Immodulon to utilize biomarkers identified by Biodesix’ machine learning platform, aiming to accelerate the clinical development of its pancreatic treatment.
A study by Biofourmis aims to improve patient centricity in the drug approval processes by using wearable technology and mobile software to monitor the quality of life for patients with heart failure.
Insilico Medicine develops a semi-automated contracting system to ease the collaboration process between AI companies and industry partners in the discovery space.
MIT has developed an ‘invisible’ device that provides several benefits over traditional patient data collection methods, including improved biomarker development and the ability to detect changes in behavior – by monitoring patients wirelessly, and through...
Janssen aims to expand the label of delivery in the US and EU for its product, Darzalex, to include subcutaneous delivery through the use of Halozyme’s technology.
A collaboration between Mercachem and Gotham leads to the generation of a molecule library, expected to enable new discovery opportunities in the epitranscriptomic targets space.
Lovelace’s support and the inclusion in a $20m NIH contract enable Exemplar to continue the development of a porcine animal model for Sickle Cell Disease research.
An Executive Order signed by President Trump aims to increase research, incentives, and treatment access for kidney disease patients and could 'fundamentally transform kidney therapeutics,' says president of the American Society of Nephrology....
Eversana adopts Cryoport’s full suite of logistics services, in an alliance expected to ‘drive synergistic growth’ for both companies and answer regenerative medicine demands.
CMIC Group is the first Japanese CRO to join the Align Clinical group and expects to improve execution of clinical trials and collaboration with life sciences companies as the industry grows globally.
Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
The two regulatory agencies have confirmed the addition of the last country to their mutual recognition agreement, with GMP inspections by Slovakia given a positive assessment.
Elligo expands its Research Ready network and adds its first oncology practice through a partnership with Austin Cancer Center, which is currently enrolling patients for breast cancer studies.
Following Gilead’s funding of Lyndra’s technology, the latter company offers exclusive rights to its therapeutics platform for long-acting HIV therapies formulations.
Highlighting the threat of AMR, the UK government has worked with the pharma industry to develop a new antibiotics payment model based on ‘usefulness’ to the NHS.
Strides’ Puducherry, India, facility has received a warning letter from the US FDA, which the company announced will lead to deferrals for 10 pending ANDA approvals.
The strategic advisory company, Trinity, opens a new office in Germany, with leadership joining from Syneos Health to work “hand-in-hand” with biopharma clients.
Belong.Life raises $14m as part of a Series B funding round with plans to expand its patient engagement platform, using and complementing Iqvia’s solutions “to transform patient engagement,” says Iqvia VP.
Panelist during the opening session of the DIA Annual Meeting last week stressed the need to work collaboratively, bringing patients into the fold as co-creators of clinical trials to ‘create a whole new landscape for research.’
With Germany’s addition to the US FDA-EMA mutual recognition agreement, only Slovakia is left to be added to the agreement, with the deadline later this month.
Sponsors to benefit from more accurate, shorter, and less costly trials through Shimmer Research and ClearSky Medical Diagnostics partnerships, says company executive.
Clinical trials are taking longer, drug development costing more, and the stakeholder group expanding – all compounding to create an "industrywide urgency to streamline how trials are run,” says Veeva VP.
Datavant enters partnership with Prognos to expand the latter’s analytics capabilities to determine clinical outcomes and inform decision making as data availability grows.
The value generated by the manufacture of medicines has doubled since 2000, with one of the smallest countries in Europe responsible for a significant proportion of the total figure.
Iqvia today launched a new “patient centered endpoints” solution, which captures the patient experience during clinical trials and real world studies, says SVP.
CRF Bracket – newly-rebranded as Signant Health – is looking to build momentum around eConsent, rethink the patient’s connection to the supply chain, and build out a stronger analytics platform, says CEO.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
Analytical software provider and CRO, Cytel, and biostatistics company, Axio Research, merge to deliver analytical solutions for clinical research drug development challenges.
Transforming statistical data into a surrogate endpoint can enable comprehension of trial results sooner than usual, but few make the cut after formal validation, says drug development expert and DIA panelist.
Females as caregivers, clinical trial participants, and biopharma leaders are among the different roles to be carefully considered as the industry aims for increased inclusion, says BBK executive.
In which areas is artificial intelligence most mature? What are the challenges to widespread adoption? Tufts and DIA recently teamed up to explore these questions.
New this year to the discussion at DIA is the conversation around data ownership, as the industry continues to face a deluge of information from more sources than ever.
Zenith-Cognizant Technologies emerges from an acquisition aimed to streamline solutions as more complex “smart factories” become a greater focus in the biopharmaceutical industry.
To investigate blockchain processes and make distribution information retrieval more efficient, the FDA tapped big name companies for a supply chain security pilot program.
Two US Attorney Generals have opened an investigation into the data breach at AMCA that compromised a combined nearly 20 million patients at LabCorp and Quest Diagnostics – as the companies’ efforts to notify the public are called into question.
Parexel forms a strategic partnership with Clariness to deploy the ClinLife platform in the Greater China area as the CRO looks to recruit and engage patients in their native language and via social media channels.
Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
