Quotient Sciences has found new owners in the UK-based PE firm, Permira, as the CDMO eyes new opportunities to expand its business into adjacent service sectors and new geographies, says CEO.
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....
Despite positive movement on the number of women serving on executive committees since 2018, the industry has seen a significant drop in positions governing profit and loss.
The Pistoia Alliance launches a project to steer the implementation of principles for data management and stewardship, which it said are required as the industry undertakes a digital transformation.
In a warning letter, the US FDA details how its inspectors discovered cGMP document awaiting shredding and records discarded in a 55-gallon drum at Strides’ facility.
Lonza to use Rockwell Automation technology as it digitizes the operations and manufacturing environments at nine of its Capsugel facilities to bring “new levels” of operational efficiency.
Novo Nordisk and Roche/Genentech top this year’s Good Pharma Scorecard, which was, established to provide rankings of pharmaceutical companies’ clinical trial transparency and data sharing practices.
Atlantic Research Group implements Greenphire’s ClinCard and ConneX reimbursement solutions in an aim to ease the clinical trial experience for both sites and patients.
Regulatory actions by the FDA have enabled rare disease drug development to become a compelling space with orphan drug designations and approvals trending upward, says life sciences industry attorney.
More than half of new drug approvals last year were for rare diseases – which face long cycle times and other operational challenges that are necessitating the rapid adoption of new solutions, per a recent Tufts report.
Scientific advances and regulatory incentives are driving the use of genetics in drug development, though the industry’s ability to perform wide-scale testing has outpaced its understanding of the results, the misinterpretation of which can have “disastrous”...
Natural history studies are essential for rare disease research and can potentially replace placebo arms in clinical trials, among several other benefits, says industry expert.
Novogene is working with Mission Bio to offer customers in China access to the Tapestri Platform, which is being used in the drug development process by LabCorp and more than a dozen institutions.
PPD’s patient enrollment business expands access to cancer patients treated in the community setting as part of a new collaboration with a hospital and outpatient center network.
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.
Recursion Pharmaceuticals plans to partner with big pharma on rare disease programs after raising $121m to build out its machine learning-enabled platform, which draws on an in-house developed dataset to support drug discovery and development.
Longboat Clinical’s new offering connects potential clinical trial participants with enrolling study sites and provides insights into online patient recruitment campaigns in real-time.
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.
The global drug discovery market is expected to reach $68bn in 2028, according to a Visiongain report, with revenue gains driven by flexibility, agility, and the ability to innovate, says Evotec executive.
DSP Clinical provides flexible monitoring support to sponsors and CROs through a new co-monitoring service that takes advantage of fluctuations in employee demand.
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.
Alten Calsoft Labs launches its first initiative for blockchain through its scalable clinical trial platform BioPharma Ledger to address life sciences processes using BlockApps middleware.
Repositive ‘increases visibility’ while ‘maintaining confidentiality’ as it makes its directory of preclinical cancer models publicly browsable as part of the relaunch of its Cancer Models Platform.
The US FDA published another warning letter sent to Akorn, which details cases of improper investigation into faulty batches, failure to exercise controls over data, and ‘poor aseptic behaviour’.
Saama and Tufts are teaming up to examine how sponsors and CROs are using automation and information technology in an aim to identify new solutions and optimize drug development.
Following Gilead’s funding of Lyndra’s technology, the latter company offers exclusive rights to its therapeutics platform for long-acting HIV therapies formulations.
Pharma and regulators are using machine learning to accelerate various pharmacovigilance activities – as the number of adverse event reports increases 10-12% each year, says Eli Lilly advisor.
AG Mednet provides imaging services to Median Technologies in support of the company's portfolio of clinical trials, including "large programs" in China.
PPD’s patient access business unit AES will support clinical trial enrollment of participants in the Synexus HealthyMinds Registry, which aims to register 30,000 adults for a five-year study.
Fresenius Medical Care integrates Frenova Renal Research into its global office in an aim to extend clinical research activities and reach more than 550 researchers.
StemoniX opens a new facility in California to house its research team working on its high-throughput microOrgan technology platforms for drug discovery and preclinical development.
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.