DC court over­rules PhRMA's bid to shut down drug im­ports from Cana­da

The DC Cir­cuit Court has struck a blow against the phar­ma­ceu­ti­cal lob­by­ing group PhRMA and oth­er plain­tiffs’ at­tempt to stop states from im­port­ing drugs from Cana­da.

Joined along­side pub­lic health group Part­ner­ship for Safe Med­i­cines and ad­vo­ca­cy group Coun­cil for Af­ford­able Health Cov­er­age, PhRMA was re­buffed by Judge Tim­o­thy Kel­ly on Mon­day, who dis­missed the civ­il suit due to a lack of stand­ing.

FDA is­sued a rule back in 2020 that would al­low states to im­port cer­tain pre­scrip­tion drugs from Cana­da, but has yet to sign off on any of the state plans for im­por­ta­tion.

From Kel­ly’s rul­ing:

The De­part­ment of Health and Hu­man Ser­vices is con­sid­er­ing al­low­ing pre­scrip­tion drugs to be im­port­ed from Cana­da un­der a statute that has lain dor­mant for decades. Plain­tiffs, a col­lec­tion of or­ga­ni­za­tions with var­i­ous in­ter­ests in Amer­i­can health­care, say that de­ci­sion would be mis­tak­en and that it was start­ed by un­law­ful process­es. But no or­ga­ni­za­tion, nor any of their mem­bers, faces a con­crete risk of harm from the in­choate im­por­ta­tion pro­gram, as is re­quired when su­ing. So the Court must dis­miss this case for lack of stand­ing.

The 26-page rul­ing not­ed that in or­der to have stand­ing, plain­tiffs must prove that they have suf­fered an “in­jury in fact,” that the in­jury is trace­able to the de­fen­dants’ con­duct, and that the in­jury is like­ly to be reme­died by a fa­vor­able de­ci­sion. And in two dif­fer­ent as­pects, the plain­tiffs had no stand­ing to bring the case against the fed­er­al agen­cies, Kel­ly ruled.

One was that “[t]he cog­niz­abil­i­ty of each of those in­juries, as the Court will ex­plain, de­pends on the like­li­hood that an in­di­vid­ual mem­ber’s drug or drugs will be the sub­ject of a pre-im­port re­quest un­der an ap­proved SIP (state im­ple­men­ta­tion plans). Be­cause it is im­pos­si­ble to do more than spec­u­late about that like­li­hood, Plain­tiffs have not es­tab­lished an in­jury-in-fact.”

Claims that drug im­por­ta­tion would im­pede ad­vo­ca­cy ef­forts, ac­cord­ing to Kel­ly, are “pro­to­typ­i­cal state­ments of harm to ‘ab­stract so­cial in­ter­ests.’”

“Plain­tiffs nowhere al­lege that their abil­i­ty to pro­vide ser­vices has been ‘per­cep­ti­bly im­paired’ or de­scribe any ‘in­hi­bi­tion’ of their ‘dai­ly op­er­a­tions,’” Kel­ly added.

The com­plaint was first filed more than two years ago in late 2020 against HHS, FDA and the then-heads of those agen­cies un­der the Trump ad­min­is­tra­tion, Alex Azar and Stephen Hahn.

The com­plaint said at the heart of the suit were HHS and FDA ac­tions that, ac­cord­ing to the com­plaint, “would per­mit phar­ma­cists and whole­salers to im­port cer­tain pre­scrip­tion drugs from Cana­da in­to the Unit­ed States with­out drug man­u­fac­tur­ers’ au­tho­riza­tion or over­sight, pre­sent­ing sig­nif­i­cant safe­ty risks.”

Mul­ti­ple states have been work­ing on try­ing to re­duce the cost of pre­scrip­tion drugs for their res­i­dents. Flori­da sued the FDA last year over the agency’s al­leged fail­ure to au­tho­rize the state’s plan to im­port drugs from Cana­da. The state had turned over a pro­pos­al years ear­li­er.

Col­orado re­cent­ly joined in, re­veal­ing qui­et­ly last year that the state was work­ing on an ap­pli­ca­tion to FDA for a part­ner­ship with three com­pa­nies to im­port low­er-cost drugs ap­proved from Cana­da to the US. The plan was es­ti­mat­ed to save Col­orado res­i­dents 60% on pre­scrip­tion med­i­cines if US reg­u­la­tors signed off.

PhRMA’s se­nior di­rec­tor of pub­lic af­fairs Nicole Lon­go tells End­points News in a state­ment:

PhRMA’s con­cerns with the le­gal­i­ty of the 2020 drug im­por­ta­tion fi­nal rule re­main un­ad­dressed by the Judge’s de­ci­sion, as well as our be­lief that it threat­ens pub­lic health. In the fi­nal rule, the ad­min­is­tra­tion punt­ed the re­spon­si­bil­i­ty for demon­strat­ing safe­ty and cost sav­ings to state gov­ern­ments. This is de­spite the clear re­quire­ment un­der fed­er­al law that the Sec­re­tary of HHS must cer­ti­fy that im­port­ed drugs both pose no ad­di­tion­al risk to pub­lic safe­ty and will lead to sig­nif­i­cant sav­ings for the Amer­i­can con­sumer. The rule need­less­ly puts the health and safe­ty of Amer­i­cans in jeop­ardy.

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

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Dif­fu­sion to hand Nas­daq spot to EIP Phar­ma for PhI­Ib de­men­tia study of ex-Ver­tex drug

One of the more than a dozen bidders for Diffusion Pharmaceuticals’ spot on Nasdaq has prevailed.

Boston biotech EIP Pharma will merge with Diffusion in an all-stock deal, with plans to start a Phase IIb clinical trial in the coming months in a common form of dementia with no approved treatments. The combined company will be renamed CervoMed.

The nine-year-old privately-held EIP is working on a former Vertex drug that it will test in a 160-person Phase IIb in patients with dementia with Lewy bodies, or DLB. The National Institute on Aging is expected to fund that trial with a $21 million grant. With the reverse merger, slated for closing in the middle of this year, EIP will be funded through that readout in the second half of 2024. EIP’s equity and debt holders will own about 77.25% of the combined company.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

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Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

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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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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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