Adder­all sup­ply woes con­tin­ue as the FDA con­firms short­age of im­me­di­ate re­lease cap­sules

While it’s been on­ly a few days since more man­u­fac­tur­ers of gener­ic Adder­all cap­sules an­nounced up­com­ing short­ages, the FDA is al­so rais­ing con­cerns on the is­sue.

The reg­u­la­tor an­nounced that there was a short­age of the im­me­di­ate re­lease ver­sion of the gener­ic, which treats AD­HD and nar­colep­sy.

In a state­ment, the FDA said it is in com­mu­ni­ca­tion with all man­u­fac­tur­ers, with Te­va re­port­ing to the agency that it is ex­pe­ri­enc­ing “on­go­ing in­ter­mit­tent man­u­fac­tur­ing de­lays.” The FDA es­ti­mates that some prod­ucts will re­turn to stock this month, but some won’t be on the mar­ket un­til No­vem­ber or De­cem­ber.

In a state­ment to End­points News, a Te­va spokesper­son said that the com­pa­ny has an “ac­tive sup­ply” of both brand­ed and gener­ic Adder­all and is pro­duc­ing and re­fill­ing the chan­nel reg­u­lar­ly at lev­els above his­tor­i­cal de­mand.

“It is pos­si­ble that some peo­ple may en­counter a back­o­rder (in­ter­mit­tent­ly) based on tim­ing and de­mand, but these are on­ly tem­po­rary. We are ac­tive­ly ship­ping both brand­ed and gener­ic Adder­all to cus­tomers, and we ex­pect in­ven­to­ry re­cov­ery in the com­ing months,” the spokesper­son said.

Oth­er man­u­fac­tur­ers are re­port­ed­ly pro­duc­ing the gener­ic drug, but there is not enough sup­ply now to meet the US mar­ket de­mand.

The FDA is ad­vis­ing that un­til sup­ply is re­stored, there are al­ter­na­tives avail­able which in­clude the use of the ex­tend­ed-re­lease ver­sion of the drug. How­ev­er, pa­tients should al­so work with health­care providers to con­sid­er the best op­tions.

“We will con­tin­ue to mon­i­tor sup­ply and as­sist man­u­fac­tur­ers with any­thing need­ed to re­solve the short­age and will up­date our web­site with new sup­ply in­for­ma­tion as it be­comes avail­able,” the FDA said.

Ac­cord­ing to the FDA’s da­ta on drug short­ages, dos­es are avail­able from Lan­nett Phar­ma­ceu­ti­cals, Alvo­gen and Sun­rise Phar­ma­ceu­ti­cals.

How­ev­er, the Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists (AH­SP) has re­port­ed short­ages in the ex­tend­ed and im­me­di­ate re­lease ver­sions from sev­er­al man­u­fac­tur­ers, in­clud­ing those from Am­neal Phar­ma­ceu­ti­cals, Cam­ber Phar­ma­ceu­ti­cals, Par Phar­ma­ceu­ti­cals, Rhodes, Sun Phar­ma, San­doz and Te­va.

The drug, which has had sup­ply is­sues for a few months, with the squeeze be­ing chalked up to, among sev­er­al rea­sons, a rise in pre­scrip­tions from in­creased dosage amounts and start­up pre­scrip­tion ser­vices, ac­cord­ing to a Bloomberg re­port.

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

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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.