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.
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Business Standard
2 days ago
- Business Standard
Servier India introduces 'Ivosidenib'(Tibsovo®), in India, First-in-class Targeted Therapy in Oncology for Rare IDH1-Mutated AML and Cholangiocarcinoma
VMPL Mumbai (Maharashtra) [India], June 5: Servier India, a subsidiary of the leading French pharmaceutical Servier Group, today announced the launch of Ivosidenib (Tibsovo®), an oral targeted therapy approved in the management of cancer patients with Acute Myeloid Leukemia (AML) and Cholangiocarcinoma, with an isocitrate dehydrogenase-1 (IDH1) mutation. Servier India received the approval on 14th May 2025, from Central Drugs Standard Control Organisation (CDSCO) for the import, sale, and distribution of the medication. Acute myeloid leukemia is a challenging hematological malignancy. Studies indicate that only about 30-40% of AML patients in India receive adequate treatment1, with high mortality rates due to rapid disease progression and infections. Cholangiocarcinomas (CCA) are rare tumours originating from bile duct. Due to their asymptomatic nature they are usually diagnosed when the disease is advanced.2 The announcement marks a significant advancement in management of the mentioned rare and difficult-to-treat cancers in India, addressing a critical unmet medical need. Speaking on the occasion, Mr. Aurelien Breton, Managing Director, Servier India, said, "Our focus is to advance oncology care by bringing innovative, precision medicines to patients who need them the most. By prioritizing access and working to make treatment options affordable to patients, we are dedicated to bridging critical gaps in cancer care across the country. This launch is a significant step forward in our mission to support healthcare providers with targeted treatment options and ultimately improve survival outcomes and quality of life for patients throughout India." IDH1 mutation occurs in approximately 7-14% of AML patients in India3, making targeted mechanisms especially relevant for this subset. "This therapy represents a significant therapeutic option in the treatment of AML and Cholangiocarcinoma. For healthcare professionals, this precision therapy offers a new, effective option that can improve patient outcomes where traditional treatments have limited success. It highlights the benefits of targeted therapy and caliber of innovation in enhancing lives and advancing cancer care in India.", highlighted Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India. Speaking on the importance of treatment access, Ms. Pratima Tripathi, Commercial Director, Servier India, said: "Our foremost priority is to ensure that the therapy is accessible and affordable to patients across India. We are actively collaborating with healthcare providers, patient advocacy groups, and policymakers to remove barriers and facilitate timely access to this important therapy. Through these partnerships, we are committed to expanding treatment options and making a meaningful difference in the lives of patients." By introducing these advanced therapies, Servier India reaffirms its commitment to advancing innovative cancer treatments that improve clinical outcomes and enhance the quality of life of patients. Disclaimer: This press release is intended solely to share regulatory and medical information regarding the launch; the reference to "Tibsovo" is not intended as a promotional or public advertisement. Use of the therapy is strictly based on a doctor's prescription and clinical discretion. About Servier India Servier India has been committed for over three decades to delivering innovative pharmaceutical solutions that improve the lives of patients and their families across India. Established in 1985 as an affiliate of the leading independent French pharmaceutical Servier Group, the company focuses on therapeutic areas such as Cardiometabolism, Neuroscience, Venous Diseases, and Oncology. Servier India has a strong pan-India presence and a dedicated workforce of around 580 that strives to address critical healthcare challenges with passion and purpose. As part of Servier group operating in over 150 countries, Servier India inherits a rich legacy of scientific excellence and patient-centric innovation. Globally, Servier invests heavily in research and development, focusing on our key therapeutic areas. About Servier Servier is a global pharmaceutical group governed by a Foundation that aspires to serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. As a world leader in cardiometabolism and venous diseases, Servier's ambition is to become a focused and innovative player in oncology by targeting rare cancers. Headquartered in France, Servier relies on a strong geographical footprint; its medicines are available in close to 140 group achieved a revenue of EUR5.9 billion in 2024. Additional Details on Ivosidenib Internationally, Ivosidenib has already received regulatory approvals in more than 42 countries, including the USA, Europe, China, UAE, and South Korea. In the United States, the US FDA approved it in 2019 as a monotherapy and later in May 2022 as a combination treatment with Azacitidine for patients aged 75 and above, or those who cannot tolerate intensive chemotherapy. The European Medical Agency (EMA) gave its approval in May 2023 for use in patients who are not fit for standard induction chemotherapy. In India, the process moved forward in April 2025, when the Subject Expert Committee (SEC) gave a positive recommendation for Ivosidenib. Following this, the DCGI granted approval for the marketing authorization in May 2025
News18
4 days ago
- News18
‘Not A Regulatory Body': Indian Pharmacopoeia Clarifies It Only Sets Standards For Drugs, Doesn't Enforce Them
