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?

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

BeiGene and Mus­tang nail down spe­cial FDA sta­tus for top drugs; Roche bags added cov­er­age for Hem­li­bra

→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.

→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.

Trump ad­min­is­tra­tion re­vives bid to get drug list prices on TV ads

The Trump administration is not giving up just yet. On Wednesday, the HHS filed an appeal against a judge’s decision in July to overturn a ruling obligating drug manufacturers to disclose the list price of their therapies in television adverts — hours before it was stipulated to go into effect.

In May, the HHS published a final ruling requiring drugmakers to divulge the wholesale acquisition cost— of a 30-day supply of the drug — in tv ads in a bid to enhance price transparency in the United States. The pharmaceutical industry has vehemently opposed the rule, asserting that list prices are not what a typical patient in the United States pays for treatment — that number is typically determined by the type of (or lack thereof) insurance coverage, deductibles and out-of-pocket costs. Although there is truth to that claim, the move was considered symbolic in the Trump administration’s healthcare agenda to hold drugmakers accountable in a climate where skyrocketing drug prices have incensed Americans on both sides of the aisle.

Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll