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Supply chain and drug pricing reform required to lower US healthcare costs
Price caps and government regulations will not lower US healthcare costs, instead supply chain and drug pricing reforms are required, says a brief by medical economist.
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Establishing a new pharmaceutical track and trace system in Dubai
Health authorities in Dubai have announced that they will introduce a new track and trace system to the emirate by mid-2020. This article investigates how this will help to improve the safety and quality of medicinal products.
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The real reason you’re struggling to stay compliant
For companies in highly regulated industries, compliance is second only to survival as a business. Yet why do so many companies struggle with compliance? Dr Rebecca Godfrey explores this issue and provides practical steps that companies can take to ensure best practice.
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Medical devices: recent developments and the potential impact of Brexit
The current regulatory system for medical devices in the UK, as an EU member state, is complex enough without the uncertainties surrounding Brexit. In this article, legal advisor Paul Ranson reviews the current and forthcoming regimes and how Brexit may impact manufacturers and regulators working in this space.
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Pelosi’s drug pricing bill passes House of Representatives
The House of Representatives has voted to approve Speaker Pelosi’s drug pricing bill in a Democrat-led chamber, say reports.
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FDA issues warning letter for misrepresentation of drug in advertisement
Alkermes, Inc. have received the warning letter after a promotional material review found it failed to adequately represent the risks of using the drug Vivitrol for patients with opioid use disorder.
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Consumers told not to use drugs recalled from Basic Reset and Biogenyx
The FDA has informed consumers not to use drugs recalled from Basic Reset and Biogenyx following consent decree for federal violations.
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Number of illegal diazepam tablets seized doubles in UK
The amount of illegal diazepam tablets commandeered at the border of the UK doubled last year, according to a report.
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Six pharma companies reported to be under investigation for opioid shipments
US prosecutors have handed subpoenas to six pharmaceutical companies and distributors for their role in the opioid crisis, as reported.
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Pelosi plan could lead to 56 fewer new medicines over decade
US Speaker Pelosi’s new drug pricing plan could impact small biotech companies, reducing their innovation by 90 percent, says new research.
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Medicine regulators should increase collaboration, says new report
The US National Academies of Sciences, Engineering, and Medicine have released a report that suggests regulators need to collaborate more to ensure drug quality.
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White House announces plan to increase US drug price transparency
Donald Trump has issued a statement outlining a plan to make drug costs in the US clearer for patients, which could also help to drive competition.
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Decision upheld in Merck hepatitis C drugs patent case
A US appeals court has upheld a ruling that threw out a $2.54 billion jury verdict Merck won against Gilead over hepatitis C treatments.
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Allergan to reportedly settle Alzheimer’s therapy lawsuit for $750m
Allergen is to reportedly settle a class-action lawsuit which alleges that it worked to delay generic competition for Alzheimer’s disease therapy Namenda.
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Teva to supply treatment in settlement agreement on Track 1 opioid case
Teva has agreed to supply opioid medication and make a cash payment in a settlement agreement that removes it from the Track 1 opioid litigation.
