President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sit­ting atop the ex­ec­u­tive branch, Pres­i­dent Don­ald Trump is the ul­ti­mate au­thor­i­ty at the FDA. He can fast track any vac­cine to ap­proval him­self. If it came to that, of course.

What he can’t do is uni­lat­er­al­ly or­der the leg­isla­tive branch to loosen the Trea­sury’s cof­fers for $6.6 bil­lion. Nor can he com­mand phar­ma­ceu­ti­cal com­pa­nies to pay for $200 vouch­ers sent to 33 mil­lion Medicare ben­e­fi­cia­ries for pre­scrip­tion drugs be­fore the elec­tion.

It didn’t stop Trump from promis­ing these very things last night at a North Car­oli­na cam­paign ral­ly. Trump was the cen­ter of an an­i­mat­ed sign­ing cer­e­mo­ny of yet an­oth­er ex­ec­u­tive or­der — the lat­est in a string of over­sold pres­i­den­tial procla­ma­tions on drug pric­ing.

Ex­ec­u­tive or­ders do not car­ry the weight of the law. De­spite that, Trump signed four ex­ec­u­tive or­ders in Ju­ly that were billed as ad­dress­ing high drug prices. Some of the ideas in the ex­ec­u­tive or­ders are in­deed provoca­tive re­forms that were once po­lit­i­cal­ly un­ten­able and have been cheered by pa­tient groups.

Yet the most am­bi­tious or­der, the so-called most fa­vored na­tions pric­ing pro­pos­al, has yet to be im­ple­ment­ed.

That has not stopped Mark Mead­ows, the pres­i­dent’s chief of staff, from claim­ing on CNN that’s where the mon­ey for the $200 se­nior cash card is com­ing from. Two oth­er ad­min­is­tra­tion of­fi­cials were sent out to speak with re­porters and re­peat­ed this false­hood.

End­points News asked PhRMA to ask if the 34 phar­ma­ceu­ti­cal chiefs on their board are down with the Pres­i­dent’s lat­est ask. A spokesper­son told us they have no ad­di­tion­al in­for­ma­tion on the cash cards. “As we’ve pre­vi­ous­ly said, one-time sav­ings cards will nei­ther pro­vide last­ing help, nor ad­vance the fun­da­men­tal re­forms nec­es­sary to help se­niors bet­ter af­ford their med­i­cines.”

It was re­vealed ear­li­er this week that PhRMA was close to a deal with Trump on drug pric­ing, on­ly to have it fall apart at the fi­nal hours be­cause Mead­ows in­sist­ed on a $100 cash card paid for by phar­ma­ceu­ti­cal com­pa­nies and sent to Amer­i­can se­niors be­fore the elec­tion.

The phar­ma­ceu­ti­cal CEOs said no to the shake­down.

It’s not clear why the Pres­i­dent and his chief of staff have now dou­bled the fig­ure to $200 and con­tin­ue to claim the phar­ma­ceu­ti­cal in­dus­try will pay for it.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Emma Walmsley (GSK via investor day livestream)

Mul­ti­va­lent mR­NA vac­cines, I/O 3.0, long-act­ing HIV drugs: The $46B game is on for the new Glax­o­SmithK­line

To understand the new GlaxoSmithKline that Emma Walmsley is promising to usher in, one must see through the old GSK.

“We know this has been a company that has perennially disappointed when you look at the first half of the last decade,” the CEO said in one of her final remarks at the long-anticipated investor day.

But after four years of strategic transformation and investment, her top team is ready to take the wraps off a shiny new version of the Big Pharma that, among other things, will strive to deliver £33 billion ($46 billion) in annual sales by 2031. It will start with a planned demerger of the consumer health business into a separate company in the middle of next year, while the new GSK retains a 20% stake as a “short-term financial investment.”

Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.