The FDA issued a warning letter to McKesson for violations concerning a possible distribution of illegitimate opioid products while calling for action in securing the supply chain from illegitimate medications, especially opioids.
Getting patients into possibly life-saving trials has long been a complex process, however, with the age of electronic health records and cloud-based data, there are opportunities for simplification.
US FDA is reaching out to the industry to agree upon ‘voluntary consensus standards’ to promote the development of drugs and reduce manufacturing cost.
Boehringer Ingelheim and IBM Canada are using blockchain technology for the first time in a clinical trial setting to test the technology’s trial management capabilities.
monARC Bionetworks’ Smart Health Record allows patients to directly share with researchers their data from various disparate sources – “creating a new data collaboration economy.”
Charles River is set to acquire Citoxlab for €448m ($510m) in cash, a deal which would bolster the CRO’s safety assessment portfolio to support its long-term organic growth aspirations, says CEO.
US FDA Psychopharmacologic Drug Advisory Committee recommends Spravato, an intranasal form of esketamine, for approval based on its favorable benefit-risk profile.
Hugh Pullen, EMVO’s president, explains what the launching of the EMVS means for the industry, and details how a potential no-deal Brexit will impact the system.
Iqvia acquired UK-based Linguamatics in January 2019 as part of the company's commitment to deliver value from artificial intelligence and machine learning.
Mylan’s recently FDA-approved Advair Diskus generic to be offered at 70% cost reduction to its reference drug, and 67% less than GSK’s generic version.
Optimapharm aims to become a leading mid-sized CRO in Europe and recently acquired the Switzerland-headquartered company Denothex as part of this goal.
Medidata is working with Cognizant to develop a set of services that will provide pharma, biotech, CROs and others with the capabilities to “digitally transform” their research and commercialization.
US FDA initiates a pilot project testing innovations in an aim to inform the development of the tracking and verification systems going into effect with the DCSA in 2023.
It will take a marriage between Silicon Valley and clinical trials expertise to drive innovation in the digital health space, which is being held back by uncertainty – and a reluctance that is keeping industry executives up at night.
Ligand Pharmaceuticals enters an agreement with Genagon to provide access to its drug development platform capable of producing fully human antibodies.
Backed by a private equity investment, Taconic Biosciences is focusing on its growth strategy, with plans to add capacity, pursue acquisitions, and develop new products, says the company’s new CEO.
Sharp invests $650,000 in its IRT solution to ensure proper supply allocations to support clinical trials and reduce costly overproduction for sponsors.
People on the move in January include new CEOs at Lonza, Taconic, MaSTherCell, Pii, and Wasdell, among several other c-suite shakeups and new hires as the industry kicks off the New Year.
The UK-based private equity firm CBPE has purchased a majority stake in Simbec-Orion and will expand the CRO's reach both geographically and across all business units.
Velocity Clinical Research officially launches following the acquisition of three US-based sites – with plans to expand globally and become one of the leading site groups in the world, says CEO.
France, Germany, and the UK recently formed INSTEX to be able to secure trade despite US sanctions on Iran, a move that has been welcomed by Novo Nordisk.
The voluntary recall, originally initiated due to a product compliant in October 2018 for mislabeling, continues for anti-seizure drug, Levetiracetam injection in single-dose bags.
Clinical trial sites often cannot keep up with patient referrals from marketing campaigns – with research suggesting that one-third of referrals are never processed, says patient recruitment firm.
QPS is expanding ‘aggressively’ at its US-based headquarters, rebuilding on a rolling basis to support a growing demand for gene therapy treatments, says VP.
As complex drugs see little competition, the FDA will distribute guidelines to increase approvals of generic medicines for ‘economic stability’ and to bring affordable drugs to patients.
The cloud-based eClinical solutions company today announced that it has received a significant investment from Flexpoint Ford, a Chicago-based private equity (PE) firm.
Aetion aims to advance the adoption of and standards for real-world evidence backed by a strategic investment from several global biopharma and health care companies.
The global software provider is discounting its reporting software for academics, as universities globally struggle with compliance and face increasing pressure to publish clinical trial results.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
The Association of Clinical Research Professionals (ACRP) is accepting applications for its inaugural ACRP All-Star Challenge for sites, as well as sponsors and contract research organizations (CROs).
Celgene, Triphase Accelerator, and Facit entered a collaboration for a first-in-class preclinical therapeutic, targeting the WDR5 protein for the treatment of leukemia and other blood cancers.
CRO stock prices fell initially following the news that Bristol-Myers Squibb was acquiring Celgene in a deal valued at $74bn. However, is 2019’s first mega-merger really a threat to service providers?
