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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.

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.

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.

1st Stem Cell Community day in Germany

For stem cells 'the process is the product,' says Pluristem

Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.

US ban for levonorgestrel supplier Qinhuangdao Zizhu raises WHO concerns

Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after inspection in 2015 according to the WHO.

Aurobindo Pharma gets Form 483 from US FDA after Bachupally inspection

The US FDA completed an inspection of Aurobindo Pharma Limited’s manufacturing plant in Bachupally, Hyderabad yesterday, issuing the Indian drug firm with a Form 483 detailing six observations.

Partnering key to deliver next-gen drug delivery tech, say industry experts

Partnering and collaborating to advance drug delivery innovation  is essential, now more than ever, say industry experts from Boehringer-Ingelheim and Merck.

UK firms should look to global opportunities to offset Brexit woes, says biotech CEO

UK life science companies must become global to help offset staffing and funding problems potentially caused by Brexit, says Arecor CEO Sarah Howell.

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