Page 10 - Biocon

Biocon's US prospects get a boost after company receives EIR from USFDA

The insulin patent win, clearance of Malaysian unit and oncology biosimilar filing are triggers

Biocon gains 5% as manufacturing unit in Malaysia gets EIR from USFDA

Biocon Sdn Bhd, a subsidiary of Biocon, received the EIR from the USFDA for the pre-approval inspection of its insulin manufacturing facility in Malaysia, for insulin glargine

Build to last

In the second part of a series, the author notes down some lessons for start-ups

Biocon: Fresh biosimilar opportunities to give a boost to its US prospects

The insulin patent win and filing of another oncology biosimilar in the US to drive earnings

Biocon receives EIR from USFDA for good manufacturing practice inspection

"We remain committed to global standards of quality and compliance," company spokesperson said

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