The EMA has revealed that it is having to cope with “significant staff losses” due to Brexit, which means that it will have to temporarily cut certain activities.
Sanofi has written to the UK’s health secretary and the chief executive of the NHS to inform them that the company is stockpiling drugs ahead of the deadline for Brexit.
The Chinese government has released a notice telling medical institutes to comply with the recall of products containing contaminated valsartan and stop using the medicine.
CTTI’s latest recommendations will help researchers deploy mobile technologies in clinical trials and “pave the way for improving how we develop medicines,” says Pfizer exec.
Pan-American countries should adopt EMA-style regulations to increase clinical trial transparency and streamline research, according to a recent report.
The industry needs “to strike a balance” between science and feasible execution as increasingly complex clinical trial protocols are impeding efficiency and driving up costs, says industry expert.
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.
The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
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.
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 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.
An EMA survey has found that 42% of businesses, with an important step in their regulatory processes occurring in the UK, are not adequately prepared to retain marketing authorisation post-Brexit.
Cross-industry discussion is expanding from early discovery to post-licensing challenges – as the nexus of innovation and policy improvements is rapidly changing, says DIA executive.
Recipharm has revealed that it will be offering a standalone serialization service to companies that have not yet prepared for the upcoming FMD deadline.
GlaxoSmithKline has selected TrialScope to facilitate clinical trial disclosure and transparency – as the benefits of patient centricity are paramount, and the risks of poor compliance magnified, says VP.
Researchers from Harvard University have developed an insulin formulation using two ionic liquids they say could lead to the development of a pill for diabetics.
Clinipace has launched a new branding for its collaborative approach to clinical trial management, which will “contribute to its goal of becoming the industry’s premier mid-sized CRO,” says CEO.
Real-world evidence, digital endpoints, and patient centricity are among the top trends in clinical trials – the benefits of which will be realized in part through advances in eClinical technology.
The drug development “finish line” is not regulatory approval, says Syenos Health chief scientific officer Judith Ng-Cashin, MD, who discusses bringing the payer and patient voice into the process.
The Croatia-headquartered contract research organization (CRO) has opened its first office in the US and plans to further expand its footprint organically and through potential acquisitions.
Saama has launched a set of artificial intelligence (AI) capabilities designed to understand "typical life science domain questions" to better support clinical trial planning, feasibility, and conduct.
Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher.
President Trump says he will sign the “big legislation” after the US House of Representatives passed the Right to Try Act – opponents of which warn lacks key patient protections.
Regulatory agencies are doubling down on compliance – and withholding funds – as the clinical research industry enters an era of accountability and transparency, say NIH officials.
The Chinese contract research and development company WuXi AppTec has raised more than $353m in its initial public offering of common stock on the Shanghai Stock Exchange.
Novartis’ recently launched FocalView app will be used in a new study to remotely collect electronic device reported outcome measurements (eDROs) from 150,000 users.
Takeda has acquired Shire for approximately $62.11bn (£46bn) to create a Japan-headquartered biopharmaceutical company with a robust pipeline and expanded geographical footprint.
The UK government has provided the “strongest possible reassurance” that it will implement the incoming European Union Clinical Trial Regulation, whatever happens in the Brexit negotiations.
Glenmark Pharmaceuticals has suspended a Phase II clinical trial at a site in India following media reports that villagers were allegedly “deceived” into participating.
Tufts Medical Center has joined TriNetX’s research network to improve its clinical trial process, further expanding the company’s reach as it looks to grow internationally and introduce new offerings in 2018.
ClinicalRM – which ICON acquired in 2016 – has become ICON Government and Public Health Solutions (GPHS), providing full-service clinical trial execution and functional services to government, NGOs, and commercial customers.
Accelovance and Linical are merging to create a contract research organization (CRO) with a global footprint in response to the need for large-scale, multinational clinical trials.
At DCAT Week, contract manufacturing and development companies from across the globe shared updates and news – from multi-million dollar investments to new business structures and areas of focus.
Porton Biopharma will look to develop GMP manufacturing capabilities for Clostridia bacteria as part of a UK collaboration developing aimed at developing microbiome targeted therapeutics.
The active ingredient for Nichi-Iko’s diabetic neuropathy drug will be the first of a number of APIs to be supplied from Eisai’s facility in Vizag, India.
