The growth of API man­u­fac­tur­ing in In­dia and Chi­na has led to nu­mer­ous warn­ing let­ters and lots of ques­tion marks around qual­i­ty con­trol and da­ta in­tegri­ty is­sues. But vi­o­la­tions by US-based API man­u­fac­tur­ers can be just as ques­tion­able.

For in­stance, in a warn­ing let­ter dat­ed last week, St. Louis-based API man­u­fac­tur­er Jost Chem­i­cal was cri­tiqued for the way it failed to ad­e­quate­ly re­spond to mold con­t­a­m­i­na­tion, fol­low­ing com­plaints from Au­gust 2018 re­lat­ed to its man­u­fac­ture of potas­si­um sul­fate.

“No­tably, you re­port­ed that ap­prox­i­mate­ly 83 per­cent of your mi­cro­bial prod­uct fail­ures were mold-re­lat­ed fail­ures,” FDA not­ed, ex­plain­ing that the site’s wa­ter sys­tems are not ad­e­quate, es­pe­cial­ly as the site man­u­fac­tures APIs that are used by cus­tomers to pro­duce ster­ile drug prod­ucts.

“Your cur­rent fre­quen­cy of test­ing and wa­ter qual­i­ty stan­dards are in­ad­e­quate to en­sure con­trol over your man­u­fac­tur­ing process­es,” the warn­ing says. “You are re­spon­si­ble for en­sur­ing the wa­ter for equip­ment clean­ing and man­u­fac­tur­ing is of suit­able qual­i­ty and does not po­ten­tial­ly con­tribute to con­t­a­m­i­na­tion of mi­crobes or mi­cro­bial byprod­ucts to API process­es.”

What’s more is that the com­pa­ny did not re­call the APIs af­fect­ed by mold.

“You did not ini­ti­ate a for­mal re­call with FDA no­ti­fi­ca­tion but in­stead in­formed your clients the lots failed to meet spec­i­fi­ca­tions and in­struct­ed them to re­turn or de­stroy the fail­ing lots,” the FDA said. “In ad­di­tion, your retests showed per­va­sive mold in three lots, but you did not ex­pand your in­ves­ti­ga­tion suf­fi­cient­ly to in­clude oth­er po­ten­tial­ly im­pact­ed lots to ful­ly ad­dress the scope of the prob­lem.”

Now, the FDA wants Jost to do a ret­ro­spec­tive re­view of out-of-spec re­sults it ini­ti­at­ed over the last three years to iden­ti­fy in­ves­ti­ga­tions that were not ex­pand­ed to in­clude all po­ten­tial­ly im­pact­ed lots.

And like some of its Chi­nese and In­di­an API coun­ter­parts, the FDA al­so warned Jost for in­suf­fi­cient con­trols over its cGMP da­ta. Not on­ly does Jost lack unique pass­words for lab in­stru­ments used to gen­er­ate an­a­lyt­i­cal da­ta for fin­ished API prod­ucts, but the in­spec­tion found that the site’s an­a­lyt­i­cal sys­tems lacked con­trols to pre­vent users from delet­ing elec­tron­ic da­ta — a ma­jor is­sue.

The site al­so lacks pro­ce­dures gov­ern­ing the re­view of au­dit trails of both pro­duc­tion and lab­o­ra­to­ry equip­ment, and the FDA al­so found its clean­ing val­i­da­tion for non-ded­i­cat­ed man­u­fac­tur­ing equip­ment is in­ad­e­quate, and its mi­cro­bial test pro­ce­dure is in­ad­e­quate.

With Keytruda bulling its way past the $5 billion mark for Q2 sales, you could say that the top execs at Merck can be believed when they say how keenly interested they are in using its cash reserves for new M&A and licensing deals. Just don’t ask what they’re negotiating to buy right now.

The analysts largely tiptoed around the biggest buzz about Merck today: that it’s engaged in discussions to buy Seagen for $40 billion-plus. They’re a polite bunch that needs to be on a first-name basis with CEO Rob Davis. But Davis was willing to emphasize that the pharma giant has the means and the intent to do more deals.

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While Rich Nelson is out as interim CEO of vTv Therapeutics, he will be continuing as the company’s EVP of corporate development as Paul Sekhri takes the mantle of president and CEO on Aug. 1.

