News | June 18, 2022
Stelis Biopharma’s two biologics manufacturing facilities receive EU cGMP accreditation
Both manufacturing facilities are based out of Benguluru, India
Both manufacturing facilities are based out of Benguluru, India
Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation
The proposed transaction involves the sale of the global biosimilars portfolio of Viatris to Biocon Biologics
The two-year agreement will grant Lonza access to IBF's prominent network and allow IBF to benefit from Lonza's manufacturing expertise and knowledge in its due diligence review of potential targets
Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020
Bora establishes a leadership position in Taiwan's CDMO sector as it continues to expand into the global CDMO market
The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
Infigratinib is not FDA-, Health Canada- or Therapeutics Goods Association-approved for any other indication
Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics
The US $600 million acquisition will see Juniper Biologics offer the world's first cell-mediated gene therapy to an estimated 300 million patients in Asia Pacific, Middle East and Africa
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