Ap­pro­pri­a­tions bill would give FDA $269M boost over FY2018 bud­get

With one day left be­fore the US gov­ern­ment faces an­oth­er shut­down, the House and Sen­ate are poised to pass a sev­en-bill spend­ing pack­age on Thurs­day to fund large por­tions of the fed­er­al gov­ern­ment through FY2019. And Pres­i­dent Don­ald Trump has said he will sign the bill.

The spend­ing pack­age comes near the end of a three-week stop­gap fund­ing mea­sure to al­low the gov­ern­ment to re­open af­ter a record 35-day par­tial gov­ern­ment shut­down that be­gan on 22 De­cem­ber 2018 af­ter Pres­i­dent Don­ald Trump re­fused to sign a short-term spend­ing bill over his de­mand for $5.7 bil­lion for a wall along the south­ern bor­der.

In­clud­ed in the Agri­cul­ture, Rur­al De­vel­op­ment, Food and Drug Ad­min­is­tra­tion, and Re­lat­ed Agen­cies 2019 ap­pro­pri­a­tions bill is $3.068 bil­lion in dis­cre­tionary fund­ing, a $269 mil­lion in­crease over FY2018 lev­els. The in­crease in bud­get au­thor­i­ty, if en­act­ed, would be the largest in­crease the agency has seen since FY2010.

If the FDA is fund­ed at the lev­els set in the fund­ing bill, the agency’s to­tal pro­gram lev­el will be $5.67 bil­lion, in­clud­ing the rough­ly $2.5 bil­lion in user fees the agency is ex­pect­ed to col­lect.

Ac­cord­ing to an ex­plana­to­ry state­ment cir­cu­lat­ed along with the bill, the $269 mil­lion in new fund­ing for FDA in­cludes “$47,000,000 to com­bat the Opi­oid Epi­dem­ic, $38,500,000 to Pro­mote Do­mes­tic Man­u­fac­tur­ing; $12,000,000 for a New Do­mes­tic Drug In­dus­try; $6,000,000 for MedTech Man­u­fac­tur­ing; $50,700,000 for New Med­ical Da­ta En­ter­prise; $25,000,000 for the Growth and Trans­for­ma­tion of Dig­i­tal Health; $43,300,000 for New Plat­form for Drug De­vel­op­ment, in­clud­ing a $5,000,000 in­crease to ful­ly fund FDA’s On­col­o­gy Cen­ter for Ex­cel­lence; $25,100,000 for Mod­ern­iz­ing Gener­ic Drug De­vel­op­ment and Re­view; and $10,000,000 for In­vest­ment and In­no­va­tion for Rare Dis­eases.”

The bill, while in­clud­ing $22.54 bil­lion in “to­tal bor­der se­cu­ri­ty fund­ing” on­ly in­cludes $1.375 bil­lion for 55 miles of phys­i­cal bar­ri­ers along the south­ern bor­der, less than a quar­ter of what Trump is re­quest­ing.

First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

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Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

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Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

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Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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