Lovelace Biomedical launched this week as a not-for-profit preclinical contract research organization (CRO) with a business model that will let it “put science first.”
Metrion has invested in new laboratories, equipment, and staff, as part of the company's continued growth strategy to form strategic alliances and add "additional breadth."
Advanced osteoarthritis patients will be barred from taking part in fasinumab trials after a sufferer enrolled in a Phase IIb study developed joint disease.
A newly opened training centre in Leeds, UK will help fulfil demand for skilled workers in the drug production space, says the head of process manufacturing.
Recipharm has said it will spend SEK5m ($567,000) on a bioanalysis laboratory in Sweden citing the lack of capacity in the Nordic region as a driver for the investment.
Thermo Fisher Scientific has revealed a preemptive pharmacogenomic risk factor screening tool to help increase drug development outcome efficiency and reduce adverse drug reactions.
Premier Research has become the most recent contract research organization (CRO) to receive funding from private equity as the industry looks for "like-minded" partners for the long run.
CMC Biologics and IDT Biologika have added Cerbios-Pharma SA and Oncotec Pharma Produktion GmbH to the companies’ PROVEO Partnership – a strategic collaboration for manufacturing antibody drug conjugates (ADCs).
Finding and validating an ingredient supplier can take up to 26 weeks says consultancy firm Rephine, which hopes to address the burden through an online API sourcing platform.
South Korea is leading emerging nations in clinical trial research in Asia, with the second highest number of approval clinical trial sites globally, according to Thermo Fisher.
Biotrial looks to run 50 clinical trials per year at its new US-based facility as it says group activities are up – with the exception of Ph I activities in France.
The US FDA has issued fours warnings against foreign drugmakers, citing reasons including problems with QC, a non-registered facility, and finished products that “did not contain any of the labeled active ingredient.”
With 40% of sites dropping out of clinical trials, the Society for Clinical Research Sites (SCRS) has launched a clinical trial Site Advisory Group (SAG) as the industry works to improve site engagement.
IMARC Research, an Ohio-based contract research organization (CRO), has expanded its footprint in the medical device market with a new office in Minneapolis, MN.
The EMA recently appealed two interim orders made by the President of the General Court of the European Union (EU) to suspend the release of clinical trial documents.
QuiO has raised $1.05m to develop its real-time adherence monitoring solution for injectable therapies – a device which could allow CROs to monitor injection events remotely.
Parexel’s Active Tracking service monitors and manages temperature-controlled medical products from the company’s central distribution centers to clinical trial sites.
AstraZeneca will supply Toprol-XL to Aralez Pharmaceuticals Trading for at least 10 years after selling the US rights to the off-patent beta blocker for $175m.
French regulators have recommended that drugs containing APIs made at Nandu Chemicals Industries’ site in Hubli, India be recalled after uncovering “serious” problems during an inspection in August.
Mappel Indústria de Embalagens says it did not know the US would regulate the dermacosmetic products made at its Sao Paulo plant as OTC drugs after FDA warning.
UK-based contract manufacturers are benefitting from the weak pound following the country’s referendum in June, but the long-term impact of Brexit is still unknown.
Nippon Fine Chemical staff formed a human barricade to prevent a US FDA team inspecting a quality control laboratory at its site in Takasago City, Japan according to a warning letter published this week.
European Union API import rules do not ensure ingredients shipped to Europe are of appropriate quality according to APIC board member, Marieke Van Dalen.
Lonza and Boehringer-Ingelheim dominate the consolidated biologics CMO space but disposable technologies and improved yields are beginning to change this, says PharmSource’s Jim Miller.
Economics, regulatory inexperience and a lack of technical skills are holding back drug industry adoption of continuous manufacturing says CMAC industrial director, Craig Johnston.
Alcami has announced its first to market Protect Your Brand™ offering, which it said will support companies looking to implement a backup supply option.
Medidata is partnering at the university level in order to educate the next generation of clinical researchers – as "the 'war on talent' is real," says company president.
Clinical trial data sharing continues to be a contentious topic in the industry, so in an attempt to demonstrate its potential, the New England Journal of Medicine (NEJM) is sponsoring the SPRINT Data Analysis Challenge.
CRF Health has appointed Jamie Moss as Chief Operating Officer (COO), an aerospace industry veteran who hopes to challenge company paradigms in his new position.
Capsugel’s Vcaps Enteric offering can speed up development of delayed release drugs by removing the need for an additional enteric film coat, the firm says.
