Pfiz­er and BioN­Tech roll out new da­ta for their bi­va­lent boost­er against new­er Omi­cron vari­ants

As Pfiz­er and BioN­Tech tout the ef­fec­tive­ness of their bi­va­lent boost­er against Omi­cron vari­ants such as BA.4 and BA.5, more Covid-19 vari­ants have been creep­ing up on the gen­er­al pub­lic. Now the part­ners are lift­ing the cov­er on new da­ta show­ing its ef­fec­tive­ness against the new­er vari­ants of the virus.

On Fri­day, Pfiz­er and BioN­Tech re­port­ed new re­sults an­a­lyz­ing the im­mune re­sponse in­duced by the bi­va­lent Covid-19 vac­cine against the new­er “sub­lin­eages” in­clud­ing BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1, with Pfiz­er and BioN­Tech stat­ing that the vac­cine “elic­its a greater in­crease in neu­tral­iz­ing an­ti­body titers” than the orig­i­nal vac­cine against these sub­lin­eages and pro­vid­ing over­all pro­tec­tion.

The da­ta, which were post­ed to bioRx­iv, shows that af­ter a dose of the BA.4/BA.5 bi­va­lent vac­cine, the neu­tral­iz­ing an­ti­bod­ies against BA.4.6 in­creased 11.1-fold, with BA.2.75.2, BQ1.1 and XBB.1 see­ing in­creas­es of 6.7, 8.7 and 4.8 re­spec­tive­ly. The pro­tec­tion with the orig­i­nal vac­cine was sub­stan­tial­ly weak­er, with on­ly a 2.3-fold in­crease of an­ti­bod­ies that can neu­tral­ize BA.4.6, for ex­am­ple.

This comes on the heels of the bi­va­lent boost­er show­ing a 13-fold in­crease to the BA.4/BA.5 vari­ants, as well as get­ting EUA from the US FDA for ages 5 years and old­er.

So far, close to 22.7 mil­lion dos­es of the Pfiz­er/BioN­Tech bi­va­lent vac­cine have been ad­min­is­tered, ac­cord­ing to CDC da­ta.

The da­ta that Pfiz­er and BioN­Tech have rolled out, come at a time when its vac­cine com­peti­tor, Mod­er­na, al­so took the lid off clin­i­cal da­ta for its bi­va­lent boost­er against ear­li­er strains. Mod­er­na’s boost­er had met its 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.

Pfiz­er and BioN­Tech do not plan on stop­ping there. On Thurs­day, the com­pa­nies an­nounced that they have start­ed an es­ti­mat­ed 180-per­son Phase I tri­al of a new pan-vari­ant Covid vac­cine com­bined with their Omi­cron-spe­cif­ic boost­er. The hope is that a longer-last­ing and more ef­fec­tive shot can be pro­duced. And, un­like the ver­sions of the mR­NA-based vac­cines, the new vac­cine doesn’t en­code for the virus’ hall­mark spike pro­tein, in­stead trig­ger­ing pro­duc­tion of oth­er vi­ral pro­teins that the vari­ants have in com­mon and that rarely mu­tate.

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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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.

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.