Coronavirus channel feed

Pascal Soriot, AstraZeneca CEO (Photo by Chris Jackson/Getty Images)

As­traZeneca picks up suite of new Covid-19 an­ti­bod­ies, shin­ing spot­light on Ox­ford-tied start­up

AstraZeneca is taking another stab at developing antibodies for Covid-19.

Having partnered with Vanderbilt University researchers to develop the long-acting antibody combo now known as Evusheld, AstraZeneca this time is betting on newly-launched RQ Biotechnology, a UK-based outfit with roots at the University of Oxford and medical research charity LifeArc.

The pharma giant swooped in with a $157 million deal — plus royalties — to acquire worldwide licenses to a suite of early-stage antibodies targeting SARS-CoV-2.

Un­per­suad­ed by the da­ta, FDA re­jects cheap, gener­ic SS­RI as a Covid-19 drug

Fluvoxamine, an SSRI already FDA-approved as an OCD treatment, appeared to show some hints of efficacy in Covid-19 too, leading University of Minnesota ID doc David Boulware last December to submit an EUA for it as an outpatient treatment for those testing positive and to prevent the progression to hospitalization.

Almost 6 months later, the FDA said Monday it’s rejecting the cheap generic drug’s Covid-19 EUA as the primary RCT from Brazil, on which the majority of the app rests: “The treatment benefit of fluvoxamine was not persuasive when focusing on clinically meaningful outcomes such as proportion of patients experiencing hospitalizations or hospitalizations and deaths.”

Covid-19 roundup: Synair­gen turns to post-hoc analy­ses af­ter failed drug tri­al; EU ter­mi­nates Val­ne­va vac­cine con­tract

After halting enrollment in an NIH-led Phase II/III study, and failing an earlier Phase III trial, UK-based Synairgen’s Covid-19 drug did show some promise in some select subgroups, the company said in its presentation of a post-hoc analysis on Monday at a conference in San Francisco.

Post-hoc analyses of the Phase III SPRINTER trial, which failed to hit its primary endpoints, showed an “encouraging signal in reduction in the relative risk (RRR) of progression to severe disease or death within 35 days (25.7% reduction in the Intention-to-Treat population and 36.3% reduction in the Per Protocol population).”

Tedros Adhanom Ghebreyesus, WHO Director-General (Salvatore Di Nolfi/Keystone via AP)

Glob­al li­cense pro­gram to re­ceive Covid-19 sup­port from the NIH

A WHO program will see some support from the Biden administration in the fight against Covid-19.

At the second Global Covid-19 Summit, the administration, through the NIH, has decided to officially license 11 Covid-19 research tools and early-stage vaccine and diagnostic candidates. This will be done through the Medicines Patent Pool (MPP), a UN-backed program, through WHO’s Technology Access Pool (C-TAP).

Is Paxlovid, the Covid pill, reach­ing those who most need it? The gov­ern­ment won’t say

As the nation largely abandons mask mandates, physical distancing, and other covid-19 prevention strategies, elected officials and health departments alike are now championing antiviral pills. But the federal government isn’t saying how many people have received these potentially lifesaving drugs or whether they’re being distributed equitably.

Pfizer’s Paxlovid pill, along with Merck’s molnupiravir, are aimed at preventing vulnerable patients with mild or moderate covid from becoming sicker or dying. More than 300 Americans still die from covid every day.

Covid-19 roundup: Can­cer biotech to sub­mit EUA for Covid drug; FDA OKs Eli Lil­ly JAK in­hibitor

As vaccine talk wanes, re-purposed treatments take center stage for Covid-19.

Veru, which started out as a cancer outfit, plans to request an EUA for its drug sabizabulin as a Covid-19 treatment for patients at high risk for acute respiratory distress syndrome (ARDS), it announced today.

Last month, Veru said its Phase III study for its Covid-19 treatment was shut down by an independent data monitoring committee due to the drug’s “overwhelming efficacy.” According to the company, sabizabulin reduced deaths by 55% compared to the standard of care group, which received remdesivir, dexamethasone, antibodies, and JAK inhibitors.

Bob Kramer, Emergent CEO

Emer­gent tossed near­ly 400M Covid-19 vac­cine dos­es in Bal­ti­more de­ba­cle, House re­port says

The exact number of doses lost in the Emergent BioSolutions mishap at its Baltimore plant has never been exactly determined. But a recent report from the US House select subcommittee on the coronavirus crisis says that the company might have destroyed nearly 400 million doses of Covid-19 vaccines after failures to meet quality standards.

The report came to the determination via requests for internal communications between Emergent executives, which the subcommittee alleges included efforts to hide evidence of contamination in “an attempt to evade oversight from government regulators.”

Steve Pearson, ICER president (Jeff Rumans)

ICER: Mer­ck­'s Covid-19 pill does­n't show 'net health ben­e­fit' but price is rea­son­able

The Institute for Clinical and Economic Review, a pharma drug pricing watchdog, recently dug into the data on three Covid-19 therapeutics, voting 11-2 that there is not enough evidence to demonstrate a “net health benefit” for Merck’s pill molnupiravir over symptomatic care of Covid-19 alone. But Pfizer’s Paxlovid and the repurposed generic drug fluvoxamine received more favorable votes.

Stanley Erck, Novavax CEO (Lee Jin-wook/Yonhap via AP Images)

Af­ter rack­ing up 41 Covid jab nods out­side US, No­vavax hits first prof­itable quar­ter but still dis­ap­points in­vestors

About four weeks before FDA’s outside advisors are slated to review Novavax’s Covid-19 jab after a long, federally-funded and winding journey that was all but Warp Speed in the US, Novavax provided an update on its first-quarter results.

It was the first three-month stretch in which the multi-decade-old Maryland biotech was not in the red as a commercial-stage company, after generating $704 million in revenue at a net income of $203 million. The investor reaction was steeply in the red, though, with shares $NVAX down nearly 22% before Tuesday’s opening bell.

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Torsten Mummenbrauer, ExeVir CEO

Scoop: Ex­e­Vir hits pause on lla­ma-de­rived Covid an­ti­body amid Omi­cron vari­ants, shifts fo­cus to sec­ond-gen work

ExeVir has returned to the drawing board after pausing work on its first-generation llama-derived Covid-19 antibody and is turning its R&D focus toward a preclinical second-gen attempt, Endpoints News has learned.

The Belgian biotech terminated a study of the antibody, dubbed XVR011, last month due to “change in company strategy for phase 2 design,” according to an update on clinicaltrials.gov. The biotech still awaits some data to confirm the scope of Omicron and its subvariants’ effect on the antibody, but ExeVir is likely to move forward without its first shot at treating the pandemic disease, CEO Torsten Mummenbrauer told Endpoints.

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