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PharmaLab Congress 2024 – what’s new for the third year in Düsseldorf/Neuss
Find out what is on offer for pharma professionals working in analytical development and microbiology QC at the 12th PharmaLab Congress being held in Germany in 2024.
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Regs & Legs
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Pharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
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Driving economic growth in UK with commercial clinical trials
The research “clearly demonstrates the financial and societal benefits that industry clinical trials bring to the economy, the NHS and to R&D in the UK”, APBI Chief Executive says about the report.
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First-in-class combination therapy authorised for endometriosis
The three-in-one oral daily tablet provides an additional treatment option to help women in the UK manage their endometriosis-associated pain.
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European Commission licenses first treatment for acanthamoeba keratitis
Following its European approval, the small molecule treatment is set to become the standard of care for patients with the ultra-rare disease.
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Alzheimer’s drug milestone “bittersweet” for certain patients
The first new dementia medicine to be licensed in over two decades shows for first time, that the course of Alzheimer disease can be modified and slow cognitive decline.
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First-in-class therapy approved for chronic skin disease
The biologic treatment targets a key driver of prurigo nodularis, with trial data demonstrating improved itch as well as skin nodules for patients with the condition.
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Regulating therapies for rare diseases – recent approvals
This article summarises some of the recent notable drug approvals in the EU and US, including a gene therapy and an enzyme replacement therapy.
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FDA approves innovative engineered cell therapy
The accelerated approval by the US Food and Drug Administration (FDA) authorises the first engineered cell therapy for a solid tumour in the US.
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Alzheimer’s drug development roundup – July 2024
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
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CHMP meeting highlights – July 2024
In its July meeting, the EMA’s human medicines committee recommended 14 medicines and held a negative opinion for authorising lecanemab to treat Alzheimer’s disease.
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Pfizer receives EU haemophilia B gene therapy approval
The single-dose gene therapy was approved for certain patients with haemophilia B in the US and Canada earlier this year, marketed as BEQVEZ.
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Generic HIV raltegravir medicines approved
The UK Medicines and Healthcare products Regulatory Agency (MHRA)’s novel approval means that certain patients with HIV have more options for treatment.
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Securing Europe’s competitiveness in life sciences
Digitalisation, R&D and AMR were highlighted as key areas of focus to support European competitiveness up to the end of the decade, as set out in new Political Guidelines for Europe.
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European Pharmacopoeia makes milestone pyrogen testing commitment
The "historic" decision from the Ph. Eur. follows publication of its texts relating to the rabbit pyrogen test (RPT) replacement strategy.
