Schulman IRB is integrating its WebPortal platform with Veeva’s eTMF solution to offer real-time IRB status updates and approval documentation to clients.
Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.
Amatsigroup has acquired single-use processing equipment and packaging tech firm Disposable-Lab SAS as part of a plan to increase its revenue to €50m this year.
ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.
EAG Laboratories has added dermal absorption studies to its GLP-compliant testing services suite, as part of the company’s plan to continue expanding its capabilities.
The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.
The implementation of serialisation regulations in 2017 are among the opportunities for drugmakers to improve manufacturing efficiencies, says IT and engineering firm Zenith Technologies.
Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.
Evotec AG and MaRS Innovation have launched Fibrocor Therapeutics LP – a new company which will focus on developing first-in-class therapeutics targeting fibrotic diseases.
A pool of contractors will compete for task orders as part of the NIAID's preclinical drug development services contract to develop therapeutics for a range of global infectious diseases.
Servier has recruited CDMO MaSTherCell SA to manufacture its universal CAR-T candidate UCART19, licensed from the biotech Cellectis as an off-the-shelf cell therapy for leukemia.
The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for a mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS).
Suzhou Pharmaceutical Technology faked quality documents, shipped a banned supplier's API to the US and failed to store materials properly according to the US FDA.
The distribution giant, McKesson Corporation, has agreed to pay the DEA's record fine of $150m after allegedly failing to report “suspicious orders” for controlled substances.
The Chapel Hill, NC-based contract research organization (CRO) has implemented PhlexEview4 as its preferred eTMF solution to support commercial and government clients.
Technology is catapulting clinical trials into a 'new era' as scientific breakthroughs bring new opportunities to an industry that has traditionally lacked innovation.
Poor communication between healthcare providers and clinical research professionals is contributing to low recruitment rates, according to a recent study by Tufts.
Helomics has signed a deal with the diagnostics firm MDNA Life Sciences Inc., to help further develop MDNA’s liquid biopsy platform and commercialize its tests for prostate cancer.
MannKind Corporation met with the US FDA last month to discuss a single-use disposable epinephrine inhaler it says could be an affordable alternative to the Epipen.
Industry groups have reiterated calls for UK drug approval and safety laws to be kept in line with EU rules, arguing that consistency benefits governments and patients Europe-wide.
President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines.
Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.
Parexel’s restructuring plan to ‘simplify the organization’ will include eliminating an undisclosed amount of positions as the CRO looks to save on costs.
Pharmaron’s acquisition of Xceleron further supports early discovery, preclinical and clinical development with expanded radiolabeled sciences capabilities.
After buying two CMOs, Japanese glassmaker AGC has made “a full-fledged launch” into the biologics manufacturing space and says it will consider further M&A opportunities.
Aerie Pharmaceuticals Inc will lease a 30,000 sq ft manufacturing facility in Ireland to commercialise its eye-drop product for Glaucoma after delays at a third party CMO.
High frequency radiation can be used to test tablet quality and structural characteristics on the production line according to scientists planning to develop low cost THz sensors.
