Joe Biden (AP Photo/Susan Walsh)

Covid-19 roundup: Biden plans for ear­ly No­vem­ber roll­out of vac­cines for kids; EMA eval­u­ates Re­gen­eron's an­ti­body com­bo

The Biden ad­min­is­tra­tion on Wednes­day an­nounced plans for a quick roll­out of the Pfiz­er/BioN­Tech Covid-19 vac­cine to kids ages 5 to 11 ear­ly next month, pend­ing FDA au­tho­riza­tion.

The ad­min­is­tra­tion plans to ini­ti­ate com­mu­ni­ty part­ner­ships with clin­ics, phar­ma­cies and hos­pi­tal sys­tems if that EUA hap­pens.

The an­nounce­ment comes as Pfiz­er’s vac­cine has shown 93% ef­fec­tive­ness in pre­vent­ing hos­pi­tal­iza­tions among ado­les­cents aged 12 to 18, ac­cord­ing to the CDC analy­sis of re­al-world da­ta re­leased on Tues­day.

The analy­sis of da­ta from 19 US pe­di­atric hos­pi­tals, which was con­duct­ed while the Delta vari­ant was at its peak from June through Sep­tem­ber, showed that among the 179 chil­dren who were hos­pi­tal­ized for Covid-19, all but six were un­vac­ci­nat­ed. And of the 29 pa­tients hos­pi­tal­ized with se­vere enough Covid-19 to re­quire life sup­port, none were vac­ci­nat­ed. Two of those pa­tients died.

While the Pfiz­er/BioN­Tech vac­cine is cur­rent­ly au­tho­rized for chil­dren as young as 12, the FDA has sched­uled an ad­comm to eval­u­ate and weigh the da­ta on the younger chil­dren on Oct. 26. And the CDC’s in­de­pen­dent ad­vi­so­ry com­mit­tee will meet on Nov. 2-3.

EMA starts eval­u­a­tion of Roche/Re­gen­eron mon­o­clon­al an­ti­body com­bo

The Eu­ro­pean Med­i­cines Agency has be­gun eval­u­at­ing Roche’s ap­pli­ca­tion for mar­ket­ing au­tho­riza­tion for the mon­o­clon­al an­ti­body com­bo Ron­apreve from Roche and Re­gen­eron.

The agency will as­sess Ron­apreve, which has won an EUA in the US and brought in bil­lions in sales, on a short­er time­line and could is­sue an opin­ion with­in two months, the EMA says.

EMA’s safe­ty com­mit­tee al­so com­plet­ed its first as­sess­ment of Roche’s risk man­age­ment plan to iden­ti­fy, char­ac­ter­ize and min­i­mize Ron­apreve’s risks. There is al­so da­ta in the works on how the an­ti­body com­bi­na­tion can be de­vel­oped and stud­ied for use in chil­dren, ac­cord­ing to the EMA’s pe­di­atrics com­mit­tee.

The EMA al­so said it will work with the Eu­ro­pean Com­mis­sion to fast track mar­ket­ing au­tho­riza­tions in all EU and EEA mem­ber states.

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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Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.

Tedros Adhanom Ghebreyesus (Denis Balibouse/Pool Photo via AP Images)

WHO rec­om­mends against the use of con­va­les­cent plas­ma for Covid-19

The World Health Organization said late today that it’s not recommending the use of convalescent plasma as a treatment for Covid-19 for mild or severe cases, but some U.S. experts disagree with the recommendations and say there are patients who can benefit from the plasma of those who’ve recovered from Covid-19.

The recommendation is informed by a review of 16 RCTs and a “meta-analysis on antibodies and cellular therapies for covid-19,” the WHO said, adding in a statement:

Gilead re­calls 2 lots of Vek­lury af­ter in­ves­ti­ga­tion con­firms com­plaint of glass par­tic­u­lates

Two lots of the Covid-19 treatment Veklury have been recalled by Gilead, the company said last week, after the appearance of glass particulates. A customer complaint was confirmed by Gilead’s investigation.

Veklury, also known as remdesivir 100 mg for injection, is used in more than half of hospitalized patients with Covid-19, according to Gilead. It raked in around $2.8 billion last year, and was the only drug approved by the FDA for this setting. But a study out of Europe dubbed DisCoVeRy found that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.

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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