News & Analysis on Clinical Trial Services & Contract Research And Development
US-based medical device manufacturing plants could experience a 20% decrease in recalls if US FDA investigators inspect the facilities on a rotating schedule, according to a new study.
SynteractHCR has moved to a new 38,000 square foot facility in Carlsbad, CA as it looks to fill the mid-market CRO void created by recent consolidation, says CEO.
Elligo Health Research has received a US FDA award through which it will gather real-world data to assess the safety of new immunotherapies.
News In Brief
Avara Pharmaceutical Services will buy AstraZeneca’s secondary solid dosage form manufacturing, packaging and distribution facility in Reims, France.
News in brief
The EMA has expanded the list of excipients that drug firms must declare on product labels in a bid to address safety concerns about undeclared components.
Niche, small-scale CROs can stand their own – despite a predicted increase in consolidation among small-sized contract services firms – says Clinical Trial Consultants (CTC) and data-focused Quanticate.
Biotech Week Boston
Successfully transferring manufacturing tech to a second facility or CMO relies on site readiness and sponsor oversight, says Janssen.
DSM Sinochem Pharmaceuticals (DSP) says tests prove CSPC Pharmaceutical Group Ltd infringed on amoxicillin production patent.
Cel-Sci Corp. says its long-running legal battle with former CRO, inVentiv Health Clinical LLC is nearing a conclusion.