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China grants Tagrisso (osimertinib) marketing authorisation
Following positive clinical trials, the Tagrisso drug has been given marketing authorisation in China for treatment of NSCLC.
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Philippines may re-introduce controversial dengue vaccine
The Philippines is considering re-introducing a dengue vaccine whose use was ceased because of links to several deaths.
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Manufacturing, Packaging & Logistics In-Depth Focus 2019
Whether by ignorance of the latest best practices, or willful disregard for patient safety, the results of careless practice can often be fatal. The articles in this in-depth focus highlight how regulatory bodies are taking action to raise the industry’s game.
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Four pharmaceutical companies accused of illegal anti-competitive conduct
The CMA has revealed findings that provisionally show that four pharmaceutical companies have broken the law.
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India to introduce mandatory barcoding of APIs
A report showing high percentages of counterfeit drugs in India has prompted the country to introduce compulsory barcoding for APIs.
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Booklet: Are you ready for EU MDR 2017/745-746?
This booklet from PQE Group is your opportunity to learn how the new EU directives - EU MDR 2017/745-746 - affect your company. Read on to find out what preparations you can make to ensure that your products comply.
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WHO announces support for drug pricing transparency
Member countries of WHO have agreed to support pricing transparency for medicines, vaccines and other health products.
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$85 million settlement agreed for opioid case in Oklahoma
Teva has agreed to pay Oklahoma, resolving allegations that illegal marketing of its medication contributed to the state’s opioid epidemic.
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FDA sends warning letter to Canadian OTC manufacturer
FDA sends warning to Petra Hygienic Systems Int LTD after they find violations of current good manufacturing practices (cGMPs).
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US drugmakers allegedly collude on generic price hikes
A coalition of 43 attorneys general allege generic drug manufacturers colluded, overcharging US states and consumers billions.
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Amgen and Astellas Pharma US agree to settlement costs for kickback charges
Amgen and Astellas Pharma US have agreed to pay a total of $124.75 million to settle allegations that they paid kickbacks to Medicare copays for their own medications.
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Legal ruling confirms that ‘routine’ discoveries can be patented
In a ruling handed down by the UK Supreme Court, Lord Hodge has confirmed that discoveries made through well-established or routine research protocols can be inventive and rewarded with a patent.
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Is the pharma sector ready for a ‘no-deal’ Brexit?
With the UK bracing itself for a 'no-deal' Brexit or some other outcome that has not yet been determined, pharma experts discussed the potential effect of Brexit on the supply chain and how to best prepare for it against the upcoming deadline.
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Discoveries made through ‘routine’ research can now be patentable
In a ruling handed down on 27 March 2019 by the UK Supreme Court, Lord Hodge has confirmed that discoveries made through well-established or routine research protocols can be rewarded with a patent...
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Further scandal for China’s pharmaceutical industry
Chinese police say they have opened an investigation into reports that at least 145 children received an expired polio vaccine...
