Lob­by­ing cam­paign killed pro­pos­al to set price lim­its on fu­ture coro­n­avirus drugs, vac­cines — re­port

As Con­gress be­gan draft­ing the emer­gency, $8.3 bil­lion spend­ing bill to com­bat the coro­n­avirus out­break, De­moc­rats sought to wrap a string around some of that fund­ing.

With $3.1 bil­lion go­ing to sup­port phar­ma­ceu­ti­cal com­pa­nies in their R&D ef­forts against the out­break, pro­gres­sive law­mak­ers want­ed to en­sure that any drugs or vac­cines that emerged from those ef­forts would be priced af­ford­ably, Politi­co re­ports. That cam­paign failed.

The bill Con­gress passed Thurs­day and which now awaits a sig­na­ture from Pres­i­dent Trump on­ly re­it­er­ates ex­ist­ing leg­is­la­tion cov­er­ing fed­er­al ac­qui­si­tions. Pro­gres­sives ini­tial­ly cir­cu­lat­ed lan­guage that would have giv­en the De­part­ment of Health and Hu­man Ser­vices the pow­er to strip in­tel­lec­tu­al prop­er­ty from com­pa­nies that priced their drugs too high. Re­pub­li­cans told Politi­co that De­moc­rats al­so pushed to al­low HHS to set prices and lim­it in­creas­es to the rate of in­fla­tion.

In­stead, af­ter a lob­by­ing cam­paign and suc­cess­ful ef­forts by Re­pub­li­cans, the bill goes the oth­er di­rec­tion. It dic­tates that al­though HHS may take steps to as­sure af­ford­abil­i­ty, It “shall not take ac­tions that de­lay the de­vel­op­ment” of a vac­cine or a drug, tak­ing away a key po­ten­tial point of lever­age.

The De­moc­rats’ pro­pos­al comes af­ter years of rhetoric from the left and from the Trump White House on the need to lim­it drug prices to as­sure greater ac­cess, in­clud­ing a re­cent House bill that would give the fed­er­al gov­ern­ment un­prece­dent­ed abil­i­ty to ne­go­ti­ate costs.

The lan­guage De­moc­rats re­port­ed­ly of­fered this past week, though, is not with­out prece­dent. From 1989 to 1995, the NIH had the abil­i­ty to re­quire “rea­son­able prices” on drugs that were built on dis­cov­er­ies fund­ed by the agency. The law was passed in the wake of a dif­fer­ent out­break, the AIDS epi­dem­ic, when the first se­mi-ef­fec­tive drug AZT — large­ly de­vel­oped through fed­er­al grants — was priced by a com­pa­ny at $8,000 to $10,000 a year.

By 1995, though, NIH di­rec­tor Harold Var­mus was help­ing spear­head an ef­fort to re­peal the law, say­ing it had dis­cour­aged pri­vate com­pa­nies from work­ing with the NIH and its sci­en­tists.

Stéphane Ban­cel

Some of the biotechs and phar­ma com­pa­nies lead­ing the re­sponse have an­tic­i­pat­ed crit­i­cism over pric­ing. Mod­er­na CEO Stéphane Ban­cel told Busi­ness In­sid­er this week that “there is no world, I think, where we would con­tem­plate to price this high­er than oth­er res­pi­ra­to­ry virus vac­cines.” Among the most ex­pen­sive res­pi­ra­to­ry vac­cines is one for pneu­mo­nia, priced at $800 for 4 shots. Ban­cel said they were un­like­ly to set a cost that high.

Crit­ics of such pro­pos­als ar­gue they lim­it drug com­pa­nies’ in­cen­tives to re­spond to a cri­sis, de­lay­ing the de­vel­op­ment of po­ten­tial­ly life-sav­ing vac­cines and ther­a­peu­tics.

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

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine -- so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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No­var­tis says Kym­ri­ah reach­es pri­ma­ry end­point in new PhII, al­though num­bers still to come

The race to develop CAR-T therapies has died down since Novartis’ Kymriah and Gilead’s Yescarta first crossed the finish line, though Tecartus also recently received approval. But the companies continue to expand their drugs’ applications, with Novartis preparing to conclude a new Phase II.

Interim data announced by the Swiss pharma show that Kymriah met its primary endpoint of complete response rate in treating patients with relapsed or refractory follicular lymphoma, the second-most common form of non-Hodgkin lymphoma. Based on preliminary trial findings, Kymriah had received RMAT designation from the FDA in April for r/r follicular lymphoma.

Scott Gottlieb (Getty Images)

Covid-19 roundup: FDA com­mis­sion­ers call for more ‘con­cert­ed ef­fort’ on con­va­les­cent plas­ma R&D; Re­gen­eron boosts case for an­ti­body cock­tail with new an­i­mal da­ta

Four former FDA commissioners have coalesced around a century-old treatment they believe can give the best weapon against Covid-19: Convalescent plasma.

Writing in The Washington Postformer FDA commissioners Mark McClellan, Margaret Hamburg, Robert Califf and Scott Gottlieb said that while more work needs to be done to prove it’s safe and effective, convalescent plasma was a “promising treatment” that “could help millions of patients with the novel coronavirus both here and abroad.” They warned, though, that for it to become an effective tool in the US’ Covid-19 response, a more “concerted effort” is needed to recruit donors and run trials.