Page 9 - Biocon

Biocon Biologics appoints Kedar Upadhye as new chief financial officer

Current CFO, MB Chinappa will take on a strategic finance role at Biocon Group

Official action indicated for Biocon arm's unit in Malaysia after FDA probe

Biocon Ltd on Wednesday said the US health regulator has classified as 'official action indicated' for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection. The OAI (official action indicated) status may cause delay and/or withholding of pending product approvals or supplements from the facility, Biocon Ltd said in a regulatory filing. "Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Ltd, has received a communication from the US Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Johor, Malaysia," a company spokesperson said in the filing. The USFDA has "determined the inspection classification as 'OAI' (Official Action Indicated). The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility", the spokesperson added. As per the USFDA, OAI implies that the regulator may withhold approval of any pending product

USFDA rejects proposed Biocon's Insulin Aspart application in CRL

Biotechnology major Biocon on Saturday said the US health regulator has issued a complete response letter for Biocon Biologics' application for Insulin Aspart, a proposed biosimilar for diabetes treatment. The US Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) to convey to the company that its initial review of an application is complete, and it cannot approve the application in its present form. "The CRL did not identify any outstanding scientific issues with the product. The CRL references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection (PAI) of our Malaysia facility for Insulin Aspart, held in August 2022," Biocon spokesperson said in a regulatory filing. The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022 that the agency found to be adequate and indicated that it would require a re-inspection of the Malaysia facility prior to the approval of the ..

Biocon, Juno Pharma ink pact for commercialisation of Liraglutide in Canada

Under the agreement's terms, Biocon will be responsible for obtaining regulatory approvals for Liraglutide and will subsequently manage the manufacturing and distribution of the product within Canada

Biocon Biologics gains EU approval for Aflibercept biosimilar, YESAFILI

According to market research firm IQVIA, Aflibercept generated about $1.8 billion in annual sales in the EU in 2022

Stocks to Watch: RIL, RR Kabel, Tata Motors, Bank of Maha, Bharat Dynamics

Stocks to Watch today, September 20, 2023: RR Kabel is set to debut at the stock exchanges on Wednesday, becoming the first entity to make a T+2 listing

Drugmaker Biocon appoints Peter Bains as group CEO effective immediately

Bains, who was named as an independent director of the Biocon board in December last year, stepped down on Monday to assume the top charge, the company said in a statement

Biocon Biologics completes integration of Viatris biosimilars business

Biocon on Wednesday said its arm Biocon Biologics has completed the integration of the acquired biosimilars business from Viatris in North America with effect from September 1, 2023. Since the acquisition agreement closed in November 2022, Biocon Biologics has executed a robust integration plan to ensure a seamless transition of partners, people, systems, and processes, Biocon said in a regulatory filing. In February 2022, Biocon Biologics had inked a pact to acquire Viatris Inc's biosimilars business for a consideration of up to USD 3.33 billion (about Rs 24,990 crore). Later, in November same year the company completed the acquisition. "Our successful North America (US and Canada) transition marks the second wave of our integration of the Viatris biosimilars' business, quickly following Emerging Markets and ahead of schedule," Biocon Biologics CEO & Managing Director Shreehas Tambe said. He further said the company would be leading the commercial operations in the US and Canada

Biocon acquires Eywa Pharma's US-based manufacturing facility for $7.7 mn

Biocon acquires Eywa Pharma's US-based manufacturing facility for $7.7 mn

Stocks to Watch on Aug 14: Adani Ports, Nykaa, Raymond, PSU Banks, Biocon

Stocks to watch on August 14, 2023: Balrampur Chini, Delta Corp, Indiabulls Housing Finance, India Cements, Manappuram Finance and Zee among nine stocks in F&O ban period on Monday.

Biocon Biologics set to integrate Viatris' biosimilars biz ahead of plan

BBL is actively working on raising funds from private equity investors to retire part of the $1.4 billion debt that was incurred due to the acquisition

Biocon Q1 results: Consolidated net profit falls 11% to Rs 148.9 cr

Biocon Ltd on Thursday reported an 11 per cent decline in consolidated net profit at Rs 148.9 crore in the first quarter ended June 30, 2023. The company had posted a consolidated net profit of Rs 167.4 crore in the same quarter last fiscal, Biocon Ltd said in a regulatory filing. Consolidated revenue from operations during the quarter under review stood at Rs 3,422.6 crore as compared to Rs 2,139.5 crore in the corresponding period a year ago, it added. Total expenses were higher at Rs 3,299.2 crore in the first quarter as against Rs 1,977.5 crore in the year-ago period, the company said. On a standalone basis, Biocon said its net profit was at Rs 46.6 crore, up from Rs 14.9 crore in the same quarter previous fiscal. Standalone revenue from operations stood at Rs 513.2 crore as compared to Rs 441.7 crore in the year-ago quarter, the filing said. The company said its board approved the appointment of Nicholas Robert Haggar as an Additional Non-Executive, Independent Director sub

Biocon Biologics announces top leadership appointments including COO

Biocon Biologics Ltd on Friday announced key leadership appointments, including those of Rhonda Duffy as Chief Operating Officer (COO) and Sandeep Athalye as Chief Development Officer. The company, a subsidiary of Biocon Ltd also announced the appointment of David Gibson as its Global Head - Business Development to lead all licensing, strategic partnering and business development activities. He joins the company from GlaxoSmithKline (GSK). Duffy will lead manufacturing, quality and supply chain management. She brings over 30 years of experience in the global pharmaceuticals industry, the company said in a statement. On the other hand, Athalye, who has been with Biocon Biologics for over six years as its Chief Medical Officer, has been elevated to Chief Development Officer to head CMC, clinical development and medical and regulatory affairs, it added. "These new additions to the leadership team bring rich, global experience which will help prepare the organisation for the future and

Biocon Biologics gets positive opinion from EMA for ophthalmology product

Yesafili aims to treat various visual impairments and age-related macular degeneration

Biocon Biologics eyes third of FY24 revenue from emerging markets

BBL, which launched Hulio, a biosimilars version of Abbvie's blockbuster drug Humira, in the US earlier this week, is planning to launch this drug in other countries in the near term

Biocon Biologics expands to over 70 countries, enters emerging markets

Completes integration of the acquired biosimilars business from Viatris

Stelis sells Bengaluru facility to Biocon arm Syngene for Rs 702 cr

Strides's 37 per cent stake in Stelis is valued at Rs 800 cr

F&O Strategy for Biocon: HDFC Securities recommends a Bull Spread

The stock price of Biocon has broken out on the daily chart with higher volumes where it closed at highest level since June 7, 2023

API manufacturing facility in Bangalore receives GMP certificate: Biocon

Shares of Biocon, on Thursday, fell nearly 1% at Rs 241.40 on BSE

Biocon IPO after integration of Viatris market: MD & CEO Shreehas Tambe

'From our perspective, we have operated with a high band and a lower band model'