A draft ICH guidance on continuous manufacturing has been opened up for comment by the FDA, as continuous manufacturing becomes an increasingly prominent topic for the generics industry.

Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.

Looking back over a busy third quarter in 2021, Generics Bulletin executive editor David Wallace picks out highlights from July to September that include major legal and regulatory developments, multiple firsts in the biosimilars arena, significant M&A activity and our annual ranking of the off-patent sector’s top 50 companies.

Zentiva’s Zent2U B2B unit has reported progress on a bioequivalence study for its sitagliptin tablets, indicating that its version will be ready for day-one entry in Europe. The development comes shortly after Zent2U announced the successful completion of a sertraline study.

Off-patent medicines must become the “focal point” of pharmaceutical policies across the world as health systems recover from the COVID-19 pandemic, Medicines for Europe and the IGBA have urged as they held their joint annual conference in Athens, Greece.

Benign prostatic hyperplasia treatment indoramin topped the UK’s steepest generic price rises in September with an average price that more than trebled, according to the latest figures from WaveData.