In this issue: Public attitudes towards mental health drugs, using real-world data in...
- How automation and man-machine collaboration is reshaping blood storage
- Novartis defends Zolgensma in face of FDA’s data concerns
- Veeva R&D summit: unifying across clinical, regulatory and quality suites
- FDA chooses IBM, KMPG, Merck and Walmart for pharma blockchain pilot
- Antimicrobial resistance: sewage samples reveal bad sanitation as a key driver
Authorised generics: a poorly known pharma tactic to fend off competition
According to the FDA, there are almost 1,200 authorised generics in the US, and they are currently being approved at a rate of one per week on average.
How automation and man-machine collaboration is reshaping blood storage
Intralogistics industry leader Jungheinrich has helped to build a fully automated blood plasma warehouse for Grifols, a multinational pharmaceutical and chemical manufacturer. Jungheinrich’s UK director of logistics systems Steve Richmond discusses what warehouse automation can do for the pharmaceutical industry.
Novartis defends Zolgensma in face of FDA’s data concerns
The US Food and Drug Administration (FDA) has issued a statement regarding data accuracy issues related with Novartis’ biologic license application (BLA) for gene therapy Zolgensma (onasemnogene abeparvovec-xioi).
Revisions and Impact
The United States Pharmacopeia (USP) is a scientific non-profit organisation that sets standards used worldwide for the identity, quality, purity and strength of medicines, as well as food ingredients and dietary supplements
Challenges for the life sciences supply chain with Brexit
Three years on from the Brexit vote and no one is any the wiser as to what the UK’s future relationship with the EU will look like. The worst-case scenario of the UK leaving without a deal or any customs arrangements could have a severe impact on the life sciences supply chain, which is heavily reliant on just-in-time deliveries. Bill DuBois from Kinaxis explains what companies are doing to cope with the uncertainty and if there are any positives on the horizon.
Veeva R&D summit: unifying across clinical, regulatory and quality suites
Veeva’s Vault platform aims to unify the clinical, regulatory and quality approaches used by pharma companies when bringing a drug to market. What are the benefits and challenges of this integrated approach?
FDA chooses IBM, KMPG, Merck and Walmart for pharma blockchain pilot
The US Food and Drug Administration (FDA) has chosen IBM, Merck, KPMG and Walmart to support its latest Drug Supply Chain Security Act (DSCSA) pilot programme, which focuses on blockchain interoperability.
Novartis denies physicians’ reports of Mayzent launch delays
A Novartis spokesperson said there are no known access delays to patients who are prescribed Mayzent, and many patients have already initiated the onboarding to Mayzent efficiently.
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