Latest news with #Fasenra
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Business Standard
6 days ago
- Business
- Business Standard
AstraZeneca Pharma rises 2% on securing CDSCO nod for Benralizumab solution
AstraZeneca Pharma share price: Pharmaceutical company AstraZeneca shares rose as much as 2.14 per cent to hit an intraday high of ₹8,089 per share on the last trading day of the week i.e. Friday, May 30, 2025. At 1:30 PM, AstraZeneca Pharma shares were trading 1.26 per cent higher at ₹8,018.90 per share. By comparison, the BSE Sensex was trading 0.21 per cent lower at 81,461.57 levels. Why did AstraZeneca share price rise in trade today? AstraZeneca Pharma share price rose after it received approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, to import for sale and distribution of Benralizumab 30 mg/ml solution for injection (brand name: Fasenra) for an additional indication. In an exchange filing, AstraZeneca Pharma said, 'This is to inform that AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) for an additional indication.' Benralizumab is used as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Besides, the approval also paves way for the marketing of Benralizumab 30 mg/ml solution for injection (Brand name: Fasenra) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any. Earlier this week, AstraZeneca Pharma India secured approval from CDSCO to import for sale and distribution of Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) for an additional indication. Osimertinib as monotherapy is used in the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and whose disease has not progressed during or following platinum-based chemoradiation therapy AstraZeneca Pharma Q4 results The Board of Directors of AstraZeneca Pharma will meet today to consider and approve the March quarter of financial year 2025 (Q4FY25) and financial year 2025 (FY25) results, along with dividend for FY25, if any. About AstraZeneca Pharma AstraZeneca Pharma is a British-Swedish multinational pharmaceutical and biotechnology company, formed in 1999 through the merger of Sweden's Astra AB and Britain's Zeneca Group. The company is dedicated to developing and selling innovative medicines across various therapeutic areas, including cancer, cardiovascular diseases, gastrointestinal issues, infections, neuroscience, respiratory conditions, and inflammation. The company has had a major presence in India for 45 years. AstraZeneca Pharma India oversees manufacturing, sales, and marketing operations, while the company also gained global recognition for its role in developing the Oxford–AstraZeneca Covid-19 vaccine Leveraging data science and artificial intelligence (AI), AstraZeneca claims to boost the success rates and efficiency of its research and development (R&D) processes. The market capitalisation of AstraZeneca Pharma is ₹20,037.38 crore, according to BSE. The company falls under the BSE500 index. The 52-week high of AstraZeneca share price is ₹9,199, while its 52-week low is ₹5,415.55.
Business Upturn
7 days ago
- Business
- Business Upturn
AstraZeneca Pharma receives CDSCO nod for expanded use of Fasenra in India
By Aditya Bhagchandani Published on May 30, 2025, 09:25 IST AstraZeneca Pharma India Limited has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Benralizumab (brand name: Fasenra) in India for an additional medical indication. The newly approved indication allows Fasenra to be used as an add-on treatment for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). This rare autoimmune condition is known to cause inflammation of blood vessels, leading to organ damage. AstraZeneca confirmed the development in a regulatory filing to the stock exchanges on May 29, 2025, under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements. The company stated that while the permission paves the way for marketing Fasenra in India for the newly approved indication, it remains subject to receipt of additional statutory clearances if required. Fasenra is already approved in India for other eosinophilic conditions, and this marks an important expansion in its therapeutic scope, potentially benefiting more patients with complex immunological diseases. 'The receipt of this permission paves way for the marketing of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) in India for the specified additional indication,' the company noted in the filing. The company secretary Manasa R signed off the communication to both BSE and NSE. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Business Standard
7 days ago
- Health
- Business Standard
AstraZeneca Pharma receives marketing approval for Benralizumab in India
AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) for an additional indication. Through this approval, Benralizumab is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). The receipt of this permission paves way for the marketing of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
Yahoo
16-04-2025
- Health
- Yahoo
Blue Cross Blue Shield now requires Oklahomans receive prior approval for severe asthma drugs
Starting today, Blue Cross Blue Shield will mandate that severe asthma patients self-administer their drugs at home, unless their provider gets prior approval from the insurance company. (Photo courtesy of Dr. Priya Bansal) Patients in five states who have severe asthma and are covered by Blue Cross Blue Shield are facing a new obstacle to getting treatment. On Tuesday, BCBS began mandating that severe asthma patients self-administer their drugs at home, unless their provider gets prior approval from the insurance company. The patients affected are those covered in Illinois, Texas, Oklahoma, New Mexico, and Montana, but not those with Medicare or Medicaid, the insurance giant says. Given as injections, the treatments in question are Fasenra (benralizumab), Tezspire (tezepelumab), Nucala (mepolizumab) and Xolair (omalizumab). All belong to a class of drugs known as biologics. The decision is expected to affect thousands of patients. It's estimated that between 5% and 10% of asthma patients have severe asthma, characterized by more flare-ups and hospitalizations. In Illinois, for example, about 860,000 patients have asthma, according to the federal Centers for Disease Control and Prevention. That means between 43,000 and 86,000 of them have severe asthma. Clinics already have loads of prior authorizations to process that often delay care, said Dr. Priya Bansal, a pediatrician and asthma and allergy physician in Illinois. Her practice sees many rural patients and those with chronic disease. 