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Orphan Drug Designations are declining, says market analysis
A report has suggested that number of Orphan Drug Designations in both the US and Europe is declining, possibly due to prices and political changes.
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US Food and Drug Administration (FDA)
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FDA announces first drug shortage in US caused by impact of COVID-19
The FDA has released a statement, announcing that the US is experiencing its first shortage as a result of the effects of COVID-19.
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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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FDA sends warning letter to KVK-Tech manufacturing facility
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
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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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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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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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How will the rise of biosimilars impact biologics?
Once patents expire for biologic medicines, a market opportunity opens up for biosimilars, a cheaper alternative. With more patents due to expire soon, what will the future look like for biologic medicines?
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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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COVID-19 update: therapeutic and regulatory developments
European Pharmaceutical Review rounds up the latest news surrounding COVID-19, including a vaccine moving to clinical trials and the FDA's update on Chinese import inspections.
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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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US pharma industry leaders support blockchain tech to aid track and trace systems
A report released by pharmaceutical industry leaders in the US demonstrates how blockchain helps to track and trace prescription medicines.
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Trends in the CDMO industry for 2020
Over the past decade, the pharmaceutical industry has witnessed rapid growth in outsourcing services, driven by various factors including the growth of small molecules, increasing API complexities and the need to optimise costs. Here, Peter DeYoung shares his thoughts on the key trends he expects to see in the contract…
