NVIDIA, King's College London, and Owkin team up to connect hospitals across the UK with federated learning, aiming to boost several fields of clinical research.
Recro Pharma announces the separation of its acute care business to launch Baudax Bio as a developer of products, including non-opioid analgesics, to concentrate on its CDMO business.
A lease agreement has been signed for the EMA to move into tailor-made premises in Amsterdam, with staff set to begin working from the space in January.
US FDA approves Fetroja, an antibiotic developed by Shionogi, for the treatment of complicated urinary tract infections, as part of the effort to fight AMR.
FDA’s Janet Woodcock testifies to Congress about the potential risks to US national security of the pharmaceutical industry’s reliance on Chinese imports.
ACRO is collaborating with the Congressional Research and Development Caucus and others to bring forth a new Cures bill focused, in part, on patient engagement, data, and digital health – with draft legislation anticipated early next year.
FDA urges manufacturers to ‘sell quality’ to fight drug shortages, releasing a report on the potential introduction of a rating system to reward transparency and investments in quality management.
Samsung continues an agreement formerly signed with Glenmark to manufacture Ichnos’ mAb treatment candidate for atopic dermatitis, as the product enters Phase III clinical trials.
This month’s people on the move includes a new therapeutic lead at Advanced Clinical, with plans to create a network of investigation sites, as well as CEOs at AIT Bioscience and Pharm-Olam, who discuss plans for moving forward.
The divergence across global market penetration of generic medicines is broad, with some countries’ markets worth close to half of the entire sector or as low as one fifth, according to IGBA.
The company’s Shanghai facility passes the European regulator’s inspection with no ‘critical’ or ‘major’ findings regarding the commercial products produced at the site.
California’s data privacy law will provide clinical trial participants with confidence that their information will not be misused – though additional clarity is needed as the pharmaceutical industry faces mounting pressure to increase transparency.
Representatives from the EMA and China’s NMPA convene to share expertise on GMP for APIs, GCP standards, and on the environmental impact of manufacturing.
Early dialogue with patients is ‘critical’ to design efficient clinical development programs for ATMPs and avoid ‘data gaps’, an executive from ARM says.
UK government signs freight capacity contracts to mitigate the risk that trade disruption will stop medicines from reaching patients related to a potential no-deal Brexit.
While the prevalence of chronic diseases boosts the demand for self-administered treatments, ease of use is becoming more important in device manufacturing, says product specialist.
Takeda has sold selected prescription and OTC products to Acino covering its Near East, Middle East and Africa portfolio, as it looks to trim down its portfolio following the acquisition of Shire.
Though the utilization of biosimilars in Europe is high, a report on the practices of eight countries suggests that more can be done to foster competition and remove barriers to entry.
US FDA gives marketing authorization to Lilly’s oral medication for the acute treatment of migraines in adult patients, adding to its Emgality approval almost exactly a year ago.
With both boards of directors in agreement, UCB is on track to add the clinical stage biopharma company and its lead drug candidate, zilucoplan, to its portfolio.
Beacon of Hope CRO is working with sponsors and other service providers to design Right to Try treatment programs, which the company’s founder says have ‘unmatched’ flexibility, an ability to treat screen fails and create ‘interim clinical milestones,’...
The recently-launched Research on Research Institute aims to deliver “transformative and translational research on research systems, cultures, and decision-making,” the need for which “has never been more vital,” says director.
After an investigation last year, the FDA cites problems across multiple sites within the Lupin manufacturing network, raising questions about ‘management oversight and control’.
US FDA expands the approval of Gilead’s Descovy to make it available for the PrEP indication, coming ahead of the entrance of generic rivals to the company’s Truvada product.
Iqvia’s Orchestrated Patient Engagement solution, powered by Belong.Life, delivers ‘hyper-personalized’ content to engage and support patients, providing insights that will benefit patients, life sciences companies, and the health care system, says CEO.
Phastar is building up its data science group as AI and machine learning ‘are rapidly modernizing clinical trials’ and Synteract boosts its centers of development in oncology and rare/orphan diseases, among other people on the move this month.
Johnson & Johnson reaches $20m settlement with two US counties on lawsuits regarding the opioid crisis, exits the upcoming federal trial involving several drug manufacturers.
With nitrosamines back in the headlines due to the recent discovery of contaminants in ranitidine, the EMA releases the five potential causes of the impurities plaguing the industry.
Rho experts speak to the challenges facing drug development, meeting unmet needs, quality by design, and advances in technology, among other topics, during a sit-down at the CRO’s headquarters.
