Up­dat­ed: FDA slaps Op­tum In­fu­sion with a warn­ing let­ter over 'in­san­i­tary' pro­duc­tion con­di­tions

The FDA is­sued a warn­ing let­ter to Op­tum In­fu­sion Ser­vices last month cit­ing a list of po­ten­tial con­t­a­m­i­na­tion con­cerns, in­clud­ing “ver­min” found in a pro­duc­tion area.

The let­ter, post­ed by the FDA on Tues­day, ac­cus­es Op­tum of pro­duc­ing ster­ile drug prod­ucts “un­der in­san­i­tary con­di­tions.” It fol­lows a Form 483 filed back in March up­on in­spec­tion of the com­pa­ny’s Chan­dler, AZ, site.

An in­ves­ti­ga­tor re­port­ed that Op­tum failed to “per­form ad­e­quate prod­uct eval­u­a­tion and take ap­pro­pri­ate cor­rec­tive ac­tion af­ter ver­min was ob­served in your pro­duc­tion area,” and af­ter “mi­cro­bial con­t­a­m­i­na­tion was re­cov­ered” in an asep­tic pro­cess­ing area.

“An op­er­a­tor placed their gloved hands out­side the ISO 5 area to re­trieve sup­plies with­out san­i­tiz­ing their gloved hands be­fore re-en­try in­to the ISO 5 hood,” the let­ter states.

While the FDA not­ed that some of Op­tum’s re­spons­es “ap­pear ad­e­quate,” the com­pa­ny “did not in­clude suf­fi­cient in­for­ma­tion or sup­port­ing doc­u­men­ta­tion.” For ex­am­ple, Op­tum said it changed pest con­trol providers, in­stalled in­sect light traps, and would put up air cur­tains and plas­tic flap cur­tains on cer­tain en­try­ways — but the FDA not­ed that it’s “un­clear when these cor­rec­tive ac­tions will be ful­ly im­ple­ment­ed.”

In ad­di­tion, Op­tum said it held on-site train­ing in re­sponse to the con­t­a­m­i­na­tion ac­cu­sa­tions. How­ev­er, the FDA said that the com­pa­ny didn’t pro­vide an Asep­tic Tech­nique Eval­u­a­tion Up­date, and rec­om­mends that man­age­ment con­duct “a com­pre­hen­sive as­sess­ment of op­er­a­tions” on its asep­tic pro­cess­ing in par­tic­u­lar, with the help of a third-par­ty con­sul­tant.

“FDA strong­ly rec­om­mends that your man­age­ment un­der­take a com­pre­hen­sive as­sess­ment of op­er­a­tions, in­clud­ing fa­cil­i­ty de­sign, pro­ce­dures, per­son­nel, process­es, main­te­nance, ma­te­ri­als, and sys­tems,” the let­ter reads.

“We are com­mit­ted to pro­vid­ing safe, con­ve­nient and af­ford­able ac­cess to med­ica­tions for our pa­tients. We have in­sti­tut­ed en­hance­ments to our cur­rent process­es to ad­dress the FDA ob­ser­va­tions,” Op­tum said in an email to End­points News.

This sto­ry has been up­dat­ed to in­clude com­ment from Op­tum.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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