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.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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