FDA approves TraceLink pilot programmes for workstreams

The two projects aim to improve the supply chain by focusing on traceability and product recalls

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EnteroBiotix secures MHRA license for clinical trial manufacturing

The Scottish microbiome specialists is also working on creating a common European regulatory framework for microbiome ...

Certara replaces in-vivo clinical studies for complex generic drug

Virtual bioequivalent was successfully used for FDA abbreviated new drug application (ANDA) approval

Almac Group launches Almac Adapt, a new patient-centric supply solution

Innovative just-in-time manufacturing (JTM) enables sponsors full late stage customisation of their clinical trial ...

Digitisation and the value of serialised data

At FutureLink Barcelona, leaders from across the life sciences industry will gather to reimagine the future of ...

Bassaire Cleanrooms builds sterility testing lab for Tepnel Pharma

The Class D cleanroom provides sterility testing in accordance with the Harmonised method and the requirements of the ...

MHRA fully reinstates Bristol Labs GMP status

The company is now well-stocked for the shortages that may be brought about by Brexit

Cannabis Europa 2019 puts CBD in the spotlight

Industry leaders will gather in London to discuss what lies ahead for the medical cannabis industry in Europe

Apceth bullish on manufacturing deal with bluebird bio

The German CDMO will operate as commercial manufacturer in Europe for Zynteglo, bluebird bio's first gene therapy to ...

USP publishes new and revised sterile compounding standards

Standards help ensure quality compounded preparations to safeguard the well-being of patients and those handling the ...

Momentum in the US cannabidiol market gains retailers' attention

Walmart and other big-name stores in talks with food and drinks makers in preparation for the day CBD-enriched products ...

The future of pharmacovigilance and the impact of automation

Pharmacovigilance (PV), the process of identifying, tracking, evaluating and preventing negative outcomes from drug ...

The recurring insanity of labelling recall — and how to avoid it

We’re all familiar with Einstein’s alleged definition of insanity: doing the same thing over and over and expecting ...

IPEC publishes position paper on supply chain security

Today’s increasingly complex global supply chains create additional risk for pharma grade excipients and therefore ...

Eli Lilly gets safety letter after Japanese patients show sensitivity

Correction: Verzenio has been reported to cause a lung disease in 14 known cases, mostly in Japan, and the warning ...