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BMS strikes $14bn deal for Karuna Therapeutics
The deal includes Karuna Therapeutics' potential first-in-class antipsychotic, xanomeline-trospium, for patients with schizophrenia and other conditions.
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Biopharmaceuticals
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MeiraGTx sells XLRP gene therapy to Janssen
Janssen will pay up to $415 million for MeiraGTx’s botaretigene sparoparvovec, a gene therapy for treatment of X-linked retinitis pigmentosa (XLRP).
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CDMO expands ADC facility in Scotland
Contract development and manufacturing organisation, Piramal Pharma Solutions, has expanded its antibody drug conjugate manufacturing facility in Scotland.
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FDA grants priority review to omalizumab for food allergies
If approved, monoclonal antibody omalizumab would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure.
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EU pharmaceutical legislation revisions: what are the implications for biopharma?
Anne Dhulesia and Sean Dyson, Partners at L.E.K. Consulting, discuss the proposed revisions to EU pharma legislation and potential implications for biopharma companies operating in Europe.
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The nitty gritty of biotherapeutics production
Caroline Peachey chats with Mahesh Bhalgat, COO at Syngene International Limited about the role of new technology in biotherapeutics production.
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Year in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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CHMP issues positive option for first gene-editing medicine
If approved, Vertex’s Casgevy (exagamglogene autotemcel) would be the first gene-editing medicine authorised in the European Union.
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Alkermes to sell Irish manufacturing facility to Novo Nordisk
The facility in Athlone, Ireland, will give Novo Nordisk additional capacity to manufacture oral products.
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Positive results for mRNA vaccine in melanoma patients
A personalised mRNA cancer vaccine in combination with MSD’s Keytruda cut the risk of cancer recurrence by almost half in melanoma patients.
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Astellas secures EC approval for VMS treatment, fezolinetant
Approval of fezolinetant gives patients in Europe a new nonhormonal treatment option to control hot flashes or night sweats associated with menopause.
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New approach for synthesis of oligonucleotide conjugates
Researchers from Aarhus University and Novo Nordisk have discovered a new synthesis method for oligonucleotide conjugates, marking a step forward in development of more targeted RNA medicines.
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Understanding the evidence used in drug product withdrawals
Samantha Lane, Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit discusses drug product withdrawals and the regulatory shift to a greater reliance on epidemiological and observational research as evidence for these decisions within Europe.
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BMS agrees $8.4bn ADC collaboration with SystImmune
Bristol Myers Squibb and SystImmune have agreed to jointly develop and commercialise BL-B01D1, a bispecific antibody-drug conjugate for solid tumours.
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Europe publishes first list of critical medicines
More than 200 active substances are included on the list, which is seen as an important tool in preventing shortages of critical medicines in the EU/EEA.
