Trump to un­veil pro­pos­al to re­duce prices on doc­tor-ad­min­is­tered drugs as midterms loom

Days away from a con­tentious midterm elec­tion bat­tle, the Trump ad­min­is­tra­tion is once again at­tempt­ing to throw its weight at ex­or­bi­tant drug prices, a hot but­ton is­sue the pres­i­dent has long ral­lied against but has so far done lit­tle about.

DC-based POLITI­CO re­port­ed last night that Trump is set to un­veil a pro­pos­al that would make sweep­ing changes to how Medicare pays for some drugs in a speech to the HHS on Thurs­day af­ter­noon, which some see as a ploy to dis­tract away from the Re­pub­li­can agen­da to over­haul Oba­macare.

The scourge of high drug prices has been met with ire on both sides of the aisle, with De­moc­rats lash­ing out at their GOP coun­ter­parts for not us­ing their con­trol of both Con­gress and the ex­ec­u­tive branch to com­pel changes to the free­wheel­ing fash­ion the in­dus­try op­er­ates on drug prices.  While on the cam­paign trail, both Hillary Clin­ton and Trump chas­tised drug­mak­ers for their pric­ing be­hav­ior and made pledges to hold the in­dus­try ac­count­able. And af­ter cap­tur­ing the pres­i­den­cy, Trump sus­tained his at­tack on the in­dus­try stan­dard of price hikes, pro­claim­ing drug­mak­ers were “get­ting away with mur­der.” In May, Trump an­nounced that drug com­pa­nies would make “mas­sive” price cuts with­in two weeks — none which ma­te­ri­al­ized. An analy­sis of brand­ed pre­scrip­tion drugs, re­leased by the As­so­ci­at­ed Press last month, found that for all in­tents and pur­pos­es it’s been busi­ness as usu­al for drug­mak­ers, with price hikes con­tin­u­ing to out­strip cuts. The on­ly sil­ver lin­ing is that the num­ber of in­creas­es has di­min­ished some­what, and are not as steep as in past years, the AP not­ed.

The mul­ti-pronged pro­pos­al that still needs re­fine­ment and pas­sage through the fed­er­al rule-mak­ing dock­et was sent to the White House last month, and is ex­pect­ed to save Medicare $17 bil­lion over five years, and shave the cost of cer­tain drugs by up to 30 per­cent, ac­cord­ing to POLITI­CO. The plan in­tends to uti­lize Medicare’s in­no­va­tion cen­ter to ne­go­ti­ate the prices for some drugs that are di­rect­ly ad­min­is­tered by doc­tors — not pre­scrip­tions pur­chased by pa­tients at phar­ma­cies — in a bid to keep them on par with low­er prices paid by oth­er na­tions, ac­cord­ing to the re­port.

The pro­pos­al will al­so out­line an “in­ter­na­tion­al pric­ing in­dex,” in which Amer­i­can drug prices would be bench­marked against 16 oth­er na­tions — such as Cana­da, Czech Re­pub­lic, Fin­land, France, Ger­many, Japan, Spain, Swe­den and the Unit­ed King­dom — where tar­get drug prices are col­lec­tive­ly 44 per­cent low­er. Prices would slow­ly be low­ered to in­ter­na­tion­al lev­els over five years. How­ev­er, this part of the pro­pos­al may run in­to trou­ble as many drug­mak­ers aren’t par­tic­u­lar­ly forth­com­ing about the prices they set­tle on for their drugs fol­low­ing ne­go­ti­a­tions with for­eign gov­ern­ments.

An­oth­er part of the new plan in­cludes let­ting pri­vate sec­tor ven­dors ne­go­ti­ate with drug­mak­ers, akin to how health in­sur­ers ne­go­ti­ate prices in Medicare’s part D pro­gram. Medicare would test this ap­proach for cer­tain ex­pen­sive drugs in cer­tain ge­o­graph­ic ar­eas, where par­tic­i­pa­tion would be manda­to­ry for physi­cians and hos­pi­tals. In ad­di­tion, of­fi­cials in­tend to amend the in­cen­tive doc­tors have to pre­scribe ex­pen­sive drugs. Amend­ing that sys­tem to a flat fee, in con­trast to a per­cent­age, could com­pel doc­tors to use the most ef­fec­tive rather than the most ex­pen­sive treat­ments, POLITI­CO said.

In 2016, Pres­i­dent Oba­ma at­tempts to af­fect change in­to the way physi­cian-ad­min­is­tered drugs were paid for fiz­zled out af­ter be­ing thwart­ed by De­moc­rats and Re­pub­li­cans alike, not to men­tion doc­tors, hos­pi­tals and the über-con­nect­ed drug lob­by. De­spite Trump’s sus­tained brava­do, his lat­est pro­pos­al may suf­fer a sim­i­lar fate.

