An em­ploy­ee com­plaint at Eli Lil­ly's Branch­burg plant al­leges al­tered qual­i­ty con­trol docs amid FDA probe — re­port

Eli Lil­ly was one of the ear­li­est play­ers in the race for a Covid-19 an­ti­body, but a se­ries of set­backs at a New Jer­sey man­u­fac­tur­ing site have set back its ef­forts. Now, an in­ter­nal com­plaint re­port­ed­ly claims that a di­rec­tor at that site know­ing­ly fudged qual­i­ty con­trol docs right un­der the FDA’s nose.

An em­ploy­ee com­plaint from Eli Lil­ly’s man­u­fac­tur­ing plant in Branch­burg, NJ, al­leged that a di­rec­tor al­tered doc­u­ments hand­ed over to FDA reg­u­la­tors as part of an ef­fort to down­play se­ri­ous qual­i­ty con­trol is­sues amid the agency’s probe at the site, Reuters re­port­ed.

The FDA has been in­ves­ti­gat­ing the Branch­burg lo­ca­tion, which pro­duces Covid-19 an­ti­body bam­lanivimab, af­ter is­su­ing a two-ob­ser­va­tion Form 483 in Au­gust that fault­ed the site for in­ad­e­quate qual­i­ty and lab­o­ra­to­ry con­trols. An un­named source told Reuters those qual­i­ty con­cerns have con­tin­ued de­spite the FDA’s fo­cus, lead­ing to the April 8 com­plaint that man­age­ment is fudg­ing its re­sults.

The ex­act dates and de­tails of the com­plaint weren’t re­port­ed. A Lil­ly spokesper­son could not be reached for com­ment by press time.

In ad­di­tion to the re­newed con­cerns at the Branch­burg site, Reuters re­port­ed the FDA has iden­ti­fied is­sues at Lil­ly’s In­di­anapo­lis fill-fin­ish plant as well, in­clud­ing “sub­stan­dard san­i­ta­tion and qual­i­ty con­trol pro­ce­dures.”

Af­ter rac­ing out to a lead in the race for a Covid-19 an­ti­body, Lil­ly has faced a se­ries of set­backs as the FDA pulled its ini­tial EUA for so­lo bam­lanivimab last month, cit­ing the rise in vari­ants. Lil­ly was al­ready fac­ing a mea­ger mar­ket for the an­ti­body and mid­dling re­sults in treat­ing hos­pi­tal­ized pa­tients. Lil­ly still sports an EUA for an an­ti­body com­bo that con­tains bam­lanivimab, but oth­er drug­mak­ers are aim­ing for more broad­ly neu­tral­iz­ing an­ti­bod­ies that can stand up to vari­ants.

The Branch­burg plant has been the fo­cus of a lot of the scruti­ny around Lil­ly’s man­u­fac­tur­ing of the an­ti­body. Back in March, Reuters re­port­ed that a top hu­man re­sources em­ploy­ee at the site claimed she was fired af­ter work­ing to blow the whis­tle on qual­i­ty is­sues at the site. Among the many com­plaints cit­ed there, the em­ploy­ee claimed the Branch­burg site had a his­to­ry of doc­u­ments go miss­ing, with em­ploy­ees of­ten sent to dig through the trash to find them.

Mean­while, ques­tions about Lil­ly’s lead­er­ship up to the very top has been called in­to ques­tion re­cent­ly. In Feb­ru­ary, the drug­mak­er oust­ed CFO Josh Smi­ley af­ter it ver­i­fied claims he had en­gaged in in­ap­pro­pri­ate com­mu­ni­ca­tions with an em­ploy­ee. Smi­ley was one of the hand­picked deputies of CEO David Ricks, who came over to Lil­ly in 2017 to help right the ship on a flag­ging pipeline.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

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By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pillar drugs of Sanofi’s $11.6 billion pickup of Bioverativ hit a big setback late last year when the FDA sent its application for approval back. Now, as Sanofi gears up to resubmit the drug for review, the drugmaker is touting pivotal data it hopes will help take it over the finish line.

Sanofi’s sutimlimab nailed all three of its primary endpoints in its Phase III CADENZA study for patients with cold agglutinin disease, a rare disorder that can cause severe anemia, without a recent history of blood transfusion, the French drugmaker said Friday. The topline results will be presented at this weekend’s virtual EHA meeting.

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Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.

Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.