In his lat­est broad­side on drug prices, Trump plays the Medicare ne­go­ti­a­tions card

Don­ald Trump plans to use the mas­sive lever­age of Medicare and Med­ic­aid spend­ing as a tool to rein in prices — a tac­tic that has long been feared by bio­phar­ma.

In an in­ter­view late Sat­ur­day with the Wash­ing­ton Post, the pres­i­dent-elect al­so said he was putting the fi­nal touch­es to a new “in­sur­ance for every­one” plan to re­place Oba­macare, though he de­clined to pro­vide specifics.

Trump set off a 5-alarm in­dus­try­wide fire alert last week when he in­sist­ed dur­ing an im­promp­tu di­a­tribe dur­ing his press con­fer­ence that phar­ma com­pa­nies had been “get­ting away with mur­der” on drug prices, which he vowed to end once he gets in of­fice in a few days. In the most re­cent in­ter­view, he piled on the bio­phar­ma in­dus­try, in­sist­ing that low­er­ing drug prices was cen­tral to mod­er­at­ing the price of health­care and the in­sur­ance need­ed to cov­er care.

“They’re po­lit­i­cal­ly pro­tect­ed, but not any­more,” he told the Post about phar­ma, adding lat­er that he was un­con­cerned about the po­ten­tial dis­rup­tion in stock prices. And that’s a com­ment that could weigh heav­i­ly on stocks as an­a­lysts pon­der the im­pact.

While Trump touched on di­rect Medicare ne­go­ti­a­tions dur­ing the elec­tion, many of the most in­flu­en­tial lead­ers of the in­dus­try had thought that they were in a still cozy spot with the in­com­ing ad­min­is­tra­tion, with time to pur­sue a ne­go­ti­at­ed peace af­ter brand­ed drug prices had es­ca­lat­ed rapid­ly in re­cent years. In­stead, phar­ma ex­ecs find them­selves pil­lo­ried by a soon-to-be-pres­i­dent as he spurs pop­ulist wrath in fa­vor of con­tro­ver­sial changes to health­care pol­i­cy.

That be­came clear dur­ing his re­cent press con­fer­ence:

“Our drug in­dus­try has been dis­as­trous. They’re leav­ing left and right. They sup­ply our drugs but they don’t make them here, to a large ex­tent. And the oth­er thing we have to do is cre­ate new bid­ding pro­ce­dures for the drug in­dus­try. They’re get­ting away with mur­der. Phar­ma has a lot of…lob­by­ists and a lot of pow­er and there’s very lit­tle bid­ding on drugs.

“We’re the largest buy­er of drugs in the world, and yet we don’t bid prop­er­ly. We’re go­ing to start bid­ding. We’re go­ing to save bil­lions of dol­lars over a pe­ri­od of time.”

Trump has a habit of speak­ing off the cuff, which can lead to some con­sid­er­able con­fu­sion. The main thrust of that com­ment was that he was fo­cus­ing on low­er­ing the price of meds, rather than tar­get­ing the glob­al drug man­u­fac­tur­ing net­work or ac­tu­al­ly es­tab­lish­ing a tra­di­tion­al kind of bid­ding mech­a­nism for fed­er­al con­tracts. In the Post in­ter­view, though, Trump al­so said that he want­ed to see more drug man­u­fac­tur­ing in the US. And he seemed pre­pare to un­cork his Twit­ter guns to help make that hap­pen.

Medicare has been pre­vent­ed by law — or, per­haps more ac­cu­rate­ly, at the in­sis­tence of law­mak­ers — that it not ne­go­ti­ate di­rect­ly on the price of a drug, though fed­er­al ben­e­fit man­agers do that on their own ac­cord. Those net prices, though, are not pub­lic.

If Medicare does di­rect­ly ne­go­ti­ate deep dis­counts, with per­haps the great­est lever­age among all buy­ers, it could well set up a trans­par­ent base­line on drug prices that every­one could work with, while al­so dri­ving new ini­tia­tives pre­vent­ing state gov­ern­ments from pay­ing more. And that could well wind up cost­ing drug man­u­fac­tur­ers dear­ly, far more than the sin­gle dig­it an­nu­al hikes many had hoped to use as a com­pro­mise for re­spon­si­ble pric­ing prac­tices.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,700+ biopharma pros reading Endpoints daily — and it's free.

Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,700+ biopharma pros reading Endpoints daily — and it's free.

Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.

Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,700+ biopharma pros reading Endpoints daily — and it's free.

Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,700+ biopharma pros reading Endpoints daily — and it's free.

George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,700+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: Nestlé whips up re­search col­lab­o­ra­tion with new­ly-un­veiled Flag­ship up­start; Mar­i­anne De Backer joins Kro­nos board

Flagship Pioneering tapped into a variety of trendy R&D themes when it officially debuted Senda Biosciences a few months ago, most prominently its focus on the microbiome, computational biology and cellular interactions. And while it’s all still in its infancy, the founders clearly elicited some high-profile attention from a major player which straddles the line between food and medicine.

Nestlé Health Science has partnered with Senda on one of its initial slate of R&D focuses, aligning itself with the biotech on metabolics, with a focus on some big targets, including obesity and glycemia.