CTTI has completed more than 25 projects on issues affecting clinical trials over the past decade, since which time the industry has changed greatly, says executive director.
IAOCR and PCMG have released a new set of standards to establish a consistent approach to managing clinical outsourcing to ensure clinical trials have a better chance of running optimally, says co-founder.
Lonza has inked a biologics deal with Denali to make neurodegenerative disease therapies, offering the Californian firm opportunity to have production “on their back doorstep.”
The first round of job cuts at a solid oral dose facility in Broomfield, Colorado earmarked for closure has taken place, says Novartis subsidiary Sandoz.
A patient-controlled injector and a prefilled pen for patients with hand dexterity issues were among the drug delivery technologies celebrated at PharmaPack Europe’s awards this year.
The US State Patent and Trademark Office has granted Teewinot Life Science Corporation its second patent this year covering biosynthetic cannabinoid production methods.
Experts from Syneos Health and UDG Healthcare comment on the current state of the global pharma contract sales market – which is estimated to reach $9.48bn by 2023.
Novo Nordisk is planning a $65m (€53m) production capacity expansion at its finished product site in North Carolina, to meet demand for diabetes and obesity medicines.
IQVIA has been contracted to expand the safety and efficacy monitoring of biologic products as part of a novel alliance with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER).
The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies filed to suspend the release in 2016.
Failure to test ingredients’ identity in an over-the-counter drug product is one of the violations that landed Polaroisin International a US FDA warning letter.
Nordic Universities will investigate 3D printing, electrospraying, and microfluidics in an industry supported collaboration aimed at revolutionising production in an age of personalised medicine.
Vetter is talking with customers to create a “stable financial plan” that will justify the manufacturer’s previously announced $320m investment for a new facility, which is not expected to break ground before 2022.
Advarra has selected TransPerfect Life Sciences as its strategic supplier of language services, including document translation, digital content localization, and interpretation services.
The Danish competition authority has determined pharmaceutical distributor CD Pharma “abused its dominant position” by unfairly increasing prices for oxytocin-based Syntocinon.
Certara has acquired BaseCase Management GmbH, a data visualization company that helps sponsors communicate health economic evidence and product differentiation information.
AstraZeneca says its hyperkalaemia candidate ZS-9 is back on track for approval after manufacturing issues at its Texas facility resulted in regulatory delays.
SIRO Clinpharm is in “a new area of growth” following the procurement of ArisGlobal’s LifeSphere Clinical platform, which has enabled the company to expand its business prospects, says CRO.
The number of new clinical trials in the regenerative market space continues to grow, says Cryport, which will provide global logistics support for TiGenix’s upcoming Phase Ib/IIa study.
Charles River has been granted commercial access to AstraZeneca’s high-throughput screening (HTS) and compound management infrastructure, an investment that will help the company "deliver optimal benefit" to its customers, says executive.
Kadam Exports Private has received a statement of non-compliance with GMP after the Danish Medicines Agency found manufacturing deficiencies at its facility in Gujarat.
Medidata and Syapse have teamed up to develop a new suite of solutions, which will aim address precision medicine challenges and accelerate clinical research in oncology for trial sponsors.
The San Diego-CA-based contract research, development, and manufacturing organization (CDMO), BioDuro, has announced a cooperation agreement with Porton Pharma Solutions.
Vical has dismissed 40 employees and abandoned a Phase III vaccine candidate in a reshuffle it says allows for greater resources on HSV-2 and antifungal trials.
An update to guidance on patient payments in clinical trials has been released by the US FDA, urging institutional review boards and investigators be wary of undue influence impacting subject consent.
Impax Laboratories has sold its CorePharma facilities and equipment to a group of industry investors which aim to reestablish the company as a "preferred partner of choice," says new CEO.
Biomedical and pharmaceutical stakeholders have heralded the news that Chinese researchers have successfully cloned a monkey and its potential to unlock further our understanding of complex diseases.
CTI Clinical Trial and Consulting Services (CTI) has opened a new office in Singapore – a location that will enable the CRO to attract and retain talent as it continues expansion in Asia.
Metrion Biosciences has acquired a portfolio of more than 2,000 small molecule potassium channel inhibitors from Japan Tobacco Inc. (JT), with potential application in a variety of clinical indications.
Weill Cornell Medicine has joined TriNetX’s global health research network, enabling it to collaborate with researchers and attract clinical trial opportunities.
