A magnetic pulse technology that can align and push nanoparticles to points distant to magnet surfaces could finally make magnets attractive for deep tissue drug delivery according to researchers.
CROs are consolidating further, this time with DaVita HealthCare Partners’ business units DaVita Clinical Research (DCR) and HealthCare Partners Clinical Research merging to further expand their services, specifically for patients with chronic kidney...
CROs Pharmaceutical Product Development (PPD) and ERT on Tuesday announced a strategic partnership to deliver ERT’s patient safety and efficacy endpoint data collection tools to help biopharma clients conduct clinical trials in a more efficient and cost-effective...
Asian API makers are turning to ‘out-of-the-box’ Manufacturing Execution Systems (MES) to help manage documentation and control quality, according to IT solutions Werum.
Patients and pharmacists can now use smartphones to check biologics are genuine with a new Merck Serono tech launched to combat counterfeiters' growing interest in high-value biopharma drugs.
Bruker Corp will pay $2.4m to settle US SEC charges that employees improperly funded Chinese officials' sightseeing trips to win analytical tech contracts at state labs.
Cancer Treatment Centers of America (CTCA) has selected the WIRB-Copernicus Group (WCG) to be its institutional review board (IRB) and thereby expand its clinical research program.
A Covance investor is raising questions over Goldman Sachs’ involvement in providing advice to the CRO’s board, which recently accepted a $6.1bn takeover offer from industry peer LabCorp.
Sweden is an expert in high-tech trials but stalls in the recruitment phase, says the academic trying to change all that with a database of biomarkers matching patients to studies.
Indian regulators have accused a hospital of conducting unauthorised clinical trials of stem cell therapies and of charging patients who took part for the treatments.
GVK Biosciences has called marketing authorisation withdrawals by various European regulators “disproportionate,” arguing that ECG results at centre of data manipulation investigation have no bearing on safety.
Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.
German contract development and manufacturing organisation (CDMO) Vetter has built a facility for pre-clinical and clinical syringe filling in Chicago.
Analyst firm N+1Singer has endorsed stem cell manufacturer Reneuron based on its “off-the-shelf” therapy pipeline and a new facility that will reduce the need to outsource.
Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.
Pharma companies have called on the Swedish government to prevent manufacturing going the way of R&D and leaving the country, after AstraZeneca closed its research in Lund in 2012.
Third-party logistics providers (3PLs) will have to report annually to the US FDA according to draft guidance published to help implement track and trace legislation.
The Indian Pharmaceutical Alliance says the quality of US FDA inspections has “significantly deteriorated” this year, and their approach is creating a climate of fear among Indian manufacturers.
Quintiles has been upgraded to stable by ratings agency Standard & Poor after a second stock offering and the consolidation of debt through a $300m securitisation facility.
Cubist will give Merck & Co leadership of the antibiotics sector according to one analyst who says renewed interest expressed by GSK, Roche and Sanofi has not produced any Ph III candidates.
R&D investment and an integrated platform are widening the divide between Medidata and its competitors, according to analysts who are confident the trial data firm can achieve target sales of $1bn.
Manufacturers developing Ebola vaccines will be immune from lawsuits following a decision by US HHS (Health and Human Services) to issue a declaration on the matter.
Horizon Discovery Group announced Monday that its bioproduction division has shipped its first commercially available engineered CHO (Chinese Hamster Ovary) cell line for use in manufacturing of antibodies.
A number of analysts recently initiated coverage on CRO PRA Health Sciences, with most predicting that the company’s recent IPO will result in a steadily growing stock price.
INC Research has expanded its partnership with the Society for Clinical Research Sites (SCRS) through the end of 2015 to become the first organization to support SCRS' new member Scholarship Program as well as the first CRO to establish a Site Advocacy...
Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.
The EMA may withdraw marketing authorisation for generic drugs trialled by GVK Biosciences next month, after German regulators suspended several products and launched a review of alleged data manipulation by the CRO.
Over the last three years US turnover in clinical monitoring has dropped from 29.4% to 16.4% and globally overall company turnover has dropped from 27.2% to 14.2% on average, according to the 16th annual CRO Industry Global Compensation and Turnover Survey.
New draft guidance from the US FDA related to track-and-trace legislation facilitates the transfer of both paper and electronic accounts of transaction info, history and statements for manufacturers, repackagers and wholesale distributors.
A company developing a pharmaceutical chewing gum containing cannabinoids extracted from marijuana has announced plans to build a manufacturing facility in the Netherlands.
Pfizer scientists wont have to run track, just share data to help catch sports cheats who use candidate drugs to enhance performance according to the World Anti-Doping Authority (WADA).
The World Health Organisation says its prequalification scheme gives free help to makers of selected APIs, drugs and vaccines who want to boost their standards and access international markets.
CRO industry group ACRO has welcomed a US NIH draft policy promoting use of a single IRB for site reviews per institute-backed multi-centre study, arguing that the approach would accelerate trials without compromising safety.
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.
