Russia set for first foreign CMOs as pharma preps for 2020 policy
Several international CMOs will establish themselves in Russia over the next few years as pharma looks to satisfy the country's manufacturing policies, the CEO of R-Pharm predicts.
Archives for July 8, 2014
Include prisoners in clinical trials, say European scientists
Scientists and ethicists have called for changes to European guidance which excludes prisoners from clinical trials.
Ophthamology CRO becomes shareholder of Nicox following $65m acquisition
European drugmaker Nicox has agreed to acquire all of the outstanding equity of US-based Aciex Therapeutics, an ophthalmic development company, which will also be a boon for ophthalmic CRO Ora.
Priority Review for Purdue’s anti-abuse hydrocodone
The US FDA has granted Priority Review Designation to Purdue Pharma’s hydrocodone bitartrate tablet which has abuse-deterrent technology.
Indian firms must invest in compliance as USFDA ups enforcement, says S&P
Indian drugmakers must invest heavily in compliance processes in response to the US FDA’s “aggressive surveillance” and inspection programme, a Standard & Poor report has said.
GRAS always greener? FDA considers overhauling OTC monograph system
The US FDA has given stakeholders more time to comment on the 40-year old monograph system used to regulate OTC drugs and reiterated its concerns that the approach does not allow it to keep up with new drug safety testing advances.
Apotex hit with warning letter on troubled API facility in India
Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16.