[ad_1] Biocon Ltd on Thursday, April 10, said its subsidiary Biocon Biologics has received the approval of the US Food and Drug Administration for Jobevne, a biosimilar Bevacizumab, for intravenous use. Jobevne is a recombinant humanised monoclonal antibody that is used to treat several types of cancer. It is a biosimilar to the reference product […]
US FDA approves Biocon Biologics’ YESINTEK for autoimmune diseases – CNBC TV18
[ad_1] Biocon Biologics has announced that the US Food and Drug Administration (FDA) has approved YESINTEK, a monoclonal antibody for the treatment of autoimmune conditions, including Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. YESINTEK works by targeting specific proteins that contribute to inflammation, offering a new treatment option for patients with these chronic […]
Biocon Biologics refinances $1.1 billion debt via debut dollar bonds and syndicated facility – CNBC TV18
[ad_1] Biocon on Thursday, October 3, said its subsidiary Biocon Biologics has refinanced its USD 1.1 billion (₹ 93,468 million) long-term debt through the issuance of USD 800 million (₹ 66,763 million) senior secured notes. This marks the largest high-yield debut bond issuance from India in the last decade. The bonds, set to mature in […]
US FDA concludes inspection of Biocon Biologics’ Insulins Facility in Malaysia – CNBC TV18
[ad_1] Biocon Biologics announced on Saturday, September 28, that the US Food and Drug Administration (US FDA) has completed a Current Good Manufacturing Practice (cGMP) inspection of its Insulins Manufacturing Facility in Johor Bahru, Malaysia. The inspection, which took place between September 17 and September 27, 2024, covered multiple biologics manufacturing units and quality control […]
CNBC-TV18 accesses USFDA observations for Biocon Biologics unit. Details here – CNBC TV18
[ad_1] CNBC-TV18 has accessed the observations that the US Food & Drug Administration (USFDA) has issued to Biocon Biologics’ Units. The facility was inspected by the regulator between July 15 – July 19, and July 22 – July 26, post which, the observations were issued along with the form-483. Observations issued by USFDA: – Procedures […]