The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is working on a pilot project investigating the feasibility of inspecting pharmacovigilance contract service providers as it’s becoming increasingly common for a MAH (marketing authorisation...
BioClinica is looking to target its new offering to the CROs and sponsors who have yet to adopt a cloud-based solution for the management and delivery of clinical trials.
Service provider and contract manufacturer WuXi PharmaTech is vouching for TruTag Technologies’ edible microtags following a pilot project adding to evidence that they can help root out counterfeits.
Late last month the China Food and Drug Administration (CFDA) began mandating that drug registration applicants self-inspect and verify clinical data to ensure that it’s authentic and reliable.
The almost-private China-based CDMO (contract development and manufacturing organization) WuXi is looking to reap larger rewards from investing in US and China pharma and biotech firms.
Epic and LabCorp’s Covance have agreed to extend their partnership to provide circulating tumor cell (CTC) technology and oncology clinical trial support in Asia.
As the outbreak of Middle East Respiratory System (MERS) slows in South Korea, logistics supplier Marken has been granted government permission to deliver the first direct to patient (DTP) shipments of clinical drugs and supplies in the country.
Bracket Global has acquired Boston-based Clintara, which will allow Bracket to integrate the Clintara platform of trial surveillance tools into its electronic platform for Clinical Outcome Assessments (eCOA).
Two early adopters of RBM (risk-based monitoring) – Bristol-Myers Squibb and Celgene – have provided details into the way they’re reducing clinical trial site visits to increase efficiencies around identifying risks earlier and more efficiently.
Industry efforts set up a drug database to help Europeans identify fake pharmaceuticals progressed this week after thee software firms signed development deals with project leader, EMVO.
As Big Pharma and biotech companies continue to outsource more of their work, one of the leaders in the preclinical and discovery space – Charles River Laboratories – is seeing more strategic relationships with both large and small clients, CEO James...
The former general counsel of Bio-Rad Technologies sued the research company in California federal court last week, claiming he was illegally fired in 2013 after he blew the whistle on the company’s bribery in China.
With the aim of getting new drugs to patients more quickly, a new House draft bill released Wednesday offers a whole set of new ideas around what the NIH and FDA can do to speed drug discovery and development.
As 20 of the largest biopharma companies have now joined industry group TransCelerate, the group is beginning to use patient centricity and connectivity to influence the clinical trial environment, CEO Dalvir Gill told attendees at the Partnerships in...
As part of efforts to reduce clinical trial start-up times, WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for human research, said it will encourage the 1,200 members of its research network to...
Piramal has agreed to sell its clinical research business based in Hyderabad, India to Indoco Remedies which will add bio-equivalence and bio-analytical services to its offerings.
In another sign that early phase research demand is picking up, North Carolina-based CRO PRA Health Sciences (PRA) is increasing its Phase I clinical footprint in the US and Russia.
Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance from the European Commission.
Research tool supplier Horizon Discovery Group and ArcherDX, a supplier of Next Generation Sequencing (NGS) fusion detection, have signed an Original Equipment Manufacture (OEM) agreement that will see Horizon’s Reference Materials supplied as a standalone...
eSource solution provider Clinical Ink is merging with CentrosHealth, a provider of mobile apps for clinical trial patient engagement and electronic patient reported outcomes (ePRO).
The NFL (National Football League) may be getting more serious about its players’ health as it recently signed a five-year agreement with Quintiles to continue and expand upon its Injury Surveillance and Analytics (ISA) service to track player injuries...
Chinese service provider WuXi PharmaTech has acquired NextCODE Health, a US and Icelandic genomic analysis and bioinformatics company, for $65m in cash.
Certara subsidiary and regulatory and medical consultancy Synchrogenix has acquired ClinGenuity, the only artificial intelligence-assisted medical writing service in the pharmaceutical industry. Terms of deal were not disclosed.
Investors only back drug innovators because they have to according to Index Venture Management's Kevin Johnson, who says less risky 'first to be second' firms are actually much more attractive.
Sterigenics International has bought Italian gamma-ray sterilisation firm Gammarad in a deal that comes amid rumors that private equity owner GTCR is looking to offload the Illinois-based contractor.
Although a growing number of sponsors and CROs have managed strategic relationships for as many as five years, sponsors still rely on a mix of outsourcing approaches to tackle their clinical programs, according to a new report.
A process development firm founded by ex-AstraZeneca employees says closure of the drugmaker’s Swedish R&D site gave it technical knowhow and former colleagues as customers.
A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.
Thermo Scientific is assessing its PK/PD data analysis software after a technical paper found discrepancies in results that may have affected drug approvals.
Fresh off the near completion of its depot in Sau Paulo, Brazil, Marken has now also completed the construction of another depot in Santiago, Chile, in order to more easily handle the influx of clinical trial specimens coming from South America.
The Association for the Accreditation of Human Research Protection Programs today announced that it has accredited three more organizations, including two independent institutional review boards (IRB) in Massachusetts and a third organization in Mexico.
Cloud-based solution provider Medidata and CRO Icon have launched a joint initiative to bring new efficiency to the administration of electronic patient-reported outcomes (ePROs) in clinical trials.
Supply chain specialist Marken announced last week the opening of their newest clinical trials depot in Sao Paulo, Brazil to help sponsors and CROs looking to conduct trials there and elsewhere.
