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?

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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