The John­son Memo­r­i­al Can­cer Cen­ter in En­field, CT is no stranger to bat­tles with in­spec­tion prob­lems, and it was hit with an­oth­er Form 483 in Oc­to­ber, af­ter a string of trou­bles not­ed by the FDA.

A num­ber of ob­ser­va­tions were made, but per­haps the most glar­ing: staff at­tach­ing wipes to a mop han­dle to try and clean pro­duc­tion equip­ment.

The site was in­spect­ed 10 times be­tween Sept. 20 and Oct. 20 of last year.

Borte­zomib is used to treat adult pa­tients with mul­ti­ple myelo­ma, a can­cer of the bone mar­row, as well as man­tle cell lym­phoma. Mar­ket­ed un­der the name Vel­cade, it was co-de­vel­oped by Mil­len­ni­um Phar­ma­ceu­ti­cals and J&J, and land­ed FDA ap­proval for in­tra­venous in­jec­tion in 2003, then sub­cu­ta­neous­ly in 2012. It was lat­er ap­proved in 2014 for pre­treat­ment of mul­ti­ple myelo­ma pa­tients. One treat­ment cy­cle in­cludes twice-week­ly in­jec­tions for two weeks, fol­lowed by a 10-day rest pe­ri­od. Take­da and Janssen co-pro­mote the drug in Japan.

Poor clean­ing prac­tices were the rea­son for the hold, in par­tic­u­lar, dur­ing the pro­duc­tion process. A tech­ni­cian was ob­served fail­ing to clean the in­ter­nal screen be­tween batch­es and used a stain­less steel mop han­dle out­fit­ted with ster­il­iz­ing wipes to clean the in­te­ri­or of a biore­ac­tor in­stead of the ap­pro­pri­ate mop, which meant that the tech­ni­cian wasn’t able to reach and clean the en­tire in­te­ri­or, in­clud­ing the back and sides.

A phar­ma­cy tech­ni­cian al­so failed to clean the sep­tum of two vials of the drug prod­uct in be­tween ster­ile pro­duc­tion ac­tiv­i­ties, and the high-ef­fi­cien­cy par­tic­u­late air fil­ter — al­so known as a HE­PA — cov­er­age wasn’t ad­e­quate enough, there­by ex­pos­ing ster­ile prod­uct, the FDA said.

Smoke stud­ies, in which man­u­fac­tur­ers must an­a­lyze air pat­tens to en­sure that the qual­i­ty can­not con­t­a­m­i­nate the drug prod­uct, were lack­ing key as­pects in Au­gust 2020, Feb­ru­ary 2021 and Au­gust 2021, the agency said.

It’s not the lo­ca­tion’s first run-in with con­t­a­m­i­na­tion prob­lems. In 2014, the site was hand­ed a Form 483 for fail­ing to pre­vent mi­cro­bial con­t­a­m­i­na­tion and mix-ups. In­ves­ti­ga­tors no­ticed wa­ter stain marks in rooms, and the com­pa­ny failed to eval­u­ate air qual­i­ty, with out­side air pen­e­trat­ing through a room used for gown­ing and prepa­ra­tion be­fore ster­il­iza­tion. HE­PA fil­ters hadn’t been prop­er­ly swapped out and were yel­low at the time of in­spec­tion, and the firm didn’t eval­u­ate the pres­sure be­tween clean rooms, some­thing es­sen­tial to pre­vent­ing con­t­a­m­i­na­tion.

Then in 2015, mold and fun­gus at the site led Con­necti­cut au­thor­i­ties to close the can­cer in­fu­sion cen­ter for months, on top of the man­u­fac­tur­ing op­er­a­tions for more than a year. The build­ing was built in 1998, ac­cord­ing to the Hart­ford Busi­ness Jour­nal, but state in­spec­tors found more than 50 se­ri­ous vi­o­la­tions at the hos­pi­tal and its treat­ment cen­ters, which in­clud­ed staff bla­tant­ly ig­nor­ing prob­lems that in­clud­ed mold and fun­gus. De­spite the in­di­ca­tion that staff was aware of the prob­lems, they weren’t dis­cussed pub­licly, ac­cord­ing to the meet­ing min­utes.

A rep­re­sen­ta­tive from the cen­ter did not re­turn a re­quest for in­for­ma­tion by pub­li­ca­tion time.

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Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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