From bombs to bro­mides? Trump’s joust­ing with bio­phar­ma may well boil down to a hand­shake on drug prices

A few months ago, the prospect of an ex­ec­u­tive or­der from Pres­i­dent Don­ald Trump on drug pric­ing would have been the cause of high anx­i­ety in bio­phar­ma. Af­ter all, Trump set­tled in­to the White House loud­ly com­plain­ing of just how bad­ly the drug in­dus­try has been rip­ping off the Amer­i­can pub­lic.

Now there are a va­ri­ety of re­ports that an EO is com­ing — and the in­dus­try could be in for a mid-year boost if in fact Trump does as ex­pect­ed and keeps the di­rec­tive lim­it­ed in scope and im­pact.

Ac­cord­ing to The Hill and a num­ber of an­a­lysts, there isn’t much that Trump can do with the flour­ish of a pen. At the top of the list is val­ue-based pur­chas­ing on the part of the fed­er­al gov­ern­ment. Ap­par­ent­ly what’s off the ta­ble are things like re­quir­ing Medicare to ne­go­ti­ate prices — with a for­mu­la­ry that would threat­en ex­clu­sion to lever­age sig­nif­i­cant dis­counts — or reim­por­ta­tion of cheap drugs from ex-US mar­kets. All that would re­quire Con­gress to pass new laws, which is some­thing that Con­gress is not good at.

Bio­phar­ma has al­ready ea­ger­ly em­braced the val­ue-based pric­ing mod­el, look­ing to work with pay­ers on a pay-for-per­for­mance plan. This process has helped blunt drug prices with­out, well, killing the goose that laid the gold­en egg, so to speak.

The Hill notes that there’s al­so in­ter­est in shoring up IP through new trade poli­cies, which is a gift.

Ever­core ISI’s Umer Raf­fat notes that val­ue-based con­tract­ing may not even be on the ta­ble. In­stead, he’s fo­cus­ing on the po­ten­tial of some low-hang­ing fruit:

•      Co­pay as­sis­tance

•      Greater pass­ing of phar­ma re­bates to the con­sumer

•      Since FDA is ac­tive­ly in­volved, I won­der if some of Scott Got­tlieb’s re­cent ideas on ex­pe­dit­ing com­plex gener­ic ap­provals etc are tout­ed as part of this ex­ec­u­tive or­der

•      Some feed­back out there that 340B hos­pi­tal dis­counts could come un­der pres­sure

All of this would be a ton­ic for a bad­ly rat­tled in­dus­try that found it­self in the un­usu­al po­si­tion of de­fend­ing its pric­ing prac­tices from a se­ries of pres­i­den­tial bomb­shells.

Some re­ports sug­gest an ex­ec­u­tive or­der could come to­day, though Raf­fat doesn’t think it’s like­ly for a few more weeks.

The way this dis­cus­sion is con­tin­u­ing, there’s less and less bite be­hind Trump’s old bark. In the end, the in­dus­try may wind up with a new com­mis­sion­er they large­ly love and some fresh ini­tia­tives that will fun­da­men­tal­ly leave the in­dus­try alone on prices.

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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