The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
Veeva Systems has boosted its capabilities in its Veeva Vault RIM to manage regulatory documents and processes for medical devices and diagnostics manufacturers.
The University of Pennsylvania School of Medicine is partnering with Medable to accelerate patient enrollment for its Light Treatment Effectiveness study.
ARG opens new offices in Warsaw as well as Amsterdam, the new home of the European Medicines Agency, both ‘ideal’ locations among Brexit uncertainty, says CEO.
Australia-based Nucleus Network has acquired an early-phase clinical research organization in the US, which has a broad range of access to specialist patient populations, says CEO.
Enteris enters a licensing agreement with Cara Therapeutics for the ongoing development of the latter’s drug candidate as it continues clinical trials.
The FDA this week released a new draft guidance encouraging the inclusion of male patients in breast cancer clinical trials, the incidence of which has increased approximately 26% over the last 25 years.
Bolstered by manufacturing advancements, the global revenues of the pharmaceutical excipients market are expected to grow at a CAGR of 5.8% in the coming years.
J&J is ordered to pay $572m to the state of Oklahoma, after a court judgement found against the pharmaceutical company for its role in the opioid crisis.
As part of its global network expansion strategy, PCI Pharma Services is investing in a new dedicated clinical facility near Dublin, Ireland, which will provide space for secondary packaging, storage, logistics, and distribution.
Cognate BioServices closes a round of growth capital from EW Healthcare Partners to secure its capabilities for the commercialization of advanced cellular therapies.
Harbour BioMed has selected PPD as its preferred CRO partner as part of a strategic collaboration to develop novel oncology and immunology therapeutics.
As the industry focuses on modernizing clinical research, Thread is set to continue expanding its virtual research platform after today announcing its acquisition by strategic investors, says company executive.
Researchers develop organ-on-an-electronic-chip platform to explore the electrophysiology of iPSC-derived cardiomyocytes and understand how the heart communicates.
Themis obtains an exclusive licence from Merck to develop vaccine candidates with an undisclosed indication, using its measles virus vector-based platform.
A joint study conducted by the EMA and FDA showed that marketing approval decisions were 90% shared for new medicines, as the agencies push for a closer working relationship.
Genentech enters a manufacturing and development agreement with Enable Injections to advance the latter’s patient-administered subcutaneous drug delivery system.
The FDA posted a public missive alongside a warning letter to a Chinese OTC drug manufacturer, highlighting the efforts it had been making to address data integrity issues.
As summer heated up, the pharmaceutical industry saw major developments in preclinical models from new software to 3D-printed tissue, all in the name of drug development.
High prevalence of skin disease and diabetes to boost the global revenues of the topical drug delivery market, with uptake in China and India boosting growth.
Computer model predicts worsening cognitive scores, opening door to the use of machine learning in the selection of participants in Alzheimer’s disease trials.
Researchers show miniature livers can develop steatohepatitis and fibrosis, pointing to potential for personalized hepatic drug discovery and toxicity platforms.
Schrödinger secures further funding, extends collaboration with Morphic Therapeutic on computational discovery platform for oral integrin drugs for the second time.
Rinvoq from AbbVie to be available in the US in late August 2019, after receiving FDA approval for the treatment of adults with active rheumatoid arthritis.
Celgene’s Inrebic becomes the first treatment for myelofibrosis to be approved by the US FDA since 2011 after having received a priority review and orphan drug designation.
Nanoscale silica bottles, a five-hundredth of the diameter of a hair, could be used to deliver cancer drugs to specific disease sites in the body, avoiding debilitating side effects.
Researchers at the University of Illinois at Chicago reported that combining activated charcoal with herpes treatment acyclovir, improves the drug’s efficacy.
Intraprise Health creates the BluePrint Protect platform designed to solve cybersecurity challenges across the pharmaceutical supply chain as third-party data sharing accelerates.
Veeva Systems launches a software application aiming to reduce the time and effort of manual data entry, which will be integrated to its cloud-based suite.
Capital Health joins Kiyatec’s clinical trial to validate a patient-specific predictor test to improve response to cancer therapies for glioblastoma and anaplastic astrocytoma.
PCRF has selected Datavant to de-identify and link patient data across its clinical research network, which will ‘empower’ medical researchers while protecting patient privacy.
Frontage Clinical Services has expanded its site in New Jersey to accommodate nicotine-related studies and is developing a portfolio of assays to evaluate tobacco-specific biomarkers.
Engineered cardiac tissues generated using Tara Biosystems' heart-on-a-chip system predict how patients will respond to a range of drugs, as demonstrated in a recent study with GSK.