The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors
Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines
US$ 800 million senior secured notes, the largest high yield debut USD bond issuance from India in the last 10 years
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
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