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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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Therapeutics
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Nilvadipine and related drugs could slow Alzheimer’s progression
Researchers have shown that Nilvadipine can slow the rate of cognitive decline in very early- and early-stage Alzheimer’s patients and have received funding to develop improved versions.
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FDA approves Isturisa (osilodrostat) treatment for Cushing’s disease
The FDA has approved Isturisa for Cushing’s disease treatment after it demonstrated significant efficacy in clinical trials.
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FDA approves DURYSTA™ (bimatoprost implant) New Drug Application
The DURYSTA ocular implant has been approved by the FDA to reduce intraocular pressure in open-angle glaucoma or ocular hypertension.
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Online pharmacy finds high levels of NDMA in metformin
Tests conducted by an online pharmacy has revealed high levels of NMDA in the diabetes drug metformin, prompting the company to press for a recall.
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CMA levels over £3.4m in fines for competition law breaches
The UK’s Competition and Markets Authority (CMA) has fined four companies in because of anti-competitive practices in the supply of nortriptyline.
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Thin film platform to preserve vaccines at room temperature developed
A new vaccine formulation has been created by researchers, which uses a peelable film during drying to preserve the medicine.
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Innovations in CAR-T therapies in APAC will make market more competitive, report highlights
Research has shown that the CAR-T therapies in development in Asia-Pacific will make the worldwide market more competitive and drive down prices.
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EC grants marketing authorisation to Givlaari® (givosiran) for acute hepatic porphyria
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
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EMA announces update on nitrosamine impurities in medicines
The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
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Cryogel: a solid vaccine for liquid tumours
Researchers have developed a solid ‘cryogel’ vaccine that has been successful in combatting acute myeloid leukaemia in mice. How was this new formulation discovered and what potential does it have for cancer patients?
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Orphan Drug Designations are declining, says market analysis
A report has suggested that number of Orphan Drug Designations in both the US and Europe is declining, possibly due to prices and political changes.
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EMA releases results from February meeting, recommending two medicines
The EMA has recommended granting marketing authorisation to two medicines and extending the indications for three more following its latest meeting.
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MHRA issues alerts over defects in Patient Information Leaflets
The MHRA has issued two alerts, one for incorrect maximum daily dosage of Ibuprofen 400mg and a second for missing safety information about Oxylan Prolonged-release tablets.
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FDA approves Advil Dual Action for over-the-counter pain relief
Advil Dual Action is the first FDA-approved an over-the-counter ibuprofen and acetaminophen combination, backed up with data from several clinical trials proving its efficacy.
