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FDA approves allogeneic stem cell transplant therapy
The first allogeneic stem cell transplant therapy to be approved based on Phase III study results has been granted by the US Food and Drug Administration (FDA).
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Regulation & Legislation
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Psychedelic medicines: are they gaining traction in Europe?
Carissa Kendall-Windless and Sian Banks of law firm Pinsent Masons discuss the development of psychedelic medicines and the legal and regulatory challenges that must be overcome for psychedelics to become safe and effective treatment options in Europe.
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ILAP: Improving access to innovative oncology treatments
With no new first-line treatment for de-differentiated liposarcoma in over forty years, Dr Christoph Zehendner, Medical Director of Boehringer Ingelheim UK and Ireland discusses the company’s ILAP designation of its investigational, innovative treatment.
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Eculizumab biosimilar gets positive CHMP opinion
Samsung Bioepis’ first haematology biosimilar, which references Soliris (eculizumab), has been recommended for approval by the CHMP.
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CHMP meeting highlights – March 2023
In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.
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Generic manufacturers sign sublicences to produce long-acting HIV medicine
Sublicence agreements signed by the Medicines Patent Pool (MPP) and three generic manufacturers could enable millions to access a long-acting HIV medicine.
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First immunotherapy recommended for advanced cervical cancer
Final draft guidance published by the National Institute for Health and Care Excellence (NICE) has recommended immunotherapy pembrolizumab drug for advanced cervical cancer.
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First-in-class plaque psoriasis oral therapy approved in EU
Bristol Myers Squibb’s Sotyktu is the only TYK2 inhibitor approved for the treatment of any disease in the European Union.
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EMA publishes mid-point regulatory science strategy report
Progression in supporting development of precision medicine was noted as an achievement in a mid-term report on the EMA’s Regulatory Science Strategy to 2025.
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First mild asthma combination reliever approved in UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first dual-combination, inhaled corticosteroid and long-acting beta2-agonist reliever therapy for mild asthma.
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First gene therapy recommended for AADC
NICE's final draft guidance has recommended the first and only gene therapy for children with aromatic L-amino acid decarboxylase (AADC) deficiency.
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First FcRn blocker approved in UK for myasthenia gravis
VYVGART (efgartigimod alfa-fcab) has been approved for adults with generalised myasthenia gravis by UK Medicines and Healthcare products Regulatory Agency (MHRA).
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Parallel import of medicinal products: regulatory update
Andrzej Siwiec and Katarzyna Bajer of DBS Law discuss recent rulings on the parallel import of medicinal products in the European Union.
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SMC accepts treatment for chronic hepatitis delta virus
Bulevirtide has been accepted by the Scottish Medicines Consortium to treat chronic hepatitis delta virus (HDV) infection in adults.
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Learning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
