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?

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”