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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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NICE recommends fremanezumab for chronic migraine prevention
The UK’s National Institute for Health and Care Excellence, NICE, recommends the use of fremanezumab on the NHS for preventing chronic migraine.
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Artificial intelligence in pharma: utilising a valuable resource
The pharmaceutical industry is set to greatly benefit from the use of artificial intelligence (AI), due to its wide range of applications. Sydney Tierney discusses how machine learning can enhance marketing, manufacturing and drug trials.
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PMP promotes success in India’s medical devices industry
According to renowned data and analytics company GlobalData, India’s phased manufacturing programme will create significant opportunities for medical device manufacturers in India.
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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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NICE fails to recommend the combination of pembrolizumab and axitinib for kidney cancer on NHS
The National Institute for Health and Care Excellence (NICE) has stated that combined use of the drugs pembrolizumab and axitinib is not recommended for untreated advanced renal cell carcinoma in adults.
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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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Malaria vaccine clinical trial for pregnant women reports promising results
The results of a clinical study for a gestational malaria vaccine has shown that the treatment is "well tolerated" and can produce an immune response.
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CHMP recommends fifteen therapeutics at latest meeting
The EMA’s human medicines committee (CHMP) recommended fifteen medicines for various approvals at its January 2020 meeting; with ten drugs receiving marketing authorisation recommendations and five receiving positive opinions for specific treatments.
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Video: Data Prep of Million Data Points at Janssen
Watch Data Scientist Patrick O’Sullivan of Janssen describe how they reduce the amount of time spent preparing data for their million data point systems.
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Recommendations made by EMA to unlock big data potential
Ten priority actions have been recommended for the European medicines regulatory network to evolve its approach to data use.
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Funding for AI in drug development, clinical trials and information synthesis hits $5.2bn
A study has suggested that while funding for artificial intelligence in pharma was $5.2bn in 2019, overall investment is slowing.
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Adopting new guidelines could get medicines from CID trials to patients faster
The ECMC has published guidelines for Complex Innovative Design trails which could improve the conduct, quality and acceptability of oncology studies, enabling patients to get access to new medications more quickly.
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Report links greater generic competition and lower generic drug prices
A new report from the FDA has shown that greater competition among generic drug makers is associated with lower generic drug prices.
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New drugs more likely to be approved if backed up by genetics, says study
A new study could aid pharmaceutical companies in their drug development efforts after if found that a drug candidate is more likely to be approved for use if it targets a gene known to be linked to the disease.