Researchers at Pierre Fabre have started to use implantable chips as biosensors to improve the data gathered whilst monitoring clinical trial subjects.
The new EU clinical trial regulation will overhaul the sector according to SynteractHCR, but are CROs prepared for the extra resources and tighter deadlines it will produce?
Out-of-place softgel capsules have led to the suspension of manufacturing at a site in France, and Catalent says the problem is almost certainly due to malicious actions.
A shortage of Clinical Research Associates (CRAs) is fuelling the “war on talent” among CROs according to an ex-monitor, who says a pre-hire simulation service can turn focus from retention to creation of staff.
Specialised drugs made using flexible technologies are the future for Roche’s small molecule portfolio, the firm says as it restructures its production network.
Horizon Pharma has hit back at allegations it was secretly working with a “captive pharmacy” to preferentially dispense its own drugs, claiming its accuser is trying to reduce competition with its own distribution service.
Quintiles will provide its open source code to tech giant Apple’s ResearchKit framework to help create more efficient and integrated clinical trial apps.
More than one hundred women are suing a subsidiary of Irish manufacturer Endo International, claiming a packaging error caused their contraception to fail and result in unwanted pregnancies.
The UK regulatory agency is recruiting for medical assessors, but with drug-device combinations, biologics and personalised medicines making the job more complex, do you have what it takes?
In the second setback for Dr Reddy’s within a week, the District Court of Delaware has granted a temporary restraining order preventing the company from selling esomeprazole, the generic version of AstraZeneca’s Nexium.
MannKind says it is confident sales of its inhaled insulin product Afrezza - commercialised by Sanofi - will pick up after disappointing growth since launch.
Unilife CEO Alan Shortall yesterday confirmed the drug delivery company is still “receiving interest from several parties under the strategic review process” and set a deadline of December 31 to announce any potential takeover. The company received its...
Legislation allowing compounders to register as outsourcing facilities was a key driver in the acquisition of PharMEDium, AmerisourceBergen says as it completes the $2.6bn deal.
AMRI attributed recent M&A activity to passing the $100m (€93m) quarterly sales milestone, reporting high double-digit growth across its API and small-scale manufacturing divisions.
A UK government report on accelerated access to medicines proposes overhauling conditional licensing and reimbursement pathways to drive drug development.
Charles River has reported strong Q3 sales despite weakness in Japan and plans to grab space in emerging early discovery, bio-testing and Chinese markets.
CMO consolidation strategy has shifted from building scale and adding geographies towards niche technologies and biologics, according to the founder of trade association PBOA.
While pharma is increasing use of automation and data integration tools in process development and manufacturing, it lags behind in electronic documentation of quality control, according to Lonza Biologics QC director Jessica Jean.
A manganese-based catalyst invented by chemists in Illinois could transform the solubility of drug candidates and improve their therapeutic properties.
Inconsistent tablet colour and issues with compressing procedures have landed Indiana OTC maker American Family Pharmacy (AFP) with a US FDA warning letter.
Alexion says it is looking to bring more manufacturing capabilities in-house, despite its CMO partner Lonza recently setting up a dedicated suite at a site in New Hampshire.
Pfizer says there were no safety or quality problems with the drugs made at the Chinese site reportedly issued with a 483 for expired materials and missing paperwork.
US researchers have found that using an ultrasound probe increases small molecule delivery through the intestinal tract of animal models and could help deliver drugs in human.
Pfizer and GlaxoSmithKline have agreed to work together on the development of a new version of the former's continuous processing technology for oral solid dosage (OSD) drugs.
It has been getting harder and harder for trial sponsors to show that drugs intended to treat neuropathic pain are effective - and the reason is surprising.
The fight between CROs for clinical research associates (CRAs) and people with certain other skillsets is hotting up, with both Icon and Quintiles identifying it as an issue faced by their businesses.
