Covid-19 vaccine developers ask the SEC to help keep the secret of how they set prices

‘When the U.S. government awarded over $10 billion in contracts and advance- purchase commitments to drug companies working on COVID-19 vaccine and treatments, it did not require the recipients of government money to agree to offer their products at fair prices or share intellectual property rights to enable faster production.

‘Now, two of the companies awarded those contracts—Pfizer and Johnson & Johnson—are trying to prevent shareholders from voting on resolutions to require the companies to disclose information about the impact of government funding on vaccine access...

‘The shareholder resolutions, filed by members of the Interfaith Center on Corporate Responsibility (ICCR), a shareholder activism organization, ask those two companies to inform their shareholders how "receipt of public financial support for development and manufacture of products for COVID-19 is being, or will be, taken into account when making decisions that affect access to such products, such as setting prices." Similar resolutions were also filed at Eli Lilly, Gilead, Merck, and Regeneron.

‘Both Pfizer and Johnson & Johnson filed "no action requests" with the Securities and Exchange Commission (SEC) in December, asking the agency to rule that the companies can withhold the proposals from shareholders. Neither company responded to The Daily Poster requests for comment.’

Read here (Newsweek, Jan 2, 2021)  

WHO study says remdesivir did not cut hospital stay or mortality in Covid-19 patients. Same with hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon

‘Gilead Sciences Inc's GILD.O remdesivir had little or no effect on COVID-19 patients' length of hospital stay or chances of survival, a clinical trial by the World Health Organization (WHO) has found. The antiviral medication, among the first to be used as a treatment for COVID-19, was one of the drugs recently used to treat U.S. President Donald Trump’s coronavirus infection.

‘The results are from WHO’s “Solidarity” trial, which evaluated the effects of four potential drug regimens, including remdesivir, hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir and interferon, in 11,266 adult patients across more than 30 countries. The study found the regimens appeared to have little or no effect on 28-day mortality or the length of the in-hospital course among patients hospitalized with COVID-19, the WHO said on Thursday.’

Read here (Reuters, Oct 16, 2020)

Gilead to start testing an inhaled version of remdesivir, making it available to vastly more patients

‘The biotech giant that developed the first effective coronavirus treatment is now looking to expand its impact. Gilead Sciences CEO Daniel O'Day said Monday that the company would start testing an inhaled version of the antiviral drug remdesivir in August. Currently, the drug is given as an intravenous infusion. If remdesivir is effective when given through a nebulizer, that "could have significant implications in helping to stem the tide of the pandemic," O'Day wrote in an open letter.’

Read here (Business Insider, June 22, 2020)

Government researchers changed metric to measure coronavirus drug remdesivir during clinical trial

‘Government clinical trial investigators changed the primary metric for measuring the success of Gilead’s experimental drug remdesivir as a coronavirus treatment two weeks before Anthony S. Fauci’s announcement that the drug would be the new “standard of care.”

‘Instead of counting how many people taking the drug were kept alive on ventilators or died, among other measures, the National Institute of Allergy and Infectious Diseases said it would judge the drug primarily on a different outcome: how long it took surviving patients to recover.’

Read here (The Washington Post, May 1, 2020)

Dr Anthony Fauci says Gilead’s remdesivir will set a new ‘standard of care’ for coronavirus treatment

• White House health advisor Dr. Anthony Fauci said Wednesday that data from a coronavirus drug trial testing Gilead Sciences’ antiviral drug remdesivir showed “quite good news” and sets a new standard of care for Covid-19 patients.
• Fauci said the median time of recovery for patients taking the drug was 11 days, compared with 15 days in the placebo group. 
• The results suggested a survival benefit, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group, according to a statement from the National Institutes of Health released later Wednesday.

Read here (CNBC, April 29, 2020)

Leaked study data finds no benefits of Remdesivir on coronavirus patients, sending Gilead stock tumbling

‘The World Health Organisation prematurely posted a draft summary of the China-based trial that was seen by STAT News before it was removed, with a WHO spokesperson telling the publication it's still being peer reviewed and finalised.

‘Gilead challenged the results in an emailed statement, however, deeming them "inconclusive" given the clinical trial was ended early resulting in low enrollment, though it noted there were trends suggesting potential benefit for patients who received treatment early.

‘That didn't stop Gilead's stock from diving down 8% to $75.37 a share in the afternoon before recovering slightly to $77.78.’

Read here (Forbes, April 22, 2020)

Dow futures rally 700 points after Gilead drug reported shows effectiveness. There are reservations about the report and clinical trials funded by Gilead

Dow futures rally. Read here (CNBC, April 16, 2020)

‘Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world.

‘The trial is investigating five- and 10-day treatment courses of remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.

‘The lack of a control arm in the study could make interpreting the results more challenging.’

Read here (STAT News, April 16, 2020)

Drugmaker Gilead Sciences funds study on "compassionate use of Remdesivir for patients with severe Covid-19" showing positive results

‘In this cohort of patients hospitalised for severe Covid-19 who were treated with compassionate-use remdesivir, clinical improvement was observed in 36 of 53 patients (68%). Measurement of efficacy will require ongoing randomised, placebo-controlled trials of remdesivir therapy. (Funded by Gilead Sciences.)’

In this short conclusion in its introduction, the paper published by the New England Journal of Medicine, mentions specifically who funded it.

Read here (New England Journal of Medicine, April 10, 2020)