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Long-running, $2.5bn lawsuit swings in Gilead’s favour

The fate of pharma company’s profits and losses largely rests on product approvals and the sales team behind them but, when a record fine is looming over a company, it can also be dependent on the court rooms.

Gilead will be breathing a sigh of relief, after a judge overturned a record $2.54 billion decision against it. The case was brought by MSD, known as Merck in North America, regarding Gilead’s blockbuster hepatitis C drugs, Sovaldi and Harvoni.

MSD had alleged that Gilead infringed its patents and had initially won the case in December of 2016.

FDA approves Gilead's Biktarvy for HIV as Viiv Healthcare launches patent lawsuit

Gilead has announced that its daily single-tablet therapy Biktarvy has received FDA approval for HIV-1 infection.

Gilead aims to claim edge with Pfizer CAR-T combo

Although those in pharma often dislike any references to drugs competing with each other for market as in a ‘race’, it’s inevitable that such allusions will be drawn between rivals.

Gilead’s recent acquisition, Kite Pharma, is one of two CAR-T therapies to receive approvals, alongside Novartis’ Kymriah, and comparing it to an arm’s race is the temptation. If that were the case, Kite’s recent team up with Pfizer looks set to test whether its treatment can go nuclear on refractory large B-cell lymphoma.

AIDS charity lambasts “ethically challenged” Gilead over price hikes

IMAGE: Wikipedia/Jeffrey Beall

The AIDS Healthcare Foundation (AHF) has strongly criticised Gilead prices increases across the board for its HIV and AIDS treatment, including pre-exposure prophylaxis (PrEP) drug Truvada.

The biotech increased the prices for three treatments in total, Truvada, Genvoya and Descovy, by 6.9%. The charity argues that this decision is unjustifiable given that a core component of all treatments is tenofovir, a drug that’s patents expired in December of last year.

Gilead makes $567m strategic acquisition for next-gen CAR-T

It’s only four months since Gilead completed its buy-out of Kite Pharma for $11.9 billion, but it’s already moving quickly to establish bolt-on technology to take its CAR-T therapy forward.

The first move in this process has been to acquire Cell Design Labs in a deal worth up to $567 million. The technology that Gilead will acquire could see it use Cell Design’s platforms to engineer CAR-T therapy to make currently elusive targets more viable, such as in other forms of cancer.

Gilead launches hep C drug Sovaldi in China at one-fifth of US price

Gilead has officially launched its hepatitis C drug Sovaldi (sofosbuvir) in the Chinese market, but with one major caveat: it will cost 58,980 yuan ($8,937) in the region, just one-fifth of its price tag in the US – a price which has fallen rapidly from the $84,000 it originally launched at.

There are around 10 million cases of chronic hepatitis C in China, says Zhang Hong, Director of the Infectious Diseases Department at Shaanxi Provincial People’s Hospital, while the total number of such cases worldwide is 130 million, according to WHO estimates.

Learning lessons from HIV to change the treatment access landscape

Published on 23/11/17 at 09:56am
Photo Credit: C. Goldsmith Content Providers: CDC/ C. Goldsmith, P. Feorino, E. L. Palmer, W. R. McManus

Greg Alton, Executive Vice President of Corporate and Medical Affairs at Gilead, reveals how the rapid development and distribution of HIV treatments globally holds important lessons in improving patients’ access to medicine.

FDA approves first-ever two-drug HIV regimen, GSK's Juluca

GlaxoSmithKline has announced that the FDA has awarded US marketing authorisation to the first two-drug regimen in the treatment of HIV.

Juluca, as the therapy is known, is a combination of dolutegravir – an integrase inhibitor from GSK’s majority-owned ViiV Healthcare – and rilpivirine, a non-nucleoside reverse transcriptase inhibitor developed by Johnson & Johnson. It will be available to patients who have been on a stable treatment regimen for at least six months.

Novartis aims for CAR-T double-approval in Europe

Just last week Novartis revealed it had applied to the FDA for a new indication in diffuse large B-cell lymphoma (DLBCL) for its CAR-T treatment, Kymriah, now the company has gone to the EMA hoping to secure two indications at the same time – jump starting its presence in the European market.

The other indication it is applying for is in acute lymphoblastic leukaemia (ALL), the type of blood cancer that Kymriah has already received approval for by the FDA.

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