Ugur Sahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

CEO Ugur Sahin: BioN­Tech and Pfiz­er will file for a Covid-19 vac­cine EUA on Fri­day

The first ap­pli­ca­tion for a Covid-19 vac­cine will reach the FDA’s desk to­mor­row.

BioN­Tech CEO Ugur Sahin told CNN Wednes­day that they and Pfiz­er plan to file for an emer­gency use au­tho­riza­tion for their joint­ly de­vel­oped vac­cine on Fri­day. The two com­pa­nies said that the sub­mis­sion could come “with­in days” af­ter they an­nounced their fi­nal ef­fi­ca­cy re­sults yes­ter­day, but they had not giv­en an ex­act date.

The EUA sub­mis­sion will come less than 11 months af­ter sci­en­tists be­came aware of the ex­is­tence of the virus now known as SARS-CoV-2, mark­ing by sev­er­al years the fastest a vac­cine has ever gone from de­sign to reg­u­la­to­ry re­view. The ef­fi­ca­cy re­sults Pfiz­er showed this week sug­gest­ed the vac­cine was 95% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19.

Pe­ter Marks, head of the agency’s vac­cine and bi­o­log­ics di­vi­sion, told Busi­ness In­sid­er this week that, once a sub­mis­sion is in, the EUA process will like­ly take “weeks.” The FDA’s in­ter­nal re­view­ers will pour over da­ta from the ap­pli­ca­tion and then send it to their ad­vi­so­ry com­mit­tee to pub­licly de­bate, ques­tion and pro­vide a rec­om­men­da­tion for or against au­tho­riza­tion.

Mon­cef Slaoui, the sci­en­tif­ic head of Op­er­a­tion Warp Speed, pre­dict­ed that an au­tho­riza­tion would come in mid-De­cem­ber. FDA re­view­ers have re­port­ed­ly been told to set aside Dec. 8 through Dec. 10 on their cal­en­dars for hear­ings on the vac­cine.

Mod­er­na, which al­so showed around 95% ef­fi­ca­cy in the first look at their Phase II read­out, is al­so ex­pect­ed to file im­mi­nent­ly for FDA au­tho­riza­tion af­ter they re­lease their fi­nal re­sults. Both Slaoui and Mod­er­na CEO Stéphane Ban­cel said an FDA ad­vi­so­ry hear­ing could cov­er both Mod­er­na and Pfiz­er’s vac­cine.

In ad­di­tion to be­ing the first Covid-19 vac­cine to reach reg­u­la­tors, the Pfiz­er and Mod­er­na can­di­dates will al­so be the first mR­NA vac­cines or ther­a­peu­tics to go be­fore the agency.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Re­gen­eron halts place­bo en­roll­ment in Covid-19 cock­tail tri­al af­ter IDMC finds 'clear' ef­fi­ca­cy — but there are no da­ta yet

Despite having already received an emergency use authorization for its Covid-19 antibody in non-hospitalized patients last November, Regeneron continued to conduct trials to evaluate the cocktail’s effectiveness. Now, the big biotech has received some good news from their IDMC.

On the IDMC’s recommendation, Regeneron will be shutting down enrollment in the placebo group of a Phase III outpatient trial for their REGN-COV program — a mix of casirivimab with imdevimab — after investigators found “clear clinical efficacy” in both doses compared to the control, the company announced Thursday. CSO George Yancopoulos also said in a statement that the cocktail can neutralize emerging strains of the novel coronavirus.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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FDA re­view­ers en­dorse J&J sin­gle-dose shot, lay­ing path for 3rd US vac­cine

J&J’s single-dose vaccine may not have produced quite the stellar numbers of the mRNA shots, but it still won a ringing endorsement from FDA reviewers, who argued in briefing documents that it could provide robust protection against the still-raging virus.

The FDA confirmed that across just under 40,000 volunteers, the vaccine proved 66% effective at preventing symptomatic Covid-19, including 72% effective in the United States. Although that’s short of the 95% figures put up by Moderna and Pfizer-BioNTech, the shot was still 85% effective at stopping severe disease 28 days after administration. There were seven deaths in the placebo group — zero in the vaccine group.

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