Eli Lil­ly's re­cent­ly re­called glucagon kits were pro­duced at trou­bled In­di­anapo­lis site — re­port

Days af­ter it was re­vealed that Eli Lil­ly’s di­a­betes in­jec­tion kit had been re­called af­ter a re­port of a mix­up of glucagon sub­stance, Reuters has re­port­ed the kits were man­u­fac­tured in the In­di­anapo­lis plant called out in a Form 483.

On Sept. 24, the kit was re­called af­ter liq­uid glucagon re­placed the pow­dered ver­sion in the kit, which could fail to treat se­vere low blood sug­ar, due to a loss of po­ten­cy. If not re­versed, ex­treme low blood sug­ar can lead to neu­ro­log­i­cal dam­age, seizures, and death. One lot, D239382D with an ex­pi­ra­tion date of April 2022, has been re­called, and the com­pa­ny is­sued a re­call the fol­low­ing day.

The re­call no­tice said that a pa­tient ex­pe­ri­enced seizures af­ter they were in­ject­ed with the drug, which was a sign that the drug wasn’t po­tent enough to be ef­fec­tive.

An Aug. 12 Form 483 called out Eli Lil­ly’s In­di­anapo­lis ster­ile in­jecta­bles plant for sev­er­al laps­es in qual­i­ty, and last week, the com­pa­ny is­sued a 95-page re­sponse. A Lil­ly spokesper­son con­firmed to news out­lets this week that the kit was pro­duced in the scru­ti­nized In­di­ana plant.

Sev­en key ob­ser­va­tions came out of the FDA’s in­spec­tion, which took place be­tween Feb­ru­ary and March of this year. A lack­lus­ter en­vi­ron­men­tal mon­i­tor­ing con­trol in asep­tic pro­cess­ing ar­eas, as well as a fail­ure to ad­dress em­ploy­ee fa­tigue were among them, with an em­ploy­ee work­ing for 14 hours on a fill­ing line, which could lead to man­u­al er­ror on the fill­ing line.

There were 66,000 glucagon kits af­fect­ed in the re­call, 19,000 of which were sent out with­in the US, and the rest in Cana­da.

The site makes bam­lanivimab and ete­se­vimab for COVID-19 and ra­mu­cirum­ab for NSC Lung Can­cer in ad­di­tion to glucagon.

The Form 483 was first re­port­ed by Reuters in May. Sep­a­rate­ly from the is­sues at the In­di­anapo­lis plant, Lil­ly em­ploy­ees in Branch­burg, NJ ac­cused qual­i­ty con­trol ex­ec­u­tives of al­ter­ing FDA doc­u­ments to down­play the se­ri­ous­ness of charges. That plant saw a hu­man re­sources of­fi­cer forced out of her job af­ter rais­ing con­cerns sur­round­ing staff short­ages and record keep­ing.

“We take the ob­ser­va­tions very se­ri­ous­ly,” the com­pa­ny stat­ed at the start of its re­sponse. “As de­tailed in our re­sponse, we have im­ple­ment­ed or are im­ple­ment­ing ac­tions to re­solve any con­cerns re­gard­ing this in­spec­tion on ag­gres­sive time­lines. We thank the in­ves­ti­ga­tors for the dis­cus­sions we had dur­ing the course of the in­spec­tion as the feed­back con­tributes to en­hanc­ing our op­er­a­tional ex­cel­lence.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty


I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.