Biden calls on Con­gress to al­low Medicare drug price ne­go­ti­a­tions

Over­shad­owed by Pres­i­dent Biden’s vac­cine man­date an­nounce­ment, the ad­min­is­tra­tion ear­li­er in the day re­leased its top pri­or­i­ties for drug pric­ing re­forms mak­ing their way through Con­gress.

The re­forms are slat­ed to save the gov­ern­ment hun­dreds of bil­lions to off­set oth­er spend­ing pri­or­i­ties.

The 29-page HHS re­port makes clear the ad­min­is­tra­tion’s strong de­sire for any leg­is­la­tion to in­clude Medicare drug price ne­go­ti­a­tions — an idea the phar­ma­ceu­ti­cal in­dus­try strong­ly op­pos­es — as well as mea­sures to slow price in­creas­es over time on ex­ist­ing drugs.

“A pro­vi­sion in the law that es­tab­lished the Medicare Part D pro­gram specif­i­cal­ly pro­hibits the HHS Sec­re­tary from in­ter­fer­ing with the ne­go­ti­a­tions be­tween drug man­u­fac­tur­ers and phar­ma­cies and plan spon­sors, re­quir­ing a par­tic­u­lar for­mu­la­ry, or in­sti­tut­ing a price struc­ture for the re­im­burse­ment of cov­ered Part D drugs,” the re­port says. “This re­stric­tion is unique to Part D and con­trasts with how drug prices are de­ter­mined in oth­er fed­er­al pro­grams, such as the use of ceil­ing prices in the VA and manda­to­ry re­bates in Med­ic­aid—both of which re­sult in low­er brand drug prices than in Medicare Part D.”

Peg­ging Medicare prices to what drug­mak­ers of­fer the VA is one of the top ideas be­ing float­ed by the Sen­ate Fi­nance Com­mit­tee, ac­cord­ing to a Stat News re­port. Sen­ate fi­nance chair Ron Wyden (D-OR) is ex­pect­ed to of­fer up a bill in the com­ing days that could set the course for what Con­gress ul­ti­mate­ly adopts when it comes to drug pric­ing re­forms.

Wyden has pre­vi­ous­ly em­pha­sized his de­sire to al­low Medicare to ne­go­ti­ate, al­though it re­mains un­known if all 50 Sen­ate De­moc­rats, all of whom will like­ly be need­ed for the bill’s pas­sage, are will­ing to back such an idea. Sens. Bob Menen­dez of New Jer­sey and Kyrsten Sine­ma of Ari­zona have pre­vi­ous­ly ex­pressed doubts.

SVBLeerink an­a­lyst Ge­off Porges said in a note this morn­ing, “from an in­dus­try point of view this pro­pos­al is an ex­is­ten­tial threat, and is like­ly to be fought tooth and nail. Giv­en the ten­u­ous ma­jor­i­ty for De­moc­rats in the House and Sen­ate, and the pri­or op­po­si­tion in the House to HR3, we be­lieve there is next to no chance that this ma­jor pil­lar of the plan gets through Con­gress.”

In the House, the En­er­gy & Com­merce com­mit­tee on Mon­day will be­gin mark­ing up its own drug pric­ing bill. That cur­rent­ly in­cludes Speak­er Nan­cy Pelosi’s HR 3, which the CBO has warned could put a damper on new drug de­vel­op­ment. But those pro­vi­sions could change de­pend­ing on the Sen­ate.

In con­junc­tion with Medicare ne­go­ti­a­tions, the ad­min­is­tra­tion en­cour­ages Con­gress to im­pose an ex­cise tax when man­u­fac­tur­ers raise the price of their prod­ucts faster than the rate of in­fla­tion, the HHS re­port adds, not­ing that Amer­i­cans spend more than $1,500 per per­son on av­er­age for pre­scrip­tion drugs and “pay prices that are far high­er than any com­pa­ra­ble na­tion.”

Oth­er pro­vi­sions from the re­port, such as in­creas­ing gener­ic drug and biosim­i­lar com­pe­ti­tion with fast FDA ap­provals, have been float­ed for years by mem­bers of Con­gress on both sides of the aisle.

But the ad­min­is­tra­tion al­so pledged its sup­port for so-called “skin­ny” la­bels, which have come un­der fire from courts re­cent­ly, and can al­low for gener­ic com­pe­ti­tion to come to mar­ket for some of the in­di­ca­tions of an ap­proved ref­er­ence prod­uct that aren’t un­der patent pro­tec­tion.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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Astel­las' hot flash­es drug will get speedy re­view at FDA; US opts out of Val­ne­va vac­cine

The FDA will decide on Astellas’ menopausal symptom drug by Feb. 22 of next year, as the Japanese pharma disclosed it had paid about $97 million to get a priority review voucher to speed up the review.

Astellas said the agency has accepted the pharma’s application for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS includes hot flashes and/or night sweats. The company said as many as 80% of women in the US experience those symptoms during or after the menopausal transition.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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