Page 22 - Biocon

USFDA completes inspection of Biocon's Telangana plant, finds no fault

A Form 483, is issued by the USFDA to notify a company's management of any objectionable condition at its manufacturing facility

Biocon aims to be global biopharma leader in 20 yrs: Kiran Mazumdar-Shaw

' While the company's insulin business recorded a strong growth in several emerging markets, its cancer biosimilar Fulphila became the first pegfilgrastim biosimilar to be available to patients in US

Biocon's Malaysia insulin facility on the path to break even in FY19

Insulin Glargine is the first biosimilar from India to be approved and launched in Japan

Biocon: Biosimilar launches prop up Q2 show; healthy returns seen in future

The strong momentum is likely to continue, led by biosimilars and steady show of other segments

Biocon one step closer to Europe nod for biosimilar of breast cancer drug

Firm obtains positive opinion on approval of Ogivri, a biosimilar to Roche's Herceptin (trastuzumab); final decision by year-end

Biocon hits new high; stock zooms 109% in one year

The stock hit a new high of Rs 718, rallying 8% in two days after the company's drug substance manufacturing site at Bengaluru campus by the US health regulator has concluded without any observations.

Biocon and Mylan's cancer biosimilar gets CHMP nod for approval in EU

The CHMP opinion for the drug to be sold under the named Fulphila will now be considered by the European Commission and the decision on approval is expected by November

Biocon targets $200 mn revenue from biosimilars on the back of EMs growth

The approval of Biocon's biosimilar insulin Glargin in about 25 countries will be a revenue driving force

Biocon Q1 net profit up 47% on strong biologics, research services business

The company gained market share in several emerging markets such as Malaysia, Algeria and UAE

For Biocon, regulatory nod to give boost to biosimilar monetisation

EU's clearance to firm's Bengaluru plant increases chances of its drug approval, launches

Biocon receives USFDA report on closure of inspection for Bengaluru unit

Biocon said that it is committed to global standards of quality and compliance in a BSE filing after receiving the Establishment Inspection Report

Biocon shares hit record high as cancer drug Pegfilgrastim gets USFDA nod

The stock hit a record high of Rs 695, up 6% on the BSE in opening deal in otherwise weak market.

Biocon sells 2% stake in Syngene for Rs 2.3 bn through open-market sale

In a separate filing, Syngene said Biocon has sold the shares for achieving minimum public shareholding requirement

Biocon dips 4% on seven USFDA observations for Bengaluru drug facility

The stock dipped 4% to Rs 634 on the BSE in early morning trade.

The obvious opportunity is biosimilars, says Biocon's Kiran Mazumdar-Shaw

A month ago, Biocon announced that its biosimilar insulin glargine trademarked as Semglee received marketing approval from the European Commission

Biocon: Monetisation of drug pipeline in emerging markets to boost earnings

While Biocon's Mylan partnership is accruing benefits, its Sandoz pact will be a long-term strategic move to strengthen its biosimilar pipeline

Biocon gets 6 USFDA observations for Malaysia facility, shares down 2%

Shares of Biocon were trading at Rs 561.30 apiece in the morning trade, down 1.93 per cent, from the previous close on BSE

Biocon hits record high on collaboration with Sandoz

The stock hit a record high of Rs 564, up 4% on NSE after the company entered into a global partnership with Sandoz to develop, manufacture and commercialise multiple biosimilars.

Biocon, Sandoz partner for immunology and cancer biosimilars' development

Second large global tie-up for an Indian company after Mylan

Biocon gets shareholders' nod for transfer of biosimilars business

The regulatory filing to the BSE added that Biocon Biologics India is a step down wholly owned subsidiary of the company