Italian API and CDMO specialist Olon is expanding its high-potency capabilities at a site in India, at the same time as unveiling plans to invest a further €30m in a domestic biotech hub.

Civica has announced a further $27.8m investment to support its plans for insulin and other essential medicines. The news comes shortly after CivicaScript announced its first launch in the form of abiraterone tablets.

Jubilant Pharmova is planning to transform its generics business with the appointment of a new managing director and CEO, after a difficult period for the unit that saw a tough Q1 amid ongoing difficulties linked to an import alert for its Roorkee manufacturing plant.

Nichi-Iko still has a long road to recovery ahead as it attempts to get its Toyama plant back on its feet.

Stelis BioPharma’s flagship Indian manufacturing facility has been cleared under an FDA Establishment Inspection Report.

Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.

Biocon has revealed that an FDA inspection of key biosimilars manufacturing facilities in Bengaluru and Malaysia in August has resulted in numerous Form 483 observations across three Biocon Biologics sites.

Zydus is set to join Natco in chipping away at BMS’ blockbuster Revlimid with its generic version, probably from Q2 while Aurobindo expects to launch by FY24. Revenues from this drug are expected to offset erosion of generic Asacol revenues even as Zydus expects volume growth and new launches to help grow its US business.

Following Novartis’ announcement that it intended to spin-off its Sandoz business into a standalone company, management from both firms commented on several key issues facing Sandoz, including the US pricing and environment and arrangements for manufacturing.