Why wait? Trump mounts an ear­ly raid on NIH’s ’17 bud­get in search of some spend­ing mon­ey

Chanelle Case Bor­den, PhD, a post­doc­tor­al fel­low in the Na­tion­al Can­cer In­sti­tute’s Ex­per­i­men­tal Im­munol­o­gy Branch, check­ing DNA gel. Gel elec­trophore­sis is a method for sep­a­ra­tion and analy­sis of macro­mol­e­cules (DNA, RNA and pro­teins) and their frag­ments, based on their size and charge. Daniel Sone / Na­tion­al Can­cer In­sti­tute 

Pres­i­dent Trump is look­ing for some ex­tra cash this year. And to get it he’s ready to start slash­ing NIH fund­ing now, rather than wait un­til the next bud­get year gets start­ed.

Ac­cord­ing to doc­u­ments mak­ing the cir­cuit in DC yes­ter­day, Trump wants to cut $1.2 bil­lion out of NIH re­search spend­ing. And the full $18 bil­lion he’s look­ing for in­cludes a $40 mil­lion hit at the FDA, ac­cord­ing to a re­port in Bloomberg, where the pres­i­dent would pre­fer to slow hir­ing in ex­change for some fast spend­ing mon­ey.

The new Trump bud­get for 2018 has al­ready set out a pro­pos­al to carve out $5.8 bil­lion in fund­ing at the NIH, which is en­joy­ing its first sig­nif­i­cant bud­get in­crease in years af­ter a bi­par­ti­san group of law­mak­ers joined hands on the ini­tia­tive.

Trump clear­ly would like to shift re­search and non-de­fense spend­ing to pay for some of his cam­paign promis­es around bor­der se­cu­ri­ty. But these cuts are not pop­u­lar among law­mak­ers. In bio­phar­ma, where the NIH seeds the drug re­search of the fu­ture, along with a con­sid­er­able amount of trans­la­tion­al work, it’s anath­e­ma.

John Crow­ley, the CEO of Am­i­cus and a guest of hon­or—with his daugh­ter Megan—at Trump’s re­cent ad­dress to Con­gress, told Ax­ios:

For me as an en­tre­pre­neur, it’s all about in­ven­tions and heal­ing, and I think NIH plays a cru­cial role. It’s part of this vir­tu­ous cir­cle that it nec­es­sary to ad­vance med­i­cines to pa­tients, which al­so in­cludes the grants that NIH pro­vides to our aca­d­e­m­ic in­sti­tu­tions. Our uni­ver­si­ty re­search sys­tem is the core for ba­sic sci­ence and ba­sic trans­la­tion­al re­search and is the ba­sis for a lot of the good ideas that come in­to a com­pa­ny like ours.

The con­tro­ver­sy has al­ready in­spired the launch of one new lob­by­ing group, the Coali­tion to Save NIH fund­ing, and a num­ber of law­mak­ers in both par­ties say that the cuts are a non­starter.

That said, with the fail­ure of Trump­care and the prospect of a new scrap over tax re­form, it’s hard to de­ter­mine who’s run­ning the shop in Wash­ing­ton these days.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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