'On any given day, we'll have anywhere from 30, to my highest was 130,' she said. The change interferes with a provider and patient decision on whether in-office or at-home treatment is best for the patient, Bansal said. 'That decision that's supposed to go on between the physician and the patient is getting taken away,' she said. 'If I have a pediatric food allergy patient and they want to get the medication in the clinic, I want to be able to have the flexibility to do that.' The sickest asthma patients are often on biologics, explained Dr. Bridgette Jones, past chair of the American Academy of Pediatrics' drug committee and the American Academy of Allergy Asthma and Immunology's asthma cough diagnosis and treatment panel. 'These are the patients that have failed at other therapies,' said Jones, a pediatric allergy and immunology physician at Children's Mercy Hospital in Missouri. 'Once you're getting to a biologic, it means that your asthma is not under control, having frequent flare-ups.' Black and Indigenous adults and children, as well as Puerto Rican people have higher rates of illness and less access to care. For people who suffer from severe asthma, the typical inhaler is often not enough. The affected drugs can help manage severe, uncontrolled asthma by reducing airway inflammation, While the drugs are approved by the U.S. Food and Drug Administration for self-injecting at home, they also come with risks for the uncommon but life-threatening anaphylaxis. That's why providers typically start patients on these drugs in-office for monitoring. But for at least one of the drugs, Xolair, the reaction can also happen up to a year into treatment. Many families are not comfortable administering biologics to their kids with severe asthma, Jones said. Clinics serving higher-need or underserved populations may often lack the resources to deal with more prior approvals, she added. A recent study by Massachusetts General Hospital and funded by Amgen, which developed Tezspire with AstraZeneca, suggested that in some states, the percentage of asthma patients with severe asthma is higher than 10%. In Texas, for example, about 23% of severe persistent asthma had severe uncontrolled disease. Stateline reporter Nada Hassanein can be reached at nhassanein@ SUBSCRIBE: GET THE MORNING HEADLINES DELIVERED TO YOUR INBOX SUPPORT: YOU MAKE OUR WORK POSSIBLE
Yahoo
15-04-2025
- Health
- Yahoo
Blue Cross Blue Shield now requires prior approval for severe asthma drugs in some states
Starting today, Blue Cross Blue Shield will mandate that severe asthma patients self-administer their drugs at home, unless their provider gets prior approval from the insurance company. (Courtesy of Dr. Priya Bansal) Patients in five states who have severe asthma and are covered by Blue Cross Blue Shield are facing a new obstacle to getting treatment. On Tuesday, BCBS began mandating that severe asthma patients self-administer their drugs at home, unless their provider gets prior approval from the insurance company. The patients affected are those covered in Illinois, Texas, Oklahoma, New Mexico, and Montana, but not those with Medicare or Medicaid, the insurance giant says. Given as injections, the treatments in question are Fasenra (benralizumab), Tezspire (tezepelumab), Nucala (mepolizumab) and Xolair (omalizumab). All belong to a class of drugs known as biologics. The decision is expected to affect thousands of patients. It's estimated that between 5% and 10% of asthma patients have severe asthma, characterized by more flare-ups and hospitalizations. In Illinois, for example, about 860,000 patients have asthma, according to the federal Centers for Disease Control and Prevention. That means between 43,000 and 86,000 of them have severe asthma. Clinics already have loads of prior authorizations to process that often delay care, said Dr. Priya Bansal, a pediatrician and asthma and allergy physician in Illinois. Her practice sees many rural patients and those with chronic disease. 'On any given day, we'll have anywhere from 30, to my highest was 130,' she said. The change interferes with a provider and patient decision on whether in-office or at-home treatment is best for the patient, Bansal said. 'That decision that's supposed to go on between the physician and the patient is getting taken away,' she said. 'If I have a pediatric food allergy patient and they want to get the medication in the clinic, I want to be able to have the flexibility to do that.' States try to rein in health insurers' claim denials, with mixed results The sickest asthma patients are often on biologics, explained Dr. Bridgette Jones, past chair of the American Academy of Pediatrics' drug committee and the American Academy of Allergy Asthma and Immunology's asthma cough diagnosis and treatment panel. 'These are the patients that have failed at other therapies,' said Jones, a pediatric allergy and immunology physician at Children's Mercy Hospital in Missouri. 'Once you're getting to a biologic, it means that your asthma is not under control, having frequent flare-ups.' Black and Indigenous adults and children, as well as Puerto Rican people have higher rates of illness and less access to care. For people who suffer from severe asthma, the typical inhaler is often not enough. The affected drugs can help manage severe, uncontrolled asthma by reducing airway inflammation, While the drugs are approved by the U.S. Food and Drug Administration for self-injecting at home, they also come with risks for the uncommon but life-threatening anaphylaxis. That's why providers typically start patients on these drugs in-office for monitoring. But for at least one of the drugs, Xolair, the reaction can also happen up to a year into treatment. Many families are not comfortable administering biologics to their kids with severe asthma, Jones said. Clinics serving higher-need or underserved populations may often lack the resources to deal with more prior approvals, she added. A recent study by Massachusetts General Hospital and funded by Amgen, which developed Tezspire with AstraZeneca, suggested that in some states, the percentage of asthma patients with severe asthma is higher than 10%. In Texas, for example, about 23% of severe persistent asthma had severe uncontrolled disease. Stateline reporter Nada Hassanein can be reached at nhassanein@ SUPPORT: YOU MAKE OUR WORK POSSIBLE
