Trump ad­min­is­tra­tion dou­bles down on slash­ing the bud­get at NIH, FDA — with a user fee hike for bio­phar­ma

Pres­i­dent Don­ald Trump is stick­ing with a con­tro­ver­sial plan to try and carve bil­lions out of the bud­gets for the NIH and the FDA, look­ing to slash re­search spend­ing and force bio­phar­ma com­pa­nies to cough up more cash for drug re­views.

But his pro­pos­als are al­ready deep in hot wa­ter — and that’s be­fore you start count­ing De­mo­c­ra­t­ic votes. A num­ber of Re­pub­li­can law­mak­ers have reg­is­tered their op­po­si­tion to these kinds of cuts to the NIH and FDA, in­clud­ing some of the par­ty’s most pow­er­ful fig­ures.

The fresh con­tro­ver­sy over the pro­pos­al got start­ed with a glitch on Mon­day af­ter­noon when the Trump ad­min­is­tra­tion pre­ma­ture­ly post­ed the bud­get pro­pos­al for HHS on­line, then tried to take it down. The Wash­ing­ton Post grabbed it, though, and you can see it here.

Al­to­geth­er, Trump wants to carve $5.8 bil­lion out of the NIH, with a bil­lion dol­lars be­ing cut from the Na­tion­al Can­cer In­sti­tute, $838 mil­lion from NI­AID and more.

The ad­min­is­tra­tion wants to chop close to a bil­lion dol­lars out of the FDA’s bud­get and pay for that by get­ting bio­phar­ma and de­vice com­pa­nies to cov­er more of the cost of prod­uct re­views through high­er user fees.

Re­pu­bi­can Sen­a­tor Lamar Alexan­der has al­ready told HHS Sec­re­tary Tom Price that the user fee is­sue is a non­starter for the 2018 bud­get, not­ing that law­mak­ers spent two years ne­go­ti­at­ing with the in­dus­try.

“It is way too late to have an im­pact on this year’s agree­ments, which have been ne­go­ti­at­ed over the last two years,” he wrote to Price, ac­cord­ing to a piece in the Wall Street Jour­nal. He added that the Sen­ate’s health com­mit­tee al­ready over­whelm­ing­ly backed the agreed on user fees.

The ad­min­is­tra­tion will face sim­i­lar kick­backs over the NIH at­tack. This de­bate over cut­ting non­mil­i­tary spend­ing to pay for Trump’s pre­ferred ef­forts has a long way to go, but the pres­i­dent will need to find a way to at­tract far more sup­port from his own par­ty if he ex­pects to get the new HHS bud­get in place in line with what he’s propos­ing.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

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FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

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