Latest news with #Osimertinib
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Business Standard
30-05-2025
- 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.
Hans India
30-05-2025
- Health
- Hans India
AstraZeneca gets CDSCO nod for lung cancer drug
New Delhi: AstraZeneca India Pharma on Thursday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) for Osimertinib tablets in strength of 40mg and 80mg. The approval marks a critical step forward with Osimertinib as monotherapy in the treatment of patients with locally advanced, unresectable (Stage III) non-small cell lung cancer, it added.
Newsweek
24-05-2025
- Health
- Newsweek
It All Started With Shoulder Pain, Then Came My Shocking Diagnosis
Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. It started with a dull ache in my right shoulder. At first, I chalked it up to bad posture or sleeping funny. Then came a strange popping sound when I rotated it. Within weeks, the pain crept into my shoulder blade and neck, persistent and disruptive—especially at night. After a few months later in October 2023, with no relief and worsening sleep, I visited a chiropractor. That is when the well-meaning theories began. "It's probably stress." "Sounds like a rotator cuff issue." "It's likely nothing serious." But, deep down, I knew something was wrong. My instincts were screaming. Two screenshots from the viral video showing Reyna Savage in hospital making a "peace sign." Two screenshots from the viral video showing Reyna Savage in hospital making a "peace sign." Instagram/@savagelatinalungs Still, the path to answers was long and winding. My chiropractor eventually referred me to an orthopedic doctor. X-rays showed nothing abnormal, so I was sent to physical therapy. But, instead of improving, the pain intensified—spreading into my mid-back and becoming unbearable at night. I finally insisted on seeing a neurologist. I remember telling him: "Something is really wrong." He agreed to order both an X-ray and an MRI. That MRI changed everything. There it was—a mass in my right lung. Two X-rays showing the mass on Savage's right lung. Two X-rays showing the mass on Savage's right lung. Instagram/@savagelatinalungs A chest CT followed. I held my breath through every scan, clinging to hope. But the results confirmed our fears: the mass was consistent with lung cancer. A biopsy soon after revealed the full picture—Stage IV non-small cell lung cancer, the second-most common form in America, already spread to my bones, adrenal gland, and lymph nodes from neck to abdomen. I'll never forget the words: "You have incurable Stage IV cancer. We can't cure it—only try to manage symptoms and slow the spread." The diagnosis shattered my world—but it also lit a fire in me to fight for my life and my family. All I could think about was my children, Dominic, then 6, and Olivia, 4, growing up without their mom; my husband, Marco, then 37, facing this alone. I was devastated—but I also knew I had to fight. Treatment was grueling. My cancer had invaded my bones, causing excruciating pain. My right lung was 50 percent filled with fluid. I underwent a pleurodesis to drain it—a painful procedure with a slow, difficult recovery. Surgery was off the table—the cancer had spread too far. But genetic testing revealed I had a protein located on the surface of cells that helps them grow called epidermal growth factor receptor mutation. This meant I could start targeted therapy—a daily pill that homes in on cancer cells called Osimertinib. Within weeks, the transformation was astounding. After six to eight weeks, scans showed remarkable improvement. I was cleared to start chemotherapy. It wasn't easy. My blood counts plummeted. There were setbacks. But just before my final round, a PET scan delivered the miracle I'd been praying for: I was cancer-free. I'll never forget ringing the bell. I didn't know at first that it symbolized the end of treatment. In my mind, it meant something bigger—health, wholeness, life. Every night before bed, I visualized myself at that bell, my husband and children beside me, clapping and cheering. That moment came true on December 27, 2024. Today, I feel stronger than ever—physically and emotionally. I listen to my body, I rest, and I protect my peace. I've learned the power of boundaries and the importance of prioritizing my health. Emotionally, I'm the happiest I've ever been. Every day feels like a gift. I'm not just surviving—I'm thriving. I've found purpose in sharing my story on Instagram @savagelatinalungs, in lifting others who are walking a similar path. Cancer changed everything. But it also gave me clarity, strength, and a voice I didn't know I had. Reyna Savage is a 35-year-old director in Project Management, who lives in Fort Lauderdale, Florida.
