With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.
Deception among clinical research participants is prevalent and a global issue, say researchers, with self-reported adherence found to be largely inaccurate.
The topic of antimicrobial resistance is back in the spotlight after the US FDA released a new website and a number of proposals to encourage the drug development in the area.
GSK has invested $27.8m into manufacturing operations in Canada, including a technology transfer of Voltaren products from facilities in Switzerland to Mississauga.
The clinical development services provider Phesi is looking to patent its method and system for developing clinical trial protocols – which enables faster patient enrollment and study completion, says CEO.
VGXI, a subsidiary of GeneOne, signed a licensing agreement with Houston Methodist Research Institute to produce RNA one of the most valued clinical ingredients.
The European Patent Office has upheld protection relating to Gilead’s costly Hepatitis C drug Sovaldi, which Médecins du Monde claims prevents patients from receiving affordable treatment.
Takeda will become the latest company to base its operations within Massachusetts, after announcing it would leave its Deerfield, Illinois headquarters.
Cytel examines the gap between controlled experiment and real-world data at a time when the industry is collecting more data from more sources than ever before.
Researchers and clinicians agree that patient engagement is imperative to address the challenges of psychiatric clinical trials, as is the reduction of the stigma attached to such conditions.
Patient centricity quite plainly means to put the patient at the “front and center,” explained Rhonda Henry, vice president, site collaborations and patient centricity, PPD – though many remain confused on how to be “patient centric.”
Looking to establish patients as partners in the drug development process, the industry has launched several initiatives driven in part by advancements in technology, still, several challenges present.
Taking inspiration from popular games such as Candy Crush and World of Warcraft, Data Cubed has developed a mHealth platform that promises to increase patient engagement in clinical research.
Integrating clinical research into the health care ecosystem improves patient engagement and quality of care while reducing costs, though only 1% of the general population participates in clinical trials.
Evotec and Almirall are using a novel approach to disrupt cell signaling to discover and develop first-in-class therapeutics targeting dermatology diseases.
MannKind Corporation, of Afrezza fame, and United Therapeutics have signed an exclusive licensing and collaboration agreement for dry powder pulmonary hypertension products.
The global biopharmaceutical services provider has launched the Patient Innovation Center to help sponsors implement patient-centric initiatives — an area in which the company is committed to innovate, says executive.
The US FDA announced a number of measures it considers as a viable means of combatting AMR, including the idea of hospitals paying a ‘subscription’ to access new medicines.
in-PharmaTechnologist (IPT) speaks to Ettore Cucchetti (EC), CEO of ACGI, about how the biopharma industry is adapting to the threat of counterfeit medicine and how he expects the industry will adopt further measures beyond those stipulated in the EU...
As Novartis looks to sell a major chunk of its generics portfolio in the US, in-PharmaTechnologist has a look back at some of the stories this year that have signposted larger, on-going trends in the US generics market.
Undisclosed pharmaceutical industry payments to authors of oncology clinical trials published in scientific journals raise concern around credibility and trustworthiness, according to a recent report.
Major pharmaceutical companies and CMOs in the US have announced emergency contingency plans, including facility closures and the relocation of drug products, as Hurricane Florence approaches southeastern shores.
Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.
Through XpertDox’s partnership with the Heart Failure Society of America (HFSA), patients and clinicians will be able to track heart failure related clinical trials.
Three family members charged with producing and supplying unlicensed medicines in the UK used pressing equipment and dyes imported from China, says MHRA.
BioIVT’s research on the mechanisms underlying the C-DILI assay introduces “a new paradigm,” which suggests BSEP inhibition alone will not lead to bile acid-induced liver injury, says study director.
The biopharmaceutical analytical and bioanalytical contract solutions provider SGS is investing more than $1.7m to expand its North American biopharmaceutical testing capabilities.
The top three myths of ‘going digital’ relate to the industry’s self-image, the perceived role of technology, and current market conditions – still, digital is not a fad and is here to stay, says industry expert.
The collaboration will integrate the functionality of Clinerion’s Patient Network Explorer with Semicrol’s Fundanet clinical trial management system (CTMS).
A study at Washington University in St. Louis has shown a new way to deliver drugs to the brainstem in a non-invasive administration: microbubbles and ultrasound.