In Nelson’s four short months as head of the North Carolina-based biotech, he saw G42 Healthcare, a UAE health tech company, invest in vTv and agree to collaborate on vTv’s Phase III study for a type I diabetes treatment. Prior to Nelson’s stepping in as CEO, Deepa Prasad had served as CEO, though she too was only there for a few months.

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Make way, Dermavant. Two months after the company vowed to upend the plaque psoriasis market with its newly approved vanishing cream, there’s another topical to contend with.

Arcutis Biotherapeutics secured a win on Friday for its phosphodiesterase-4 (PDE4) inhibitor roflumilast, now marketed as Zoryve in plaque psoriasis for children and adults ages 12 and up.

You may recognize roflumilast as the active ingredient in AstraZeneca’s COPD drug Daliresp. PDE4s have long been used to treat skin and other inflammatory conditions, with Otezla being one of the most notable. However, earlier generations carry burdensome side effects, most commonly nausea, diarrhea and vomiting that “really limited the usefulness of PDE4s,” CEO Frank Watanabe said.

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Most pharma TV commercials include a link at the end of the ad, offering a website link for viewers who want more information. It turns out millions of them do. So far in 2022, AbbVie, Novo Nordisk and AstraZeneca are leading the pharma pack with the most engagements garnered, according to data for the first half of 2022 from TV ad tracker EDO.

AbbVie’s Allergan Vuity eyedrops for age-related blurry vision drove the most searches among pharma TV advertising, generating 3.43 million searches after ad runs. That’s more than double the total for the next searched TV ad at No. 2, Novo Nordisk’s Ozempic, which notched 1.7 million, in EDO’s research.

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AstraZeneca CEO Pascal Soriot has been “pruning the tree” for quite some time, cutting a slate of unwanted programs across a range of indications over the last few quarters. And though the chief executive revealed two new cuts on Friday, he said he’s just about ready to put the clippers down and focus on “trying to grow new branches.”

Soriot expects the next couple of years to be “extremely rich in clinical results,” with more than 20 Phase III readouts slated for next year.

Beyond the back and forth of whether Democrats’ drug price negotiation plan is necessary to bring down costs, or just a thinly veiled attempt at price controls, the nuts and bolts of the deal mean pharma companies will inevitably see the tail ends of certain small molecule and biologic sales peter out before they otherwise would have in today’s marketplace.

While the bill’s text is not set in stone, and the Senate parliamentarian may still take issue with the excise tax that CMS will use to ensure companies comply with the negotiated prices, SVB Securities explained to investors how more than a dozen drugs from Eli Lilly, AstraZeneca, AbbVie and J&J, among others, would lose out on some revenue just before their generic competitors hit the market.

AbbVie’s executive team stayed right on track in Q2, with its Skyrizi franchise — now newly approved for Crohn’s — continuing to rack up impressive sales, making up for some unexpected weakness from a stronger dollar. The erosion of the Imbruvica franchise, however, dragged down the stock price $ABBV 5% Friday.

That set the stage for a bullish presentation by CEO Rick Gonzalez, who carefully steered the conversation around the looming loss of US exclusivity with Humira to the formulary discussions now underway that would allow the megabrand to continue to generate revenue in 2023 and 2024, as AbbVie’s newer entries became better established and some hot pipeline picks get a chance to prove themselves in pivotal trials.

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While Sarepta has three antisense oligonucleotide therapies approved — albeit not without controversy — for Duchenne muscular dystrophy, it has been working on a long-term treatment in the form of a gene therapy.

After posting positive results for its Roche-partnered gene therapy, dubbed SRP-9001, earlier this month, the Cambridge, MA-based biotech says it now intends to pursue an accelerated approval for its latest Duchenne treatment. Sarepta shares $SRPT rose about 10% on the news in early Friday trading.

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Labcorp announced this morning that it is spinning out most of its CRO business, eight years after its $6 billion Covance acquisition.

Labcorp will keep its core business directed at diagnostic testing, the company said Thursday morning after the Wall Street Journal reported the split earlier in the morning, citing sources familiar with the matter. A tax-free spinout is expected in the second half of next year, the company said.

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

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