Want to pass an FDA inspection? Do not answer back, do not volunteer information and do not sign anything, says an ex-auditor and regulatory consultant.
Nisso Soda Co. has partnered with Mutchler Pharmaceutical Ingredients to try and win a greater share of the US hydroxypropyl cellulose market months after expanding production capacity.
A proposed prescription drug price cap in the wake of the Turing Pharmaceuticals controversy will lead to reductions in R&D spending and could have a negative knock-on effect for CROs say experts.
Trilantic Capital Partners Europe has bought a majority stake in Doppel Farmaceutici, citing the growth potential of Europe’s contracting market as the driver.
Contractor Trenzyme GmbH has licensed a CHO cell line-based expression system from Swiss firm Celonic AG in a deal designed to expand its service offering.
MannKind has cut more jobs in efforts to streamline operations, leaving the inhalable insulin manufacturer around a third smaller than this time last year.
A UK firm has launched a searchable database of genomic data from sources all over the world that it says will accelerate development of personalised medicines.
The US FDA has issued a product safety alert and recommended a compounding pharmacy cease manufacturing operations after observing unsanitary conditions at a Californian facility.
In an exclusive Q&A, nanoparticle pioneer Kathryn Whitehead wishes industry would invest more in delivery vehicles and predicts Alnylam will be first to commercialise an siRNA therapeutic.
Evotec has been hired to manage candidate drug compounds by the US National Cancer Institute (NCI) under an agreement the CRO hopes will help it win further contracts.
Sterigenics will triple gamma sterilisation capacity at a site in Arkansas on the back of strong demand from pharmaceutical and medical device customers.
Drug companies still outsource to make fixed costs variable rather than to try and improve their public profiles through sustainable sourcing according to a Deloitte analyst.
Medical affairs and post-market research are fast growing opportunities for CROs according to observers who say drug companies are starting to outsource more late-phase and post approval work.
Innovate Pharmaceuticals has launched what it claims is the world’s first shelf-stable liquid aspirin, and says it is on the look-out for a licensing partner for the “$500m” market.
Drug companies still outsource to cut costs but environmental concerns and therefore contractors’ green credentials are increasingly important say industry experts.
Demand for biopharmaceutical testing is in part responsible for higher capacity utilisation but, despite encouraging signs, it is too early to say if preclinical pricing will improve accordingly says Envigo.
Blocking the neuropeptides that regulate arousal and appetite could lead to a treatment for cocaine addiction, says Heptares which has received an NIH development grant.
