Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden ad­min­is­tra­tion tries to wran­gle the de­tails of its in­fra­struc­ture bill, Sen­ate Fi­nance Com­mit­tee Chair Ron Wyden (D-OR) took a con­crete step for­ward on drug pric­ing re­forms on Tues­day and un­veiled five prin­ci­ples for such re­forms, in­clud­ing pro­vid­ing Medicare with the abil­i­ty to ne­go­ti­ate prices.

“Al­low­ing the Sec­re­tary of HHS to ne­go­ti­ate the price Medicare will pay cre­ates a much need­ed mech­a­nism to achieve fair­er prices when the mar­ket has failed to do so,” Wyden wrote.

The call for such ne­go­ti­a­tions rep­re­sents a shift for Wyden, as he pre­vi­ous­ly au­thored a drug pric­ing re­form bill with Sen. Chuck Grass­ley (R-IA) that did not in­clude such ne­go­ti­a­tions.

So why the shift? Wyden said that many old­er drugs com­mand high prices be­cause they face no com­pe­ti­tion from gener­ics and oth­er new drugs launch at steep prices with lit­tle jus­ti­fi­ca­tion. As an ex­am­ple of an un­fair launch price, he point­ed to Bio­gen’s new Alzheimer’s drug Aduhelm, which launched at a price that’s “far be­yond any rea­son­able jus­ti­fi­ca­tion of the clin­i­cal val­ue to pa­tients, care­givers, or so­ci­ety.”

The new plan comes as a coali­tion of em­ploy­ers and health care pur­chasers are call­ing on the top House and Sen­ate lead­ers to take a hard look at the “as­tro­nom­i­cal price” of Aduhelm and “move bold­ly” to en­act pre­scrip­tion drug pric­ing re­form.

But Wyden sounds more keen on a tar­get­ed, rather than a one-size-fits-all ap­proach.

In craft­ing a price ne­go­ti­a­tion pol­i­cy, Con­gress must tack­le four is­sues, ac­cord­ing to Wyden: “a. Es­tab­lish clear cri­te­ria for mar­ket fail­ure and for which drugs to ne­go­ti­ate the price; b. De­fine what con­sti­tutes a fair price in these cir­cum­stances; c. Give the Sec­re­tary both tools and guide­lines to ne­go­ti­ate a fair price; and d. Cre­ate the right in­cen­tives to en­sure that phar­ma­ceu­ti­cal com­pa­nies par­tic­i­pate in the ne­go­ti­a­tion process.”

While the time­line on when a bill may be draft­ed is un­known at this point, price re­form ad­vo­cates have been push­ing for some­thing this sum­mer, while in­dus­try ad­vo­cates are look­ing to do what they can to stop price con­trols.

An­oth­er top pri­or­i­ty for Wyden in ad­dress­ing drug pric­ing is en­sur­ing that pa­tients see sav­ings at the phar­ma­cy counter, es­pe­cial­ly for spe­cif­ic types of crit­i­cal drugs, such as in­sulin, for which “the re­bate dy­nam­ics are ex­treme and in­hibit­ing ac­cess.”

Wyden al­so said he wants to re­quire re­bates on drug price hikes above in­fla­tion to rein in com­pa­nies that gouge the mil­lions who take old­er drugs, and he wants to ex­tend these pric­ing re­forms be­yond Medicare and Med­ic­aid.

“Poli­cies that tar­get both ex­or­bi­tant prices of drugs and re­duce out-of-pock­et spend­ing for pa­tients must ex­tend be­yond Medicare,” he wrote.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.