Kamala Harris speaking yesterday at the Des Moines Register Iowa Presidential Candidate Forum [via Getty]

Who’s the tough­est on drug prices? A game of po­lit­i­cal one-up­man­ship is dri­ving the pol­i­cy de­bate in Wash­ing­ton

Ear­li­er this week we got a look at Sen­a­tor Ka­mala Har­ris’ po­si­tion on drug prices. She’s propos­ing that HHS take an av­er­age price from sin­gle-pay­er sys­tems like the UK, Ger­many and Cana­da — which lever­age mar­ket ac­cess for low­er prices — and use that to set the US price. Any­thing drug com­pa­nies col­lect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:

While fam­i­lies strug­gle to make it to the end of the month, phar­ma­ceu­ti­cal com­pa­nies are turn­ing record prof­its. They’re spend­ing near­ly as much on ad­ver­tis­ing as R&D. They’re ma­nip­u­lat­ing their mar­ket pow­er to hike prices on life­sav­ing gener­ic drugs. They’re mak­ing twice the prof­it of the av­er­age in­dus­try in Amer­i­ca and still in­creased drug prices by 10.5% over the past six months alone. Mean­while, they are charg­ing dra­mat­i­cal­ly high­er prices to Amer­i­can con­sumers.

That’s an es­ca­la­tion on Joe Biden’s plan, which in­cludes drug im­por­ta­tion from those cheap­er mar­kets as well as al­low­ing Medicare to ne­go­ti­ate prices — some­thing that vir­tu­al­ly all Dems agree on now.

John Car­roll Cred­it: End­points News, Pharm­Cube

Trump, mean­while, has every­one guess­ing about what he means by a “most fa­vored na­tion” clause, but he’s heaped just about every kind of abuse pos­si­ble on drug com­pa­nies and the prices they charge in the US — rel­a­tive to the rest of the de­vel­oped world. Trump al­so has fo­cused on im­port­ing sin­gle-pay­er drug prices to force the WAC down, and will like­ly make his an­ti-Big Phar­ma cam­paign a big part of the re­elec­tion strat­e­gy, even though the bulk of Re­pub­li­can law­mak­ers in Con­gress may qui­et­ly op­pose any such move.

If the De­moc­rats win, they would be hard put to over­come the kind of op­po­si­tion the Re­pub­li­cans would put up to a cam­paign promise like Har­ris’s. The re­al threat lies in Trump’s abil­i­ty to by­pass the Re­pub­li­cans in Con­gress and work a deal with the De­moc­rats — even though they’re at each oth­er’s throats right now.

Joe Biden tak­ing ques­tions at the Des Moines Reg­is­ter Iowa Pres­i­den­tial Can­di­date Fo­rum on Ju­ly 15, 2019 [via Get­ty]

Click on the im­age to see the full-sized ver­sion

What­ev­er hap­pens, bio­phar­ma will find it­self pil­lo­ried at every cam­paign stop as the can­di­dates pitch in with a pop­u­lar and en­tire­ly bi­par­ti­san pop­ulist theme, shriv­el­ing the in­dus­try’s rep at a time drug hunters are en­joy­ing un­prece­dent­ed suc­cess in gain­ing sub­stan­tial fi­nan­cial back­ing for re­search.

So far, po­lit­i­cal tox­i­c­i­ty has failed to cre­ate much of a head­wind on that score. But there’s a long way to go be­fore the votes are cast in the 2020 elec­tion. And right now the theme in Wash­ing­ton po­lit­i­cal cir­cles is cen­tered on po­lit­i­cal one-up­man­ship — find­ing new ways to ap­pear to be the tough­est on phar­ma, re­gard­less of how that plays with small biotechs.

For now, though, drug pric­ing pow­er in the US re­mains en­tire­ly in the hands of the in­dus­try. And what are they go­ing to do about it?

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.