Strug­gles with FDA con­tin­ue for Lupin as it is hand­ed an­oth­er Form 483

Trou­bled gener­ics man­u­fac­tur­er Lupin has strug­gled with FDA clean­ing and process val­i­da­tion guide­lines for the past four years. Now, the In­di­an com­pa­ny’s been hit with an­oth­er Form 483, fol­low­ing an in­spec­tion car­ried out be­tween March 22 and April 4.

The ci­ta­tion is in re­gards to vi­o­la­tions at the Tara­pur, In­dia man­u­fac­tur­ing fa­cil­i­ty. A let­ter ad­dressed to the Na­tion­al Stock Ex­change of In­dia is dat­ed April 5.

“The in­spec­tion closed with four ob­ser­va­tions,” the no­tice, signed by com­pa­ny sec­re­tary RV Sa­tam, says. “We are con­fi­dent of ad­dress­ing the ob­ser­va­tions to the US FDA’s sat­is­fac­tion. We are com­mit­ted to ad­her­ence and full com­pli­ance with cGMP reg­u­la­tions and up­hold the high­est qual­i­ty stan­dards across our man­u­fac­tur­ing sites.”

Lupin’s fa­mil­iar with clash­es with the FDA. In 2020, the FDA took is­sue with the Tara­pur plant’s con­di­tions. Lupin has been hit with 36 in­spec­tion ci­ta­tions since De­cem­ber 2011, the FDA’s on­line data­base shows.

Just in Ju­ly, Lupin sub­sidiary Nov­el Lab­o­ra­to­ries re­ceived a warn­ing let­ter af­ter drug residue was found left on tablet press­es and the man­u­fac­tur­ing process was not val­i­dat­ed af­ter equip­ment changes, the FDA said in the let­ter. It was the first vi­o­la­tion at that site, but the third in four years for sites with­in the com­pa­ny’s net­work.

Two of the com­pa­ny’s sites in In­dia, one in Goa and an­oth­er in Man­dideep, were is­sued warn­ing let­ters in 2017 and 2019, re­spec­tive­ly, for sim­i­lar cGMP vi­o­la­tions. Those two fa­cil­i­ties made prod­ucts that, at the time, made up more than 40% of Lupin’s sales.

The news comes around the same time that the com­pa­ny re­ceived ten­ta­tive ap­proval from the FDA to mar­ket a gener­ic equiv­a­lent of Gilead’s Vem­lidy, used to treat he­pati­tis B and HIV in­fec­tion. That will be made at the com­pa­ny’s Nag­pur Fa­cil­i­ty site in In­dia. It all re­ceived ap­proval for its AN­DA for gener­ic Pris­tiq ex­tend­ed-re­lease tablets and launched Merzee cap­sules in the US all in the last two weeks, as well as ac­quired a port­fo­lio of brands from An­glo-French Drugs & In­dus­tries.

Lupin has 15 man­u­fac­tur­ing sites through­out the world, in­clud­ing lo­ca­tions in Brazil, Mex­i­co, Flori­da and Bal­ti­more.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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As the amox­i­cillin short­age drags on, sev­er­al sen­a­tors pres­sure FDA and HHS for so­lu­tions

With the US staring down several drug shortages this year, one in particular is now catching lawmakers’ attention.

A bipartisan group of senators sent a letter to HHS Secretary Xavier Becerra and FDA commissioner Robert Califf expressng “strong concern” about the amoxicillin shortage for patients and general public health. Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA) are pushing for FDA and HHS to start working more forcefully to address the amoxicillin shortage along with the other drug shortages.

Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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