Yahoo
20-05-2025
- Business
- Yahoo
CCM Biosciences Announces Presentation of Data on its First-In-Class NSCLC Drug Program at ASCO 2025
Company's NSCLC drug program is focused on overcoming both mutational and non-mutational resistance to 3rd-generation EGFR inhibitors and outperforms other investigational 4th-generation inhibitors in a wide range of drug resistance models. MOUNT LAUREL, N.J., May 20, 2025--(BUSINESS WIRE)--CCM Biosciences, a diversified pharmaceutical discovery and development company, today announced the upcoming presentation of its 4th-generation EGFR inhibitor drug program for non-small cell lung cancer (NSCLC) at the 2025 Annual Conference of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3 in Chicago. NSCLC, which accounts for 80% of lung cancer, is the most common cause of cancer death worldwide. Epidermal growth factor receptor (EGFR)-activating mutations (Del19 or L858R) are major oncogenic drivers of NSCLC. EGFR-positive NSCLC accounts for approximately 30% of all diagnosed cases of NSCLC (a similar market size to PD-L1-positive NSCLC, which is addressed by the world's top-selling drug, Keytruda®). The current standard of care for EGFR-positive NSCLC is comprised of 3rd-generation inhibitors, most notably Osimertinib (Tagrisso®), whose annual sales exceed $6 billion. Most patients treated by tyrosine kinase inhibitors (TKIs) will eventually develop resistance mutations including the T790M gatekeeper mutation. Osimertinib, a 3rd-generation covalent TKI, is efficacious against the T790M resistance mutation and prevents its onset if administered as first line therapy. However, treatment with Osimertinib inevitably induces additional mutations, especially the C797S mutation, as well as various off-target resistance mechanisms. To date, there are no approved therapies capable of overcoming mutational or non-mutational resistance to 3rd-generation TKIs. As such, there is an urgent unmet medical need to develop next-generation EGFR inhibitors that overcome these forms of resistance. While billions of dollars have been invested over the last several years on the development of 4th-generation EGFR inhibitors that overcome tumor resistance to 3rd-generation inhibitors, due to the diversity of resistance mechanisms, these inhibitors have failed to progress beyond early-stage clinical trials. At ASCO 2025, CCM Biosciences' presentation "Novel, potent and selective fourth-generation inhibitors targeting EGFR for NSCLC therapy" in the Lung Cancer – Non-small cell – Metastatic session (Abstract #: 8622, will report novel 4th-generation, orally bioavailable EGFR inhibitors (CCM-205, CCM-245 and CCM-308) that can overcome both on-target and off-target resistance in lung cancer models, significantly outperforming the aforementioned 4th-generation inhibitors in the face of resistance to 3rd-generation inhibitors, and have significant potential clinical applications. In addition to their potent activity as monotherapies, CCM-205 and CCM-245 are highly efficacious in combination with 3rd-generation EGFR inhibitors as well as anti-EGFR antibodies, neither of which can maintain or regress tumor volume in the presence of resistance as monotherapies. CCM Biosciences is advancing clinical candidates from its EGFR inhibitor program to investigational new drug (IND) filing this year for entry to clinical trials. The company is actively partnering with biotechnology and pharmaceutical companies for co-development rights in selected countries. CCM Biosciences, a sister company of the global chemical and pharmaceutical services company PMC Group, Inc., is also a Featured Exhibitor at ASCO 2025 -- -- and will be showcasing both its drug programs and the state-of-the-art platforms used to discover and develop them. About CCM Biosciences CCM Biosciences is a diversified biotechnology company dedicated to discovering and developing novel drugs, including small molecules, gene therapies, biologics, and nanomedicines within multiple corporate subsidiaries. CCM's patented drug discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, Physical Review, American Chemical Society journals, Biophysical Society journals and Nature Publishing Group journals. These platforms are complemented by the contract research, development, and manufacturing organizations (CRDMO) at PMC Group, the sister company of CCM Biosciences and a global chemical and pharmaceutical company with ~$1 billion in annual revenue, enabling fully integrated drug discovery and development. View source version on Contacts Anisha Ghosh anisha@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
National Post
20-05-2025
- Business
- National Post
