Advanced osteoarthritis patients will be barred from taking part in fasinumab trials after a sufferer enrolled in a Phase IIb study developed joint disease.
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.
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.”
Parexel’s Active Tracking service monitors and manages temperature-controlled medical products from the company’s central distribution centers to clinical trial sites.
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.
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.
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.
A “quality mark” for firms that source from green API suppliers would add patient choice element to fight against antimicrobial resistance according to DSM Sinochem Pharmaceuticals.
The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).
Per the collaboration, Marken’s worldwide depot network will provide the infrastructure needed for Faubel to deliver its smart label technology across the clinical trials supply chain.
Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
Viagra counterfeiters in Poland imported APIs made in China via the UK, Greece and Romania according to police who shut down a major manufacturing operation last week.
Systech International has extended its strategic partnership with the serialization automation supplier ServicePoint as the company looks towards the Russian serialization market.
Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
Digital health devices are increasingly being used by the industry to collect patient-generated data in clinical trials and improve medication adherence – and adoption is expected to increase.
Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012 to £400m ($520m).
Sarepta Therapeutics says it is considering selling its FDA priority review voucher to support manufacturing scale-up for Exondys 51, its approved Duchenne Muscular Dystrophy drug.
The full-service contract development and manufacturing organization (CDMO) for investigational medicinal products has purchased a new building to expand its high containment manufacturing and development operations.
Shire has abandoned its partnership on CTI BioPharma’s oral kinase inhibitor pacritinib seven months after deaths in a Phase III trial halted its clinical development.
Through their strategic commercial partnership, Medidata and SHYFT Analytics are aiming to increase access to healthcare data analytics in clinical trials.
Pharmaceutical Product Development, LLC (PPD), has announced the completed acquisition of Evidera as the two companies commit to making the “seamless offering a reality.”
More than two months after Britain decided to leave the EU, companies reevaluate the state of business and what comes next, specifically for jobs within the industry.
PharmaJet has inked a multi-year deal with the World Health Organization for its needle-free technology, which uses 80% less vaccine than traditional methods.
The study will evaluate how critical biomarkers and cell-therapy cancer vaccines are impacted by temperature and transport packaging at deep frozen temperatures.
Impax Laboratories has issued a voluntary recall for one lot of its Lamotrigine Orally Disintegrating Tablet due to incorrect labeling of its blister packs.
The Pennsylvania plant released 27 lots of clonidine HCl tablets containing potentially contaminated active pharmaceutical ingredients (APIs), among several violations of cGMP the Agency said.
Currently, the top ten CROs represent more than half the market, and as the industry continues to grow analysts suggest companies expand revenue streams through “nontraditional” services offerings.
