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Gilead halts COVID-19 remdesivir trial due to enrolment issues, efficacy of the drug uncertain

A clinical trial in China investigating Gilead’s antiviral therapy remdesivir as a potential treatment for COVID-19 has been placed on hold after it failed to enrol an adequate number of participants, sending the company’s shares down by 3%.

The Phase 3 trial sought to determine the drug’s efficacy in mild to moderate cases of COVID-19 in hospitalised patients, with time to clinical recovery being the primary measure of success. It was thought that the drug could provide more benefit in this patient population than in more severe cases.

Judge increases the amount of damages Gilead owes Bristol-Myers Squibb in CAR-T legal dispute

Photo by A4

A judge has ruled that Gilead Sciences owe Bristol-Myers Squibb (BMS) additional funds after infringing on one of the company's patents.

In December, a California jury decided to award Bristol-Myers Squibb $752 million regarding Gilead’s CAR-T treatment Yescarta. Gilead had acquired Kite Pharma in 2017 to gain Yescarta, and Bristol-Myers Squibb alleged the treatment's development was based on a patent owned by Juno therapeutics, that BMS acquired in 2018.

Gilead's promising COVID-19 drug remdesivir shows benefit in 68% of hospitalised patients

Gilead has provided an update on its ongoing efforts against the novel coronavirus, revealing data from a cohort analysis of its antiviral therapy remdesivir, one of the most promising treatments for patients hospitalised by COVID-19.

The findings, published in The New England Journal of Medicine, were drawn from 53 participants hospitalised due to severe complications with COVID-19, 34 of which were being treated with mechanical ventilation at baseline, including four patients who were also receiving extracorporeal membrane oxygenation.

Second Genome to help drive development of Gilead therapies in potential $1.5bn deal

Gilead and microbiome science specialist Second Genome have announced they are to partner up to advance a selection of the former’s therapeutics in a deal worth a potential $1.5 billion.

As part of the four-year collaboration, Second Genome will use its proprietary Microbiome Analytics Platform to identify biomarkers which can drive clinical response in up to five of Gilead’s investigational products in inflammation, fibrosis and other conditions.

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.

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