Biden HHS seeks to dis­miss PhRMA’s law­suit to stop Cana­di­an drug im­ports

As the FDA has yet to au­tho­rize any state plans to im­port pre­scrip­tion drugs from Cana­da, the Biden ad­min­is­tra­tion called on the US Dis­trict Court for DC late last week to dis­miss a PhRMA law­suit over the im­ports be­cause any po­ten­tial harms re­main spec­u­la­tive.

Biden’s HHS said PhRMA’s “whole­sale at­tack” on the rule that al­lows states to sub­mit such plans to the FDA has not yet af­fect­ed their mem­ber com­pa­nies “in any con­crete way and per­haps nev­er will.”

The call to dis­miss the suit, which aligns the Biden ad­min­is­tra­tion with the Trump pol­i­cy, notes that two pro­pos­als from Flori­da and New Mex­i­co have been sub­mit­ted to FDA, but the agency has not of­fered a time­line for when it will de­cide on ei­ther one.

Law firm Cov­ing­ton & Burl­ing, on be­half of PhRMA, filed a cit­i­zen pe­ti­tion with the FDA in Jan­u­ary to de­ny Flori­da’s ap­pli­ca­tion, and it filed an­oth­er cit­i­zen pe­ti­tion in March call­ing to de­ny New Mex­i­co’s too.

For Flori­da, PhRMA crit­i­cized the pro­pos­al be­cause it does not in­clude the name of a Cana­di­an whole­saler that would be nec­es­sary for the plan to work, and it del­e­gates sig­nif­i­cant re­spon­si­bil­i­ties to a pri­vate sec­tor ven­dor to work out the de­tails. For New Mex­i­co, PhRMA took is­sue be­cause the state did not pro­vide a for­eign sell­er, im­porter, or FDA-reg­is­tered repack­ager or re­la­bel­er, and it pro­vides on­ly the first it­er­a­tion of the list of drugs to be im­port­ed.

But Biden’s HHS ex­plains how the rule al­low­ing the sub­mis­sion of these state pro­pos­als asks noth­ing of PhRMA’s mem­ber com­pa­nies. And be­cause the rule and state pro­pos­al process has on­ly been in the works for a few months, FDA needs time to eval­u­ate whether to ac­cept or de­ny the ap­pli­ca­tions, Biden’s HHS main­tains.

“To even be el­i­gi­ble for au­tho­riza­tion, a pro­gram must sat­is­fy up­front (and con­tin­ue to demon­strate there­after) a host of strin­gent reg­u­la­to­ry re­quire­ments re­lat­ed to pa­tient safe­ty and drug sup­ply chain se­cu­ri­ty, as well as show sig­nif­i­cant cost sav­ings to Amer­i­can con­sumers,” the Biden ad­min­is­tra­tion’s mo­tion to dis­miss says. “FDA pos­sess­es dis­cre­tion to de­ny any pro­pos­al that does not fa­cial­ly meet the reg­u­la­to­ry re­quire­ments. Even if a pro­pos­al is fa­cial­ly com­plete, the agency still may with­hold au­tho­riza­tion.”

Fol­low­ing the court fil­ing, Flori­da Gov. Ron De­San­tis (R) on Fri­day as­sert­ed that it “puts the Biden Ad­min­is­tra­tion on the record in sup­port of the FDA rule,” which he said could po­ten­tial­ly save the state be­tween $80 mil­lion and $150 mil­lion in the first year alone. He al­so pushed the FDA to act quick­ly in de­cid­ing on the pro­pos­al, say­ing, “Florid­i­ans have been wait­ing long enough for low­er drug prices, and there is no good rea­son to keep them wait­ing.”

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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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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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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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.

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.