Syngene plans to expand its capacity and capabilities at its Bangalore and Hyderabad campuses to meet anticipated long-term demand
Refinancing will improve liquidity and help in reinvestment, says company
Zydus Lifesciences on Saturday said it has received approval from the US health regulator to produce generic prostate cancer treatment drug. The company has received approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide capsules (40 mg), it said in a regulatory filing. Enzalutamide capsules are androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer. The drug will be produced at the group's manufacturing site in Moraiya, Ahmedabad, Zydus said. As per IQVIA MAT July 2024 data, Enzalutamide capsules (40 mg) had annual sales of USD 869.4 million in the US. The group now has 400 approvals and has filed over 465 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.
Biocon Ltd on Thursday said it has signed a licensing and supply agreement with Tabuk Pharmaceutical Manufacturing Company to commercialise its 'GLP-1' products for treating diabetes and chronic weight management in select countries of the Middle East. Under the agreement, the company will develop and manufacture the products and Tabuk Pharmaceuticals -- a fully-owned subsidiary of Astra Industrial Group, a leading pharmaceutical company in the Middle East and North Africa (MENA) region, will hold the marketing authorisation rights, and be responsible to register, import and promote them in the region, Biocon said in a regulatory filing. The agreement also provides for a provision to expand to other 'GLP' products, as well as the option of a tech transfer that will enable localised manufacturing at a later stage, it added. The partnership with Tabuk Pharmaceuticals paves the way for the company's vertically integrated, complex GLP1 formulations entry into Saudi Arabia and other ...
Two Phase 3 studies have demonstrated that patients can safely switch between adalimumab, a well-known biologic therapy, and its biosimilar, adalimumab-fkjp
Biotechnology firm Biocon said its subsidiary has received approval from the US health regulator to market a generic medication to treat chronic heart failure. Biocon Pharma has received approval of its ANDA for Sacubitril/Valsartan Tablets, in 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths, from the US Food and Drug Administration (USFDA), the company said in a regulatory filing. Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The medicine is also used to treat paediatric patients over the age of one year. The approval further adds to Biocon's portfolio of vertically integrated, complex drug products, the company said.
Agreement clears way for Indian company to launch treatment in Europe, Canada and other markets
Biocon Biologics on Thursday said it has inked a pact with Janssen for launching a biosimilar medication for the treatment of autoimmune diseases in Europe, the United Kingdom, Canada, and Japan. The company, a subsidiary of Biocon Ltd, has inked a settlement and licence agreement with Janssen Biotech Inc, Janssen Sciences Ireland, and Johnson & Johnson. This agreement clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara. As per the terms of the settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in Europe, the UK, Canada, and Japan, the company said in a statement. Regulatory filings in these markets are currently under review, it added. Biocon Biologics had earlier announced a settlement agreement in the US for Bmab 1200 launch no later than February 22, 2025, once approved by the USFDA. The US health regulator has accepted the company's Biologics License Application (BLA) for Bmab 1200 for ...
Kiran outlines how being vertically integrated puts Biocon in a strong position
Bevacizumab is used to treat colon and rectal cancer, cervical cancer etc
Biocon's generics would join at least 15 other generics or biosimilars in development by Chinese drugmakers ahead of an expiry of patent protection on semaglutide
Bengaluru-based company announces 'strategic partnership' with Handok
European markets closed on a negative note, with Germany's DAX falling 0.22 per cent and the UK's FTSE dropping 0.09 per cent
Peter Bains discusses their efforts to gain market share in key regions, the impact of lower active pharmaceutical ingredient prices, and growth plans for biosimilars and generics
Company says approval is a 'significant milestone' and marks entry in new therapeutic area in the US
Biocon has re-appointed Kiran Mazumdar Shaw as an Executive Director of the company for a further period of 5 years starting April 2025
Biocon Q4FY24 results: The company board has recommended a final dividend at the rate of 10 per cent i.e. Re. 0.50 per equity share
Q4 FY24 company results: Dixon Technologies, Jindal Stainless, Power Finance Corporation, Thomas Cook will also release their financial results
Nifty50 outlook: On the downside, the 21,850-22,150 zone is anticipated to provide support. Traders are advised to maintain caution
Syngene International shares ended the day's trade on BSE at Rs 694.2 apiece, down one per cent