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Regulatory & Safety: Top Headlines

EMA proposes changes to Ph I guidelines after fatal BIA 10-2474 trial

iStock/neil stanners

21-Jul-2016 - European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.

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GSK to expand recall of antibiotics made at Worthing API unit

21-Jul-2016 - GSK will recall more antibiotics made at a UK API unit that has been offline since the US FDA raised contamination concerns last year.

Update: Sandoz remains committed to launching 5 biosims by 2020

US FDA rejects Sandoz’s Neulasta biosimilar

19-Jul-2016 - The US FDA has issued Sandoz with a complete response letter for its Neulasta biosimilar.

Report: Congress needs to update human research regulations

19-Jul-2016 - Ethical principles for conducting research involving humans were originally detailed in 1978 – today, a new report is urging Congress to make updates to the decades old document.

Constipation med linked to 46 B. cepacia cases in US recalled by PharmaTech

19-Jul-2016 - A constipation medication made by PharmaTech LLC has been recalled after being linked to an outbreak of the bacteria B. cepacia in five US states.

FDA adds 4 API manufacturers to 'Red List'

19-Jul-2016 - Two Chinese and two Indian companies have been banned from importing APIs to the US – one manufacturer says it’s making GMP compliance a “priority.”

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CDSCO imposes 45 day limit on provision of supplemental data

19-Jul-2016 - Drug manufacturers seeking approval in India now have 45 days to provide the CDSCO with any supplementary information or the application will be rejected.

Ziopharm investigating death in Ph I trial of brain cancer gene therapy

18-Jul-2016 - Ziopharm Oncology has started investigating a death that occured during a Ph I trial of its candidate brain cancer gene therapy, Ad-RTS-hIL-12.

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