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Gilead subsidiary Kite Pharma to open CAR-T manufacturing facility in Maryland

Gilead Sciences subsidiary Kite Pharma has announced plans to open a new CAR-T manufacturing facility in Frederick County, Maryland (US).

The new 20-acre site will extend the firm’s ability to manufacture various CAR-T therapies including Kite’s cancer treatment Yescarta.

Tim Moore, Executive VP of Technical Operations at Kite, explained: “This new facility in Frederick County builds on our substantial technical capabilities and rapid progress in making personalised CAR-T and TCR cell therapies for people with cancer.”

Gilead's selonsertib crashes at Phase 3 in NASH

Gilead has broken the news that its apoptosis signal-regulating kinase 1 (ASK1) inhibitor selonsertib failed to meet its primary endpoint at Phase 3 in the treatment of bridging fibrosis (F3) due to nonalcoholic steatohepatitis (NASH).

When evaluated in 802 participants, the therapy failed to achieve a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH in a pre-specified week 48 analysis. Just 9.3% of those taking an 18mg dose and 12.1% of those taking a 6mg dose achieved such  an improvement compared to 13.2% with placebo.

Top Ten most popular articles on Pharmafile.com this week!

This week was a good one for clinical trials and a bad one for employees after both Gilead and GSK announced redundancies as Janssen scored twice in Phase 3 trials in chronic kidney disease and HIV.

Top Ten most popular articles on Pharmafile.com this week!

This week was an excellent week for recommendations and approvals after Eisai, MSD, Pfizer, BMS and ViiV scored wins. Meanwhile Britain’s cost effectiveness body NICE turned down Astellas’ Xtandi in prostate cancer.

Nevertheless our top story looked at Gilead’s announcement they would be laying off one fifth of their workforce. The news came as shares in Indivior plummeted by as much as 70% amid fraud allegations.

Gilead to lay off one fifth of sales force

Gilead Sciences is preparing to lay off around a fifth of its salesforce in anticipation for the expiry of patents on two of the company’s older drugs.

Gilead will lay off around 150 cardiopulmonary sales representatives as generic versions of the firm’s heart drugs, Letairis and Ranexa, are set to hit the market.

While Letairis and Ranexa brought in $943 million and $758 million, respectively, in 2018 – Ranexa’s patent expires next month while multiple generics have already been approved for Letairis.

Gilead accused of ripping off US taxpayers

Gilead have been accused of ‘ripping off’ US taxpayers after the firm was revealed to have generated $3 billion in sales from preventative HIV drug Truvada, despite the fact it was developed  by the US government.

While the American government patented the PrEP drug in 2015, the government has not received a single penny in royalties from Foster City-based Gilead Sciences.

Nevertheless Gilead charge between $1,600 and $2,000 a month for Truvada. Meanwhile, generic versions of the drug are sold for as little as £20 for a month’s supply in the UK.

Top Ten most popular articles on Pharmafile.com this week!

HIV hit the headlines this week after it was announced that a British man known only as the ‘London Patient’ had been cured of HIV after receiving a bone marrow transplant from a donor with natural resistance to the immunodeficiency virus. Meanwhile Gilead offered positive results with HIV drug Biktarvy.

The news comes as sources told Reuters OxyContin drugmaker Purdue Pharma was exploring bankruptcy as a get out for the lawsuits they face over their role in manufacturing the opioid crisis.

Gilead's Biktarvy maintains HIV suppression for 48 weeks in children and adolescents

Gilead has lifted the curtain on new Phase 2/3 efficacy data for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, also known as BIC/FTC/TAF), revealing that the drug demonstrated high efficacy in maintaining virologic suppression in already virologically suppressed adolescents and children aged six years and older living with HIV.

The trial evaluated the drug’s effects when administered once daily in 50 patients aged 12 to <18 and 50 patients aged six to 12 years of age, all of whom had an undetectable viral load (HIV-1 RNA &

Gilead's CAR-T therapy Yescarta rejected for NHS use in Scotland

It’s bad news for Scottish patients living with aggressive forms of non-Hodgkin lymphoma (NHL) as it emerges that the Scottish Medicines Consortium has chosen to reject Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel).

The decision means that patients who may have exhausted all other avenues of treatment will not be able to receive the treatment on the NHS in Scotland, with many not expected to survive longer than six months in these cases.

Gilead shares drop 4% after failure of NASH drug to meet primary endpoint

Gilead’s treatment for the progressive fatty liver disease, NASH, has failed to meet its primary goal in a phase 3 trial, causing shares in the company to fall by as much as 4%.

Gilead’s treatment for Nonalcoholic Steatohepatitis (NASH), a drug called selonsertib, did not meet its primary endpoint in a randomised, double-blind, placebo controlled Phase 3 trial involving 877 patients.

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