Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The gener­ics man­u­fac­tur­er Lupin has been giv­en an­oth­er Form 483 from the FDA this year.

US reg­u­la­tors in­spect­ed Lupin’s phar­ma­ceu­ti­cal man­u­fac­tur­ing site in the town of Man­dideep, In­dia from Nov. 14 through Nov. 23, with the 14-page re­port mark­ing 16 ob­ser­va­tions.

The in­spec­tion re­port stat­ed that the site did not have the ap­pro­pri­ate con­trols over its com­put­er sys­tems to en­sure that changes in “mas­ter pro­duc­tion” or records are on­ly done by au­tho­rized per­son­nel, along with writ­ten pro­ce­dures not be­ing es­tab­lished to con­duct an­nu­al re­views of records as­so­ci­at­ed with drug batch­es.

In­spec­tors al­so not­ed that the site had 68 bags filled with “shred­ded doc­u­ments” at the site’s trash col­lec­tion area. But the site didn’t have an ad­e­quate­ly de­scribed process for which GMP doc­u­ments should be shred­ded.

The “rou­tine cal­i­bra­tion” of au­to­mat­ic and me­chan­i­cal equip­ment was al­so not done. Pro­ce­dures for the qual­i­ty con­trol unit were not in writ­ing and not be­ing ful­ly fol­lowed.

For ob­ser­va­tions re­lat­ed to ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs), in­spec­tors found that “crit­i­cal process pa­ra­me­ters” in the man­u­fac­tur­ing of in­gre­di­ents were not be­ing con­tin­u­ous­ly mon­i­tored. Com­put­er sys­tems did not have “suf­fi­cient con­trols” to pre­vent changes to da­ta or unau­tho­rized ac­cess. A num­ber of oth­er spe­cif­ic ob­ser­va­tions re­lat­ed to en­gi­neer­ing prac­tices and oth­er pro­ce­dures.

End­points News reached out to Lupin for com­ment on the in­spec­tion and oth­er de­tails but did not re­ceive a re­sponse by press time.

This is not the first time this year that Lupin has been un­der the mi­cro­scope from the FDA. An in­spec­tion from Oct.3 to Oct. 14 of this year, at Lupin’s biosim­i­lar man­u­fac­tur­ing fa­cil­i­ty in Pune, In­dia, had 10 ob­ser­va­tions not­ed. Some of the items not­ed by FDA in­spec­tors in­clud­ed not ap­pro­pri­ate­ly eval­u­at­ing for a mi­cro­bial con­t­a­m­i­na­tion and pro­tec­tive ap­par­el that was not al­ways be­ing worn.

Lupin has al­so been hand­ed down a warn­ing let­ter this year as well. The let­ter re­ceived in Oc­to­ber not­ed that it had sus­pend­ed the pro­duc­tion of drugs for the US mar­ket and must no­ti­fy the FDA if it wants to restart mak­ing drugs for the US.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.