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sofosbuvir

Gilead receives EU approval for combo hepatitis C treatment

Gilead Sciences (NASDAQ: GILD) has received a marketing authorisation approval from the European Commission for combination treatment Epclusa (sofosbuvir/velpatasvir) for patients with all genotypes of chronic hepatitis C.

This latest approval comes following the US Food and Drug Administration’s (FDA) decision to approve Epclusa just two weeks ago.

Gilead presents data highlighting progress and efficacy in liver and hepatitis C therapies

Gilead (NASDAQ: GILD) has presented a broad range of results on its current and potential therapeutics at the International Liver Congress 2016 in Barcelona Spain.

Federal jury rules in MSD’s favour in Gilead blockbuster hepatitis C drug dispute

Gilead’s dominance of the hepatitis C market is under severe threat after a federal jury ruled in favour of MSD and Ionis Pharmaceuticals, who claimed to hold crucial patents related to sofosbuvir, a compound key to Gilead’s global hepatitis C drug sales of $19 billion last year alone.

Gilead’s Sovaldi wins Drug Discovery of the Year Award

Sovaldi bottle
The judges say Sovaldi has been a 'game-changer' for hepatitis C

Gilead Science’s hepatitis C treatment Sovaldi has been awarded the British Pharmacological Society’s prestigious Drug Discovery of the Year 2016.

The Society says Sovaldi (sofosbuvir) dramatically improves the chances of a cure to the disease compared to historic treatments. 

The award is made to the team of Gilead researchers responsible for the development of Sovaldi, in recognition of the drug making a significant impact on an unmet medical need and offering a significant improvement over existing treatment options. 

FDA sued over failure to disclose Sovaldi data

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Two groups that campaign for wider access to medicines have filed a lawsuit against the FDA, in a bid to force the regulator to disclose the clinical trial data behind the approval of two blockbuster hepatitis C drugs.

The Yale University Global Health Justice Partnership and the AIDS non-profit charity the Treatment Action Group, have filed a joint lawsuit against the FDA claiming the US healthcare body was too slow to fully disclose key clinical trial data that led to the approvals of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir).

China rejects Gilead’s Sovaldi patent

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Manufacturer of the blockbuster hepatitis C treatment Sovaldi Gilead has seen its application for a patent in China rejected following a challenge by an access to medicines campaign group.

The decision opens the door for Chinese manufacturers to produce copycat versions of Sovaldi (sofosbuvir) for the Chinese market at a fraction of the price of Sovaldi – which costs more than £30,000 for a course of treatment.

The Pharmafocus debate: Is the price of new hepatitis C treatments fair?

Published on 27/04/15 at 01:26pm

YES - says Richard Bergström, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), who argues that blaming the pharma patent system for hepatitis C drugs’ prices is a non-starter.

New hepatitis C treatments have been a regular feature in healthcare news of late, not least because they offer that most elusive of gifts: a cure.

Gilead presents new Sovaldi data

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Gilead is looking to several new studies to support future new Sovaldi combinations and broadened treatment groups for its hepatitis C drug.

The US firm says the data, presented at the International Liver Congress in Vienna this week, supports the development of an investigational regimen of Sovaldi (sofosbuvir), in combination with two investigational hep C treatments – a NS5A inhibitor GS-5

Gilead frustrated despite final NICE Sovaldi nod

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NICE has published final guidance confirming its approval of Gilead’s controversial blockbuster hepatitis C treatment Sovaldi – but Gilead and the NHS are still coming to blows over the treatment’s delayed implementation.

NICE has concluded that Sovaldi (sofosbuvir) is an effective use of NHS resources, but because of its high price – £33,000 for a 12-week course of treatment – NHS England has asked for the deadline for services and funding to be in place to be extended until August, much to the frustration o

Pharma is boosting pipelines to avoid patent cliff

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Biogen Idec and Gilead have weaker pipelines, primarily because both firms have already launched their high-profile drugs

Pharmaceutical companies have improved their pipelines of new drugs over the last 18 months according to financial analysts Moody's Investors Service.

The firm that produces reports around the financial outlook of companies and countries says pharma has improved its pipelines of new drugs, but that potential losses due to patent expirations has also increased since mid-2013.

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