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.”

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.

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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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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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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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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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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