Peter Marks, CBER director (Greg Nash/Pool via AP)

CBER's Pe­ter Marks says Covid-19 shots to mir­ror flu shots: Man­u­fac­tur­ers will be in­ter­change­able

On Jan. 26, the FDA’s vac­cines ad­comm will meet to dis­cuss the fu­ture of Covid-19 boost­er shots and vari­ant strain se­lec­tion mov­ing for­ward, and CBER Di­rec­tor Pe­ter Marks yes­ter­day pre­viewed some of what will be dis­cussed in that meet­ing.

As the bi­va­lent boost­er up­take has stalled, par­tic­u­lar­ly among chil­dren, Marks is now point­ing to ways to sim­pli­fy the process.

The VRB­PAC ad­comm won’t on­ly look at what the com­po­si­tion of these Covid-19 vac­cines should be, and what’s the tim­ing for se­lect­ing new strains, but al­so how of­ten strain se­lec­tion should take place, he said, not­ing that the FDA is “try­ing to get to some sense of nor­mal­cy for how we treat vac­ci­na­tions.”

While not­ing the var­ied vial sizes and types of vac­ci­na­tions for dif­fer­ent age groups from Pfiz­er and Mod­er­na, which cre­ates chal­lenges for keep­ing things straight for phar­ma­cists, he pledged to sim­pli­fy the process so that it more close­ly mir­rors the in­fluen­za shot mod­el, with caveats around the dif­fer­ences be­tween Covid-19 and the flu.

Marks, speak­ing in con­ver­sa­tion with Dana DeShon, chair of the pro­fes­sion­al as­so­ci­a­tion for pe­di­atric nurse prac­ti­tion­ers’ im­mu­niza­tion spe­cial in­ter­est group, as part of the Covid-19 Vac­cine Ed­u­ca­tion and Eq­ui­ty Pro­ject, an­swered a ques­tion on whether a child un­der 4 years old who com­plet­ed the Mod­er­na pri­ma­ry se­ries could re­ceive a Pfiz­er boost­er:

“The is­sue would be that for these vac­cines, un­less they’ve moved in­to a new age range, we rec­om­mend the un­der 4s stick with the same brand,” Marks said.

But he added that this ques­tion cir­cles back to the rea­son for hold­ing this ad­comm, not­ing:

This is one of the is­sues that needs some sim­pli­fi­ca­tion be­cause ul­ti­mate­ly we’d like things to be as sim­ple as they are with in­fluen­za vac­cines where it doesn’t mat­ter what man­u­fac­tur­er’s vac­cine you’ve re­ceived. It would be nice to es­sen­tial­ly swap out. That will be con­sid­ered at that time, and hope­ful­ly with­in a cou­ple of months there will be bet­ter guid­ance in that re­gard.

Pfiz­er and Mod­er­na did not im­me­di­ate­ly re­spond to ques­tions on mak­ing their shots the same.

The CDC al­so notes on its web­site that while all flu vac­cines will pro­tect against the same 4 flu virus­es, dif­fer­ent flu vac­cines are man­u­fac­tured dif­fer­ent­ly, and dif­fer­ent prepa­ra­tions have dif­fer­ent in­di­ca­tions li­censed by the FDA, such as for a spe­cif­ic age range. In ad­di­tion, LAIV (the nasal spray flu vac­cine) is not rec­om­mend­ed for use in some pop­u­la­tions, the CDC says.

The dif­fer­ences be­tween the Mod­er­na and Pfiz­er Covid-19 vac­cines came to a head with the re­cent boost­er au­tho­riza­tions.

For Pfiz­er and BioN­Tech’s Covid vac­cine, the FDA re­cent­ly au­tho­rized a new bi­va­lent third dose for chil­dren 6 months through 4 years of age who have not yet re­ceived the third dose of the three-dose pri­ma­ry se­ries with the mono­va­lent ver­sion. But the mono­va­lent ver­sion of Pfiz­er-BioN­Tech’s vac­cine re­mains au­tho­rized for ad­min­is­tra­tion as the first two dos­es of the three-dose pri­ma­ry se­ries in in­di­vid­u­als 6 months through 4 years of age, and as a two-dose pri­ma­ry se­ries for in­di­vid­u­als 5 years of age and old­er, and as a third pri­ma­ry se­ries dose for in­di­vid­u­als 5 years of age and old­er who are im­muno­com­pro­mised.

For Mod­er­na, its bi­va­lent boost­er, just as it is for those 6 years and old­er, is now au­tho­rized for chil­dren 6 months through 5 years of age at least 2 months af­ter com­ple­tion of pri­ma­ry vac­ci­na­tion with the mono­va­lent Mod­er­na vac­cine.

Sim­i­lar to Pfiz­er, Mod­er­na’s mono­va­lent ver­sion is al­so au­tho­rized as a two-dose pri­ma­ry se­ries in in­di­vid­u­als 6 months and old­er and as a third in the pri­ma­ry se­ries dose for in­di­vid­u­als 6 months of age and old­er who are im­muno­com­pro­mised.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Credit: Shutterstock

New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Troy Tazbaz, FDA's newly-named director of the Digital Health Center of Excellence (Oracle via YouTube)

Or­a­cle ex­ec­u­tive Troy Tazbaz named new FDA di­rec­tor of dig­i­tal health

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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