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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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Pharma reputation worst among other industries in US
An annual report has found that the pharmaceutical sector is the lowest regarded industry among US citizens.
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Pakistan lifts Indian import ban for essential medications
A ban on Indian trade to Pakistan has been partly changed to allow the import of drugs after a shortage of critical medicine.
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NICE recommends voretigene neparvovec for use on NHS
The voretigene neparvovec gene therapy treatment has been highlighted in draft guidance by NICE for availability on the NHS.
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China and the evolving regulatory landscape
The Chinese pharmaceutical industry has been lagging behind in terms of drug development and bringing new products to the market. In this article, Megha Baruah discusses the changes the National Medical Products Administration (NMPA) of China is making to existing policies and informs on guidance documents that have been released…
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China’s drug bulk-buy programme has been expanded
China has expanded a pilot drug bulk-buying programme to almost the entire country which is adding pressure on pharma companies.
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Mylan generic of lung cancer drug Alimta approved
Mylan NV's generic version Eli Lilly and Co’s lung cancer drug, Alimta, has been given tentative approval by the FDA.
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Biologics and generics reported to save NHS £700m
An NHS-wide plan to use more generic and biologic products has reportedly saved the healthcare provider £700 million since 2016.
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Drugs with ingredients from threatened species not covered by Chinese insurance
The Chinese government has announced that medicines containing ingredients from threatened species such as pangolins will no longer be eligible for insurance coverage.
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Small molecules dominate FDA drug approvals this month
This August saw nine new green lights from the FDA, all small molecules, which makes up a third of the approvals this year.
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Antibody drug conjugates market to be worth $15bn by 2030
Antibody drug conjugates are presently recognised as a potent class of targeted anticancer therapies which will result in growth in the market.
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Amgen patent claims invalidated by US district court
A US district court has invalidated Amgen's patent claims for antibodies targeting PCSK9.
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Health union leaders warn of medicine shortages in event of no-deal Brexit
A statement from 11 health union leaders highlights the possibility of severe drug shortages if the UK leaves the EU without a deal.
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Farxiga has been granted Fast Track status by the FDA
Fast Track designation has been granted to Farxiga to prevent heart and kidney failure in patients with chronic kidney disease.
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China to relax generic drug import laws
The government in China has stated that small quantities of generic medicines that are legal in foreign countries will no longer be classed as “fake drugs”.
