In this issue: Making manufacturing work in gene and cell therapies, AI generated...
- Pharma Technology Focus – Issue 75
- Brexit and the pharmaceutical industry: guidelines for drug precursors in case of a no-deal
- US Appeals Court upholds ruling on CRISPR patents in favour of Broad Institute
- NICE rejects NHS use of Roche’s Ocrevus for PPMS
- Cannabinoids breakthrough signals hope for epilepsy treatment
AstraZeneca’s Lumoxiti secures FDA nod to treat hairy cell leukaemia
AstraZeneca and its research and development arm MedImmune have obtained approval from the US Food and Drug Administration (FDA) for the use of Lumoxiti to treat adults with relapsed or refractory hairy cell leukaemia (HCL).
Brexit and the pharmaceutical industry: guidelines for drug precursors in case of a no-deal
The UK Government has added to its list of industry-focused technical notices laying out its preparations for a possible no-deal Brexit. The updates primarily focused on the energy industry, but a guideline on the handling of drug precursor chemicals has been added to the five previously stipulated for the medical industry.
Shire gets marketing clearance for Veyvondi in Europe
Irish biotechnology firm Shire has secured authorisation from the European Commission (EC) to market Veyvondi for the treatment of adults with von Willebrand disease (VWD).
US Appeals Court upholds ruling on CRISPR patents in favour of Broad Institute
The US Court of Appeals for Federal Circuit has upheld an earlier ruling by the Patent Trial and Appeal Board (PTAB) in 2017.
Federal court invalidates Acorda’s patents covering MS drug Ampyra
The US Court of Appeals for the Federal Circuit has invalidated four patents held by biopharmaceutical company Acorda Therapeutics covering multiple sclerosis drug Ampyra (dalfampridine).
FDA seeks more clinical data on GSK’s mepolizumab for COPD
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for an application of GlaxoSmithKline (GSK) pulmonary drug mepolizumab to treat chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts.
Janssen’s Invokana and Vokanamet receive expanded labelling in Europe
The European Commission (EC) has approved expanded labelling of Janssen Pharmaceutical’s Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) to include positive cardiovascular outcomes.
NICE rejects NHS use of Roche’s Ocrevus for PPMS
In its final draft guidance, the UK’s pricing regulator the National Institute of Health and Care Excellence (NICE) has not recommended Roche’s Ocrevus (ocrelizumab) for routine National Health Service (NHS) use to treat primary progressive multiple sclerosis (PPMS).
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