The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.
The World Health Organisation (WHO) has urged pharma companies to help combat neglected tropical diseases (NTDs) via increased drug donations.
DSM Sinochem (DSP) has announced its intention to increase antibiotic production capacity at its facility in Delft, the Netherlands.
Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
Tory Prime Minister Teresa May’s decision to call a snap election to stymie opposition of her stewardship of Brexit will see the MHRA limit communication to essential information.
The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.
Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.