Trump's White House pro­pos­es raft of cuts to sci­ence R&D bud­gets, but FDA scores high­er funds

Pres­i­dent Trump’s 2020 bud­get pro­pos­al is out, and it calls for a slew of cut­backs to sci­ence fund­ing at NIH and the Na­tion­al Sci­ence Foun­da­tion, while of­fer­ing to boost the cof­fers at the FDA. The plan now goes to a split Con­gress, like­ly to weigh in and sig­nif­i­cant­ly al­ter the White House’s blue­print.

Over­all, the ad­min­is­tra­tion has pro­posed a rough­ly 12% cut to the HHS bud­get to $87.1 bil­lion. The NIH bud­get has been culled even as it en­hances the agency’s re­spon­si­bil­i­ty by ad­vo­cat­ing for pub­licly-fund­ed R&D ini­tia­tives to end new HIV trans­mis­sions by 2030 and de­vel­op new treat­ments for pe­di­atric can­cer. To be sure, this White House has pro­posed cuts to the NIH for the last two years — but the agency en­joys bi­par­ti­san sup­port in Con­gress and leg­is­la­tors will like­ly bat away any sug­ges­tions to shave the in­sti­tute’s bud­get in the com­ing fis­cal year.

Among the key propo­si­tions laid out in­clud­ed cap­ping out-of-pock­et costs for the el­der­ly cov­ered by Medicare, aug­ment­ing the FDA’s au­thor­i­ty to crack down on drug­mak­ers look­ing to thwart gener­ic drug ap­provals and com­pe­ti­tion, and re­form the 340B pro­gram by ask­ing par­tic­i­pat­ing fa­cil­i­ties to re­port how they are us­ing sav­ings.

Un­sur­pris­ing­ly, the bud­get al­so re­it­er­at­ed the White House’s fo­cus on rein­ing in drug prices, in­clud­ing em­pow­er­ing state gov­ern­ments to ne­go­ti­ate prices as part of their Med­ic­aid bud­gets di­rect­ly with man­u­fac­tur­ers and shore up trans­paren­cy so pa­tients are not sad­dled with sur­prise bills.

“The pro­posed bud­get in­creas­es the drum­beat on drug pric­ing re­form, and makes the pos­si­bil­i­ty of ei­ther ex­ec­u­tive and/or leg­isla­tive ac­tion in­creas­ing­ly like­ly,” Leerink Ana Gupte wrote in a note, sug­gest­ing that the pro­pos­al’s re­peat­ed fo­cus on prices fol­low­ing the HHS pro­pos­al to elim­i­nate drug man­u­fac­tur­er re­bates in­di­cates change is in the off­ing at the end of the com­ment pe­ri­od on April 8. “Our ex­pec­ta­tion that ma­jor change will be like­ly de­layed to 2021 af­ter the elec­tion.”

A cru­cial piece of pro­posed leg­is­la­tion was the im­po­si­tion of $100 mil­lion in user fees for the e-cig­a­rette in­dus­try, one that has fre­quent­ly met the ire of out­go­ing FDA com­mis­sion­er Scott Got­tlieb, who has long ad­mon­ished man­u­fac­tur­ers for en­tic­ing youth in­to nico­tine de­pen­den­cy with ex­pert­ly mar­ket­ed prod­ucts. At the mo­ment, these fees are lim­it­ed to cig­a­rettes, cig­ars and some oth­er to­bac­co prod­ucts. The funds will be used to de­vel­op a “reg­u­la­to­ry frame­work for the ap­pro­pri­ate over­sight of e-cig­a­rettes and in tak­ing con­tin­ued steps to re­duce youth use of all to­bac­co prod­ucts,” the FDA said in a sep­a­rate state­ment on Mon­day.

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

Covid-19 roundup: As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Forget 1 billion. AstraZeneca is now promising to supply 2 billion doses of Oxford University’s Covid-19 vaccine around the world per year.

Three new partners are coming on board to help reach that goal, as well as a broader vision to ensure access for nations that have been largely left out of the bargaining table.

CEPI — the coalition that’s been doling out grants to support other vaccine projects — is providing $383 million to support manufacturing of 300 million doses, while Gavi the Vaccine Alliance will chip in $367 million and be in charge of the procurement and distribution, a spokesperson told Wall Street Journal. A separate licensing agreement directs the Serum Institute of India to produce 1 billion doses for low- and middle-income countries, with the first 400 million due before the end of the year.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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Michael Gladstone, partner at Atlas Venture

At­las rais­es new $400M fund amid spree of VC rais­es. Here’s what they’ll spend it on

You can add another few hundred million to the now Montana-sized reservoir of cash biotech VCs have raised since the WHO declared Covid-19 a pandemic.

Atlas Venture, the prominent Kendall Square incubator, has raised $400 million for its twelfth biotech fund, their first in 3 years. After a string of mammoth new raises from other major VCs in April and May, the total pot now stands between $5 billion and $6 billion, depending on how you slice it.

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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.

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.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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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.