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FDA warns three Hepatitis C drugs may worsen liver function in some rare cases

The FDA has warned that three Hepatitis C (HCV) drugs made by AbbVie, Gilead and MSD are worsening liver function and causing liver failure in some patients.

The US regulator said it has identified 63 cases in which HCV drugs Mavyret, Zepatier, and Vosevi were worsening liver function in patients with symptoms of moderate-to-severe liver impairment and other serious liver problems.

Gilead challenges Government over patents on preventative HIV drug Truvada

Gilead is challenging the US Government’s patents on PrEP drug Truvada.

The Foster City firm has submitted a challenge to the US Patents and Trademark Office (PTO) over the Department of Health and Human Service (HHS) patent on preventative HIV drug Truvada.

In a statement from August 21, Gilead said: “We strongly believe that the patents granted to HHS since 2015 for PrEP and PEP are not valid.”

Medicare will cover CAR-T therapies in United States

Medicare will cover the cost of Novartis’ and Gilead’s CAR-T therapies Kymriah and Yescarta, the US Centers for Medicare and Medicaid services (CMS) said.

Medicare, the federal government’s health plan for over-65s has said it will cover the FDA approved CAR-T therapies Kymriah and Yescarta when provided in healthcare facilities that have programmes in place to track patient outcomes, known as REMS.

Gilead's PrEP drug Descovy should be approved for men and transgender women but not cis-gender women, FDA advisory panel says

Independent experts on a panel advising the FDA have voted in favour of Gilead’s new PrEP drug Descovy in men and transgender women who have sex with men.

However the panel voted against expanding Descovy’s label to cover the drug as a preventative treatment for cis-gendered women.

Descovy which is a combination of emtricitabine and tenofovir alafenamide, is currently approved as a treatment for chronic HIV.

California drugmaker Gilead are now seeking approval for the drug as a means of reducing the risk of contracting of HIV.

Gilead buys Novartis' herpes, flu and cold virus preclinical programmes

Gilead has acquired the rights to three of Novartis’ preclinical antiviral programmes, including investigational compounds with the potential to treat influenza, herpes and human rhinovirus, the virus that causes the common cold.

The deal will see Gilead acquire the exclusive global rights to develop and commercialise novel small molecules against the three undisclosed targets.

The deal will see Novartis receive an upfront payment of an undisclosed amount and up to $291 million in milestone payments on reaching commercial and developmental milestones.

Gilead invests $5.1 billion into Galapagos NV

Gilead has entered into a 10 year partnership with Belgo-Dutch biotech Galapagos NV.

The collaboration will see Gilead invest $5.1 billion in Galapagos. The deal will give Gilead access to Galapagos’ portfolio which includes six molecules in clinical trials, 20 preclinical programmes and a proven drug discovery platform.

Gilead will pay Galapagos $3.95 billion upfront and a further $1.1 billion equity investment which Galapagos will use to expand and accelerate its research and development programmes.

ViiV Healthcare's two drug HIV therapy beats Gilead's three drug treatment in Phase 3 trial

Pfizer and GlaxoSmithKline’s HIV company, ViiV Healthcare, has said its two-drug combo Dovato (dolutegravir and lamuvidine) met its primary endpoint of maintaining viral suppression for 48 weeks in patients who had switched from a three drug cocktail made by Gilead.

Dovato proved successful in supressing HIV for 48 weeks in patients who had previously maintained viral suppression on Gilead’s TAF-containing regimen. Additionally, ViiV said patients did not develop resistance to Dovato.

US Government awarded new patent on preventative HIV drugs PrEP

The Department of Health and Human Services (HHS) has been awarded a new patent on drugs that prevent HIV.

The US Patent office has awarded the US government a patent on drugs derived from HIV drug Tenofovir that inhibit the transmission of HIV.

The new patent may reignite a dispute between the government and PrEP drugmaker Gilead over the rights to PrEP drug Truvada and its successor Descovy.

In May 2019, campaigners called on the government to enforce the CDC’s patents on the use of Truvada as a preventative treatment for HIV.

Gilead signs deal with Nurix Therapeutics worth more than $2.3 billion

Gilead has signed a deal with San Francisco biotech Nurix Therapeutics – a company focused on developing drugs that control levels of the enzyme ubiquitin E3 ligases which are responsible for the breakdown of proteins in human cells.

Dysregulated and/or mutated proteins play a central role in the development and progression of many human diseases. It is hoped that by controlling protein levels Nurix’s technologies will be able to tackle cancer and other challenging diseases.

Gilead inks deal with Canadian antibody discovery firm AbCellera

Gilead has entered into an agreement with Canadian monoclonal antibody discovery firm AbCellera.

The two firms will take part in a cross border collaboration to support the discovery of new therapeutic antibody candidates for infectious diseases.

Under the terms of the agreement AbCellera will receive upfront and research payments and is eligible to receive downstream clinical and commercial milestone payments and royalties on net sales of products.

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