Eli Lil­ly sued by whistle­blow­er over drug man­u­fac­tur­ing is­sues

An em­ploy­ee at a phar­ma man­u­fac­tur­ing plant that has drawn the ire of the FDA and the DOJ, is bring­ing a suit against her for­mer em­ploy­er.

Phar­ma com­pa­ny Eli Lil­ly is be­ing brought to court in New Jer­sey by a for­mer em­ploy­ee who is seek­ing dam­ages af­ter act­ing as a whistle­blow­er.

The case cen­ters around the plain­tiff Am­rit Mu­la, a for­mer as­so­ciate di­rec­tor of em­ploy­ee re­la­tions at Lil­ly’s plant in Branch­burg, New Jer­sey.

Be­gin­ning in Au­gust 2018, and con­tin­u­ing un­til her ter­mi­na­tion, Mu­la be­gan to in­ves­ti­gate em­ploy­ee com­plaints of se­ri­ous vi­o­la­tions to the FDA con­cern­ing reg­u­la­tions in the man­u­fac­tur­ing of Lil­ly phar­ma­ceu­ti­cal drugs. Mu­la is al­so to have al­leged­ly wit­nessed and re­port­ed em­ploy­ees fail­ing to ad­here to cur­rent GMPs.

Mu­la al­so no­ti­fied the FDA that the plant failed to com­ply with FDA-man­dat­ed stan­dard op­er­at­ing pro­ce­dures, along with fail­ing to re­port batch con­t­a­m­i­na­tions, im­prop­er­ly dis­pos­ing of caus­tic sub­stances in­to wa­ter­ways as well as fal­si­fy­ing qual­i­ty as­sur­ance test­ing.

In par­tic­u­lar, the fail­ures of pro­duc­tion Mu­la ob­served and re­port­ed were pri­mar­i­ly re­lat­ed to the sale of the di­a­betes drug Trulic­i­ty.

The case al­leges that through­out Mu­la’s in­ves­ti­ga­tions, Lil­ly of­fi­cials con­tin­u­al­ly told Mu­la to stop in­ves­ti­gat­ing or to un­der­play the sever­i­ty of the vi­o­la­tions, and af­ter Mu­la re­peat­ed­ly pres­sured site lead­er­ship to rem­e­dy the sit­u­a­tion, Lil­ly ex­ec­u­tives al­leged­ly re­spond­ed by mar­gin­al­iz­ing, ha­rass­ing and even­tu­al­ly ter­mi­nat­ing her po­si­tion around March 28, 2019.

The case doc­u­ments said that Mu­la con­duct­ed a da­ta in­tegri­ty in­ves­ti­ga­tion, which re­vealed that at least sev­en em­ploy­ees fal­si­fied records and that the man­u­fac­tur­ing de­part­ment was con­sis­tent­ly over­due on cGMP train­ing. She al­so un­cov­ered that sev­er­al Branch­burg site em­ploy­ees re­peat­ed­ly record­ed that SOPs were per­formed while know­ing that a re­quired step had been in­ten­tion­al­ly omit­ted and then mis­rep­re­sent­ed da­ta was be­ing record­ed in cGMP doc­u­ments. She al­so found that sev­er­al em­ploy­ees had failed to com­plete manda­to­ry cGMP train­ing, among oth­er in­frac­tions.

Mu­la is seek­ing re­in­state­ment and oth­er in­junc­tive re­lief as well as com­pen­sato­ry dam­ages.

Lil­ly’s Branch­burg plant has been in the gov­ern­ment’s crosshairs for a while. In 2021, the FDA was in­ves­ti­gat­ing the lo­ca­tion, which pro­duces Covid-19 an­ti­body bam­lanivimab, for in­ad­e­quate qual­i­ty and lab­o­ra­to­ry con­trols.

The DOJ al­so hit Lil­ly with a sub­poe­na re­quest­ing ad­di­tion­al doc­u­men­ta­tion on its work at a Branch­burg.

This is not the end of Lil­ly’s le­gal woes as in May, Lil­ly, along with two oth­er com­pa­nies, is al­so fac­ing a law­suit brought on by the Arkansas At­tor­ney Gen­er­al al­leg­ing that the phar­ma com­pa­nies col­lud­ed with ben­e­fits man­agers (PBMs) to ar­ti­fi­cial­ly dri­ve up in­sulin prices.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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