As the amox­i­cillin short­age drags on, sev­er­al sen­a­tors pres­sure FDA and HHS for so­lu­tions

With the US star­ing down sev­er­al drug short­ages this year, one in par­tic­u­lar is now catch­ing law­mak­ers’ at­ten­tion.

A bi­par­ti­san group of sen­a­tors sent a let­ter to HHS Sec­re­tary Xavier Be­cer­ra and FDA com­mis­sion­er Robert Califf ex­press­ing “strong con­cern” about the amox­i­cillin short­age for pa­tients and gen­er­al pub­lic health. Sens. Amy Klobuchar (D-MN), Sher­rod Brown (D-OH), Ed Markey (D-MA) and Bill Cas­sidy (R-LA) are push­ing for FDA and HHS to start work­ing more force­ful­ly to ad­dress the amox­i­cillin short­age along with the oth­er drug short­ages.

The let­ter says, in part:

We urge the De­part­ment of Health and Hu­man Ser­vices and the Food and Drug Ad­min­is­tra­tion (FDA) to con­vene the Drug Short­age Task Force and work with stake­hold­ers, in­clud­ing providers, on iden­ti­fy­ing fac­tors and po­ten­tial so­lu­tions to mit­i­gat­ing the amox­i­cillin short­age. Fur­ther, we re­quest an up­date on FDA ini­tia­tives to pre­vent and mit­i­gate drug short­ages.

The let­ter not­ed that amox­i­cillin, of­ten used to treat pe­di­atric ill­ness­es, is in short sup­ply due to a “record high lev­el of res­pi­ra­to­ry ill­ness­es” that spiked de­mand for it and oth­er med­i­cines, lead­ing to de­lays in care.

Erin Fox

Erin Fox, the se­nior phar­ma­cy di­rec­tor at the Uni­ver­si­ty of Utah Health, not­ed that while sen­a­tors such as Klobuchar have been vo­cal about drug short­ages for years, the sit­u­a­tion is not cut and dried.

“FDA can’t make any drug com­pa­ny make any drug no mat­ter how crit­i­cal or life-sav­ing. This is re­al­ly up to the gener­ic drug mak­ers to make these prod­ucts. Most of the com­pa­nies refuse to pro­vide a re­al rea­son for what is go­ing on – and they don’t have to do so pub­licly,” Fox told End­points News via email.

Fox not­ed that the FDA’s drug short­age task force has out­lined so­lu­tions. How­ev­er, none of them have been im­ple­ment­ed yet.

Michael Ganio

Michael Ganio, the se­nior di­rec­tor of phar­ma­cy prac­tice and qual­i­ty at the Amer­i­can So­ci­ety of Health Sys­tem Phar­ma­cists (ASHP), said that while it is a good thing to see mem­bers of con­gress de­vot­ing at­ten­tion to drug short­ages be­cause short­ages can have a detri­men­tal ef­fect, it’s not just amox­i­cillin in short sup­ply.

“Amox­i­cillin is one of more than 260 drugs cur­rent­ly in short sup­ply, so it is im­per­a­tive that we im­ple­ment some crit­i­cal mea­sures to shore up the re­silience of our na­tion­al drug sup­ply chain to en­sure that pa­tients are able to get the med­ica­tion ther­a­py they need,” Ganio said.

For the cur­rent sit­u­a­tion on amox­i­cillin, Ganio said that the short­age will like­ly last un­til at least ear­ly 2023 and will de­pend on the du­ra­tion and scope of the out­break of “pe­di­atric res­pi­ra­to­ry in­fec­tions.” He al­so not­ed that ASHP is notic­ing re­port­ed short­ages of amox­i­cillin al­ter­na­tives such as amox­i­cillin/clavu­lanate.

One of the pro­duc­ers of the drug, San­doz, told End­points in late Oc­to­ber that fac­tors in­clud­ing man­u­fac­tur­ing ca­pac­i­ty, scarci­ty of raw ma­te­ri­als and the en­er­gy cri­sis, among oth­ers, are af­fect­ing pro­duc­tion, but the com­pa­ny added it is “on track” to bol­ster its sup­ply and is try­ing sev­er­al ways to boost its man­u­fac­tur­ing ca­pac­i­ty.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.