Rochelle Walensky, CDC director (Greg Nash/Pool via AP Images)

UP­DAT­ED: CDC di­rec­tor over­rules ad­vi­sors on boost­ers, rec­om­mend­ing third shots for at-risk work­ers

Pres­i­dent Joe Biden’s at­tempt to roll out Covid-19 boost­er shots has been far from smooth sail­ing, and the CDC di­rec­tor added to the bumpi­ness ear­ly Fri­day morn­ing.

Di­rec­tor Rochelle Walen­sky re­versed a CDC ad­vi­so­ry pan­el’s rec­om­men­da­tion that boost­ers should not be ad­min­is­tered to adults at risk of oc­cu­pa­tion­al ex­po­sure, such as teach­ers and health care work­ers. The high­ly un­usu­al move came af­ter the CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices rec­om­mend­ed Pfiz­er/BioN­Tech boost­er shots for those old­er than 65 and younger, high-risk adults, but vot­ed 9-6 against al­low­ing the shots for at-risk jobs.

“At CDC, we are tasked with an­a­lyz­ing com­plex, of­ten im­per­fect da­ta to make con­crete rec­om­men­da­tions that op­ti­mize health,” Walen­sky said in a state­ment. “In a pan­dem­ic, even with un­cer­tain­ty, we must take ac­tions that we an­tic­i­pate will do the great­est good.”

The move came “well past mid­night” on Fri­day morn­ing, per a New York Times re­port.

ACIP’s vote would have put the agency at odds with the FDA’s au­tho­riza­tion for the Pfiz­er/BioN­Tech boost­ers, which en­dorsed the shots for high-risk oc­cu­pa­tions ear­li­er this week. Walen­sky’s de­ci­sion like­ly will help move Biden’s boost­er plan fur­ther along, de­spite Biden com­ing un­der crit­i­cism for leapfrog­ging reg­u­la­tors.

Boost­ers for health care work­ers, teach­ers and oth­ers with a high-risk of con­tract­ing the virus at work has been an os­ten­si­ble stick­ing point for the White House in re­cent weeks. The Biden ad­min­is­tra­tion had orig­i­nal­ly sought boost­ers for the broad­er pop­u­la­tion as ear­ly as last Mon­day, but that soon be­came un­like­ly to hap­pen.

Af­ter news of the de­ci­sion made the rounds, top biotech an­a­lyst Ge­of­frey Porges sent out a note lat­er Fri­day morn­ing call­ing Walen­sky’s move “all pol­i­tics.” Porges said, in part:

This es­tab­lish­es that the tra­di­tion­al vac­cine ap­proval and rec­om­men­da­tion process is even more politi­cized in the cur­rent ad­min­is­tra­tion than it was in the pri­or one, and is bound to spark a storm of out­rage and protest from the vac­ci­na­tion and pub­lic health com­mu­ni­ties. We ex­pect there to be sev­er­al res­ig­na­tions from the com­mit­tee, which will add to the tur­moil around the vac­cine rec­om­men­da­tion process, and we view this as fun­da­men­tal­ly un­der­min­ing the in­tegri­ty of that process.

Porges said that vac­cine de­vel­op­ment con­tin­ues to be fun­da­men­tal­ly un­der­mined by the boost­er de­bate, hurt­ing phar­ma com­pa­nies, con­sumers and oth­er na­tions that re­ly on the US CDC for guid­ance. But with the de­ci­sion now in hand, it’s “open sea­son” for boost­ers. Porges ex­pects Mod­er­na to re­ceive au­tho­riza­tion for its boost­er shots with­in a few weeks, though Pfiz­er is on its way to dom­i­nat­ing the mar­ket.

Pe­ter Marks

Walen­sky’s re­jec­tion of her agency’s ad­vice bears sim­i­lar­i­ties to the FDA’s tu­mul­tuous ad­comm on boost­ers last week. Af­ter the pan­el re­ject­ed the ex­tra shots for the gen­er­al pop­u­la­tion, CBER di­rec­tor Pe­ter Marks re­turned with an ad­di­tion­al vot­ing ques­tion re­gard­ing old­er adults, as well as an “in­for­mal poll” on health­care work­ers, teach­ers and the like.

The sec­ond vot­ing ques­tion had not been re­vealed un­til pan­el mem­bers vot­ed down the first 16-2. Marks re­vised the word­ing to al­low for a boost­er EUA in old­er pop­u­la­tions de­spite Pfiz­er sub­mit­ting an sBLA.

While ad­vis­ers unan­i­mous­ly en­dorsed third shots for both pop­u­la­tions, the lat­ter was not a for­mal vot­ing ques­tion and came af­ter an ex­tra­or­di­nary back-and-forth be­tween Marks and se­nior FDA vac­cine of­fi­cial Mar­i­on Gru­ber over what da­ta should’ve been con­sid­ered in the orig­i­nal, nar­row ques­tion. Gru­ber, along with an­oth­er top vac­cine staffer, Philip Krause, an­nounced their in­tent to re­tire last month af­ter rais­ing con­cerns with boost­ers in the Lancet.

Fri­day’s move comes as on­ly the sec­ond time in the CDC’s his­to­ry where the di­rec­tor has gone against ACIP rec­om­men­da­tions, ac­cord­ing to a CN­BC re­port. The oth­er in­stance came back in 2003 in a de­ci­sion re­gard­ing small­pox vac­cines.

This ar­ti­cle has been up­dat­ed to in­clude com­ment from biotech an­a­lyst Ge­of­frey Porges.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.

In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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