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.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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How the bio­phar­ma in­dus­try is help­ing to pay for the bi­par­ti­san in­fra­struc­ture bill

Senators on Sunday finalized the text of a massive, bipartisan infrastructure bill that contains little that might impact the biopharma industry other than two ways the legislators are planning to pay for the $1.2 trillion deal.

On the one hand, senators are seeking to further delay a Trump-era Medicare Part D rule related to drug rebates, this time until 2026. Senators claim the rule could end up saving about $49 billion, but the PBM industry has attacked it as it would remove rebates from a safe harbor that provides protection from federal anti-kickback laws. The pharmaceutical industry, however, is in favor of the rule and opposes this latest delay as it continues to point its finger at the PBM industry for the rising cost of out-of-pocket expenses.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.