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The Latest Breaking News from AstraZeneca Plc

The Daily Biotech Pulse: FDA Approves Bristol Myers' Oral Heart Disease Drug, European Approval For Merck's Keytruda, Genocea Restructures, Zymeworks' Takeover Bid

Here's a roundup of top developments in the biotech space over the last 24 hours.

Benzinga

AstraZeneca Clocks Q1 COVID Vaccine Sales Of $1.2B, Keeps Overall FY22 Outlook

AstraZeneca Plc's (NASDAQ:AZN) total revenue jumped 60% Y/Y at CER to $11.39 billion in Q1 FY22, beating the consensus of $10.99 billion. The growth reflects the contribution of the Alexion medicines and several Vaxzevria contracts that are expected to complete the delivery by half year 2022. Core EPS came in at $1.89,…

Benzinga

Daiichi Sankyo - AstraZeneca's Enhertu Receives Third Breakthrough Therapy Tag In Breast Cancer

The FDA has granted Breakthrough Therapy Designation (BTD) to Daiichi Sankyo (OTC:DSKYF) and AstraZeneca Plc's (NASDAQ:AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. The designation covers patients who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months…

Benzinga

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AstraZeneca's COVID-19 Antibody Provides Protection For At Least Six Months In High-Risk Individuals

AstraZeneca plc (NASDAQ:AZN) shared detailed results from the PROVENT Phase 3 pre-exposure prophylaxis (prevention) trial of Evusheld (tixagevimab and cilgavimab), formerly AZD7442. The data showed that Evusheld reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and 83% in the six-month follow-up analysis, compared to placebo. There were no…

Benzinga

Daiichi Sankyo - AstraZeneca's Enhertu Receives Priority Review In US For Lung Cancer

The FDA has accepted for review AstraZeneca plc (NASDAQ:AZN) - Daiichi Sankyo's (OTC:DSNKY) supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for non-small cell lung cancer (NSCLC) setting. The application covers unresectable or metastatic NSCLC whose tumors have a HER2 (ERBB2) mutation and who have received prior systemic therapy. The application has also been…

Benzinga

Japan's Health Ministry Panel OKs Approval Of Novavax's COVID-19 Vaccine: Report

Japan's health ministry panel authorized a plan to approve Novavax Inc's (NASDAQ:NVAX) COVID-19 vaccine, which is set to be the fourth such vaccine to be approved in Japan. It will be available for first and second shots with an interval of three weeks. The Novavax product is a recombinant protein vaccine that uses…

Benzinga

AstraZeneca Bets $25M On Preclinical Bispecific Antibody

Harbour BioMed has announced a global out-license agreement with AstraZeneca plc (NASDAQ:AZN) for CLDN18.2xCD3 bispecific antibody (HBM7022). HBM7022 is a novel bispecific antibody generated from HBM's HCAb Based Immune Cell Engagers (HBICE) Platform. HBM7022 is currently in the preclinical stage, which crosslinks tumor cells and T cells by targeting a tumor-associated antigen (Claudin18.2) and…

Benzinga

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AstraZeneca's Ultomiris Shows Sustained Improvements In Functional Activities In Neuromuscular Disease

AstraZeneca Plc (NASDAQ:AZN) shared new and prolonged follow-up results from the Phase 3 CHAMPION-MG trial open-label extension (OLE) of Ultomiris (ravulizumab-cwvz) in generalized myasthenia gravis (gMG). Ultomiris demonstrated long-term efficacy, with improvements in activities of daily living, muscle strength, and quality of life sustained through 60 weeks. Ultomiris was also well tolerated throughout…

Benzinga

AstraZeneca's Imfinzi Flunks In Late-Stage Advanced Cervical Cancer Study

AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) and chemoradiotherapy did not achieve the primary goal of improving survival in patients with locally advanced cervical cancer. The Phase 3 study, dubbed "CALLA," tested progression-free survival of patients with the combination against chemoradiotherapy alone. "While the results were not what we hoped for, insights from the trial…

Benzinga

AstraZeneca Mulls Ditching US Approval For Its COVID-19 Vaccine: FT

Citing AstraZeneca Plc's (NASDAQ: AZN) head of research and development, the Financial Times reported that the Company

