News & Analysis on Clinical Trial Services & Contract Research And Development
Cancer drug developer CEL-SCI announced Tuesday that since dropping CRO inVentiv Clinical back in 2013, patient enrollment in the trial run by its two new CRO partners – Aptiv Solutions and Ergomed -- has increased more than eight fold.
From CPHI India 2014
SGS has doubled testing capacity at its Mumbai facility, explaining that Indian API makers’ failure to invest in quality has been good for business.
Drugmakers including China in multi-regional trials would need to submit dossiers filed elsewhere for CFDA review, open up non-Chinese sites to inspections and conduct local studies under draft guidelines proposed by Beijing regulators.
GlaxoSmithKline is significantly reducing the size of its R&D team in the US, though about 450 of those employees who will be laid off in the Research Triangle Park (RTP), North Carolina area will find new jobs with CRO Parexel.
Another warning letter has landed in the hands of Ranbaxy execs, this time from German regulators charging the company with failing to comply with GMP standards.
Johnson Matthey has completed its acquisition of API and pharmaceutical intermediate manufacturing capacity in Scotland.
Evotec and Sanofi have entered into exclusive negotiations for a major strategic partnership that will include a €250m ($310m) minimum guaranteed commitment from Sanofi over the next five years.
The EMA has called for feedback on plans to require drugmakers to state whether their drugs contain solubility-enhancing cyclodextrin excipients.