Eli Lil­ly's much-ma­ligned Branch­burg plant earns a fed­er­al sub­poe­na amid whistle­blow­er claims tied to Covid-19 work

With Eli Lil­ly’s work on Covid-19 an­ti­bod­ies fac­ing mul­ti­ple set­backs at the FDA and state lev­el, the plant re­spon­si­ble for pro­duc­ing the drugs has seen a flush of em­ploy­ee com­plaints al­leg­ing fudged doc­u­ments and poor con­di­tions. Now, the De­part­ment of Jus­tice is get­ting in­volved and wants to see Lil­ly’s pa­per­work.

The DOJ hit Lil­ly with a sub­poe­na re­quest­ing ad­di­tion­al doc­u­men­ta­tion on its work at a Branch­burg, NJ plant, the In­di­anapo­lis drug­mak­er said in an SEC fil­ing. The scope of the DOJ’s in­ves­ti­ga­tion is un­clear, but in ear­ly May, Reuters re­port­ed that the com­pa­ny’s em­ploy­ees ac­cused an ex­ec­u­tive of al­ter­ing doc­u­ments re­quired by reg­u­la­tors to down­play qual­i­ty con­trol prob­lems at the plant.

The com­plaint al­leged that the ex­ec­u­tive rewrote find­ings from a Lil­ly tech­ni­cal ex­pert to make the con­clu­sion more fa­vor­able.

“Lil­ly is co­op­er­at­ing ful­ly with the in­ves­ti­ga­tion,” the drug­mak­er said in a stat­ment. “Lil­ly had pre­vi­ous­ly en­gaged ex­ter­nal coun­sel to con­duct an in­de­pen­dent in­ves­ti­ga­tion of cer­tain al­le­ga­tions re­lat­ing to Branch­burg. Lil­ly, through its coun­sel, is in­ves­ti­gat­ing these al­le­ga­tions thor­ough­ly.”

The FDA has been in­ves­ti­gat­ing the plant that pro­duces an­ti­body bam­lanivimab af­ter is­su­ing a two-ob­ser­va­tion Form 483 in Au­gust that not­ed qual­i­ty and lab­o­ra­to­ry con­trols that were not up to par.

The ac­cu­sa­tions are the lat­est set­back for Lil­ly’s Branch­burg plant. The com­pa­ny’s EUA was pulled by the FDA af­ter cit­ing a rise in vari­ants, and in March, Reuters re­port­ed that a hu­man re­sources em­ploy­ee claimed she was fired af­ter blow­ing the whis­tle on qual­i­ty is­sues at the site. A his­to­ry of miss­ing doc­u­ments was among those is­sues, with em­ploy­ees some­times sent to dig through the trash to re­cov­er them.

The Form 483 al­so re­vealed that in­ad­e­quate da­ta sur­round­ing GMP vi­o­la­tions were dis­closed in the nec­es­sary doc­u­ments, and the com­pa­ny didn’t open a “de­vi­a­tion” in­ves­ti­ga­tion on at least one oc­ca­sion be­cause it cit­ed a mix­up as “an iso­lat­ed oc­cur­rence,” de­spite sim­i­lar in­ci­dents with sim­i­lar cir­cum­stances.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

Andrew Schiermeier, Intellia

Black­stone throws $250M be­hind In­tel­lia-Cellex quest to com­bine CRISPR and con­trol­lable CAR-Ts

So here’s how Blackstone is spending its $4.6 billion biopharma pot.

The private equity firm announced Tuesday they were teaming with the CRISPR biotech Intellia and the little-known German CAR-T startup GEMoaB to launch a new — and so far unnamed — CAR-T company. Blackstone, the sole investor, will pour $250 million into the joint venture and take a third ownership. Intellia and Cellex, GEMoaB’s parent company, will each take another third.

Con­sor­tium of 5 drug reg­u­la­tors plot path to in­crease har­mo­niza­tion through 2024

A group of drug regulators from Australia, Canada, Singapore, Switzerland and the UK on Tuesday unveiled their strategic plans for the next three years, laying out how they’ll work together on reviewing new drugs to reduce duplication across borders.

While understanding that the biopharma industry is truly global, the group, known collectively as the Access Consortium, seeks to better align their respective regulatory and policy approaches for pharmaceuticals, with an aim to facilitate faster access to high quality, safe and effective health products.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,900+ biopharma pros reading Endpoints daily — and it's free.

Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.