Re­pub­li­cans un­veil a drug price bill to ri­val the De­moc­rats — promis­ing low­er prices and more cures

Nan­cy Pelosi un­veiled the De­moc­rats’  drug pric­ing bill back in Sep­tem­ber and brought the fight straight to the in­dus­try with a pro­pos­al to em­pow­er the US gov­ern­ment to ne­go­ti­ate prices for se­lect drugs. Re­pub­li­cans, who de­cried the bill reeks of heavy-hand­ed gov­ern­ment in­ter­ven­tion which will sti­fle in­no­va­tion, now have a coun­ter­pro­pos­al they claim will re­sult in cheap­er drugs and in­cen­tivize R&D — fur­ther cloud­ing the prospects of a bi­par­ti­san com­pro­mise that could land on Don­ald Trump’s desk.

“On­ly one of these bills has the po­ten­tial to be­come law. While Speak­er Pelosi’s par­ti­san plan is dead on ar­rival in the Sen­ate and won’t be signed by Pres­i­dent Trump, H.R. 19 could be on Pres­i­dent Trump’s desk to­day,” said Re­pub­li­can Whip Steve Scalise in a state­ment on Mon­day. And in an ac­knowl­edg­ment that the Re­pub­li­can ef­fort would need Pelosi’s sign-off to reach a vote — a high­ly un­like­ly event — Scalise con­tin­ued, “Speak­er Pelosi must come to her sens­es. I am call­ing on her to bring H.R. 19 to the House floor for a vote this week. Amer­i­cans need a bi­par­ti­san so­lu­tion to pre­scrip­tion drug prices, not an­oth­er doomed pro­pos­al from the De­moc­rats.”

Re­pub­li­cans and De­moc­rats both ar­gue drug prices in the Unit­ed States are too high — the in­dus­try holds the crown for the least fa­vored sec­tor by Amer­i­cans, falling be­hind the fed­er­al gov­ern­ment it­self — but so far no­body can agree on just how to make the US health care sys­tem great again.

The 350-page Re­pub­li­can bill, HR19, pro­pos­es cre­at­ing the role of a ‘chief phar­ma­ceu­ti­cal ne­go­tia­tor’ at the Of­fice of the Unit­ed States Trade Rep­re­sen­ta­tive to ad­vo­cate on be­half of Amer­i­can pa­tients in trade agree­ments with re­spect to pre­scrip­tion drug prices.

In ad­di­tion, the bill seeks to lim­it an­nu­al out-of-pock­et costs for Medicare ben­e­fi­cia­ries at $3,100; caps the cost of in­sulin for se­niors in the Medicare Part D pro­gram; re­quires in­sur­ance com­pa­nies to make in­for­ma­tion about drug prices trans­par­ent at doc­tor’s of­fices so pa­tients are ap­prised of the po­ten­tial costs be­fore a pre­scrip­tion is writ­ten; and ‘stream­lines’ the reg­u­la­tion of over-the-counter prod­ucts.

Some of the pro­pos­als in HR19 al­so mir­ror poli­cies ad­vo­cat­ed by bi­par­ti­san leg­is­la­tion cur­rent­ly un­der con­sid­er­a­tion in the Sen­ate, in­clud­ing the CRE­ATES act which is de­signed to en­sure gener­ic drug­mak­ers can ac­cess brand­ed drugs to de­vel­op copy­cats, and pro­hibits “pay-for-de­lay” deals, where man­u­fac­tur­ers of brand­ed drugs main­tain their mo­nop­o­lies by of­fer­ing gener­ic com­pa­nies re­wards for de­lay­ing the launch of knock­off prod­ucts. 

The De­moc­rats’ drug pric­ing bill — HR 3, which is set to face a vote this week — could com­pel man­u­fac­tur­ers to com­ply with the prices set by the HHS, or face grave penal­ties and teth­ers the price of the some of the na­tion’s most ex­pen­sive drugs to an in­ter­na­tion­al price in­dex. Un­sur­pris­ing­ly, the bill — which promis­es to cut fed­er­al spend­ing by $345 bil­lion be­tween 2023 and 2029 — elicit­ed the ire of the in­dus­try that has so far thrived by tak­ing a lais­sez-faire ap­proach to pric­ing. Var­i­ous analy­ses have sug­gest­ed the bill, which is un­like­ly to be signed in­to law, could re­sult in be­tween 8 to 100 few­er drugs from reach­ing the mar­ket over the next decade.

A raft of Re­pub­li­can law­mak­ers is­sued state­ments sup­port­ing HR19 on Mon­day, sug­gest­ing not on­ly is HR19 su­pe­ri­or to HR3, but is far more like­ly to be signed in­to law.

“This (bill) con­tains mea­sures with bi­par­ti­san sup­port in the House and Sen­ate, can be­come law, and de­serves a vote. Mean­while, Speak­er Pelosi’s par­ti­san drug pric­ing scheme is not on­ly bad pol­i­cy, it’s nev­er go­ing to be­come law,” said the ar­chi­tects of HR19, Kevin Brady, the se­nior Re­pub­li­can on the pow­er­ful Ways and Means Com­mit­tee, along with Greg Walden (R-OR) and Vir­ginia Foxx (R-NC).

