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.
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...
25-Nov-2014 - The advent of Big Data in clinical trials will mean companies not using digital biomarkers are unlikely to exist by 2025, the President of cloud-based technology firm Medidata has warned.
10-Nov-2014 - The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies.
21-Oct-2014 - Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.
26-Sep-2014 - At the request of the European Commission, the EMA (European Medicines Agency) announced Friday that it would open a review into findings that GVK Biosciences’ site in Hyderabad, India falsified...
25-Sep-2014 - Concerns over India-based GVK Biosciences have been raised in a letter from France’s ANSM (Agency for Medicines and Health Products Safety) to marketing authorization holders following a GCP (good clinical...
23-Sep-2014 - The US Food and Drug Administration (FDA) says compounding pharmacies must not manufacture medicines for hospitals and doctors’ offices, except for named patients.
23-Sep-2014 - 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...