Benzinga

Europe Kickstarts Reviewing AstraZeneca Application For Its COVID Antibody

European Medicines Agency has started reviewing AstraZeneca Plc's (NASDAQ:AZN) application for antibody-based COVID-19 therapy but gave no timeline for a conclusion. Infections from COVID-19 are still rising in parts of the world, including Europe. On Tuesday, China posted a steep jump in daily COVID-19 infections, with new cases more than doubling from a…

Benzinga

Europe begins reviewing application for AstraZeneca COVID drug

Europe's drug regulator said on Tuesday it had begun reviewing AstraZeneca Plc's application for antibody-based COVID-19 therapy, a key step towards approval of the treatment in the region, but gave no timeline for a conclusion.

Reuters

FDA Declines To Approve AstraZeneca's Asthma Treatment For Chronic Nasal Condition

The FDA has declined to approve AstraZeneca Plc's (NASDAQ:AZN) asthma medicine, Fasenra (benralizumab), to treat chronic rhinosinusitis with nasal polyps, a condition characterized by benign growths that cause pain and stuffiness. The FDA has issued a complete response letter following AstraZeneca's application to extend the use of Fasenra and requested additional clinical data…

Benzinga

AstraZeneca-Sanofi's Nirsevimab Shows 75% Efficacy Against RSV In Healthy Infants

AstraZeneca Plc (NASDAQ:AZN) and Sanofi SA (NASDAQ:SNY) have shared detailed results from the MELODY Phase 3 trial evaluating nirsevimab in respiratory syncytial virus (RSV). The data showed that a single dose of nirsevimab met the primary efficacy endpoint reducing the incidence of medically attended lower respiratory tract infections caused by RSV by 74.5% compared to…

Benzinga

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Benzinga

AstraZeneca, GSK's COVID-19 Therapies Lose Efficacy Against Omicron's Subvariants

The FDA authorized an increased dose in the case of AstraZeneca Plc's (NASDAQ:

Benzinga

Blood Clot Risk After First AstraZeneca COVID-19 Shot Very Small - UK Study Shows

A large study into rare blood clots linked with AstraZeneca Plc's (NASDAQ: AZN) COVID-19 vaccine found

Reuters

Exclusive-Short AstraZeneca shelf life complicates COVID vaccine rollout to world's poorest

Asharq Al-Awsat

Short AstraZeneca Shelf Life Complicates COVID Vaccine Rollout to World’s Poorest

The relatively short shelf life of AstraZeneca Plc's COVID-19 vaccine is complicating the rollout to the world's poorest nations, according to officials and internal World Health Organization documents reviewed by Reuters. It is the latest headache to plague the COVAX vaccine-sharing project, co-led by the WHO and aimed at getting…

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Benzinga

Why Are AstraZeneca Shares Trading Higher Today

Adding AstraZeneca Plc's (NASDAQ: AZN) Lynparza to Johnson & Johnson's (NYSE: JNJ) Zytiga (abiraterone) extended the time to live without disease progression in patients with newly diagnosed

Asharq Al-Awsat

US FDA Advisers Say More Data Needed for Cancer Drug Tested in China

A panel of outside advisers to the US Food and Drug Administration on Thursday voted to recommend that Innovent Biologics Inc and Eli Lilly and Co be required to conduct a trial of their lung cancer drug that is applicable to the US population. Data submitted to the FDA for…

Benzinga

AstraZeneca Records Bumper COVID-19 Vaccine Sales Of ~$4B In FY21

AstraZeneca Plc's (NASDAQ: AZN) total revenue jumped 63% Y/Y to $12.0

Benzinga

Pfizer, AstraZeneca or J&J COVID-19 Shots Boost Sinovac Regime, Brazilian Study Shows

A third booster dose of a COVID-19 vaccine from either AstraZeneca Plc (NASDAQ: AZN), Pfizer Inc (NYSE: PFE) - BioNTech SE (NASDAQ:

Benzinga

AstraZeneca Rolls Out "Unprecedented' Three Year Survival Data For Imfinzi/Treme Combo In Liver Cancer

A combination of tremelimumab and AstraZeneca Plc's (NASDAQ: AZN) Imfinzi (durvalumab)

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