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FDA greenlights Gilead's Epclusa in hepatitis C patients over six years old

Gilead’s Epclusa (sofosbuvir and velpatasvir) has been awarded new marketing approval from the FDA in the treatment of hepatitis C virus (HCV) in children and adult patients, it has been revealed.

The decision is relevant to patients of at least six years of age or those who weigh at least 37 pounds, have any of the six strains of HCV, and have either mild or no cirrhosis. Epclusa adds the approval to its belt alongside an existing FDA approval for HCV in adult patients.

Gilead acquires immuno-oncology firm Forty Seven in $4.9 billion deal

Gilead has revealed it is to acquire the immunology firm Forty Seven in a deal valued at $95.50 per share in cash, which brings the total valuation of the latter company to $4.9 billion.

The deal secured unanimous approval from both companies’ Boards of Directors and is expected to close in the second quarter of the year.

First US coronavirus trial launched into Gilead's remdesivir

The first US clinical trial investigating a treatment for the COVID-19 coronavirus has been launched by the US National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH).

The trial, which is being conducted at the University of Nebraska Medical Center (UNMC), will evaluate the efficacy and safety of Gilead’s antiviral therapy remdesivir in adult patients hospitalised with the coronavirus.

Sanofi’s head of strategy and business development to retire amid company review

One of Sanofi’s most senior strategy bosses is set to retire at the end of the month. Muzammil Mansuri, Executive Vice President of Strategy and Business Development, leaves the company during a strategic review.

Mansuri started out as a research scientist at Shell before moving to Bristol-Meyers. His last role before joining Sanofi in 2016 was the Senior VP of R&D Strategy and Corporate Development at Gilead Sciences.

Gilead's filgotinib combos fall short in lupus and Sjögren’s syndrome

Gilead’s impending regulatory submission of its JAK inhibitor filgotinib to the FDA for the treatment of rheumatoid arthritis has been marred by its failure in mid-stage trials elsewhere, the company has admitted.

Studies investigating the efficacy of combos built on the drug in the treatment of the immune system disorders cutaneous lupus and Sjögren’s syndrome failed to meet their primary endpoints, Gilead execs conceded in a results call.

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.

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