Thermo Fisher’s clinical research subsidiary, PPD, invests $59 million in sample management and testing capacity for vaccines and cell and gene therapy products with its expansion of laboratory operations in Kentucky.
The company will split into two separate entities, one will focus on the development of neuroscience therapies and the other will become a standalone CDMO.
The long-running case relates to the change of formulation to its Levothyrox product, specifically the information the company provided when the product was altered.
CPhI Frankfurt takes place next week: covering the full supply chain from research and manufacturing to packaging and finished products. Here’s five ideas on how to make the most of the event.
A ‘significant shift’ is under way in global outsourcing strategies: with the sector moving away from phase-appropriate development in favor of a more forward-looking model – with experts advising starting the search for an outsourcing partner as early...
The company opens a bioanalytical lab in the US, which offers an additional 59,000-square-feet of space to the overall facility, making it “one of the largest laboratories of its kind.”
ConcertAI has introduced a digital trial solution informed by its collaboration with Bristol Myers Squibb to simplify patient identification, consent, IRB approval, and contract negotiations.
Clinical software surveillance company launched automated patient identification solution to bolster patient enrollment and reduce staff time needed to screen patients.
A federal judge in the Southern District of Florida has sentenced two Florida women to prison for their part in a conspiracy to falsify clinical trial data.
Updated interim results from Part A the RINGSIDE pivotal Phase 2/3 study of the company’s AL102 new drug showed consistent early tumor shrinkage with measures deepening over time, plus good tolerability at all doses.
Cardiff-based CatSci is investing in its oligonucleotides capability that will enable the company to make oligos from nanomole quantities up to 30 grams using solid phase synthesis.
Digital enrollment for Lark Health’s Cardiovascular Disease DCT is sped up by using the “tapestry of the entire internet” through Curavit and 1nHealth.
Sanofi has teamed up with TrialSpark to jointly acquire and advance clinical-stage candidates, leaning on its partner’s tech-enabled drug development capabilities to hustle the programs toward approval.
According to the agency, Teva communicated that it would have difficulties supplying immediate release formulations of the drug due to manufacturing delays.
Walmart joins rival retailers by launching its service for clinical trial recruitment, stating that it will focus on older, rural, women and minority populations.
The company, through its subsidiary, PPD, announced that it had created a network that would provide learning materials to those investigators and research sites looking to use decentralized clinical trials (DCTs) for drug development.
Massive Bio partners with Perthera.ai to improve cancer clinical trial enrolment through the use of AI technology to connect oncologists and patients with biomarker-based therapy options.
Clinical data findings from Actinogen’s Phase 2a study measuring the effects of Xanamem in patients with biomarker-positive Alzheimer’s Disease validated company’s ongoing program.
Indegene’s partnership with Tealium leverages AI-driven data strategy for life sciences companies to navigate the industry’s connected technology ecosystem.
The company announces the submission of a 510(k) premarket notification application for its investigational inhaled nitric oxide delivery system for its INOmax gas product.
OMEC.AI is the first startup to emerge from the alliance of pharma companies and investors that created AION Labs, and will focus on improving the efficacy and safety of drug candidates.
The company states that with the expansion of its digital services, its digital supply chain operations platform is the first end-to-end solution of its kind on the market.
The Danish company becomes the latest large pharma company to invest in NLRP3 assets, with these types of treatments holding the potential to treat a variety of diseases linked to inflammation.
The regulatory agencies of six European countries are now actively prompting clinical trials sponsors to publicly report their clinical trial results—and have the power to issue fines of up to €250,000 ($243,000) for noncompliance.
The company announces further measures against a counterfeiting network it accused of being responsible for selling illegitimate Gilead HIV medications.
