Drug Approval | September 30, 2024
USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
The inspection concluded with the issuance of a form 483 with five observations
The inspection concluded with the issuance of a form 483 with five observations
Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression
The Notes shall not be offered or sold in India
These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity
The companies will combine Nanoform’s Biologics platform with the Celanese VitalDose Drug Delivery platform to further optimize controlled release of biologics
Multi-year collaboration focuses on development of biodegradable antimicrobial peptides with broad application possibilities in the areas of skin care and healthcare
He will lead the final stages of work to commission the 54,000-square-foot facility and then lead ongoing operations at the site
Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025
Revolutionary technology will further boost OneSource’s scientific services offerings
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
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