Advanced Clinical is partnering with Cognitive Clinical Trials to overcome recruitment road blocks in Alzheimer’s clinical trials and expedite research through patient centric model.
The decision, influenced by the expected loss of exclusivity for Restasis, will allow the company to ‘improve efficiencies’ across its manufacturing network, a spokesperson explained.
The Association of Clinical Research Professionals (ACRP) is developing competence standards for principal investigators (PIs) as part of its goal to reduce variability in performance across various clinical research roles.
CROs this month have made significant new hires with WCG adding eight to its scientific leadership team, PPD hiring four, and BioIVT filling its new-created role of CCO.
Also, making the move from Bioclinica, David Kiger has been named...
A study published by graduate students at MIT showed that a synthetic mRNA-based ‘programming language’ can control protein expression in gene therapy.
LabCorp has launched Pixel by LabCorp, a consumer-initiated wellness test offering that allows for sample self-collection and access to online results.
After Pharm-Olam conducted an orphan disease trial for therapy for a rare blood disorder, the European Commission granted it marketing authorization, and FDA is to give it priority review.
The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations.
BBK is looking to bring balance to the doctor, patient relationship by improving lines of communication and the productivity of office visits with its online resource, Clinical Notifier.
InvVax’s universal flu vaccine candidate has demonstrated preclinical success as the company prepares for a Phase I clinical trial, supported by a Series A fundraising round.
Sponsors are encouraged to use a master protocol approach to accelerate clinical development programs, though experts say the advantages and challenges should be carefully weighed.
Clinical trial transparency efforts are falling short, with half of trials left unreported, according to a recent UK parliamentary committee report, which calls on the government to take action.
ScieGen Pharmaceuticals has recalled certain batches of hypertension drug irbesartan, after a probable carcinogen was detected in supplier Aurobindo’s API.
Takeda is in talks to sell Shire’s experimental inflammatory bowel disease pipeline in an effort to meet European regulators approval for the acquisition.
The CRO WuXi AppTec and Schrödinger have launched Faxian Therapeutics, a new company that will focus on accelerating drug discovery and advancing new therapies through global collaboration.
Thermo Fisher opened a new business center and biorepository along with an expanded distribution center, to help support mounting demand for clinical trial supply chain logistics.
A consumer rights watchdog is calling on regulators to suspend research at a Minnesota-based medical facility in response to concerns surrounding informed consent for a study involving Ketamine.
President Donald Trump signed the SUPPORT Act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn't the only crisis.
Nascent next-generation processing technologies are expected to have a significant effect on how drugs are brought to market – faster and more cost-effectively than ever before, says industry expert.
President Donald Trump signed the SUPPORT act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn’t the only crisis.
Aspen will spend a record sum on transforming its Port Elizabeth manufacturing site, marking the ‘single biggest pharmaceutical investment’ in South Africa to date.
AAPS PharmSci 360 is a new conference this year, created in response to a desire for “fresh science,” specifically with chemical and biomolecular components. So what can you expect?
SPI Pharma has launched Mannogem XL mannitol for the production of various forms of tablets, which the firm says enhances productivity compared to compendial mannitol.
A proof-of-concept study using patient-derived cells to test drug response in clinical trials demonstrates the benefits of precision medicine, movement to which is the future of study design, says researcher.
Idifarma’s seventh project with Palobiofarma will see the CDMO provide drug formulation, development and manufacturing services for respiratory disease candidate PBF-2987.
The FDA’s recent guidance on complex generics ‘increases clarity’ for Indian drugmakers targeting the US market, according to India Ratings and Research.
Icon reported a record number of new business awards in Q3 and outlined its three-part patient recruitment strategy as well as global hiring – and acquiring – plans.
Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.
WuXi Biologics and CANbridge Pharmaceutical have entered into a long-term partnership to develop and commercialize a portfolio of biotherapeutics for rare diseases.
SGS announced it will provide new in vitro toxicology services at its Mississauga, Canada Laboratory following an investment in instruments and laboratory capabilities.
LabCorp sees significant opportunity to grow its Covance Drug Development business in the face of a potentially challenging 2019 and is on track to deliver costs savings as part of its LaunchPad initiatives.
An MHRA audit of Recipharm’s facility in Ashton-under-Lyne has revealed the CDMO was deficient in certain manufacturing procedures for potent products.
