Sutro Biopharma and Merck have signed a collaboration and licensing agreement, which will leverage Sutro's proprietary cell-free protein synthesis and site-specific conjugation platforms.
The dozens of ‘devastating, unprecedented and dangerous’ forest fires raging across Sweden are far from manufacturing and industrial centres, says Swedish Association of the Pharmaceutical Industry.
Researchers have halted a clinical trial testing sildenafil citrate – the active ingredient in Pfizer’s Viagra – in pregnant women, following reports of baby deaths.
PPD has expanded its central lab technology capabilities with the launch of a new client portal and a companion application for its Preclarus investigator site portal.
The digital health startup ObvioHealth has launched a new mobile clinical study platform to streamline patient recruitment, reporting, and post-marketing surveillance.
Synexus is looking to register 30,000 adults for a five-year study with the goal of identifying potential prevention methods and possible treatments for Alzheimer’s disease and other dementias.
Pfizer, AbbVie, and GlaxoSmithKline are among the members of a clinical trial data-sharing and analytics platform designed to speed up the discovery and development of new treatments.
Moderna Therapeutics has announced the opening of a state-of-the-art manufacturing site in Norwood, Massachusetts, built to advance their work in the messenger RNA (mRNA) platform, after announcing the plans for the site in 2016.
UK-headquartered Concept Life Sciences says completing FDA registration means it can test raw pharmaceutical materials and finished products for the US market.
CRO executives are being urged to write letters of support for more high throughput clinical research centres in the UK, which could help attract foreign investment, says IAOCR.
The US FDA has drawn industry attention to the potential of 3D printing and continuous manufacturing, which it says could “improve drug quality, address shortages of medicines, lower drug costs, and bring pharmaceutical manufacturing back to the US”.
The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
Genstar Capital, the private equity firm behind Bracket, has purchased CRF Health in a deal that will create a combined organization with more than 1,500 employees globally.
The industry is increasingly engaging in collaborations to gain access to technology, such as AI, which is being touted as a potential solution to some of the most challenging aspects of running clinical trials.
Ignoring pediatric considerations is no longer an option for the development of new medicines – though clinical trials in children are still not widely accepted by society, explains industry executive.
Cure Pharmaceuticals says it plans to apply its drug delivery technologies to Therapix Biosciences’ cannabinoid-based drug pipeline for non-pain indications.
“Arbitrary upper age limits for trial entry are almost never justified,” says FDA, which has renewed its efforts to include older adults in clinical trials and tackle some of the key enrollment challenges.
While senior citizens consume roughly one third of all medications – and make up only 13% of the population – factors that complicate geriatric clinical trials leave gaps in knowledge and developments.
It has been nearly 20 years since a currently available drug was tested and approved specifically for the newborn population, say industry experts who are calling for education and policy changes to address the needs of this special patient population.
The first ever drug to treat smallpox has been approved by the US FDA, after having been created by SIGA Therapeutics in coordination with several US departments.
Antoxerene and investor firm Juvenescence have collaborated to form FoxBio Inc., an offshoot focused on small molecule drug discovery for the pathways of ageing.
The US FDA has joined other national regulatory bodies across the globe in recalling certain valsartan medicines, which were found to contain a probable carcinogen.
WCG and InformedDNA have established a new center for genetics and precision medicine in clinical trials – the increasing complexity of which, while potentially daunting, also creates the opportunity for transformational value, say industry experts.
The Scientist.com and HealthEconomics.com partnership connects real-world evidence (RWE) and health economic outcomes research (HEOR) sponsors and providers to help democratize pharmaceutical research, says company exec.
The Russia-based CRO Atlant Clinical has received certification in the organization and management of clinical trials – demand for which continues to increase despite political and economic challenges.
The US FDA announced a task force has been formed to prevent the shortage of drugs, by addressing the ‘underlying structural concerns’ that allow this to happen.
Velos has released a new clinical research analytics platform in which the source information is reorganized and reclassified to make it “considerably more useful for clinical research,” says CEO.
Synteract has acquired the dermatology CRO Cu-Tech, opening a fifth center of development as part of its strategy to develop “highly-expert therapeutic areas of focus,” says CCO.
Pfizer has announced a major shakeup of its business by splitting into three units: Innovative Medicines, Established Medicines and Consumer Healthcare.
