Page 8 - Biocon

Biocon, Mylan win patent case for insulin device against Sanofi in US

Development takes Biocon a step closer to commercialise its glargine biosimilar Semglee in America

Biocon partner's Cancer drug licence application gets USFDA approval

The application sought approval of Mylan's drug for treatment of patients with metastatic colorectal cancer with fluorouracil-based chemotherapy

USFDA accepts Biocon-Mylan's Avastin biosimilar application for review

The application seeks approval of biosimilar bevacizumab for treatment of patients with metastatic colorectal cancer in addition to other ailments

USFDA accepts proposed biosimilar application by Mylan, Biocon for review

The application seeks approval of Bevacizumab for the first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy

Biocon gets two observations from USFDA for Bengaluru-based API plant

Biocon shares on Thurday ended 0.17 per cent up at Rs 299.20 apiece on the BSE.

Biocon hits 52-wk high as Malaysian unit gets 3 observations from US FDA

The stock of India's biggest biotechnology company was trading higher for the third straight day, and has surpassed it's previous high of Rs 321 touched on February 15, 2019 in the intra-day trade.

Biocon gets 3 observations from US health regulator for Malaysia facility

The FDA has set a target action date for its Insulin Glargine application in June 2020

Kiran Mazumdar-Shaw wins EY Entrepreneur of the Year award for 2019

Awards announced for nine other categories; Adi Godrej gets Lifetime achievement award

Multiple growth levers for Biocon; ramp-up, new biosimilars to boost profit

Ramp-up and new biosimilars should help boost profit

USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facility

Biocon Ltd on Monday said the US health regulator conducted a pre-approval inspection and good manufacturing practice (GMP) examination of the API manufacturing facility and has issued a Form 483, with five observations. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. "The US Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) and GMP inspection of the Active Pharmaceutical Ingredients (API) manufacturing facility of Biocon Ltd," Biotechnology major said in a filing to BSE. At the conclusion of the inspection of the Bengaluru facility, which took place between January 20-24, 2020, the agency issued a Form 483, with five observations, the filing said. "We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of ...

US to lead Biocon Biologics' drive towards $1 billion revenue

The company is uniquely positioned in the US as it is the only Indian pharmaceutical firm with two commercialised biosimilars in the market

Biocon's pre-tax profit rises 9% to Rs 315 crore in Oct-Dec quarter

The consolidated Ebitda margin stood at 27% in Q3FY20.

Stocks that Prabhudas Lilladher is bullish on: Buy Biocon, Eicher Motors

Biocon has maintained a strong base near 280 levels which is a good support level and currently has indicated a positive bullish candle pattern to imply strength

True North to invest Rs 536.25 crore in Biocon Biologics for 2.44% stake

This values Biocon Biologics at Rs 21,450 crore or around $3 billion, on a pre-money equity basis

Why CMD role separation remains a work in progress despite deadline nearing

Sebi, in its October 2017 report on corporate governance, said listed firms should have a different person heading the management and another in place as chairman of the board

US launch of second oncology biosimilar to boost Biocon's earnings

Even as the Street will monitor product ramp-up, commercialisation of more biosimilars will drive prospects further

Biocon elevates Chief Financial Officer Siddharth Mittal as Joint MD & CEO

Mittal takes over from Arun Chandavarkar, who retired on November 30 after 29 years at Biocon

Siddharth Mittal succeeds Arun Chandavarkar as CEO, Joint MD of Biocon

Bengaluru-headquartered biopharmaceuticals company Biocon Ltd on Tuesday said Siddharth Mittal has taken over as its chief executive officer and joint managing director. "Siddharth Mittal has taken over as Chief Executive Officer & Joint Managing Director of the company starting December 1, 2019," the company said in a BSE filing. Mittal has been serving as Chief Financial Officer (CFO) of Biocon since August 2014, the filing said. Mittal takes over from Arun Chandavarkar who retired as chief executive and joint MD of the company on November 30. "I am very pleased to welcome Siddharth as CEO & Joint MD of Biocon," Biocon CMD Kiran Mazumdar-Shaw said.

Biocon climbs 5% on launch of Ogivri biosimilar in US market

Ogivri is used to treat breast cancer and gastric cancer and Biocon has regulatory approval to sell it in more than 80 countries worldwide.

Biocon and Mylan launch Trastuzumab biosimilar Ogivri in US market

Ogivri will be launched at a competitive discount for customers to help ensure access and increase treatment options for patients