The US FDA has sent Wockhardt a warning letter for its manufacturing plant in Waluj, India just days after UK authorities issued the site with a certificate of non-compliance.
US CBO claims that proposed track and trace legislation will not be too expensive for drugmakers already used to similar laws in California are ‘misguided’ according to an industry consultant.
WuXiPRA, the new China-based joint venture between the two CROs, has named contract research veteran James Pusey, MD, as president and general manager.
Computational biology firm Blackfield has won its fourth Big Pharma contract in a year, with Anglo-Swedish drugmaker AstraZeneca signing up for its genomics services
Molecular Profiles has received the regulatory thumbs up on a second manufacturing facility and says it can offer its clients a breadth of services uncommon for CMOs.
The FDA has proposed a rule to allow its inspectors to detain adulterated or misbranded drugs found during an inspection for a short period of time and until the appropriate action is undertaken.
The EFPIA has selected software firm Solidsoft for its anti-counterfeit European Medicines Verification System (EMVS) powered by Microsoft's cloud-based platform Windows Azure.
Simple steps to secure Rwanda’s pharma supply chain may serve as an example for other larger African countries looking to curtail the spread of falsified or substandard drugs, experts say.
Ernst & Young (E&Y) analysts will try to illuminate the Sunshine Act for Greenphire's customers in the third collaboration the trial payment technology firm has signed in as many weeks.
Intertek has acquired Melbourn Scientific, citing its capabilities in delivery device testing and formulation services as the key drivers for the deal.
Programming errors in a vendor's EDC system meant some patients were mistakenly given placebo during a trial of an ALS (amyotrophic lateral sclerosis) drug candidate being developed by Cytokinetics.
US drugmakers must stop ‘doing the minimum’ and put patient safety at the heart of their audit plans according to excipient industry expert Chris Moreton from FinnBrit Consulting.
Collaboration and intelligence sharing has seen pharmaceutical cargo theft decline heavily since Lilly fell prey to an $80m heist in 2010, says industry expert.
Academia and early-stage biotech companies are more frequently looking to fill holes in their expertise and preclinical capacities through the use of CROs, according to a commentary in Nature Reviews Drug Discovery.
India’s top drug regulator is calling on manufacturers that received unauthorized drug approvals and manufacturing licenses to prove the safety and efficacy of their marketed drugs by August 31.
Apparently some folks at DIA weren't discussing 'cloud-based' solutions this year but, as Outsourcing-pharma.com didn't find them, here's the news from those who are adding a little cumulonimbus to their blue-sky thinking.
In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.
In an effort to stave off expected drug shortages, the EC has approved a waiver that will allow US API manufacturers to export their products to Europe.
The Big Pharma company has licensed a range of compounds to molecule research tools company Abcam to be made available for sale to pre-clinical researchers.
Manufacturers’ quality issues were among the most prevalent reasons for drug shortages, according to a survey conducted by the ISPE (International Society for Pharmaceutical Engineering).
The US Supreme Court has ruled unanimously that naturally occurring DNA is not patentable “merely because it has been isolated,” but synthetic DNA can be patented.
Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
GSK has ‘paused’ a Phase I trial of an MS drug and fired its China R&D chief, Jingwu Zhang, after finding 'manipulated' data in a paper published in Nature Medicine in 2010.
Failure to clean up unsanitary conditions at a US plant and address cGMP violations at a facility in Puerto Rico have earned Baxter another warning from the US FDA.
In a rare win for a CRO, Quintiles was awarded a two-year, $1.088M research grant from the Patient-Centered Outcomes Research Institute (PCORI) to compare the effectiveness of uterine fibroid treatments.
Packaging specialist Contract Pharmaceutical Services of Australia (CPSA) has received a warning letter from the US FDA due to humidity control violations on products distributed in the US.
French authorities are investigating if a packaging mix-up at generics giant Teva Pharmaceutical Industries played a role in the death of a man in Marseilles last week.
Janssen has recalled 179 batches of an oral contraceptive after problems with the release of the active pharmaceutical ingredient (API) were discovered.
The Commissioner of the FDA says laboratory-developed diagnostic tests needs to be regulated for clinical validity to stop erroneous results and ensure patient and clinician confidence.
The ever-expanding market in China has plenty of room for 3rd party pharmaceutical distribution and logistics companies says UPS as it opens a new facility in Zhejiang Province.
