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Jean-Pierre Sommadossi, Atea president and CEO (file photo)

Roche wades deep­er in­to Covid-19 fight, ink­ing an­tivi­ral pact with $350M cash fol­low­ing Re­gen­eron deal

Roche is making its first bet on an antiviral against Covid-19 in style, shelling out $350 million in cash to grab ex-US rights.

The drug comes from Atea Pharmaceuticals, the 7-year-old biotech created by Pharmasset co-founder Jean-Pierre Sommadossi, which essentially rebranded itself as a Covid-19 fighter in May when it closed a whopping $215 million venture round. Over a dozen investors bought in, including marquee names like Bain Capital and RA Capital.

UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a source familiar with the matter saying that the trial would have been suspended had the volunteer been given the experimental Covid-19 vaccine, implying that they were part of the placebo arm.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US vac­cine tri­als

It may have come a day late, but the FDA has finally posted the discussion items that its outside experts will review during tomorrow’s adcomm on the new wave of Covid-19 vaccines now in the clinic.

There are no specific vaccines or data to discuss. Instead, the agency wants feedback on its overall approach. And they’re willing to go late into the evening to get it.

Here’s the rundown:

1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the respective guidance documents.

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President Trump and Anthony Fauci (Yuri Gripas/Abaca/Sipa via AP Images)

Covid-19 roundup: Stéphane Ban­cel sees De­cem­ber EUA for Mod­er­na at ear­li­est; Trump trash­es Fau­ci as 'dis­as­ter' and 'id­iot'

Stéphane Bancel’s new estimated timeline for Moderna’s Covid-19 vaccine puts his company on track to score an emergency use authorization in December — given the interim Phase results turn out positive in November.

Per the trial protocol, the first interim analysis of the Moderna vaccine’s efficacy will happen when 53 people in the entire study, which is enrolling 30,000 volunteers, get symptomatic disease. The data safety monitoring board would then review the unblinded results and check the breakdown between the vaccinated and those given placebo.

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Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today a £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers who are intentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

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Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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FDA of­fi­cials, ex­perts dis­cuss im­pact of Covid-19 on cell and gene ther­a­pies

While the FDA is still receiving investigational new drug applications (INDs) for cell and gene therapies, officials are concerned about the impact of the Covid-19 pandemic on clinical trials.

“It’s clear that COVID-19 has adversely affected all aspects of development of cell and gene therapies,” said CBER director Peter Marks at the Alliance for Regenerative Medicine’s Meeting on the Mesa. “For some of the studies that are ongoing there are some real challenges to overcome in terms of endpoints that may have been missed.”

Chris Christie has recovered after testing positive for Covid-19 (AP Images)

Covid-19 roundup: Can Ab­b­Vie’s dis­ap­point­ing NASH drug ceni­crivi­roc find suc­cess fight­ing cy­tokine storms?; Trump al­ly Chris Christie says he re­ceived Lil­ly's an­ti­body cock­tail

After getting passed down the line to AbbVie through a couple of biotech buyouts, the pharma giant is now in line to see if their drug cenicriviroc can score a success in the global war against Covid-19.

The NIH has selected this drug — which has proven underwhelming as a NASH-targeted therapy — as one of 3 it will test in a new adaptive study dubbed ACTIV-1 Immune Modulators, which is looking for new ways to fight off the cytokine storms that kill some patients.

Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

The prospect of an Oc­to­ber OK large­ly closed, Pfiz­er's Al­bert Bourla promis­es not to sub­mit for EUA un­til No­vem­ber

For weeks in late summer and early fall, Pfizer CEO Albert Bourla insisted they would likely know whether their vaccine works by the end of October and then “immediately” submit for an FDA OK, fueling concerns that President Trump could push through a politically motivated EUA on the eve of Election Day. But now, in the latest of a series of moves that appeared designed to distance his company from a potential political maelstrom, Bourla has made clear they won’t go to regulators for about another month.

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