Last Updated: The clarification comes in the wake of increased global scrutiny of Indian-made drugs The Indian Pharmacopoeia Commission (IPC) has issued a clarification on its role amid growing concerns over impurities in medicines and the quality of drug manufacturing in India, News18 has learnt. In a notice issued by the apex authority titled 'Clarification on impurity limits published in the Indian Pharmacopoeia", it mentions that the IPC 'is in receipt of enquiries from various stakeholders…" and hence, it has been issuing the clarification. The IPC, which is responsible for setting the official quality standards for medicines in India, made it clear that while it defines the standards for impurities in drugs, it is not involved in approving or regulating new medicines. It said that responsibility lies with regulatory bodies like the CDSCO (Central Drugs Standard Control Organisation) and State Licensing Authorities. Both government departments, the Indian Pharmacopoeia Commission (IPC) and the apex regulatory agency, CDSCO, are headed by Dr Rajeev Singh Raghuvanshi. Impurities are small amounts of unwanted substances that may be present in a drug. While some impurities are acceptable within strict limits, their control is crucial to ensure the safety and effectiveness of medicines. The IPC sets impurity limits based on global standards and scientific data submitted by drug manufacturers. These limits are meant to serve as guidelines for making safe medicines, but final approval is always in the hands of the drug regulators. 'The IPC is an autonomous institution under the Ministry of Health & Family Welfare that is solely responsible for setting official drug standards… The IPC does not have any role in the regulatory review and approval of new drugs in India…the CDSCO and/or state licensing authorities are competent to take regulatory decisions." The clarification comes in the wake of increased global scrutiny of Indian-made drugs. Experts had raised questions about whether the IP includes adequate impurity limits for commonly used medicines. However, IPC, in the notice, has reiterated that it works in a consultative and advisory capacity, not as a regulator or certifying body. 'Impurities may be considered by the regulatory authority, provided it is supported with valid scientific justification and relevant data," it said. The notice, signed by Raghuvanshi, also pointed out that 'it is clarified that, in any case, the IPC does not have the mandate to approve or endorse impurity specifications…" Moreover, it added, 'the IPC, being a standard-setting organisation, is also not responsible to express opinion or recommendation in such regulatory matters." In fact, it has asked drug-makers and stakeholders 'to engage with the IPC by submitting scientific evidence to support monograph revisions, wherever required, to promote harmonisation with global standards". First Published: June 04, 2025, 10:26 IST
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Business Standard
5 days ago
- Business Standard
Biocon share price pops 2% on CDSCO nod for diabetes drug; key details here
Biocon share price: Bengaluru-based biopharmaceutical company Biocon shares were in demand in a weak market on Tuesday, June 3, 2025, with the stock rising up to 1.85 per cent to hit an intraday high of 340.25 per share. However, at 11:00 AM, Biocon share price was trading 0.49 per cent higher at 335.70 per share. What is the reason behind the uptick in Biocon share price? Biocon's share price saw an uptick following key regulatory approvals in India for its Liraglutide drug. The company received approval from the Central Drugs Standard Control Organisation (CDSCO) for its Liraglutide drug substance, while its wholly owned subsidiary, Biocon Pharma, secured approval for the Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge). Liraglutide is a synthetic analog of the GLP-1 peptide and is administered as a once-daily injection. It is a generic version of Victoza and is indicated for the treatment of Type 2 Diabetes Mellitus in adults, adolescents, and children aged 10 years and older, as an adjunct to diet and exercise. The original formulation was approved in the EU in 2009 and in the US in 2010. The approvals were granted under the CDSCO's recently introduced 101 route, which recognises approvals from established global regulatory authorities, streamlining the approval process in India. Siddharth Mittal, chief executive officer and managing director, Biocon, said: 'The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes. India has one of the highest numbers of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further. The approval enables us to address a critical need by making this drug available, and aligns with Biocon's mission to provide affordable, lifesaving medications to those who need it the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India'' 'With GLP-1 therapies projected to be a substantive future growth driver for Biocon, the Company remains committed to reinforcing its position as a key player in this area,' Biocon said, in a statement. Biocon Q4 results Biocon reported a strong financial performance for the fourth quarter of FY25, with consolidated net profit surging 153 per cent year-on-year (Y-o-Y) to ₹344 crore, up from ₹136 crore in the same quarter last year. Profit before tax (PBT) rose 53 per cent Y-o-Y to ₹487 crore. The company's Board also approved plans to raise up to ₹4,500 crore through various funding options, including qualified institutional placement (QIP), rights issue, or other permissible methods. The robust growth was driven by solid performance across its generics, biologics, and research services segments. Total consolidated revenue for the quarter stood at ₹4,454 crore, compared to ₹3,966 crore in Q4 FY24. Ebitda rose 16 per cent to ₹1,115 crore, with the margin maintained at 25 per cent. READ MORE About Biocon Biocon is a global biopharmaceutical company focused on developing and supplying affordable therapies for chronic diseases such as diabetes, cancer, and autoimmune disorders. The company manufactures and markets novel biologics, biosimilars, complex small molecule APIs, and generic formulations across India, the US, Europe, and other key markets. It is also advancing a pipeline of novel immunotherapy assets.
