More news – Page 48
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NewsEuropean regulators prepare for AI in pharma
A coordinated workplan, which runs to 2028 will help European regulators embrace opportunities for artificial intelligence.
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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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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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NewsCHMP issues positive option for first gene-editing medicine
If approved, Vertex’s Casgevy (exagamglogene autotemcel) would be the first gene-editing medicine authorised in the European Union.
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NewsAlkermes to sell Irish manufacturing facility to Novo Nordisk
The facility in Athlone, Ireland, will give Novo Nordisk additional capacity to manufacture oral products.
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NewsPositive results for mRNA vaccine in melanoma patients
A personalised mRNA cancer vaccine in combination with MSD’s Keytruda cut the risk of cancer recurrence by almost half in melanoma patients.
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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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NewsNew approach for synthesis of oligonucleotide conjugates
Researchers from Aarhus University and Novo Nordisk have discovered a new synthesis method for oligonucleotide conjugates, marking a step forward in development of more targeted RNA medicines.
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NewsBMS agrees $8.4bn ADC collaboration with SystImmune
Bristol Myers Squibb and SystImmune have agreed to jointly develop and commercialise BL-B01D1, a bispecific antibody-drug conjugate for solid tumours.
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NewsEC approves treatment for rare haematological disorder
The European Commission has approved Europe's first treatment for adults with indolent systemic mastocytosis, a rare haematological disorder.
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NewsEurope publishes first list of critical medicines
More than 200 active substances are included on the list, which is seen as an important tool in preventing shortages of critical medicines in the EU/EEA.
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NewsConstruction starts on $400m biosimilars production centre in Slovenia
Lek Pharmaceuticals, part of Sandoz, has started building a $400 million biologics manufacturing centre in Slovenia.
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NewsFDA approves first cell-based gene therapies for sickle cell disease
The US FDA has approved Vertex’s Casgevy and bluebird bio’s Lyfgenia, for one-time treatment of sickle cell disease in patients 12 years and older.
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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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NewsASH 2023: microbiome-based therapy shows potential in graft-versus-host disease
Data presented at the 2023 American Society of Hematology (ASH) Annual Meeting suggest that the off-the-shelf microbiome therapeutic could offer a “potentially life-saving approach” in graft-versus-host disease (GvHD).
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NewsMHRA authorises Mounjaro for weight management
The UK MHRA has authorised Eli Lilly's Mounjaro (tirzepatide) for weight loss and weight management in adults.
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NewsAbbVie to buy neuroscience specialist Cerevel Therapeutics for $8.7bn
AbbVie plans to acquire neuroscience specialist Cerevel Therapeutics for $45 per share, or around $8.7 billion.
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News'Innovation-first' mindset vital for advanced therapies sector future
Improving data harmonisation and investing in the advanced therapy sector’s workforce are some of the key recommendations the sector must take to advance the field and increase patient access, a new report highlights.
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NewsCommon drug could facilitate “huge step-change” in managing type 1 diabetes
A common rheumatoid arthritis drug can suppress the progression of type 1 diabetes, research shows, making it the first disease-modifying, oral treatment of its kind for the condition.
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NewsAntibody-immunotherapy combination shows promise in lung cancer
A study evaluating the combination of a PD1 inhibitor with dupilumab enabled one out of six lung cancer patients to achieve a near-complete clinical response two months post-treatment, a paper states.