Texas drug man­u­fac­tur­er smacked with FDA warn­ing let­ter over mul­ti­ple vi­o­la­tions

A Texas drug man­u­fac­tur­ing fa­cil­i­ty has drawn the FDA’s ire over miss­ing records, in­ad­e­quate process­es and faulty con­trols on a laun­dry list of in­frac­tions out­lined in an agency warn­ing let­ter.

Fort Worth-based Monarch PCM, which makes phar­ma­ceu­ti­cal liq­uids, tablets, creams and lo­tions among oth­er prod­ucts, was in­spect­ed by the FDA from June through Au­gust last year. The new FDA warn­ing let­ter dat­ed June 10, 2022, list­ed the com­pa­ny’s meth­ods, fa­cil­i­ties and con­trols for a range of man­u­fac­tur­ing and pro­cess­ing is­sues that did not con­form to cur­rent good man­u­fac­tur­ing prac­tices (CGMP).

The warn­ing let­ter con­tained sev­er­al vi­o­la­tions that par­tic­u­lar­ly con­cerned the FDA, start­ing with the com­pa­ny fail­ing to in­ves­ti­gate any un­ex­plained dis­crep­an­cies or batch fail­ures.

The FDA main­tains that the com­pa­ny failed to ad­e­quate­ly in­ves­ti­gate out of spec­i­fi­ca­tion (OOS) re­sults for both drug com­po­nents and fin­ished drug prod­ucts, in­val­i­dat­ing mi­cro­bial re­sults due to lim­it­ed and in­ad­e­quate in­ves­ti­ga­tions. The com­pa­ny al­so failed to thor­ough­ly in­ves­ti­gate mul­ti­ple out-of-lim­it mi­cro­bial re­sults in both old and new wa­ter sys­tems. Ad­di­tion­al­ly, the com­pa­ny did not ad­dress po­ten­tial root caus­es as nu­mer­ous aque­ous-based drug prod­ucts were man­u­fac­tured and re­leased dur­ing a pe­ri­od from 2019 to 2021.

The com­pa­ny failed to ex­tend mi­cro­bial con­t­a­m­i­na­tion in­ves­ti­ga­tions to oth­er po­ten­tial­ly im­pact­ed drug prod­ucts, the let­ter adds.

An­oth­er ma­jor is­sue? Monarch failed to use ap­pro­pri­ate­ly de­signed and sized equip­ment in the man­u­fac­ture or pro­cess­ing of drug prod­ucts. Specif­i­cal­ly, its wa­ter sys­tems and man­u­fac­tur­ing equip­ment were not de­signed, cleaned and main­tained ap­pro­pri­ate­ly with the FDA not­ing sev­er­al in­frac­tions spe­cif­ic to the wa­ter is­sues.

The com­pa­ny re­spond­ed by in­cor­po­rat­ing a new wa­ter sys­tem per­for­mance qual­i­fi­ca­tion pro­to­col and de­vel­op­ing a plan to ex­e­cute the new pro­to­col, but the re­spons­es were not suf­fi­cient for the FDA.

The com­pa­ny’s qual­i­ty con­trol unit al­so failed to re­spon­si­bly en­sure drug prod­ucts man­u­fac­tured were fol­low­ing CGMP stan­dards, the FDA charges. The FDA in­spec­tors, for in­stance, found test­ing for Burk­holde­ria cepa­cia com­plex (BCC or B. cepa­cia) was not per­formed as re­quired per es­tab­lished spec­i­fi­ca­tions, batch pro­duc­tion records were not be­ing es­tab­lished and CGMP records were miss­ing pri­or to the in­ves­ti­ga­tion.

The com­pa­ny al­so failed to es­tab­lish and fol­low a prop­er­ly writ­ten test­ing pro­gram de­signed to as­sess the sta­bil­i­ty char­ac­ter­is­tics of drug prod­ucts.

The FDA let­ter says a fail­ure to ad­dress the mat­ters can re­sult in reg­u­la­to­ry or le­gal ac­tion in­clud­ing seizures or an in­junc­tion. Un­re­solved vi­o­la­tions may al­so pre­vent oth­er fed­er­al agen­cies from award­ing con­tracts. The FDA can al­so with­hold the is­suance of ex­port cer­tifi­cates or the ap­proval of new ap­pli­ca­tions.

The com­pa­ny was giv­en 15 days from the June 10th is­sue date to re­spond to the let­ter.

Monarch did not re­spond to an in­quiry from End­points News by press time.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Governor John Carney, Lieutenant Governor Bethany Hall-Long, Mayor Kenneth Branner, Jr., Delaware Prosperity Partnership President Kurt Foreman, WuXi AppTec Chairman and CEO Ge Li, WuXi AppTec Co-CEO and WuXi STA CEO Minzhang Chen, and others celebrate the groundbreaking for the WuXi STA Middletown campus.

WuXi breaks ground on Delaware fa­cil­i­ty, boost­ing its US pres­ence

While Middletown, Delaware’s main claim to fame was the site location for the film the Dead Poets Society, the city will soon play host to a massive manufacturing outfit.

WuXi AppTec’s contract research and manufacturing subsidiary WuXi STA, has broken ground on a 190-acre manufacturing campus in Middletown.

According to the company, this site will be WuXi’s second facility in the US, and it will create around 500 full-time jobs by 2026, but there are plans to kick off operations in 2025.

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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