Regardless of the quality of the raw materials used in bioproduction processes, variability is a very common threat that can be addressed, says Thermo Fisher executive.
PPD puts the spotlight on special patient populations by supporting clinical trials with Asian participants, preparing developers to expand into the Asian market.
While exhibiting its offering in self-administration devices at the CPhI Worldwide event in Frankfurt last week, West told us how patient convenience drives design and development.
Driven by market demand, De Dietrich develops an API production set that enables continuous manufacturing of molecules that require exothermic chemical reactions.
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.
Speaking at CPhI 2019, Piramal CCO puts the spotlight on patients who ultimately 'pay the bill,' and explains how this mentality could reshape the CDMO business.
The modeling and simulation solutions provider Simulations Plus has been contracted to support countermeasure development for acute radiation syndrome in a partnership with a global pharma company.
The state of information exchange is creating challenges for CROs, which are increasingly investing in technology and shifting away from paper-based processes, per Veeva’s annual report.
Dassault Systèmes’s $5.8bn acquisition of Medidata is complete – opening up ‘a new world of virtual twin experiences’ for health care, according to the French software firm.
Many patients use an app to manage their health – good news for the clinical trials industry, which is continually looking for new ways in which to engage and support patients.
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.
Cycle looks to benefit from the advantages of Zydis oral disintegrating tablet technology, developed by Catalent, for four of its drug products treating rare diseases.
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.
Vetter recently completed a successful pilot project to automate aspects of its secondary packaging series with the use of a dual-arm robot – which provides a high degree of continuity and precision, says CDMO.
Romaco’s Push Packs, made from recyclable polyolefin laminate, are the ‘first ever’ recyclable unit dose packaging for solid drug products, according to the company.
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.
In-PharmaTechnologist steps inside Siemen's Digital Experience Centre to learn about the digital services that aim to transform the manufacturing of pharmaceuticals.
By Richard Klein, director of expanded access programs and policy, GE2P2 Global Foundation
In a letter to the editor, Richard Klein, director of expanded access programs and policy for the GE2P2 Global Foundation, outlines three reasons why Right to Try is less flexible than expanded access.
GSK announces it initiated Phase III trials for gepotidacin, the first in a new class of antibiotics, as an potential treatment for urinary tract infection.
ConvergeHealth by Deloitte has launched a new platform for the health care ecosystem that provides clinical trial participants and patients with personalized support and connection to their care teams.
Escient Pharmaceuticals has entered the market after closing a $40m Series A financing round – and has contacted Eurofins Discovery for integrated drug discovery services.
LabCorp acquires South Bend Medical Foundation’s diagnostic clinical laboratory testing business, which pathology and blood banking services to patients in Indiana, Michigan, Ohio, and Illinois.
The online marketplace for outsourced research has expanded its compliance solution to include animal welfare – and is working with customers to increase transparency and educate researchers.
Icon boosts its hybrid clinical trial and site support services with the acquisition of Symphony Clinical Research, a provider of in-home and alternate site services.
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.
As part of an evaluation of its manufacturing network, the company concluded that the Ringaskiddy production building was no longer a competitive, long-term option.
