Covid-19 roundup: Eli Lil­ly's RA drug gets so­lo OK from FDA; Emer­gent gets green­light to re­sume man­u­fac­tur­ing at Bayview site

The FDA late Wednes­day ex­tend­ed the EUA for Eli Lil­ly’s rheuma­toid arthri­tis drug Olu­mi­ant (baric­i­tinib) to be used as a so­lo treat­ment for Covid-19 in hos­pi­tal­ized adults and pe­di­atric pa­tients who need sup­ple­men­tal oxy­gen.

The oral drug was pre­vi­ous­ly cleared in con­junc­tion with Gilead’s remde­sivir to treat those hos­pi­tal­ized with Covid-19.

In a Phase III study re­port­ed in April, Olu­mi­ant did not meet its pri­ma­ry end­point. The drug failed to reach sta­tis­ti­cal sig­nif­i­cance for the dif­fer­ence in rate of pa­tients need­ing non-in­va­sive or in­va­sive ven­ti­la­tion for the first time, or those who died af­ter 4 weeks. But FDA said that the re­vised EUA for baric­i­tinib was sup­port­ed by da­ta from that study, which showed a re­duc­tion in the pro­por­tion of pa­tients who died af­ter 4 weeks of fol­low-up com­pared to pa­tients treat­ed with the stan­dard of care alone.

In May, Eli Lil­ly ex­pand­ed its drug li­cense with three gener­ic drug­mak­ers out of In­dia, in an ef­fort to curb the coun­try’s sec­ond wave of Covid cas­es. Baric­i­tinib was grant­ed emer­gency use ap­proval in In­dia for the treat­ment of adult pa­tients who need oxy­gen and are hos­pi­tal­ized.

Emer­gent re­sumes man­u­fac­tur­ing at Bayview site

Rough­ly three months af­ter man­u­fac­tur­ing at Emer­gent BioSo­lu­tions’ Bal­ti­more Bayview plant was halt­ed, the FDA has giv­en the com­pa­ny the go-ahead to re­sume pro­duc­tion.

The pro­duc­tion of J&J’s Covid-19 vac­cine will re­sume — af­ter the site shut down fol­low­ing a con­t­a­m­i­na­tion in­ci­dent that re­sult­ed in the dis­card­ing of mil­lions of Covid-19 dos­es. A batch of drug sub­stances in­tend­ed for the As­traZeneca vac­cine came in close prox­im­i­ty with a J&J batch, con­t­a­m­i­nat­ing it.

“The Amer­i­can peo­ple should have high ex­pec­ta­tions of the part­ners its gov­ern­ment choos­es to help pre­pare them for dis­as­ter, and we have even high­er ex­pec­ta­tions of our­selves,” Emer­gent CEO Bob Kramer said in a state­ment. “We have fall­en short of those lofty am­bi­tions over the past few months but re­sump­tion of man­u­fac­tur­ing is a key mile­stone and we are grate­ful for the op­por­tu­ni­ty to help bring this glob­al pan­dem­ic to an end. We’d like to thank our gov­ern­ment part­ners as well as John­son & John­son for their sup­port.”

De­mand for J&J’s sin­gle-dose jab has waned in the US re­cent­ly, but it re­mains a vi­able op­tion for coun­tries over­seas that are lack­ing ad­e­quate dos­es, par­tic­u­lar­ly those try­ing to in­oc­u­late peo­ple in rur­al ar­eas.

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

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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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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

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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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.

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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