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.
News in brief
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
19-Jul-2016 - The US FDA has issued Sandoz with a complete response letter for its Neulasta biosimilar.
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.
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.
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.”
News in brief
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.
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.
Regulatory & Safety: Featured news
Valeant, Rentschler, Celgene, MannKind, and Syngene are among those welcoming new leaders for 2016. Oh, and Turing waves goodbye to Martin Shkreli… welcome to a New Year’s CEO special.