The US FDA has sent a warning letter to Tris Pharma, a New Jersey-based manufacturer that makes ADHD drug Quillivant XR (methylphenidate HCl) for Pfizer.
Frontage Laboratories has acquired Concord Biosciences, taking a “significant step” towards the company’s goal of building a global organization, says CEO.
Patient recruitment is underway for a genomics-based pilot program to study opioid abuse and addiction – a first step in extending precision medicine into clinical practice for addiction, says CRO Genemarkers.
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.
Ferring Pharmaceuticals is buying Rebiotix and says its lead candidate has the potential to be the first human microbiome product approved anywhere in the world.
KBI will provide services to ReForm to further develop and validate its biologic formulation platform and in turn, will gain access to ReForm’s proprietary excipient technologies.
Regulations are changing across the globe as patients, the scientific community, and other stakeholders call for increased clinical trial data transparency.
With less than a year until the full implications of Brexit set in, Parexel consultants urge the industry to not wait – assess potential risks, such as to the clinical supply chain, and take actions to mitigate them.
Project Data Sphere aims to accelerate research by providing cancer clinical trial data from various sources to “any and all scientists” – and has named pharma industry veteran Bill Louv as its new president to ensure it delivers.
The synthetic DNA provider Twist Bioscience Corporation has completed a private placement of $50m to advance its proprietary, silicon-based DNA Synthesis Platform.
The CRO industry is expected to grow at a CAGR of 5-6% over the next 5 years, despite a move by Big Pharma to take more control of clinical trials, bringing work back in-house.
Nanoparticle delivery technology that transports compounds to the bloodstream and cells can increase bioavailability and reduce adverse effects of cannabinoids and bioactive compounds, says NanoSphere Health Sciences.
Exactis Innovation is standardizing its sequencing labs as it aims to quickly match at-risk cancer patients with clinical trials through its longitudinal, biopsy-led registry.
CMAB Biopharma has raised $34m in Series B financing to upgrade its GMP facilities – and has entered into collaboration agreements with “several” biopharma clients, says CDMO.