CCM Biosciences Announces Presentation of Data on its First-In-Class NSCLC Drug Program at ASCO 2025
Article content Company's NSCLC drug program is focused on overcoming both mutational and non-mutational resistance to 3 rd -generation EGFR inhibitors and outperforms other investigational 4 th -generation inhibitors in a wide range of drug resistance models. Article content Article content MOUNT LAUREL, N.J. — CCM Biosciences, a diversified pharmaceutical discovery and development company, today announced the upcoming presentation of its 4th-generation EGFR inhibitor drug program for non-small cell lung cancer (NSCLC) at the 2025 Annual Conference of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3 in Chicago. Article content NSCLC, which accounts for 80% of lung cancer, is the most common cause of cancer death worldwide. Epidermal growth factor receptor (EGFR)-activating mutations (Del19 or L858R) are major oncogenic drivers of NSCLC. EGFR-positive NSCLC accounts for approximately 30% of all diagnosed cases of NSCLC (a similar market size to PD-L1-positive NSCLC, which is addressed by the world's top-selling drug, Keytruda®). The current standard of care for EGFR-positive NSCLC is comprised of 3 rd -generation inhibitors, most notably Osimertinib (Tagrisso®), whose annual sales exceed $6 billion. Most patients treated by tyrosine kinase inhibitors (TKIs) will eventually develop resistance mutations including the T790M gatekeeper mutation. Osimertinib, a 3rd-generation covalent TKI, is efficacious against the T790M resistance mutation and prevents its onset if administered as first line therapy. However, treatment with Osimertinib inevitably induces additional mutations, especially the C797S mutation, as well as various off-target resistance mechanisms. To date, there are no approved therapies capable of overcoming mutational or non-mutational resistance to 3rd-generation TKIs. As such, there is an urgent unmet medical need to develop next-generation EGFR inhibitors that overcome these forms of resistance. While billions of dollars have been invested over the last several years on the development of 4 th -generation EGFR inhibitors that overcome tumor resistance to 3 rd -generation inhibitors, due to the diversity of resistance mechanisms, these inhibitors have failed to progress beyond early-stage clinical trials. Article content At ASCO 2025, CCM Biosciences' presentation 'Novel, potent and selective fourth-generation inhibitors targeting EGFR for NSCLC therapy' in the Lung Cancer – Non-small cell – Metastatic session (Abstract #: 8622, will report novel 4 th -generation, orally bioavailable EGFR inhibitors (CCM-205, CCM-245 and CCM-308) that can overcome both on-target and off-target resistance in lung cancer models, significantly outperforming the aforementioned 4 th -generation inhibitors in the face of resistance to 3 rd -generation inhibitors, and have significant potential clinical applications. In addition to their potent activity as monotherapies, CCM-205 and CCM-245 are highly efficacious in combination with 3 rd -generation EGFR inhibitors as well as anti-EGFR antibodies, neither of which can maintain or regress tumor volume in the presence of resistance as monotherapies. Article content CCM Biosciences is advancing clinical candidates from its EGFR inhibitor program to investigational new drug (IND) filing this year for entry to clinical trials. The company is actively partnering with biotechnology and pharmaceutical companies for co-development rights in selected countries. CCM Biosciences, a sister company of the global chemical and pharmaceutical services company PMC Group, Inc., is also a Featured Exhibitor at ASCO 2025 — — and will be showcasing both its drug programs and the state-of-the-art platforms used to discover and develop them. Article content CCM Biosciences is a diversified biotechnology company dedicated to discovering and developing novel drugs, including small molecules, gene therapies, biologics, and nanomedicines within multiple corporate subsidiaries. CCM's patented drug discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNAS, Nucleic Acids Research, Physical Review, American Chemical Society journals, Biophysical Society journals and Nature Publishing Group journals. These platforms are complemented by the contract research, development, and manufacturing organizations (CRDMO) at PMC Group, the sister company of CCM Biosciences and a global chemical and pharmaceutical company with ~$1 billion in annual revenue, enabling fully integrated drug discovery and development. Article content Article content Article content Article content Article content Article content
