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US FDA issues Sun with Form 483 after Dadra plant inspection

The US FDA has handed Sun Pharmaceutical Industries Ltd a Form 483 detailing critical observations made during an inspection of its Dadra, India facility.

WHO pressures Big Pharma to donate more drugs for tropical diseases

The World Health Organisation (WHO) has urged pharma companies to help combat neglected tropical diseases (NTDs) via increased drug donations.

DSM Sinochem to up capacity at Delft antibiotic intermediates plant

DSM Sinochem (DSP) has announced its intention to increase antibiotic production capacity at its facility in Delft, the Netherlands.

Samsung Bioepis to take on J&J with FDA approved Remicade biosimilar

Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.

UK MHRA announces pre-election quiet period

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.

EMA and FDA agree how drug firms should include Q8, Q9 and Q10 QbD concepts in applications

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.

Wearable drug delivery tech firm Unilife files for Chapter 11 bankruptcy

Unilife Corporation has filed for Chapter 11 bankruptcy and confirmed that a key customer for its wearable injectors business has halted a project.

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