Page 14 - Biocon

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.

Biosimilars portfolio monetisation key for Biocon

Biocon's results for the quarter ending March 2017 was muted due to longer timelines for product approvals in some emerging markets, discontinuance of some in-licensed products and impact of the fire at Syngene, its subsidiary.The research arm, Syngene, which contributed about 30 per cent to overall sales, saw a 14 per cent year-on-year decline in business in March quarter as a fire incident in December last year led to a temporary disruption. The small molecules and biologics business, contributing about half to revenues, also saw flat sales. Only branded formulations saw good growth of 25 per cent, but since it forms only 15 per cent of revenues, it was not enough to prevent overall sales from declining two per cent year-on-year to Rs 925 crore. Bloomberg consensus estimates had pegged revenues at Rs 1,061 crore.With lower sales, Ebitda at Rs 182 crore came significantly lower than estimates of Rs 253 crore. So did net profit, which at Rs 127 crore missed consensus estimates of Rs ..

Biocon Q4 net up 75% at Rs 135 cr

Issues bonus shares in the ratio of 2:1

Biocon board to consider bonus issue today; shares jump nearly 10%

Biocon's stock zoomed 9.57 per cent to touch its one-year high of Rs 1,168 on BSE

Biocon surges 5% on bonus issue plan

The board will meet on April 27, to consider bonus issue shares

Setback for Roche: Mylan, Biocon can now sell generics of its cancer drug

Delhi HC also allows them to use Trastuzumab data for breast, metastatic & gastric cancer therapy

Biocon sees growth from new markets, no risk from USFDA biosimilar norms

The biologics segment was the main contributor to revenue and grew 61 per cent y-o-y