All Drug Development articles – Page 29
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NewsInnovative 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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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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NewsPreventative approach could reduce immunotherapy side effects
Research suggests that giving prophylactic treatment prior to immunotherapy could eliminate the need for the latter to be administered in hospitals.
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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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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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ArticleLeveraging innate cell engagers for lymphoma treatment
In this interview, Andreas Harstrick, CMO of Affimed discusses the evolution of the lymphoma treatment landscape and the promise of innate cell engagers for treating cancer.
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OpinionTrends shaping capsule development
In this interview from CPHI Barcelona, Julien Lamps from Lonza CHI discusses trends shaping capsule development.
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NewsBMS 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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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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NewsSanofi stops development of lung cancer drug
Sanofi is discontinuing development of tusamitamab ravtansine for certain types of non-small cell lung cancer after a Phase III clinical trial did not meet its endpoint.
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NewsCDMO 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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NewsNICE recommends combination therapy for prostate cancer
Lynparza (olaparib), which is being co-developed by AstraZeneca and MSD, showed clinically meaningful benefit when used with abiraterone and prednisone or prednisolone to treat hormone-relapsed metastatic prostate cancer.
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NewsFDA 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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ArticleEU 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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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.