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MHRA issues alerts over defects in Patient Information Leaflets
The MHRA has issued two alerts, one for incorrect maximum daily dosage of Ibuprofen 400mg and a second for missing safety information about Oxylan Prolonged-release tablets.
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FDA approves Advil Dual Action for over-the-counter pain relief
Advil Dual Action is the first FDA-approved an over-the-counter ibuprofen and acetaminophen combination, backed up with data from several clinical trials proving its efficacy.
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American Health Packaging voluntarily recalls ranitidine tablets
Ranitidine tablets have been recalled due to the possibility of the products containing unacceptable levels of NDMA.
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Video: A complete bioburden testing system
The new Milliflex Oasis® system for bioburden and pharmaceutical water testing enables pharma QC labs to raise their productivity.
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Takeda acquires PvP Biologics following coeliac disease drug trial
A statement by the Takeda reveals the company has acquired PvP as part of a development and option agreement for the drug TAK-062.
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NICE does not recommend polatuzumab vedotin to treat lymphoma
NICE has formed a negative opinion for Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine to treat diffuse large B-cell lymphoma.
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Five of the most recent developments in anti-cancer therapeutics
European Pharmaceutical Review investigates five of the latest cancer drug approvals and clinical trial results.
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Novartis launches review of Beovu after safety concerns, says report
An external review of the medicine Beovu has been announced by Novartis, which produces the drug, according to a new report.
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Dry eye syndrome therapies in pipeline show promise, says report
A report has revealed that the products in the pipeline to treat dry eye syndrome are expected to expand the number of options available for patients.
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FDA accepts Zejula sNDA application as a maintenance treatment for ovarian cancer
The developers of Zejula (niraparib) have announced the FDA will assess the sNDA application under the Real-Time Oncology Review (RTOR) pilot programme.
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FDA approves first generic of ProAir HFA inhalation aerosol
The generic of ProAir HFA (albuterol sulfate) inhalation aerosol has been approved by the FDA to advance patient access to lower-cost medicines.
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FMD alert issued for diamorphine hydrochloride lyophilisate for solution by MHRA
A defect in the 2D matrix for the expiration date of diamorphine hydrochloride lyophilisate for solution has been announced by the MHRA.
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FDA centres collaborate to evaluate conclusions of pharmacogenetic testing
The FDA has released a statement that two of its centres will collaborate to provide information on gene-drug interactions they believe have sufficient supporting evidence.
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India to hold pharma companies responsible for drug quality after reforms
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.
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Digital trends and predictions for pharma in 2020
Bridging the gap between information and operational technology will allow pharma to excel this year. Here, the forthcoming digitalisation trends are projected.
