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Gilead’s blood cancer pill approved in Europe

Zydelig image

Gilead has gained European Commission approval for its new blood cancer pill Zydelig (idelalisib) as it looks to expand further into oncology.

Zydelig is a first-in-class oral treatment for two incurable blood cancers, namely: chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL).

For the treatment of CLL, Zydelig has been approved for use in combination with Roche’s arthritis and cancer drug MabThera (rituximab) for patients who have received at least one prior therapy.

Gilead allows generic prices for Sovaldi

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Gilead will allow Indian generic drug firms to make cheap copies of its new hepatitis C pill Sovaldi in an effort to make it more affordable for the poor.

The US firm says that seven Indian drugmakers, including Ranbaxy and Cipla, will be able to manufacture and sell Sovaldi (sofosbuvir) for $900 for a full course of treatment.

Vertex ditches its once-stellar hep C drug

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Vertex will stop selling its once-blockbuster hepatitis C drug in the US this autumn after being crushed by new therapies.

The announcement comes after Vertex confirmed that it sent a letter to American doctors earlier this week to inform them that Incivek (telaprevir) would not be available after 14 October.

Vertex had already said in May that it would withdraw from the hepatitis C market, but had not said when it would stop making the drug.

Roche’s blood cancer drug gains EU approval

Roche

The European Commission has approved Roche’s new leukaemia drug Gazyvaro (obinutuzumab) as competition for the blood cancer market heats up.

Specifically the licence is for the drug, in combination with chlorambucil chemotherapy, for patients with previously untreated chronic lymphocytic leukaemia who are too frail for intensive therapy.

EMA approvals for rival blood cancer drugs

EMA HQ
The EMA's building in London

Gilead and Janssen are set to face off in Europe after the CHMP recommended both of their rival blood cancer drugs be approved on the continent.

Janssen’s Imbruvica (ibrutinib) and Gilead’s Zydelig (idelalisib) have been recommended for chronic lymphocytic leukaemia (CLL) patients who have received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy.

FDA approves Gilead’s blood cancer drug

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The Food and Drug Administration has approved Gilead Sciences new treatment Zydelig (idelalisib) to treat three types of blood cancer. 

The US regulator has given the all clear to the drug for patients with forms of chronic lymphocytic leukaemia, follicular lymphoma and small lymphocytic lymphoma. 

Sovaldi scores in HIV patients

Sovaldi (sofosbuvir) image

Patients with HIV and hepatitis C virus (HCV) have responded well to a combination of Gilead Sciences’ Sovaldi and ribavirin in a new study of 223 people.

The trial, reported in the Journal of the American Medical Association (JAMA), found that there was a 76% sustained viral response (SVR) in patients co-infected with HCV genotype 1 and HIV after 24 weeks of treatment.

This sort of impressive response is a major factor in why Sovaldi is expected to reach around $10 billion in sales by next year, and is on course to become the biggest selling medicine in the world.

AbbVie hep C treatment fast-tracked

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The European regulator is to fast-track AbbVie’s oral, interferon-free treatment for adults with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.

The regimen is a fixed-dose combination of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin (RBV).

The manufacturer’s applications, submitted last month, have been validated and are under accelerated assessment by the European Medicines Agency (EMA). Last week, the US Food and Drug Administration gave the same applications priority review status.

NICE rejection looms for Sovaldi

In a draft recommendation published today NICE is asking Gilead for more information on its new hepatitis C pill Sovaldi (sofosbuvir) – and is currently not minded to recommend the treatment for NHS England funding.

Professor Carole Longson, director of the NICE centre for health technology evaluation, explains: “The availability of new treatments, like sofosbuvir, that can shorten the duration of [older injectable drug therapy] interferon, or which in some cases don’t need to be taken with interferon at all, would potentially encourage more people to seek treatment.

Sovaldi hurdles first drug pricing barrier

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Scotland’s NHS will pay for Gilead’s new hepatitis C pill Sovaldi despite rising concern over its high cost.

The Scottish Medicines Consortium, which assesses the cost-effectiveness of new medicines in Scotland, will allow Sovaldi (sofosbuvir) to be funded in the country for patients with genotypes of the disease from one to six. 

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