In a landmark announcement, Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd, revealed its settlement and license agreement with Janssen Biotech Inc., and Johnson & Johnson. This agreement signifies a crucial step forward, granting Biocon Biologics the license to commercialize its Bmab 1200, a proposed biosimilar to […]
In a significant stride for global pharmaceuticals, Lupin Limited has garnered tentative approval from the United States Food and Drug Administration (U.S. FDA) to introduce its generic version of Apalutamide Tablets, 60 mg, echoing the renowned Erleada Tablets by Janssen Biotech, Inc. With an aim to tap into the vast US market, Lupin’s Abbreviated New […]
Dong-A ST, the South Korean pharmaceutical company, has received confirmation from the European Medicine Agency (EMA) of the acceptance of their Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara (ustekinumab). The MAA was submitted to the EMA by Accord, a subsidiary of Intas Pharmaceuticals, on June 23rd, and the agency accepted the submission […]
The US Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the Janssen COVID-19 Vaccine, Ad26.COV2.S, developed by Johnson & Johnson’s subsidiary, Janssen Biotech. This marks the third vaccine authorized by the FDA to combat COVID-19, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Details of the Authorization: The […]
Alligator Bioscience said that the investigational new drug application for its CD40 targeting antibody mitazalimab has been approved by the US Food and Drug Administration (FDA). The IND approval enables the Swedish biotech company to begin clinical trials for mitazalimab in the US. According to Alligator Bioscience, a new benchmark data was recently published which […]
Janssen Biotech acquisition of bermekimab: Janssen Biotech, a Janssen Pharmaceutical Company of Johnson & Johnson, has agreed to acquire all rights to bermekimab, an investigational compound for certain skin disorders, from XBiotech, in a deal worth up to $1.35 billion, as per the latest pharma acquisition news. Bermekimab, which is an anti-IL-1alpha monoclonal antibody (mAb), […]