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.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Horizon Therapeutics CEO Tim Walbert fronts the pharma company's new

Q&A: Hori­zon CEO Tim Wal­bert goes from C-suite to face of the brand

Horizon Therapeutics CEO Tim Walbert runs a rare disease company, but he’s also a patient. While his condition hasn’t been a secret, Walbert is stepping out for the first time as the face of rare disease in Horizon’s new corporate campaign called “It’s Personal.”

Or rather, as one of the faces of rare disease — other Horizon employees will also share their stories as patients and caregivers as part of the effort.

Walbert is familiar with the typical long path of rare disease patients. He was first diagnosed as a junior in college with an autoimmune disease similar to rheumatoid arthritis, but he spent another 10 years before receiving a second rare disease diagnosis. More recently, he unfortunately added the role of caregiver to a child with a rare disease when his 13-year-old son was diagnosed last year with two autoimmune conditions.

Walbert joined Horizon as CEO in 2008 after working at Abbott — now AbbVie — in immunology on the launch of anti-inflammatory biologic Humira. Before that he worked at Searle, now part of Pfizer, on pain med Celebrex. The then-fledging Horizon had only a handful of employees and no office space, literally working from Walbert’s living room.

Lately though, Horizon’s been on a tear. Despite a pair of major setbacks with the pandemic closing infusion centers just weeks after its key Tepezza thyroid eye disease approval and then later when Catalent cancelled Tepezza manufacturing slots to prioritize Covid-19 vaccine production, the company reported $820 million in Tepezza sales in 2020. That accounted for about 40% of the pharma’s record $2.2 billion in 2020 sales, blasting past $1.3 billion in 2019 sales.

While “It’s Personal” is Horizon’s first corporate branding effort, the growing pharma company has long relied on direct-to-consumer advertising as a key part of its commercialization strategy. It’s also invested heavily in unbranded awareness campaigns including RareIs which began as a social media awareness campaign that’s evolved into a rare disease resource and support community platform.

Walbert recently talked to Endpoints MarketingRx senior editor Beth Snyder Bulik about Horizon’s new campaign, and the rare personal journey that’s helped steer his career.

How did the new “It’s Personal” campaign come about? Can you talk about your personal connection and why you wanted to do it?

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