news
Medreich ranitidine tablets recalled due to possible NDMA contamination
Medreich Plc is recalling a number of ranitidine products due to possible contamination with an impurity N-nitrosodimethylamine (NDMA).
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Medical Devices Regulation: delays and confusion
The EU Medical Devices Regulation will apply in May 2020. Maurits Lugard and Josefine Sommer of Sidley Austin LLP examine what the changes mean for the medtech industry.
news
NIAID stops HIV vaccine trial after review finds treatment ineffective
The US NIAID has stopped its HVTN 702 clinical trial for an HIV vaccine after an independent board found that the treatment did not prevent the condition.
news
Efficient Laboratories Inc recalls flu treatment due to contamination
Rompe Pecho EX, Rompe Pecho CF and Rompe Pecho MAXliquid are being recalled due to microbial contamination.
news
NICE does not recommend esketamine for treatment-resistant depression
Esketamine nasal spray did not receive a positive opinion from NICE due to inadequate comparisons to other therapies and concerns over its cost effectiveness.
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EMA announces next steps for UK pharma industry after Brexit
The EMA has released a statement, outlining the future for the UK's pharmaceutical industry in the transition period following Brexit and thereafter.
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EU court rules GSK committed ‘pay-for-delay’ in paroxetine case
The Competition and Markets Authority (CMA) announced the EU Court of Justice agreed that GSK had paid to delay other competitors entering the UK paroxetine generics market.
news
Specific batches of levothyroxine recalled as precautionary measure
Due to a notification of the impurity, liothyronine, exceeding the specification limit, certain batches of levothyroxine 100micrograms/5ml oral solution are being recalled.
whitepaper
Whitepaper: What our remediation projects are saying about the industry
31 January 2020 | By
Based on a study of the pharma industry’s remediation projects, this white paper from NSF looks at the key issues behind GMP non-conformance. It also includes questions to ask yourself when making changes to your processes and systems.
news
EC approves KTE-X19 for treatment of mantle cell lymphoma
KTE-X19, an investigational CAR T-cell therapy, has been granted marketing authorisation by the European Commission.
news
MHRA alert: missing information on Dr Reddy’s finasteride information leaflet
According to the MHRA, the finasteride 5mg tablets produced by Dr Reddy’s do not contain certain warnings and precautions in the patient information leaflets.
news
Survey finds 87 percent of pharmacists concerned about medicine supply post-Brexit
New findings reveal that the majority of pharmacists are worried about the supply of medicine to the UK after Brexit and believe their pharmacies will be impacted.
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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.
news
Class 2 medicines recall of LEO Laboratories Picato gels
LEO Laboratories is recalling its Picato (ingenol mebutate) gels from pharmacies and wholesalers over a possible risk of skin malignancies; the products must be returned to suppliers for credit.
news
Rise in pharmaceutical applications to increase demand for mass spectrometers in Europe
Researchers predict that the market for mass spectrometers will be worth $1.9 billion by 2025 due to demand for faster and more accurate technology.
