Page 11 - Biocon

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

Investors cheer Biocon progress; stock gains 230% in past two years

Bengaluru-based Biocon has added Rs 21,000 crore in market value over the past couple of years, its stock jumping 230 per cent to Rs 512 a share on Monday. Well in contrast to the 22 per cent drop in the Nifty pharma index. As the US government takes steps to bring down drug prices, stocks of Indian pharmaceutical suppliers dropped. For instance, Sun Pharmaceutical lost 30.5 per cent in this period, wiping away Rs 56,000 crore in market value for investors.Investors' love for Biocon, the biosimilars maker, has not come easily. For, developing a copycat version of biologic drugs is far more expensive and takes much longer than developing a generic version of chemical drugs. Biocon was for long a laggard in the Indian pharma pack. A five-year analysis of Indian pharma stocks showed it grew 61 per cent in the first three years, much below the 98 per cent achieved by the Nifty Pharma.Analysts estimate the cost of developing a generic drug rarely exceeds $5 million (Rs 32 crore) or takes ..

Biocon surges 14% on USFDA approval for biosimilar of cancer drug Herceptin

The stock surged 14% to Rs 510, also its all-time high on the BSE in early morning trade on back of heavy volumes.

Nod for Trastuzumab will open lot of markets: Kiran Mazumdar-Shaw

Kiran Mazumdar Shaw is the chairperson and managing director of Biocon , the company which recently received US Food and Drug Administrator's approval for its anti cancer drug Trastuzumab

Biocon secures nod for its first biosimilar in US

A biosimilar is a copy of an innovator biologic drug and is made of living cells

Triggers falling into place for Biocon

May start monetising its biosimilars by FY19, 30-40% jump in profit likely

Biocon's branded business gets a boost with anti-cancer drug

At present, Biocon sells branded formulations, including biologics and biosimilars, in India and the UAE

Biocon gains over 7% after receiving EIR from USFDA

The stock surged 7% to Rs 420 on the BSE in early morning deal, trading close to its 52-week high of Rs 424 touched on July 19, 2017 in intra-day trade

Biosimilar can boost Biocon sentiment

Weak Q2 results led to downward revision of estimates

Biocon up 5% as USFDA issues CRL for proposed Biosimilar

The stock moved higher by 5.5% to Rs 363 on BSE in noon deal after the company said the USFDA has issued a Complete Response Letter (CRL) for proposed Biosimilar Pegfilgrastim.

Biocon receives CRL from USFDA for anti-cancer drug

Biotechnology firm Biocon today said the US health regulator has issued complete response letter (CRL) for proposed biosimilar Pegfilgrastim, indicated for use in the treatment of cancer. The company, however said it does not expect this CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the US. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan. "The U.S. Food and Drug Administration has issued a complete response letter (CRL) for Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim," Biocon said in a regulatory filing. It further said: "The CRL relates to the pending update of the BLA with certain CMC data from facility requalification activities post recent plant modifications. The CRL did not raise any questions on biosimilarity, pharmacokinetic/ pharmacodynamic data, clinical data or immunogenicity". "We do not expect this CRL to impact the commercial ..

Biocon gains as insulin facility in Malaysia gets GMP nod

The stock was up 5.3% to Rs 353 on BSE in early morning trade.

Biocon's Malaysian arm gets EU certification for insulin facility

Biocon's Malaysia facility was inspected by the European Medicines Agency (EMA) in April 2017