That may well be the case — the White House last week is­sued a scathing re­view of HR3, ac­cus­ing the Pelosi bill of fa­vor­ing short-term sav­ings over the “long-term cost of Amer­i­can pa­tients los­ing ac­cess to new life­sav­ing treat­ments.” But with De­moc­rats firm­ly in charge of the House of Rep­re­sen­ta­tives, HR19 faces a sim­i­lar­ly quixot­ic road to Trump’s desk, with ar­ti­cles of im­peach­ment threat­en­ing to over­shad­ow the po­lit­i­cal cal­en­dar.

In a sec­ond big set­back for Covid-19 an­ti­body treat­ment hopes, Re­gen­eron halts en­roll­ment for more se­vere pa­tients

Regeneron has just delivered more bad news for the hope that neutralizing antibodies could be used to treat patients with more severe forms of Covid-19.

The New York biotech said today that an independent monitoring committee recommended halting enrollment of patients who need high-flow oxygen or mechanical ventilation in one of the trials on their antibody cocktail, after finding “a potential safety signal” and “an unfavorable risk/benefit profile.” The news comes a week after the NIH scrapped a trial of Eli Lilly’s Covid-19 antibody after finding it was having little effect on an initial cohort of hospitalized patients.

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Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

No­vo Nordisk qui­et­ly nabs a rare 'break­through' sta­tus in NASH for its cash cow

Earlier this month, the small French biotech Inventiva touted themselves as having won the first FDA breakthrough designation in NASH since Intercept grabbed the first one back in 2015, before the disease had become one of biotech’s hottest areas. Unbeknownst to them, though, a much larger European rival had already landed the status months prior.

Novo Nordisk, the Danish metabolic giant, disclosed in their Q3 report Friday that back in August, the FDA gave them breakthrough status for semaglutide, their blockbuster diabetes drug, in NASH, or non-alcoholic steatohepatitis. The designation sets Novo up as a leading contender in a new wave of companies developing treatments for a silent and widespread disease that, despite a series of setbacks, is still viewed by many as a huge potential market.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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As­traZeneca sells off heart fail­ure and hy­per­ten­sion drugs to Chep­lapharm for $400M

Out with the old and in with the new: AstraZeneca is selling off two heart failure and hypertension drugs to Germany-based Cheplapharm, bagging $400 million and making way for development in other areas.

Cheplapharm paid $200 million for the European rights to Atacand (candesartan cilexetil) and Atacand Plus (candesartan cilexetil and hydrochlorothiazide) back in 2018. They’re now doubling that amount for commercial control in more than 70 countries.

News brief­ing: Ax­o­vant faces months of de­lay on lead Parkin­son's gene ther­a­py; Chi­nese CAR-T biotech nabs $100M

One of Axovant’s top gene therapy prospects for its second act is hitting a roadblock that could push its clinical timelines back by almost a year.

In an update, the biotech said it was informed about delays in CMC data and third-part fill-finish issues around mid-October by its manufacturing partner, Oxford Biomedica. Axovant has been developing a suspension-based process for the Parkinson’s drug; with that taking longer than expected, it now believes “it is unlikely that its planned randomized, sham-controlled trial of AXO-Lenti-PD will enroll patients by the end of calendar year 2021.”

Ugur Sahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

Covid-19 roundup: Flush with $486M con­tract, As­traZeneca signs Lon­za up to man­u­fac­ture an­ti­bod­ies; BioN­Tech's Ugur Sahin ex­pects vac­cine da­ta 'in a fort­night'

Days after scoring a $486 million BARDA contract to develop and manufacture its long-acting antibody combo for Covid-19, AstraZeneca has tapped Lonza to produce the drug substance at its mid-scale facility in Portsmouth, NH.

The drug, dubbed AZD7442, puts together two antibodies, first discovered by scientists at Vanderbilt University Medical Center, derived from convalescent patients who recovered from a SARS-CoV-2 infection. AstraZeneca licensed them in June and has since further engineered them with half-life extension and reduced Fc receptor binding.

CEO Kenji Yasukawa (Astellas)

In ear­ly blow to Ken­ji Ya­sukawa's R&D re­vamp, Astel­las drops out of the TIG­IT race, cit­ing PhI fail­ure

Just after AstraZeneca jumped into the TIGIT race, Astellas quietly disclosed that it was leaving, dropping out of a hunt for an immunotherapy approach that has shown tantalizing promise but remains largely unproven.

Astellas revealed in their second quarter earnings today that they’ve ended development of the anti-TIGIT antibody they acquired in their up to $400 million buyout of Potenza in 2018. The Japanese pharma had been testing it in combination with Keytruda in a 300-person Phase I study on patients with advanced solid tumors. A smaller study testing the antibody alone was completed, 2 years ahead of schedule, in July.

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Trou­bled Unum re­brands as Co­gent Bio­sciences, re­places CEO Chuck Wil­son with An­drew Rob­bins; Jen­nifer Fox ap­point­ed as CFO at David Hung-led Nu­va­tion Bio

→ Rife with turmoil and hit with a barrage of FDA holds as it spiraled into penny-stock territory, Unum Therapeutics hopes a new name — Cogent Biosciences — and a new CEO can turn its fortunes around. Andrew Robbins takes control now and succeeds Chuck Wilson, who founded Unum in 2014.

The cell therapy biotech stumbled out of the gate when it debuted on Nasdaq in 2018 and revealed that 2 of its 9 patients died in one arm of their ACTR087 trial. The FDA would hand down 3 different holds, two for ACTR087 and another for its experimental therapy ACTR707. Adding insult to injury, Unum shed around 60% of its workforce and jettisoned its old pipeline in favor of a new one a few months ago.