Slovakian contract manufacturer Saneca says the opportunity to tap the Russian market is huge despite protectionist policies and changing GMP inspection requirements.
Roche, Merck and Lilly are among those calling for regulatory harmonisation and free movement of goods between the EU and the UK once the latter leaves the Union.
Transitioning to a single strategic contract research organization (CRO) reduced Bayer’s administrative burden, but the restructuring was met with some resistance, said the firm.
WIRB Copernicus Group (WCG) has expanded its portfolio of companies to include the pharmacovigilance and drug safety solution provider Vigilare International.
The industry is expected to use an increasing amount of real world evidence, including social media data, which will be used to support new drug applications, according to a recent Tufts report.
As the industry continues to externalize components of the supply chain, global regulatory authorities are requiring a “quality-by-design” (QbD) approach to help mitigate risk across the drug development process.
The industry has reached an inflection point with 200 new health-related apps added daily – the use of which could lead to potential annual savings of $46bn, says IQVIA.
ICON and the International Consortium for Health Outcomes Measurement's (ICHOM) pilot patient outcomes platform – known as ‘Globe’ – aims to improve drug development procedures.
Clinical trials conducted outside of India – which test drugs for the Indian market – must include Indian subjects, according to a ruling in India last month.
The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.
A proposed regulation in New Jersey demonstrates a lack of understanding regarding the clinical trial process and has clear collateral damage to research conduct in the state, ACRO testifies.
A year after implementing its policy on the publication of clinical data, reports on 50 medicines have been published and more than 80,000 documents downloaded – outcomes achieved through industry collaboration, says EMA.
Clinical trial sponsors plan to release more trial results summaries over the next year as part of patient engagement efforts, according to a recent survey.
“Bring Your Own Device” (BYOD) in clinical trials will be a “critical component” of future research says Bracket CEO following the company’s acquisition of mProve Health.
Parexel has partnered with Microsoft to advance patient-centric technologies and help deliver on the promise of personalized medicine following a need for efficiency and innovation in drug development.
Evidera has expanded its patient-centered research services, the advancement of which will enable the introduction of better treatments, faster, says team VP.
WuXi AppTec’s acquisition of ResearchPoint Global (RPG) follows the release of a new guideline that will enable Chinese companies to accept clinical trial data from other countries.
Antimalarial drug resistance in Southeast Asia is threatening the control and elimination of malaria, and drug makers can help, says a tropical medicine expert.
Niche, small-scale CROs can stand their own – despite a predicted increase in consolidation among small-sized contract services firms – says Clinical Trial Consultants (CTC) and data-focused Quanticate.
Clinical trial participants often misunderstand the differences between research and clinical care – a ‘longstanding problem’ that an enhanced informed consent process could diminish, says report.
AstraZeneca has said it will wait to see how Brexit negotiations progress before deciding whether to make mid-to-large scale manufacturing investments in the UK.
Patient iP has been growing its Connected Site Network over the past two years – as it aims to curate one of the largest patient-centric, longitudinal clinical data sets in the world, says CEO.
Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).
The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.
EQT's acquisition of Certara is a bet on the continued convergence of healthcare and technology as the industry further adopts biosimulation to advance drug development.
Enhanced clinical trial design legislation proposes an alternative to the Right to Try Act – both of which address the FDA's current compassionate use program.
AB Science SA has halted French trials of its Ph III drug candidate masitinib after regulators uncovered good clinical practice (GCP) and pharmacovigilance deviations in an earlier study.
