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Covid-19 roundup: Ger­many pours near­ly $450M in­to BioN­Tech; As­traZeneca still has­n't re­sumed its vac­cine tri­al in the US

Pfizer CEO Albert Bourla has made a point since the pandemic’s early days of rejecting US assistance for their Covid-19 vaccine, separating them from the rest of the big players and casting the old pharma giant as a dynamic company that could move better and faster alone.

The story, though, for their German biotech partner BioNTech — the company whose mRNA technology is actually behind their vaccine — is a little different. In June, the European Investment Bank gave BioNTech €100 million debt financing to support manufacturing and development.

Covid-19 roundup: Eli Lil­ly de­clares suc­cess on JAK block­er in NIH tri­al; UK gives small biotech a big vac­cine deal

The NIH-led study that gave the world the first positive, randomized remdesivir result has come back with a second one, showing that, when combined with remdesivir, an Eli Lilly molecule can slightly improve on time to recovery over remdesivir alone.

The ACTT-2 trial, a follow-up that began after the remdesivir section was completed, enrolled over 1,000 hospitalized Covid-19 patients and found that those given the antiviral remdesivir plus the Eli Lilly JAK inhibitor baricitinib recovered a median of “approximately one day” sooner than those given remdesivir alone. Similar to the IL-6 inhibitors from Regeneron and Roche — which failed in Phase III trials — baricitinib was designed to tamp down the overactive immune response seen in the later stages of Covid-19.

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AstraZeneca CEO Pascal Soriot (Getty Images)

Six days af­ter a star­tling tri­al halt, As­traZeneca gets a green light to re­sume dos­ing their Ox­ford Covid-19 vac­cine

Six days after an abrupt and startling halt of their late-stage study of the Oxford vaccine for Covid-19, AstraZeneca is back in business. And we also learned on Saturday that Pfizer and BioNTech are boosting the size of their fast-running Phase III, with plans to add 14,000 people to the study to provide a more diverse group to test.

AstraZeneca put out a statement Saturday that UK regulators had offered a green light to start dosing again after concluding that it was safe for volunteers to take it. But the multinational player is not offering any detailed information about the severe adverse event that stopped the study, triggering headlines around the globe.

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Covid-19 roundup: NIH spot­lights blood thin­ners in its next big tri­al; All it took was a pan­dem­ic to get JPM out of SF

After immune modulators and antibodies, blood thinners are the next class of drugs to be put through a Phase III trial organized under the NIH’s ACTIV initiative.

Three different anticoagulants have been named for the master protocol: heparin, aspirin and apixaban. Informed by studies suggesting that many patients who died from Covid-19 have formed unusual blood clots throughout their bodies — including in their smallest blood vessels — the NIH wants to see which therapies are the most effective at preventing or reducing them and thus improving outcomes for patients.

Pas­cal So­ri­ot says 2020 ap­proval still pos­si­ble for As­traZeneca's Covid-19 vac­cine as the world awaits the safe­ty board­'s de­ci­sion

Moderna was the first company to put a vaccine candidate into humans, but for much of the pandemic it was AstraZeneca and their academic partners at Oxford University putting out the most aggressive timelines. They signed deals with the UK promising to supply doses as early as September and Sarah Gilbert, the vaccine’s academic architect, talked, albeit cautiously, about getting efficacy data by that time.

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Ex­clu­sive: Gink­go teams with un­known up­start in hunt for Covid-19 an­ti­body

Ginkgo Bioworks, with its vast warehouses of automated robots and bioreactors, has played a behind-the-scenes role in the anti-Covid fight since the start of the pandemic. They’ve helped produce the mRNA for Moderna’s mRNA vaccine, joined a consortium to help discover and analyze antibodies, and they’ve quietly laid out grand plans to use Illumina machines to test millions of Americans per day.

Anthony Fauci (AP Images)

Covid-19 roundup: Fau­ci re­it­er­ates Oc­to­ber vac­cine OK 'un­like­ly'; Pfiz­er and BioN­Tech re­serve 200M dos­es for EU

Anthony Fauci is doubling down on the message that a vaccine authorization by November 3 is “unlikely,” even if not impossible, joining a growing chorus of government officials who are going against ultra-optimistic timelines from certain developers.

Echoing Moncef Slaoui — the scientific chief of Operation Warp Speed — who sees a low chance of the ongoing Phase III trials reading out before the end of October, Fauci told Judy Woodruff on PBS NewsHour that data that can offer a definitive answer on the leading vaccines’ safety and efficacy are more likely to arrive “by the end of the year.”

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An­a­lysts as­sess fall­out af­ter As­traZeneca halts PhI­II Covid-19 vac­cine dos­ing to probe a pos­si­ble se­ri­ous ad­verse event

Investigators at AstraZeneca have ordered a halt to dosing their closely-watched Covid-19 vaccine in order to probe a potentially severe adverse event — reportedly involving inflammation of the spinal cord — suffered by one of the trial participants.

In a statement out Tuesday evening, a spokesman for the pharma giant told Endpoints News that the study had been put on hold to investigate an illness. Later Tuesday, they sent a revised statement, which noted that the halt is voluntary, not ordered by regulators. It reads:

Phar­ma's bat­tered rep gets a mod­est facelift in the lat­est in­dus­try rat­ings from Gallup — but it's still look­ing pret­ty bad

When the pandemic started up earlier this year, quite a few pharma execs felt it was the perfect opportunity to mend fences with the American people — which had developed a largely contemptuous view of drug makers. Nothing symbolized the industry’s public relations predicament better than the Gallup poll last September, which had pharma bumped to the very bottom of a long list of industries ranked by the public’s opinion.

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Kee Woo-Sung, Celltrion

Cell­tri­on to be­gin mass pro­duc­ing an­ti­body treat­ment be­fore get­ting ap­proval

In the race for something — anything — to rein in the pandemic, Celltrion says it will begin mass-producing its potential Covid-19 antibody treatment this month. The Incheon, South Korea-based company hopes to snag emergency approval shortly thereafter.

The drug has gone through a Phase I trial with 32 volunteers in South Korea, and will be tested in 9 more patients in another Phase I study before advancing to later-stage trials, per a Reuters report. The biotech says it’s going to regulators for emergency approval soon — but could produce about 1 million doses before even getting the green light.