Speaker of the House Nancy Pelosi (D-CA)(Photo by Bill Clark/CQ Roll Call via AP Images)

House pass­es $35 month­ly in­sulin caps, but Sen­ate re­mains a ques­tion mark

De­moc­rats and Re­pub­li­cans re­mained di­vid­ed over how to low­er the price of in­sulin, and on the House floor Thurs­day, Dems vot­ed to­geth­er with 12 Re­pub­li­cans to pass a bill to cap in­sulin prices at $35 per month, by a vote of 232-193 (and 6 didn’t vote). In the Sen­ate, the pic­ture isn’t so clear.

House Speak­er Nan­cy Pelosi (D-CA) took to the floor on Thurs­day, ex­plain­ing how the price of in­sulin has sky­rock­et­ed in re­cent years, with the top man­u­fac­tur­ers pulling in record-break­ing prof­its by charg­ing the US sig­nif­i­cant­ly more than oth­er coun­tries.

Work­ing par­ents on in­sulin are re­port­ing of­ten hav­ing to choose be­tween pay­ing the bills and pro­tect­ing the health of a loved one, Pelosi said. And while the bill ef­fec­tive­ly cuts what many of those who re­ly on in­sulin will pay at the phar­ma­cy counter, it doesn’t hit the prices set by the phar­ma man­u­fac­tur­ers, nor does it help those who are unin­sured.

The same in­sulin price cap bill passed the House last year but didn’t muster the votes in the Sen­ate. How it will fare in the Sen­ate again re­mains un­known, al­though Dems will like­ly need 60 votes, mean­ing Re­pub­li­cans will have to join them, un­less they use a tac­tic known as rec­on­cil­i­a­tion, which al­lows for just a sim­ple ma­jor­i­ty. Re­pub­li­cans pre­vi­ous­ly used rec­on­cil­i­a­tion to get their tax law passed un­der the Trump ad­min­is­tra­tion.

“There is a path for­ward in the Sen­ate to pass the leg­is­la­tion through rec­on­cil­i­a­tion,” David Mitchell, a can­cer pa­tient and founder of Pa­tients For Af­ford­able Drugs Now, said in a state­ment. “In or­der to de­liv­er on their promis­es to all pa­tients — in­clud­ing those who de­pend on in­sulin — the Sen­ate must act ur­gent­ly to ap­prove the broad pro­vi­sions al­ready passed by the House.”

And al­though Re­pub­li­cans slammed the bill on Thurs­day’s floor de­bate as mis­guid­ed, some of the same House Re­pub­li­cans pre­vi­ous­ly backed a Trump ad­min­is­tra­tion move that re­quired more than 1,600 plans to cap in­sulin co­pays at $35 a month.

Rep. Cathy Mc­Mor­ris Rodgers (R-WA), who vot­ed against the in­sulin bill on Thurs­day, called out the PBMs for hid­ing low­er drug costs from pa­tients, say­ing this bill gives these mid­dle­men a pass.

“We should be low­er­ing the cost [of in­sulin] with­out go­ing down the road of price con­trols,” she said.

Rep. Vir­ginia Foxx (R-NC) sim­i­lar­ly vot­ed “Nay” and called the bill “one step clos­er to so­cial­ized med­i­cine,” say­ing it “sets an ex­treme­ly dan­ger­ous prece­dent.” Con­gress shouldn’t know­ing­ly raise pre­mi­ums, she said.

But De­moc­rats coun­tered that this bill would pro­vide a lit­er­al life­line to many with di­a­betes.

House Ma­jor­i­ty Leader Ste­ny Hoy­er (D-MD) said the bill is not a form of price con­trol as the com­pa­nies are still go­ing to charge what they charge.

Oth­er De­moc­rats said this should be the first step to even more drug pric­ing re­forms, in­clud­ing al­low­ing Medicare to ne­go­ti­ate on drug prices.

“At the end of the day, I hope that we can still bring for­ward a rec­on­cil­i­a­tion bill with ad­di­tion­al re­forms this year. I know we need to do Medicare drug price ne­go­ti­a­tion,” Rep. Ang­ie Craig (D-MN), the lead spon­sor of the in­sulin bill, told Politi­co.

Sen­ate ma­jor­i­ty leader Chuck Schumer has vowed to hold a vote in the Sen­ate on the in­sulin cap bill af­ter the East­er re­cess.

Ed­i­tor’s note: Ar­ti­cle up­dat­ed with more de­tails on the vote.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

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Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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