Proximity Health Solutions aims to tackle clinical trial recruitment by meeting patients where they live – using its access to local thought leaders and community venues to educate and enroll potential participants in close proximity to investigator sites.
Novartis exercises its option to license Ionis’ RNA-targeting cardiovascular drug, adding to its cardiovascular treatment portfolio, as Entresto reaches the three-year mark on its patent.
The pharmaceutical and biotech consultancy has opened a new office in Dublin, Ireland ahead of Brexit, the final outcomes of which remain unknown, says CEO.
Haselmeier to provide assembly, labeling, and packaging services for its drug-device combination products following recent permission given to Germany-site.
A number of companies spent the early part of the year creating and then filling new positions, which has seen another big pharma company follow the trend of appointing a chief digital officer.
Clinical trial sites are challenged by fragmented financial processes, according to a new study by the Society of Clinical Research sites and Greenphire released this week at SCOPE 2019.
Lonza enters private label partnership to manufacture and globally commercialize AllCell’s hematopoietic primary cells to provide greater access to researchers.
PPD’s agreement with China-based Happy Life Tech focuses on site selection, patient recruitment, and real-world evidence generation for customers globally.
A low volume, high margin business model will facilitate the development of new antibiotics and see big pharma return to the space, suggests Entasis CEO.
With the recent marriage between technology and science aimed at innovating aspects of clinical trials panels composed of experts from fields outside of pharma could prove to be impactful.
Artificial intelligence advances threaten data privacy, according to a new study, which found it is possible to re-identify individuals using their physical activity data.
Shimmer designed its new Verisense platform from the ground up after finding that current activity trackers fail to meet the “basic needs of the clinical research market,” says company executive.
US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.
In full-year financials, AstraZeneca announced that its R&D arm, MedImmune, will be absorbed into the overall company as it restructures its R&D units into specific therapy areas.
The EMA needs to fix problems with the clinical trial registry to improve reporting across Europe, says TranspariMED founder, as seemingly small issues can “seriously hinder compliance.”
The industry has advanced to a point that should justify the financial investment in new technology, though uncertainty, and a lack of support, are hindering movement.
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
Lonza and Emerald Health enter an agreement for the large-scale manufacturing of a synthetic derivative of CBD and its oral drug product for the treatment of MS and other CNS diseases.
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.
