An FDA in­spec­tion found sev­er­al is­sues in­clud­ing spore-re­lat­ed con­t­a­m­i­na­tion in the man­u­fac­tur­ing area at a site in the city of Chun­cheon, South Ko­rea.

The in­spec­tion took place be­tween Aug. 12 and Aug. 20 last year at the NO. 2 fac­to­ry for Hugel, a mak­er of bot­u­linum tox­in(s), der­mal fillers and oth­er aes­thet­ic prod­ucts. The in­spec­tion it­self found sev­er­al ma­jor ob­ser­va­tions at the site in FDA doc­u­ments that were dis­closed on Tues­day.

The Form 483 not­ed that clostrid­i­um bot­u­linum spores, which can cause ill­ness, were present in the com­pa­ny’s drug sub­stance man­u­fac­tur­ing ar­eas. The FDA not­ed that the area could not stop spore con­t­a­m­i­na­tion risk to oth­er man­u­fac­tur­ing ar­eas. The FDA al­so found that the site’s de­con­t­a­m­i­na­tion ef­forts were not ad­e­quate as the dis­in­fec­tants used were not able to de­con­t­a­m­i­nate the spores.

The Form 483 al­so not­ed that the spores were not a part of stan­dard en­vi­ron­men­tal mon­i­tor­ing at the site.

In ad­di­tion, the FDA found an im­pu­ri­ty with a par­tic­u­lar prod­uct batch and found that more than 12 log­books went miss­ing af­ter sev­er­al years. A work­ing cell bank that is used to man­u­fac­ture drugs was found to be mixed up with an­oth­er work­ing cell bank.

A batch fail­ure was al­so not­ed by the FDA with dam­aged vials and op­er­a­tors tak­ing breaks be­ing ma­jor caus­es.

Hugel joins sev­er­al man­u­fac­tur­ers in Ko­rea that have hit reg­u­la­to­ry walls in the past year. Last year, Sam­sung Phar­ma­ceu­ti­cal’s man­u­fac­tur­ing op­er­a­tions had to be sus­pend­ed af­ter South Ko­rea’s health reg­u­la­tor found that a pro­duc­tion man­ag­er was tasked with re­spon­si­bil­i­ties for two dif­fer­ent plants, which vi­o­lat­ed a law re­quir­ing each plant to be man­aged by one per­son. This led to six drugs be­ing halt­ed from be­ing pro­duced for sev­er­al months.

In April of this year, Vivo­zon had to halt drug pro­duc­tion and was or­dered to re­call and dis­card 13 drugs af­ter vi­o­lat­ing good man­u­fac­tur­ing prac­tice stan­dards.

Oth­er com­pa­nies such as Cell­tri­on and Dae­woong Phar­ma­ceu­ti­cal have al­so re­ceived ob­ser­va­tions from the FDA since 2017.

In 2020, as a result of the CARES Act, drug manufacturers are now required to report new data annually to the FDA, including the amount of each listed drug that was manufactured, prepared or processed for distribution.

The guidance, which was unveiled last year, detailed specifics about reporting with the changes to the National Drug Code (NDC), as well as other details surrounding specific products and how they should be reported. While manufacturers of APIs, drugs and consultants did get their reports to the FDA, there was still a level of confusion and a need to clarify some details.

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Alnylam has detailed positive APOLLO-B data for its pivotal trial of patisiran in treating transthyretin-mediated — or ATTR — amyloidosis with cardiomyopathy. And the results spell out a clear advantage over a placebo in preventing a rapid decline in a 6-minute walk test.

But bound to get immediate attention are unanswered questions on the drug’s health benefits and how the drug and placebo data tracked in the study for an increasingly common heart ailment compared to the disaster that befell a rival therapy at BridgeBio. On that score, there was a wild difference between the two studies in the placebo arm, where patients typically see swift deterioration.

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J&J has settled a case with a former employee who accused top execs — including former CEO Alex Gorsky and former R&D head Mathai Mammen — of gender discrimination and retaliation leading up to her eventual termination after 25 years with the pharma giant.

The case was dismissed with prejudice on Aug. 8, after the dispute had been “amicably resolved,” according to court documents released a week ago. J&J has not responded to multiple requests for comment as of press time.

PARIS — A little more than four years after Bristol Myers Squibb proudly unveiled a $3.6 billion, next-gen I/O alliance with Nektar, including about half of that in cold, hard cash, investigators have turned up at ESMO with the full set of disastrous Phase III data that helped ice the whole deal.

We learned back in March that Opdivo plus Nektar’s IL-2 therapy bempeg flunked a Phase III melanoma study. Now we’re learning that the combo actually performed significantly worse than Opdivo alone, while raising added safety threats for the patients in the combo arm.

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While Florida Gov. Ron DeSantis has been publicly feuding with the FDA after accusing the federal agency of dragging its feet on approving the state’s drug import plan, Colorado is announcing its own partnership with a handful of companies, including a Canadian subsidiary, in an attempt to bring down drug prices.

The state quietly announced in mid-August that it is putting together an application to the FDA for a partnership with three companies to import lower-priced medicines approved in Canada into the US. According to a statement, the program is estimated to save Coloradans 60% on prescription medicines, if US regulators sign off on it.

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Health inequity in the US increasingly drew attention through the pandemic, with long-existing disparities exacerbated — and spurring financial support and promises of help from pharma companies. Now the Merck Foundation is taking a step further with a new fund to focus equity efforts specifically on cancer care.

The goal of the $20 million Alliance for Equity in Cancer Care debuted on Thursday is to go beyond clinical interventions in cancer and drive much-needed surrounding support for underserved people and communities. The initiative includes grants to seven cancer centers, hospitals and researchers across the country including Boston Medical Center, Memorial Sloan Kettering Cancer Center in New York, Mary Bird Perkins Cancer Center in Baton Rouge, Louisiana, and the ASCO Foundation’s Conquer Cancer in Montana.

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Does your pharma brand speak Spanish? Not just translating advertising copy into the language, but authentically speaking to people with consideration of different Hispanic cultures?

That’s what pharma brands should be doing if they want to reach the “crucial” Hispanic audience, according to Publicis Health Media (PHM).

Statistically, the Hispanic population is growing at a rapid pace — by 23% over the past decade compared to 7% overall US population growth, according to Pew Research — but more than that specific to pharma and healthcare, they are active, engaged and interested in more health information.

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While just three brand-name inhalers approved between 1986 and 2020 now face generic competition (thanks in a large part to patent thickets and companies shifting old active ingredients to new devices), the same sort of long monopoly extensions are not as prevalent for nebulizers, a new study published today in Nature Biotechnology explains.

The Harvard and University of Calgary authors note that nearly one-third of brand-name nebulizer solutions, which include drugs for asthma or other conditions in an aerosol mist form, faced generic competition before expiration of FDA-listed patents, compared to just 2% of brand-name inhalers.

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PARIS — AstraZeneca and Merck arrived at ESMO with long-term data on their blockbuster cancer drug and European confab staple Lynparza, which ushered in the PARP inhibitor market in December 2014.

The datasets this time around were a mixed bag — the Big Pharma partners detailed five-year follow-up results to the PAOLA-1 Phase III and seven-year analysis of the SOLO-1 Phase III, two trials that have drummed up plenty of interest at the annual oncology meetup across the pond.

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

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