President Biden (Oliver Contreras/Sipa USA/Sipa via AP Images)

Biden looks for $9B+ in new Covid funds as Sen­ate pass­es res­o­lu­tion to end emer­gency de­c­la­ra­tion

The lame duck ses­sion is here and the Biden ad­min­is­tra­tion yes­ter­day asked Con­gress for $9.25 bil­lion in new Covid-19 fund­ing for vac­cines, treat­ments and tests even as Pres­i­dent Biden’s Covid-19 co­or­di­na­tor said ear­li­er this week that this win­ter like­ly won’t come with a big surge of new in­fec­tions.

Re­pub­li­cans have spurned three pre­vi­ous re­quests by this ad­min­is­tra­tion for emer­gency Covid funds. The new funds would help to cre­ate Op­er­a­tion Warp Speed 2.0, dubbed “Pro­ject Covid Shield,” that would help to de­vel­op next-gen vac­cines and treat­ments as three vari­ants — BA. 5, BQ.1.1 and B.Q.1 — make up more than 70% of US in­fec­tions, ac­cord­ing to the CDC. Biden is al­so call­ing for more funds for the glob­al Covid fight, in ad­di­tion to $750 mil­lion to fight HIV, he­pati­tis C and mon­key­pox.

Ashish Jha

And de­spite Ashish Jha’s com­ments at a STAT event sig­nal­ing an in­com­ing surge of cas­es is un­like­ly, the White House said yes­ter­day that it needs these ad­di­tion­al re­sources to en­sure ad­e­quate sup­plies and “to help pre­pare for a pos­si­ble win­ter surge,” as well as to “smooth the path to com­mer­cial­iza­tion for vac­cines and ther­a­peu­tics, ac­cel­er­ate re­search and treat­ment for long COVID, and de­vel­op next-gen­er­a­tion vac­cines and treat­ments.”

The first wave of BAR­DA and fed­er­al fund­ing un­der Warp Speed went to at least nine dif­fer­ent vac­cines and ther­a­peu­tics that lat­er be­came some of the biggest block­buster med­ical prod­ucts of all time.

The US still has am­ple sup­plies of a hand­ful of treat­ments, in­clud­ing Pfiz­er’s Covid pill Paxlovid, Gilead’s an­tivi­ral Vek­lury, as well as Mer­ck’s pill Lagevrio, As­traZeneca’s Evusheld and Eli Lil­ly’s bebtelovimab. AS­PR said ear­li­er this month that Paxlovid, Vek­lury and Lagevrio are ex­pect­ed to re­tain ac­tiv­i­ty cir­cu­lat­ing vari­ants, in­clud­ing BQ.1 and BQ.1.1.

Biden and De­moc­rats have un­til Dec. 16 to get the new funds passed, just as Re­pub­li­cans have re­it­er­at­ed their strong op­po­si­tion to new Covid-19 funds.

The Sen­ate yes­ter­day passed a joint res­o­lu­tion that Re­pub­li­cans put for­ward to ter­mi­nate the emer­gency de­c­la­ra­tion for Covid-19.

Sen. Roger Mar­shall (R-KS), who in­tro­duced the res­o­lu­tion, praised the pas­sage of it and called out Pres­i­dent Biden’s “60 Min­utes” in­ter­view com­ment that the pan­dem­ic was “over.”

“Yet de­spite all the ad­vances we’ve made in our fight against the virus and the vic­to­ri­ous de­c­la­ra­tion by our Chief Ex­ec­u­tive, this ad­min­is­tra­tion in­sists the na­tion­al emer­gency de­c­la­ra­tion re­main in place,” Mar­shall said.

The Biden ad­min­is­tra­tion said it would ve­to the res­o­lu­tion, not­ing in a state­ment of pol­i­cy yes­ter­day:

The na­tion­al emer­gency en­ables the Ad­min­is­tra­tion to more ef­fec­tive­ly re­spond to COVID-19, in­clud­ing en­sur­ing that nec­es­sary sup­plies are prompt­ly avail­able to re­spond to the virus and fa­cil­i­tat­ing the de­liv­ery of health care at a time when our health sys­tem has been un­der tremen­dous and pro­longed stress.

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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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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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.

Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

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Days af­ter re­port­ing PhI­II fail­ure, GSK pulls BC­MA drug from US mar­ket — but it's not giv­ing up en­tire­ly yet

GSK is pulling its BCMA-targeting drug from the US market, ending a short, two-year run for a high-profile product that, among other things, was hailed for marking the pharma giant’s return to oncology.

The company is initiating the process for withdrawal at the request of the FDA, which in turn was based on the negative readout of a confirmatory Phase III trial earlier this month. In that trial, GSK’s Blenrep failed to extend progression-free survival over standard of care for patients with multiple myeloma who have received at least two prior lines of therapy.

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