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FDA approves Tepezza for the treatment of thyroid eye in adults
The US FDA approved Tepezza (teprotumumab-trbw), the first treatment for thyroid eye, on the basis of two trials in which the drug improved eye protrusion in patients.
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Hannah Balfour (European Pharmaceutical Review)
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Tiofarma admits role in illegal agreement causing fludrocortisone price hikes
The CMA has announced Tiofarma admits taking part in an anti-competitive agreement with Amilco and Aspen which resulted in huge price increase in fludrocortisone acetate tablets.
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Effectiveness of HPV vaccines Cervarix and Gardasil under question
Analysis of the designs of Phase II and III efficacy trials for HPV vaccines suggest they overstated their effectiveness against cervical cancer, according to researchers.
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The intricacies of rising drug prices in the US
Following 250 US drug price increases in 2020 already, this article explores why costs are rising, what changes could ensure brand reputations remain intact and what manufacturers can do to ensure they get their share.
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Patents for NLRP3 inflammasome-inhibiting compounds granted in US and Europe
Inflazome has announced that the US and EU will grant patents to their NLRP3 inflammasome inhibiting compounds.
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EC approves Darzalex® in combination with VTd for multiple myeloma
The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.
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Immuno-oncology and personalised medicine to drive pharma in 2020
A survey of industry professionals states they expect immuno-oncology therapies and personalised medicines to continue to shape the pharmaceutical industry in the coming year.
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Less than half of US clinical trials comply with reporting regulations
Researchers have found that only 41 percent of trials reported their findings with a year after completion and suggest that over $4 billion in fines could have been collected in just 12 months.
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Regulatory expansion submitted for SPRAVATO® (esketamine) nasal spray
Janssen have applied to the EMA to extend the use of esketamine to a short-term treatment for the rapid reduction of depressive symptoms in adults with MDD who are suicidal with the intent.
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Professor Trevor Jones appointed chairman of the European Medicinal Cannabis Association
Professor Trevor Jones, CBE, FMedSci is the new chairman of EMCA, a body that seeks to advocate for evidence-based policy and improving supply and manufacture of quality medicinal cannabis.
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Strengthened regulatory systems are needed to improve drug safety, says report
The report reveals practical regulatory reforms that could move the globe closer to the UN’s goal of achieving universal health coverage by 2030.
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First living robots, called ‘xenobots’, could be used in drug delivery
Using embryonic stem cells from frogs, scientists have created living robots; called xenobots, these organisms are able to heal after injury and could be the future of drug delivery.
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Global neoantigen cancer vaccine market to generate $1,826.1m revenue by 2030
A study suggests the global neoantigen cancer vaccine market will grow exponentially due to expected drug launches, new technology reducing costs and currently unmet needs of the market.
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NICE approves palbociclib with fulvestrant on the CDF for treatment of some breast cancers
The NICE committee has made palbociclib with fulvestrant available on the Cancer Drug Fund for patients with hormone receptor-positive, HER2-negative, advanced breast cancer.
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Phase III STRENGTH trial for Epanova in mixed dyslipidaemia will close
On recommendations by an independent committee, AstraZeneca will close its STRENGTH trial for Epanova, which has shown low likelihood of being beneficial to patients with mixed dyslipidaemia.