After scientists and reporters raised red flags about a study, Cassava Sciences is being accused of falsifying data in pursuit of an Alzheimer’s treatment.
This year’s DIA Global Annual Meeting (taking place June 19-23 in Chicago) reunites professionals for face-to-face learning and networking opportunities.
The agency has approved an expanded indication for Qelbree extended-release capsules to treat attention deficit hyperactivity disorder in younger patients.
The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.
Working with numerous partners, DiMe has introduced the 3Ps of Digital Endpoint Value to help inclusion of digital endpoints in drug reimbursement decisions.
The agency's requested funding for FY 2023, nearly 34% higher than for FY 2022, calls for investments in public health modernization and pandemic preparation.
An expert from the institutional review board services company advises what trends to look for in the clinical trial industry over the course of coming months.
The pharma firm has announced the agency has approved the company’s investigational new drug application for its Phase II trial of pemvidutide for obesity.
The Medicines and Healthcare Products Regulatory Agency has released proposals to bolster trials legislation, asking citizens for input on the suggestions.
The World Health Organization has recommended the drugs for COVID-19 patients, broadening the range of therapies to combat the virus behind the pandemic.
A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.
US President Joe Biden singled out the pharmaceutical industry in his recently issued Executive Order on Promoting Competition in the American Economy.
A leader from the trial management specialist says sites and sponsors prepare for International Council for Harmonization guideline changes on the horizon.
The US agency’s latest actions and advice against the virus include information on test recalls, , approval and reauthorization of treatments, and more.
The medical device tech firm is poised to assist manufacturers in navigating the new European Medical Device Regulation, which goes into effect this week.
The US agency continues to keep a watchful eye over the nation’s pandemic response, issuing advice to professionals and taking action where appropriate.
As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering resources and guidance.
Formerly Parexel Informatics, the renamed clinical research technology company has broken off and will operate as an independent company going forward.
As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.
The clinical site services provider continues its series of strategic company purchases by bringing the Irish trial technologies firm under its umbrella.
The federal agency has offered updates, advice and action regarding the COVID-19 pandemic, helping life-sciences professionals stay on top of developments.
The US agency continues to issue advice for life-sciences professionals engaged in work related to the virus, and keep an eye out for fraudulent products.
The bipartisan bill calls for an assessment of the country’s pharma supply chain, including potential vulnerabilities and impact of foreign manufacturing.
The ninth annual event, taking place in Boston mid-November, will feature industry professionals addressing manufacturing practices, regulatory updates and market trends.
A representative of the research and development firm offers perspective on how the industry has shifted in recent years, thanks to a number of forces.
The federal agency continues to offer advice for healthcare and pharma industry professionals, and to take action against companies acting out of bounds.
Although control measures are applied, falsified medicines are present in the supply chain in Niger, with solutions requiring cross-country collaboration, says the country’s Ministry of Health.
The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.
Parexel and CluePoints to use CSM solutions for preclinical and clinical risk-based monitoring, after regulatory guidelines impact mutual acceptance of data across the US, EU and Japan.
Drug development – a dynamic and evolving process – is modernizing at an unprecedented rate, says industry expert, who stresses that change must continue to fully explore the opportunities.
The UK Parliament is putting pressure on universities failing to publish data from clinical trials – with plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.
The EMA recently outlined five strategic goals with a focus on fostering clinical trial innovation, optimizing capabilities in modeling and simulation, as well as exploiting AI and investing in special populations, among other objectives.
President Donald Trump signed the SUPPORT act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn’t the only crisis.
Ajinomoto’s amino acid technologies division announced a 10% price increase across all of its markets due to rising costs of manufacturing and transportation.
Hu-manity.co is taking on the human data marketplace with its mission to establish a 31st Human Right: Legal ownership of human data as property – a shift that could help improve clinical research and increase transparency, to begin.
IIVS is collaborating with global laboratories to validate an improved skin sensitization reactivity method to meet toxicology and regulatory requirements.
Syneos Health has acquired the UK-based advisory firm Kinapse in a deal that will double its consulting footprint in Europe and further strengthen its commercial offerings – one company's fastest-growing lines of business, says CEO.
In an update on the implementation of the new Clinical Trials Regulation, the MHRA expresses increased confidence that the UK will exit the EU with a deal – and reaffirms its commitment to align with parts of the legislation “within the UK’s control.”
Ignoring pediatric considerations is no longer an option for the development of new medicines – though clinical trials in children are still not widely accepted by society, explains industry executive.