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WHO launches "historic" multinational study to investigate most promising COVID-19 therapies

Image credit: Leif Jørgensen / CC BY-SA (https://creativecommons.org/licenses/by-sa/4.0)

The World Health Organization continues to push forward in the global fight against the novel coronavirus, and has announced the enrolment of the first patients in a set of “historic” multinational clinical trials to investigate four of the most promising therapies against the pathogen.

The first participants were recruited in Norway and Spain, with further patients due to join the study. The trials, known collectively as SOLIDARITY, aim to build a base of clinical evidence for what have been touted as some of the most promising treatments against the disease.

Gilead asks FDA to rescind its Orphan Drug status for potential coronavirus treatment following criticism

Photo by Gage Skidmore

Gilead Sciences has submitted a request for the FDA to rescind its offer of Orphan Drug designation for remdesivir in treating coronavirus, after a huge public backlash.

COVID-19: Gilead freezes compassionate access to remdesivir due to "overwhelming demand", BMS and Lilly delay new study launches

As national governments continue to ramp up measures to contain the ongoing COVID-19 coronavirus outbreak, so too are pharma and biotech organisations in the race to find a working treatment for the disease.  

Gilead has emerged at the front of the pack with its antiviral therapy remdesivir, which is currently proceeding through two late-stage clinical trials. But as a result of tentative success the drug has shown, the company has said it is facing “overwhelming demand” of compassionate use requests to receive the treatment.

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.”

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