HCL Technologies and Oracle Health Sciences announce a collaboration to “bridge the gap” between the potential of mobile health and the realities of adoption, says EVP.
Daiichi Sankyo’s Turalio becomes the first FDA-approved TGCT treatment, after receiving breakthrough therapy, priority review and orphan drug designation.
'Oncology Repurposing Engine' uses artificial intelligence to identify potential drug candidates among generics and off-patent drugs that may be repurposed as cancer therapies.
The EMA demands drug developers to change the name of medicines containing liposomal, following reports of ‘serious medication errors’, some leading to death.
API recalls have sparked discussion on the development of impurities during manufacturing and the ways in which risks can be mitigated, according to an industry expert.
At a time when innovation is rapid, clinical development is evolving at the same pace, and new technologies are bringing disruptive opportunities to research, says AbbVie executive.
Biopharmaceutical companies are increasingly relying on CROs in Japan, says an executive with PRA, which recently established a new subsidiary in the country.
Massive Bio is looking to create the world’s largest AI-enabled ‘just-in-time’ oncology site network to accelerate study recruitment – and believes that 15-20% of advanced-stage cancer patients can be enrolled in clinical trials, says CEO.
Analytical solutions provider, Cytel, launches its East On Demand system to provide small biotechs access to more flexible software for adaptive trial design.
Product Specific PTRS, Evaluate’s machine learning platform, aims to help assess the likelihood of a drug reaching the market – managing the risks of drug development.
Takeda and Sosei both have a proud heritage in Japan and recently entered a billion-dollar partnership with Sosei to discover, develop, and commercialize molecules for patients in need around the world.
It’s a lot more complicated than a simple technology – says Iqvia global head of virtual trials, who shares four lessons learned during a discussion at the company’s headquarters in Research Triangle Park.
Samsung Biologics and UCB agree to an additional drug substance manufacturing deal to produce an anti-tau candidate currently in Phase I clinical trials to treat progressive supranuclear palsy.
Caprion Biosciences and HistoGeneX join forces, combining the two businesses to provide a source for immune monitoring, protein characterization, and tissue pathology solutions, as immunotherapy landscape evolves.
Javara teams up with a doctor-owned medical practice to increase access to clinical trials – based on the needs of the patient, rather than the needs of big pharma, says CEO.
Aptar’s needle-free, emergency powder formulation treatment for patients with diabetes and severe hypoglycemia is the company’s first combination drug delivery device with active packaging.
Roche agrees for Sanofi to be responsible for the OTC marketing and distribution of Tamiflu in the US market, as it works on approval for its Xofluza competitor product.
CordenPharma has a new CEO, Arbour Group advances plans to expand in RTP, Ashfield brings on a former Iqvia VP, and Recursion adds to its c-suite after raising $121m this month.
Growing need for validated storage capacity sees Lyophilization Services of New England complete an expansion its cGMP storage capabilities at its New Hampshire site.
Lonza enters a partnership with Vineti to advance its ‘vein-to-vein’ delivery network, creating an end-to-end ordering and manufacturing process in support of cell and gene therapy development.
Aiming to speed up and facilitate the clinical development of liver failure treatments, Taconic launches the first commercially available diet-induced NASH rodent model.
Cambrex to scale up its solid form screening and crystallization process development facility in Edinburgh to answer market demand for larger scale crystallization.
To further support Asia-Pacific oncology trials, NeoGenomics opens new Singapore-based pharma services laboratory in the same building as PPD Laboratories’ central lab.
Sanofi to manufacture and commercialize Opiant’s investigational treatment for acute cannabinoid overdose, which could become the first treatment for the condition.
The acquisition of two migraine therapies from Dr Reddy’s has been completed by Upsher-Smith, adding different drug delivery treatment options to its migraine product portfolio.
Years in the making, ACRES launches a global accreditation program, which will ‘dramatically’ benefit all research stakeholders, including sponsors, CROs, regulators, monitors, as well as patients, says CEO.
July has seen a number of actions taken by regulators to manage the supply of medicine, including a crackdown on CBD manufacturers and repackers of opioid medication.
Phesi launches an AI-powered SaaS solution to mitigate potential costly delays through a search and select investigator function to determine trial sites for clinical studies.
Immodulon to utilize biomarkers identified by Biodesix’ machine learning platform, aiming to accelerate the clinical development of its pancreatic treatment.
Litmus Health today released a new version of its end-to-end real-world data platform for clinical research – as the industry increasingly adopts wearable technology to monitor patients in their homes, says CMO.
Merck to invest in its North Carolina facilities as it expands production capacity to meet demand for its HPV vaccine Gardasil, and grow its packaging operations
