Taconic Biosciences’ new solution enables researchers to generate and maintain mice with custom microbiome profiles, alterations to which can significantly affect drug efficacy.
Enesi Pharma and OVG sign a collaborative agreement, hoping to combine a promising ingredient and an innovative delivery method to produce a plague vaccine.
The $74bn deal appeared to be fraying around edges, as certain shareholders voiced dissent, but a vote saw the deal pass with support from more than 75% of investors.
Charles River Laboratories has extended its ongoing collaboration with the CHDI Foundation by five-years – and is closing its San Diego, CA-based research model production facility.
monARC Bionetworks' new app enables patients to track symptoms between clinic visits – while also passively collecting environmental data, such as location and air quality.
Using automated chain-of-custody systems can save study sponsors and CROs a minimum of $1.3m per clinical trial in operating costs, according to a recent report from Almac.
NC-based FHI Clinical last week officially launched as a new full-service contract research organization with a global team the “right size” to adjust when needed, says CEO.
Catalent Pharma Solutions has opened its new, 30,000-square-foot Shanghai, China-based clinical supply facility, which is expected to employ up to 100.
An observation by the US FDA notes that Aurobindo had no established control procedures to monitor its manufacturing process, resulting in batches contaminated with unidentified material.
Circuit Clinical partners with the University at Buffalo’s genomics and biorepository program to add personalized medicine capabilities to its service offering lineup.
VivaLNK’s wearable sensor platform – currently being used in a clinical trial to remotely monitor patients – integrates hardware, connectivity, and application software, taking an "uncommon" approach in the medical technology space, says CEO.
Bringing together the food industry’s know-how and pharma’s manufacturing expertise, the new joint venture from Lonza and Chr. Hansen is positioned to pioneer the live biotherapeutic products space – addressing medical needs not met with ‘conventional’...
The European Commission approves Pfizer’s Vizimpro monotherapy for the first-line treatment of non-small cell lung cancer, as the market is projected to grow to $26.8bn by 2025.
GSK’s Dovato is approved by the US FDA for the treatment of individuals with HIV with no previous antiretroviral therapy, in a first for a two-drug, fixed-dose, complete regimen.
GE Healthcare’s Edison platform collaborates with ACR AI-Lab to extend its AI capabilities and allows ACR members access to algorithm creation in an aim to turn research into product development.
Deep Lens closes $14m Series A financing as it continues to expand its digital pathology platform to enable patient identification at time of diagnosis, fast-tracking trial enrollment.
The global genomic data and insights company expands its US footprint with the addition of a new genetic analysis laboratory as part of its mission to improve lives through genomics.
The company’s Mavenclad treatment gains approval from the US FDA for the treatment of multiple sclerosis, eight years after it had been initially rejected.
Researchers describe a technique to quantify a person’s “immune age,” information which could help design and analyze clinical trials – improving the drug development process, among other “impressive” possibilities, says industry expert.
WCG acquires Analgesic Solutions for advisement on protocol design and the development of clinical trials in which pain is an indicator of an underlying condition.
Bristol-Myers Squibb enters a multi-year strategic agreement with Concerto HealthAI to use machine learning to aid in protocol design for precision treatment and improved patient outcomes.
Catalent Pharma invests $5m in drug development center of excellence to expand its hot melt extrusion capabilities for formulation and drug delivery method optimization.
Twist Bioscience, a synthetic DNA provider, enters a strategic collaboration with LakePharma to bolster antibody discovery and optimization for biologic drug development.
CTI expects to create up to 50 new jobs over the next several years in response to significant growth in the pharma and biotech industry, specifically in cell and gene therapies, says CEO.
Metrion Biosciences looks to partner and move its lead candidate into clinical trials later this year fueled by a funding round which will also see its drug discovery services expand throughout 2019.
Clinical trials often rely on outsourced testing which poses potential logistical and cost challenges, though researchers recently demonstrated the viability of bringing these tests in-house to speed turnaround time – and more quickly match patients to...
With 70% of its customers in North America and demand increasing, the UK-based CDMO Sterling Pharma Solutions has acquired CiVentiChem’s US facility in Cary, North Carolina.
The discussion surrounding clinical trial awareness has evolved “from mere conversations to action, creativity, and inclusivity from multiple stakeholders,” and will continue to evolve as we work together to create a paradigm shift in awareness, says...
Since finalizing its risk-based monitoring guidance in 2013, the FDA is providing additional information in a new Q&A that reinforces the importance of performing risk assessments for all studies.
The Brazil-headquartered antibiotics company announces that it has invested in two new buildings, a few years after running into regulatory trouble due to non-compliance with cGMP.
US FTC rules that Endo used its dominant position in the market to delay competition from Impax with an illegal pay-for-delay deal for its Opana ER product.
TriNetX acquires Belgium-based Custodix NV to support industry partners looking to collaborate with non-US hospitals – becoming a “one-stop-shop” for clinical data, says SVP.
Horizon Discovery is working with St George’s University Hospital and EMQN to develop reference material for non-invasive prenatal testing, which is being increasingly adopted in the UK and abroad.
Sinclair Research and Turner Scientific sign an exclusive partnership through which the CROs will offer ototoxicity testing services – and improve regulatory guidance regarding the ears to protect patients, says company executive.
