Brexit deal could negatively impact medical device development in UK, says report
New research suggests that a Brexit deal would obligate the UK to adhere to the EU MDR, imposing tighter restrictions on development and so hinder the industry.
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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.
FDA approves first interactive digital inhaler sensor
The FDA has given its first approval to an interactive digital inhaler sensor that allows patients to manage their condition by providing instructions and recording usage data.
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.
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.
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.
Supplemental New Drug Application submitted for anaemia treatment in Japan
In a bid to address an unmet clinical need for patients in Japan, roxadustat has been presented as a potential treatment for a particular kind of anaemia.
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.
Low costs of dispersible products to drive single-use bioprocessing market
Research has predicted that the global single-use bioprocessing market will exhibit a CAGR of 13.6 percent over the forecast period until 2025.
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.
Key principles for electronic product information implementation in EU released
The EC, EMA and HMA have published key principles on the various benefits of sharing medicinal product information electronically and how to implement this system.
FDA grants priority review to selpercatinib New Drug Application
Priority review has been given to the NDA for selpercatinib to treat advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.
Colour-changing bandages can release antibiotics and prevent resistant microbes
Research has developed bandages which change colour and release antibiotics and/or reactive oxygen species in response to an infected wound which could curb the spread of antibiotic resistance.
Drug delivery and packaging trends for 2020 revealed
Pharmaceutical industry experts have highlighted the key trends for the coming year for drug delivery and packaging.
FDA releases guidance on gene therapy manufacturing
In an effort to support innovation in the development of gene therapy products, the FDA has released guidance to provide regulatory clarity for product developers.
