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Positive results announced for acute myeloid leukaemia treatment trial
Positive topline results have been announced from a Phase II trial of VENCLEXTA® (venetoclax) in combination with azacitidine in patients with acute myeloid leukaemia (AML).
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Rachael Harper (European Pharmaceutical Review)
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Indian drug manufacturing facility issued FDA warning letter
Windlas Healthcare Private Ltd has been sent a warning letter by the FDA for violations of current good manufacturing practice regulations.
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Mass cytometry could reveal best cancer drug regimens for clinical trials
Researchers have developed a new technology that could provide real-time analysis of patient samples during clinical trials to reveal the best cancer treatment regimens.
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Spiral vortex streamlines delivery of nanomaterials into cells
Researchers have developed a new device, called a ‘spiral hydroporator’, which uses the power of a tiny fluid vortex to rapidly and efficiently deliver nanomaterials into cells.
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Licence of Esmya (ulipristal acetate) suspended
Esmya (ulipristal acetate)'s licence has been suspended due to the risk of serious liver injury, says the UK government.
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Fast Track designation granted to chronic kidney disease treatment
The US FDA has granted Fast Track designation to Jardiance® for the treatment of chronic kidney disease.
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FDA announces changes that will soon affect compounders
A change to the law will soon be impacting compounding of certain products beginning on 23 March 2020 the US Food and Drug Administration (FDA) has announced.
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Development initiated for a plasma-derived COVID-19 therapy
An anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) is being developed to treat infected, high-risk individuals with COVID-19.
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Thermo Fisher Scientific to acquire QIAGEN for $11.5bn
Thermo Fisher Scientific Inc has announced that it is to acquire QIAGEN N V for a value of €39 per share at current exchange rates.
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FDA and EMA accept licence applications for multiple sclerosis treatment
The FDA and EMA have accepted licence applications for ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS).
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Lilly announces agreement to acquire Dermira for $1.1bn
Eli Lilly has announced it is to acquire Dermira for $18.75 per share, or approximately $1.1 billion, which will expand Lilly's immunology pipeline.
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Experts highlight importance of reducing pharma packaging waste
At a recent event, pharmaceutical packaging experts discussed strategies to reduce waste and protect the bottom line.
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FDA Breakthrough Therapy granted to bladder cancer treatment
FDA Breakthrough Therapy Designation has been granted to PADCEV™ in combination with pembrolizumab in first-line advanced bladder cancer.
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Voltaren approved for arthritis pain over-the-counter in the US
Voltaren Arthritis Pain has been approved by the FDA as an over-the-counter product for the temporary relief of arthritis pain.
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Updated restrictions announced for multiple sclerosis treatment
A revised indication, additional contraindications and strengthened monitoring requirements has been recommended for Lemtrada (alemtuzumab) following a review.
