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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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Developing novel therapies for NASH
In this exclusive interview, Dr Hank Mansbach, Chief Medical Officer of 89bio discusses clinical development of FGF21 therapy to treat fatty liver disease.
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Takeda to build £600m plasma therapy manufacturing site
Takeda’s largest manufacturing capacity expansion investment in Japan will fund the build of a new facility for plasma-derived therapies.
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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NICE's final draft guidance has recommended the first and only gene therapy for children with aromatic L-amino acid decarboxylase (AADC) deficiency.
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Could Dupixent be the first biologic to treat COPD?
Dupixent® is the first biologic to demonstrate significant improvement in lung function compared to placebo, a pivotal Phase III trial has shown.
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Collaboration to produce 3D screen printed pharmaceuticals
A new collaboration between two industry players for cGMP production of 3D screen printing technologies could reduce drug development costs.
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Identifying origin of fungi in cleanrooms
Microbiology expert Tim Sandle’s recent video examined identifying the origin of fungi in pharmaceutical cleanrooms.
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CPHI Pharma Awards marks 20th anniversary
Three new categories added to the CPHI Pharma Awards mark its 20th anniversary edition and celebrates innovation in the industry.
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Kite releases pivotal CAR T therapy Phase III study results
Yescarta® is the first treatment in over 30 years to show statistically significant improvement in overall survival in R/R large B-cell lymphoma versus historical SOC.
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MHRA approves prostate cancer combination therapy
The first PARP inhibitor to show clinical benefit with a new hormonal agent in first-line metastatic castration-resistant prostate cancer has been granted UK approval.
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BioNTech to jointly develop novel antibody for cancers
ONC-392, an anti-CTLA-4 monoclonal antibody for solid tumours will be jointly developed by BioNTech and biopharma OncoC4.
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Novartis releases long-term data for SMA gene therapy
Long-term follow-up study data for Zolgensma®, Novartis’ one-time gene therapy for spinal muscular atrophy (SMA), has shown promising overall milestone achievements.
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MHRA to trial stem cell robot for cell therapies
The second-ever stem cell-producing robot, being tested by the UK MHRA, could produce safer, cost-effective treatments for diseases like cancer.
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GOSH and Leucid to manufacture novel CAR T therapy
Great Ormond Street Hospital and Leucid Bio will manufacture a novel lateral CAR targeting NKG2D ligands, under a first-of-its-kind manufacturing agreement.
