Lengthening supply chains increase the risk of patients becoming exposed to substandard or counterfeit materials in medicines, while pharmaceutical research in the post-genomic era is exposing patients to a swathe of new drug mechanisms. It is critical that patients exposed to developmental or marketed drugs are guaranteed ethical and transparent processes from industry, regulators and other healthcare organisations.
17-Aug-2016 - As regulators push the industry to adopt adaptive studies to reduce risk to both patients and manufacturers, the FDA has finalized a guidance outlining key issues and recommendations.
26-Jul-2016 - The European Medicines Agency (EMA) has released a concept paper proposing changes to its current guidance on first-in-human clinical trials.
12-Jul-2016 - The FDA has placed on clinical hold on Juno’s Ph II clinical trial of JCAR015 following the death of two patients last week and will “continue to work” to ensure...
29-Jun-2016 - After the Bial trial tragedy earlier this year, panelists gathered at DIA to discuss what went wrong and how to move forward as an industry.
25-May-2016 - CRF Health has launched TrialConsent, an electronic solution promoting better comprehension, compliance, and retention rates in clinical trials.
20-Apr-2016 - BioClinica and ArisGlobal have partnered to offer customers a comprehensive pharmacovigilance service as "one size fits all" model evolves.
15-Feb-2016 - CTI Biopharma has confirmed the Phase III trial halted after patient deaths last week was being conducted by a CRO and in-house researchers.
11-Feb-2016 - The US FDA has ordered CTI BioPharma to halt a Phase III trial of a cancer drug candidate after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”
15-Jan-2016 - A clinical trial being run by Biotrial has been suspended after six serious adverse events.
07-Jan-2016 - In 2016 clinical trial and real-world data will become increasingly important in the decision to prescribe medicine, Parexel President and COO Mark Goldberg told Outsourcing-Pharma.com.
19-Nov-2015 - A more patient-focused approach will expedite clinical trials and responsive CROs will have the competitive advantage, say AstraZeneca, EMD and Bayer.
02-Nov-2015 - 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.
29-Oct-2015 - The Coalition for Clinical Trials Awareness (CCTA) has called for a federally-supported public health campaign to make people more aware of drug research and the value of participating in studies. ...
23-Sep-2015 - European regulators and the WHO have begun sharing confidential information about drug applications, quality, and inspections under a new agreement.
20-Aug-2015 - The Italian Ministry of Health has banned compounding pharmacies from preparing drugs containing any of seven APIs after chemists were discovered making dangerous off-label weight loss treatments.
11-Aug-2015 - 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.
17-Jul-2015 - Agilent and A*STAR have partnered to create quicker, more accurate ways of testing the sugar content of therapeutic proteins and monoclonal antibodies (mAbs) that are tailored for commercial producers.
29-Apr-2015 - Sponsors can license biosimilars for multiple indications without performing clinical studies for each area, the EMA and FDA agree.
26-Feb-2015 - The use of substandard and falsified drugs in clinical trials has been neglected and new information on product quality should be included in the GCP (good clinical practice) guidelines from...
20-Feb-2015 - The China Food and Drug Administration (CFDA) is proposing to amend its GCP (good clinical practices) to add more specific responsibilities for sponsors, Ethics Committees (ECs) and sites as part...
12-Feb-2015 - None of the drugs the EMA wants suspended over concerns about data manipulation at GVK Biosciences are sold in Switzerland says Swissmedic.
07-Jan-2015 - India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill that would amend the country’s landmark law governing pharmaceuticals from 1940.
15-Dec-2014 - 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.
11-Dec-2014 - 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.
04-Dec-2014 - 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...