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MHRA approves ‘safer’ medicine alternative for rare disease
A new drug has been approved in the UK as a safer alternative to corticosteroids to treat Duchenne muscular dystrophy (DMD).
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Therapeutics
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Achieving optimal advanced process control in bioproduction
Model Predictive Control (MPC) “stands out as a beacon of advanced control” in continuous manufacturing, through its ability to enhance efficacy within bioproduction, research suggests.
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Boehringer plans €120m European manufacturing expansion
The manufacturing capacity for some of Boehringer Ingelheim’s medicines, in disease areas including mental health and cardio-renal-metabolic conditions, will benefit from the European facility expansion.
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GenAI in pharma: where are we today?
EPR speaks to Henry Levy, President, Life Sciences at Clarivate to gain a sense of how artificial intelligence (AI), and particularly Generative AI (GenAI), is transforming the pharmaceutical industry.
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First European ustekinumab biosimilar to Stelara approved
The first biosimilar to Stelara® is now approved in Europe, a biologic therapy with indications across gastroenterology, dermatology, and rheumatology.
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Tackling the complex development landscape of pain medicines
In this exclusive interview, Torsten Madsen, CEO of Hoba Therapeutics, highlights the current clinical development landscape, challenges, and opportunities for pain management medicines.
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Vaccine demonstrates benefit in delaying cancer relapse
Data from the Phase I trial showed that the cancer vaccine offered an 86 percent reduction in the risk of relapse or death in pancreatic and colorectal cancers.
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Microbiome innovation: have we forgotten the basics?
Here, Chrysi Sergaki from the Medicines and Healthcare products Regulatory Agency (MHRA), UK, explores how innovators and regulators can navigate the challenges affecting the development and regulation of microbiome therapeutics to bring safe and efficacious therapies to patients as soon as possible.
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Pfizer achieves novel EU approval for prostate cancer treatment
TALZENNA® is the first PARP inhibitor approved in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC) in the EU.
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New collaboration could transform neonatal therapy
With no currently approved medicines for the prevention of bronchopulmonary dysplasia (BPD) in extremely pre-term infants, a new pharmaceutical collaboration could produce the first major therapeutic breakthrough for this patient group in decades.
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Transforming pharmaceutical manufacturing: The AI revolution
The integration of artificial intelligence (AI) in pharmaceutical manufacturing is set to open a brand-new chapter in this industry's development, as well as unprecedented opportunities for strengthening quality control and improving decision-making. In this article, Dr Gonesh Chandra Saha, Head of the Department of Computer Science & Information Technology at…
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Innovative biologic for myasthenia gravis granted European approval
The biologic is approved based on Phase III study data in generalised myasthenia gravis (gMG), which demonstrated that rozanolixizumab facilitated statistically significant improvements in gMG-specific outcomes compared to placebo.
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Expanded Pluvicto production gets FDA go-ahead
Novartis has obtained US manufacturing authorisation for radioligand therapy PluvictoTM at its largest, state-of-the-art radioligand therapy facility.
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Positive data from schizophrenia clinical trials revealed
Newron Pharmaceuticals and Lyndra Therapeutics’ have announced positive data from key clinical trials in schizophrenia and schizoaffective disorder.
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Collaboration to develop novel AI-designed oncology therapy
Stemline Therapeutics is set to pay Insilico Medicine an initial $12 million for its novel AI-designed KAT6 inhibitor as a potential breast cancer treatment.