The speech, Trump’s first ad­dress to the health de­part­ment, is ex­pect­ed at 2 pm. It fol­lows some mod­est, al­beit in­di­rect, suc­cess­es for the ad­min­is­tra­tion in push­ing back at the phar­ma­ceu­ti­cal in­dus­try.  This month an HHS pro­pos­al re­quir­ing drug­mak­ers to re­veal prices in their TV ads came to the fore, in ad­di­tion to the pas­sage of a law ban­ning gag-claus­es, which pre­vent phar­ma­cists from in­form­ing cus­tomers when it’s cheap­er to pay in cash for a drug in­stead of us­ing in­sur­ance, as STAT not­ed.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Sev­er­al weeks af­ter get­ting hit with an RTF, Y-mAbs lands ap­proval for its oth­er neu­rob­las­toma can­di­date

Nearly two months after handing Y-mAbs a refusal to file letter for one of its main neuroblastoma candidates, the FDA gave the biotech an accelerated OK for the other — but with a box warning.

Y-mAbs, which flew mostly under the radar until a few years ago, snagged approval for naxitamab-gqgk as a second-line treatment in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). Patients older than 1 year old can take the drug for relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. The good news cushioned last month’s blow, sending the company’s stock $YMAB — which sank more than 18% upon news of the RTF — up 10.15% as of Monday morning.

Scoop: Google’s GV spear­heads the Spot­light syn­di­cate — back­ing an up­start biotech aimed at ‘de­moc­ra­tiz­ing’ gene edit­ing

CRISPR had no sooner started to shake the very foundations of drug development before its limitations began to loom large. Gene editing could change the world — if only you could get around the hurdles that threatened to trip up every program.

So it’s only natural to see CRISPR 2.0 taking shape before the pioneers can get the lead therapies through development. And who better than Google’s GV venture arm to take the lead spot in a small syndicate backing some scientists with their own unique twist on a solution?

FDA gives Rhythm the green light for set­melan­otide, a drug aimed at re­duc­ing obe­si­ty in cer­tain ge­net­ic dis­or­ders

A little over a year after completing successful pivotal trials, Rhythm Pharmaceuticals $RYTM has its first drug approval on its hands.

The Boston-based biotech announced Friday that the FDA gave setmelanotide the thumbs-up for three rare genetic disorders that result in obesity in patients six and older. It’s the agency’s first such approval, Rhythm said, with the indicated deficiencies being the POMC, PCSK1 and LEPR genes. Rhythm will market the drug as Imcivree, and plans to have it on the shelves in the first quarter of 2021.

Pascal Soriot (Getty)

As­traZeneca CEO So­ri­ot plans new study to test that con­tro­ver­sial 90% ef­fi­ca­cy fig­ure, wait­ing for US da­ta be­fore go­ing to FDA

Pascal Soriot spent the long Thanksgiving weekend digging AstraZeneca out of a hole, promising to put an end to the questions around its interim Phase III vaccine data by conducting a new study while going to regulators with a large part of what it already has.

AstraZeneca and its partners at Oxford had initially touted high-level results from two studies conducted in the UK and Brazil as positive. But the enthusiasm was soon shadowed by confusion as observers probed into how the highest, 90% efficacy was seen in a dosing regimen given to a small group of volunteers due to an error. Among a larger cohort given the intended shots, the vaccine was only 62% effective, a rate that would’ve been respectable had Pfizer/BioNTech and Moderna not posted efficacy rates of 94%, 95% for their mRNA candidates. And many weren’t sure what to make of the average 70% number that AstraZeneca ran in headlines.

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Robert Clarke (Kinaset)

Ki­naset launch­es with $40M and a JAK in­hibitor from Vec­tura's old pipeline

Kinaset Therapeutics is joining the search for a better severe asthma treatment, picking up where Vectura left off when it decided to clear house last year.

UK-based Vectura — which took a big hit when its most advanced candidate flopped in a Phase III asthma trial back in 2018 — recently shifted to a CDMO model, offloading all of its R&D programs. Robert Clarke, who’s worked on inhalable therapeutics for 21-plus years, had close contacts at the company and took a look at what they were offering. After doing some research, he was attracted by VR475, a pan-JAK inhibitor.

Stephané Bancel (Endpoints at JPM20)

Mod­er­na cal­i­brates fi­nal Covid-19 vac­cine ef­fi­ca­cy at 94.1% — and to­day it's gun­ning for the EUA

Nearly a year ago, as the coronavirus emerged in China, the NIH and four major companies bet on an unproven genetic technology as the best tool for developing a vaccine to stem the outbreak. Today, a second such vaccine is heading to the FDA.

Moderna said Monday that they will request an emergency use authorization from the FDA after a final analysis showed their mRNA vaccine was 94.1% effective at preventing symptomatic Covid-19. The data confirm the results from an interim analysis and matches efficacy Pfizer and BioNTech showed in a Phase III study, setting the biotech up to potentially nab one of the first two Covid-19 vaccine OKs.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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