All Industry news articles – Page 3
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Industry newsSouth Africa set to investigate J&J over MDR-TB drug pricing
Johnson & Johnson is set to be investigated by South Africa’s Competition Commission for its prices charged for TB drug bedaquiline.
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Industry newsEMA proposes novel method to assess CKD therapy efficacy
Glomerular filtration rate slope can be used as a surragate end point to assess clinical benefit for treatments in CKD in some trial settings.
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Industry newsNICE recommends AI to aid radiotherapy treatment in England
First guidance from National Institute for Health and Care Excellence for use of artificial intelligence as tool for healthcare professionals.
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Industry newsNICE approves use of Rimegepant in NHS to treat acute migraine
Rimegepant is the first, and only, NICE-recommended treatment for acute migraine and is soon to be made available on the NHS in the UK.
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Industry newsFDA committee finds OTC decongestants to be ‘ineffective’
An FDA committee has reviewed phenylephrine − the active ingrediant in many over the counter decongestants − and agreed it is ineffective.
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Industry newsEMA future ‘VetMeds’ for healthy animals and humans; seminar
In the lead up to the EMA’s Veterinary Awareness Day, Ivo Classen sits down to discuss the agency’s progress in the field of veterinary medicines.
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Industry newsCovid vaccines ‘not to be offered routinely’ to healthy under-65s
Only over-65s will get vaccination offered this year, the Joint Committee on Vaccination and Immunisation has advised UK government.
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Industry newsUK doubles capacity for certification of medical devices
TÜV SÜD, Intertek, and TÜV Rheinland UK have been designated as UK Approved Bodies to assess and certify general medical devices.
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Industry newsMHRA publishes ‘recognition route’ revised guidance
The MHRA has issued guidance on its International Recognition Procedure, which will replace the EC Decision Reliance Procedure from January 2024.
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Industry newsSemaglutide may help with PCOS and addiction disorders
Studies of diabetes and weight-loss drugs are underway to determine if they could also help manage a range of other conditions.
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Industry newsBurkina Faso gives R21 malaria vaccine approval in children
Burkina Faso’s regulatory agency – Agence Nationale de la Regulation Pharmaceutique – has approved the R21/Matrix-M malaria vaccine for children.
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Industry newsGlobal life sciences consultancy created from SSI/NDA merger
US-based SSI Strategy buys Sweden-based regulatory affairs consultancy NDA Group AB; Strömquist stays on as President of NDA unit.
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Industry newsHuman COVID drug set to treat FCov-23 coronavirus in cats
A virulent strain of feline coronavirus has spread through Cyprus, and veterinarians on the island have received a first batch of anti-COVID pills.
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Industry newsDevices sold on second-hand market retain sensitive data
Infusion pumps sold on secondary markets in the US were found to carry sensitive information about the hospitals that once owned them.
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Industry newsRapid COVID-19 breath test device shows promise
A small, COVID-19 breath test device – developed by researchers from Washington University, St. Louis– can detect the SARS-CoV-2 virus.
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Industry newsSafe use of AI is subject of EMA reflection paper
The EMA has published a draft paper on how artificial intelligence can support the development and use of human and veterinary medicines.
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Industry newsPatient groups get pharma funding; often petition NICE
An investigation by The Observer reveals how patient groups receiving funding from pharma often petition NICE for NHS approvals.
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Industry newsOff-label prescription of diabetes drug causes shortage
A spike in weight-related prescription of diabetes drug Ozempic has contributed to a national shortage, affecting those who need it.
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Industry newsFDA's Emerging Technology Programme
The FDA’s Emerging Technology Programme intends to assist industry in gaining regulatory approval for innovative technology drug applications.
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Industry newsFDA approves its first nonprescription birth control pill
FDA approves first over-the-counter (OTC) contraceptive pill for use in the US − it is expected to become the most effective OTC birth control.