Six Form 483 observations of GMP deficiencies have been received from the US FDA by Biocon after the agency inspected the Malaysian manufacturing facility for its insulin aspart biosimilar. However, the Indian firm – which is partnered with Viatris on the product, for which an interchangeability designation is also being sought – insisted that US commercialization plans would not be affected.

Neuraxpharm has appoints Viatris’ head of finance in Germany as its new commercial central region officer and country manager to strengthen its position in the German market, while Stada has hired a new head of consumer health in Germany. Meanwhile, the AAM has made multiple key appointments and Hyloris, Siegfried and Mayne Pharma have made top-level additions.

Plus deals involving Biosplice/Haisco, SciClone/Tarveda, Everest/Sinovent/SinoMab, Kyowa Kirin/AM-Pharma, Sandoz/Bio-Thera, Dr. Reddy’s/Citius, Jiangsu Hengrui/Mabworks, GeneQuantum/BrightGene, Innovent/GenFleet and Takeda/Mirum.

As India gets set to resume COVID-19 vaccine diplomacy from October, a new rule which will require Indians visiting UK who are fully vaccinated with AstraZeneca partner Serum Institute’s vaccine to undergo quarantine has sparked a row. Meanwhile, Indian companies await a nod from the WHO for wider acceptance of their COVID-19 vaccines.