Standardization in preclinical animal studies may be a cause of poor reproducibility – making translation to humans in clinical trials difficult, if unlikely, say researchers.
Tax policy reforms have made the US and UK attractive locations for drugmaker investment, says PwC’s Jean Delaney, but argued Ireland is “still well positioned on the tax front.”
The UK-based CRO Clintec International has expanded its partnership with Medidata to include the latest generation of its electronic data capture (EDC) technology.
Alira Health has acquired Clinical Assistance Programs (CAP), a contract research organization (CRO), which complements the company’s consulting, medical affairs, regulatory, and R&D services, says exec.
Bioclinica’s Individual Case Safety Report (ICSR) team has processed more than one million cases after doubling its processing volume since 2016 – as demand for ICSR outsourcing increases.
The detection of cracks of the surface of glass vials has prompted a voluntary recall of Labetalol Hydrochloride Injection made at Pfizer’s troubled McPherson, Kansas facility.
Charles River has launched a new online tool to help researchers design in vitro and in vivo oncology research studies – to put the power of data in the hands of scientists, says exec.
ACRP is partnering with a Singapore-based institute to ensure the workforce is appropriately trained ahead of anticipated growth in clinical trials throughout Asia.
In the days of personalised medicine, 3D printing and nanotechnology, consultant David Chesney says regulators must “keep pace” to redefine current good manufacturing practice.
Lonza has increased its encapsulation capacity and invested in highly potent active pharmaceutical ingredient (HPAPI) services at a facility in Tampa, Florida.
Avid Bioservices has been selected to manufacture a commercial drug substance for Enzyvant, a subsidiary of Roivant Sciences, which is developing a therapy to treat Farber disease.
The global health research network TriNetX has developed a new chemotherapy lines of treatment identification algorithm to help researchers identify potential clinical trial patients.
Takeda Pharmaceuticals will work with Wave Life Sciences to develop nucleic acid therapies for central nervous system disorders, including Huntington’s and Lou Gehrig’s disease.
Strategikon Pharma has released a new cloud-based solution to help plan, source, and manage clinical programs – with the goal of eliminating paper-based processes.
Reckitt Benckiser Group says it will be disciplined in its M&A strategy but remains silent on speculation it is buying Pfizer’s consumer healthcare business.
In an open letter to the US Food and Drug Administration (FDA) AllTrials implores the agency to fine clinical trial sponsors that don’t publish trial results on ClinicalTrials.gov – as no fines have been issued to date.
Researchers have published new international guidelines for the inclusion of patient-reported outcomes in clinical trial protocols with the goal of providing high-quality evidence and enhancing patient care.
Avid Bioservices expects new contractual commitments in the coming weeks and months after raising more than $20m and completing its transition to a dedicated CDMO, says CEO.
Boehringer Ingelheim has joined the Society for Clinical Research Sites as a Global Impact Partner (GIP) to help identify new approaches to working with sites.
Scientist.com is working to implement an improved contractual landscape ahead of GDPR implementation in May, in order to ensure global compliance among sponsors and CROs.
Technology investments are catalyzing the study start-up process – and with more investment coming in from CROs, sponsors complete all site-related activity 6 to 11 weeks slower, according to a recent Tufts report.
AMAG has received approval for its preterm birth risk reduction product combining the drug product supplied by Pfizer and Antares Pharma’s auto-injection system.
Two Chinese and one Korean over-the-counter (OTC) drugmakers have received US FDA warnings for violating good manufacturing practice (GMP) regulations for finished pharmaceuticals.
PCI Pharma Services (PCI) has announced its intent to acquire Pharmaceutical Packaging Professionals (PPP) as the company focuses on growth and rapid expansion.
In response to stakeholder feedback, the US FDA has issued a final guidance detailing changes to the regulatory classification of co-crystals, from intermediate to API.
Agilent Technologies says changes in the industry this year will present opportunities for continued growth in its pharma processing equipment and consumables business.
The Republic of Ireland will move its population from short-acting to extended half-life haemophilia therapies, under an exclusive two-year deal with Sobi.
Merck Sharp & Dohme (MSD) plans to build a biologics facility at a former small molecule manufacturing site in Swords, Ireland, which it closed last year.
HealthCarePoint has announced a mutual collaboration with Clinerion through which members of the company’s BlueCloud Sponsor Network will gain access to Clinerion’s patient database via a dynamic map.
Parexel has launched a new offering that enables customers to manage patient biological sample assets across the supply chain, as precision medicine becomes more prominent, says VP.
