Stéphane Bancel, Moderna CEO (Charles Krupa/AP Images)

Mod­er­na touts 'su­pe­ri­or' an­ti­body lev­els against Omi­cron for au­tho­rized Covid-19 bi­va­lent boost­er

In Sep­tem­ber, Mod­er­na re­ceived FDA emer­gency use au­tho­riza­tion for its BA.4/BA.5-tar­get­ing bi­va­lent boost­er vac­cine, mR­NA-1273.222, based on pre­clin­i­cal da­ta for the shot as well as Phase II/III clin­i­cal tri­al da­ta study­ing a sim­i­lar bi­va­lent boost­er tar­get­ing the Omi­cron BA.1 sub­vari­ant.

Now, the mR­NA biotech says it has pos­i­tive clin­i­cal da­ta on mR­NA-1273.222 it­self to bur­nish the pro­file of the Covid-19 vac­cine.

The boost­er met the pri­ma­ry end­point, in­duc­ing sig­nif­i­cant­ly high­er neu­tral­iz­ing an­ti­body titers against BA.4/BA.5 com­pared to a boost­er dose of mR­NA-1273 — the orig­i­nal Spike­vax vac­cine.

Close to 11.3 mil­lion dos­es of the mR­NA-1273.222 vac­cine have been ad­min­is­tered, ac­cord­ing to CDC da­ta.

Mod­er­na al­so took the chance to high­light fi­nal da­ta on the ear­li­er BA.1-tar­get­ing boost­er, mR­NA-1273.214, which isn’t au­tho­rized as the FDA pri­or­i­tized shots against the preva­lent BA.4/BA.5 strains. Still, it spurred su­pe­ri­or neu­tral­iz­ing titers against mul­ti­ple Omi­cron vari­ants, in­clud­ing BA.4/BA.5, com­pared to mR­NA-1273.

CEO Stéphane Ban­cel high­light­ed how the su­pe­ri­or re­sponse against Omi­cron per­sist­ed for at least three months af­ter the mR­NA-1273.214 boost­er.

As for mR­NA-1273.222, which com­bines both the orig­i­nal strain of SARS-CoV-2 and the BA.4/BA.5 sub­vari­ants of the Omi­cron strain, in­ves­ti­ga­tors tracked a 15.1-fold in­crease in geo­met­ric mean titer (GMT). With sim­i­lar BA.4/BA.5 titers pre-boost­er, the GMT ra­tios for mR­NA-1273.222 ver­sus mR­NA-1273 were 5.11 and 6.29 for par­tic­i­pants with and with­out SARS-CoV-2 in­fec­tion pre-boost­er, re­spec­tive­ly.

In the tri­al, par­tic­i­pants re­ceived mR­NA-1273.222 about 9.5 months af­ter their pri­or vac­ci­na­tion, while those who got mR­NA-1273 got it 4.5 months af­ter their pre­vi­ous shot.

In­ves­ti­ga­tors took sam­ples from about 40 par­tic­i­pants for an ad­di­tion­al ex­plorato­ry analy­sis to mea­sure the boost­ers’ ef­fi­ca­cy against a new vari­ant.

De­spite a 5-fold drop in titers com­pared to BA.4/BA.5, Mod­er­na still re­port­ed “ro­bust” ac­tiv­i­ty.

“Our bi­va­lent boost­ers al­so show, in re­search as­says, neu­tral­iz­ing ac­tiv­i­ty against BQ.1.1, an in­creas­ing­ly dom­i­nant emerg­ing vari­ant, con­firm­ing that up­dat­ed vac­cines have the po­ten­tial to of­fer pro­tec­tion as the virus con­tin­ues to evolve rapid­ly to es­cape our im­mu­ni­ty,” Ban­cel said.

The US gov­ern­ment has a $1.74 bil­lion deal with Mod­er­na in place to pur­chase 66 mil­lion dos­es of mR­NA-1273.222, as well as op­tions to pur­chase up to an­oth­er 234 mil­lion dos­es of vac­cine boost­ers.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.

Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.