Phase II trial ENHERTU is the first therapy to show broad activity across HER2-expressing advanced solid tumors where there are currently no approved HER2-directed therapies DESTINY-CRC02 Phase II trial also demonstrated positive antitumor activity and consistent safety in patients with... Read More

AstraZeneca to proceed with regulatory filings to convert from conditional to full approval in the US and EU WILMINGTON, Del. / Jun 05, 2023 / Business Wire / ANNEXA-I, a post-marketing Phase IV trial to assess the efficacy and safety of ANDEXXA (andexanet alfa) in patients on oral FXa inhibitor treatment including apixaban and rivaroxaban experiencing an intracranial hemorrhage, will be stopped early. 1 The decision is... Read More

Treatment with adjuvant TAGRISSO reduced the risk of death by more than half WILMINGTON, Del. / Jun 04, 2023 / Business Wire / Positive results from the ADAURA Phase III trial showed AstraZeneca’s TAGRISSO ® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA)... Read More

WILMINGTON, Del. / Jun 03, 2023 / Business Wire / Positive results from a planned interim analysis of the DUO-O Phase III trial showed that treatment with a combination of LYNPARZA ® (olaparib), IMFINZI ® (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly... Read More

First global Phase III trial of immunotherapy and chemotherapy combination to demonstrate clinical benefit in this setting Trial will continue to assess event-free survival WILMINGTON, Del. / Jun 02, 2023 / Business Wire / Positive high-level results from a planned interim analysis of the MATTERHORN Phase III trial showed treatment with AstraZeneca’s IMFINZI ® (durvalumab) added to standard-of-care FLOT (fluorouracil,... Read More