Page 24 - Biocon

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

Biocon falls 8% on heavy volumes

In past one month, the stock was down 21% against 2% decline in Sensex.

Biocon up 9% as breast cancer biosimilar gets USFDA panel nod

The stock soared 8.88% to settle at Rs 399.20 on BSE

Biocon hits record high after US FDA approves new breast cancer drug

The stock surged 10% to Rs 404 on BSE in early morning trade on back of heavy volumes.

Biocon surges 11% ahead of USFDA meet for new drug filing

It touched an intraday high of Rs 360 and an intraday low of Rs 340

Setback for Biocon's European biosimilar plans

French regulator's observations about the formulation facilities will delay product launches

Biocon to address French regulator concerns in a quarter: Mazumdar Shaw

Kiran Mazumdar Shaw, chairman and managing director of Biocon says that India's largest Biopharma company will take remedial measures at its drug product facility within a quarter and ask the French medical regulator to inspect its facility again to get certified for good manufacturing practice (GMP). Biocon has filed for regulatory approvals to market its biosimilars - Trastuzumab and Pegfilgrastim, in the highly regulated European market with the European Medicines Agency (EMA). French National Agency for Medicines and Health Products Safety or ANSM conducted the mandatory site inspections on behalf of EMA as part of its pre approval procedures. "There are no data integrity issues and no product quality issues. The concerns that they have expressed, we are taking remedial measures in short time, within a quarter and as soon as we are ready, we will ask them for a re-inspection," said Shaw. "There will be no material impact"ANSM had conducted audits in March and approved GMP ...

Mazumdar-Shaw appointed to Board of Live Love Laugh Foundation

Welcoming Mazumdar-Shaw, Deepika said mental health is an area that requires sustained effort

Biocon hits three-month low on USFDA observation for Bengaluru facility

The stock hit three-month low of Rs 984 on BSE in intra-day trade

Biocon falls over 10% in five trading days

The stock dipped 5% to Rs 1,031, extending its 6.8% decline in past four trading days on the BSE.