All Clinical Development articles – Page 20
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NewsNew 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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ArticleTransforming 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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NewsPositive 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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NewsCollaboration 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.
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NewsNovel drug delivery method shows promise in Alzheimer's
Ultrasound combined with a biologic treatment has demonstrated the ability to safely reduce brain amyloid plaques in the brains of Alzheimer’s patients, a first-in-human study shows.
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NewsBoehringer Ingelheim agrees $2bn siRNA therapeutic collaboration
The collaboration seeks to develop new siRNA treatments for the liver diseases nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH).
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NewsMHRA authorisation is first endocrine therapy innovation in decades
A new breast cancer treatment that reduced the risk of progression or death by 45 percent compared to standard of care in a Phase III trial, has been authorised by the UK Medicines & Healthcare products Regulatory Agency (MHRA).
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NewsDriving QbD as a quality standard in drug development
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
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NewsFinancial factors to support and challenge Pharma in 2024
While constraints such as inflation and drug pricing pressures will impact pharma’s growth in 2024, patent expiration of biologics is expected to support the industry over the next few years, research suggests.
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NewsAstraZeneca to advance haematology cell therapy
The new acquisition grants AstraZeneca rights to a new CAR-T cell therapy with a differentiated manufacturing process that could provide a potential best-in-class blood cancer treatment.
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ArticleDeveloping point-of-care CAR T manufacturing
Driven by technological advances there is now increased scope for point-of-care manufacturing of CAR T-cell therapy. Arnon Nagler, Professor of Medicine at Tel Aviv University, discusses key benefits, challenges and lessons learned from developing an in-house programme.
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NewsMeiraGTx 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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NewsOtsuka to commercialise hereditary angioedema drug in Europe
Japanese company Otsuka Pharmaceutical will pay $65 million is to commercialise Ionis’ hereditary angioedema candidate in Europe.
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News$260 million funding injection for Danish vaccines initiative
The Novo Nordisk Foundation is investing up to $260 million in a vaccines research and development initiative focused on respiratory diseases.
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ArticleYear 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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NewsPsilocybin-assisted therapy reduces depressive symptoms in cancer patients
Results from a Phase II clinical trial indicate that psilocybin-assisted therapy could benefit individuals with cancer and major depression.
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NewsAstellas 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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ArticleNK cell immunotherapy: what’s next in clinical development?
In this interview, Innate Pharma’s Yannis Morel, Executive Vice President of product portfolio strategy and business development, delves into the unique advantages of using multi-specific antibodies capable of engaging NK cells against tumours for oncology indications, and shares key data from the company’s ongoing and recent clinical trials.
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NewsGSK immuno-oncology treatment achieves novel EU approval
The EC’s approval of the immuno-oncology treatment “will define a new standard of care for certain patients with advanced or recurrent endometrial cancer in the EU,” says principal investigator of the RUBY trial.
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ArticleAdvancing AOCs to transform the delivery of RNA therapeutics
In this article, Dr Michael Flanagan discusses how a new class of medicines called antibody oligonucleotide conjugates (AOCs) have the potential to overcome a major challenge encountered with many established RNA-based therapeutics: delivery to tissues outside the liver. Last year, AOCs demonstrated the first-ever successful targeted delivery of RNA into ...