Te­va tem­porar­i­ly pad­locks a plant af­ter FDA cites it for con­t­a­m­i­na­tion

Af­ter FDA in­ves­ti­ga­tors un­veiled a list of prob­lems that were found at a Te­va Phar­ma­ceu­ti­cals plant in Irvine, CA, in­clud­ing mold stem­ming from wa­ter leaks, the com­pa­ny said it will halt pro­duc­tion at that site un­til it is able to meet qual­i­ty ex­pec­ta­tions.

A Te­va spokesper­son con­firmed the tem­po­rary man­u­fac­tur­ing stop­page Mon­day morn­ing in an email to End­points News, say­ing that that pro­duc­tion will re­sume af­ter a re­view is con­duct­ed.

“In an ef­fort to min­i­mize im­pact on pa­tients, we are work­ing close­ly with the FDA Drug Short­age Staff and FDA Of­fice of Man­u­fac­tur­ing Qual­i­ty as we work through this re­view,” the spokesper­son wrote. “We will en­sure that the agency and rel­e­vant cus­tomers are aware of our progress as we move for­ward.”

The Form 483 from the FDA led to the re­call of more than 2.5 mil­lion vials of drugs that might not be ster­ile, Bloomberg re­port­ed Mon­day morn­ing. In Feb­ru­ary, Te­va pulled 1.5 mil­lion vials off of the shelves af­ter mold was de­tect­ed in the air of man­u­fac­tur­ing ar­eas.

A Ju­ly in­spec­tion found that un­treat­ed wa­ter dam­age led like­ly to the mold gen­er­at­ing in the walls, and min­i­mal steps had been tak­en to pre­vent the fur­ther spread of mold and bac­te­ria through­out the site.

Ac­cord­ing to Bloomberg, which said it ob­tained the in­spec­tion doc­u­ments in re­sponse to a Free­dom of In­for­ma­tion Act (FOIA) re­quest, the bench­es that were used to change in­to scrubs were dirty. Ad­di­tion­al­ly, fac­to­ry work­ers of­ten wore scrubs out­side the build­ing to take out the trash and use the re­stroom, fail­ing to change them again once they re-en­tered the man­u­fac­tur­ing site. Equip­ment had not been test­ed for steril­i­ty or harm­ful or­gan­isms since it had been in­stalled 21 years ago, Bloomberg re­port­ed.

The state­ment from Te­va said:

We have care­ful­ly re­viewed the 483 and are tak­ing ex­ten­sive ac­tions to en­sure the agency’s ob­ser­va­tions are ful­ly ad­dressed. All Te­va fa­cil­i­ties have strict and com­pre­hen­sive qual­i­ty pro­to­cols in place and as part of the work we are do­ing in re­sponse to the re­cent In­spec­tion, we will fur­ther en­hance our ef­forts to en­sure that we meet or ex­ceed all reg­u­la­to­ry re­quire­ments.

The an­nounce­ment comes as Pres­i­dent Joe Biden’s ad­min­is­tra­tion has at­tempt­ed to per­suade Big Phar­ma to ramp up do­mes­tic drug pro­duc­tion. Gener­ic drugs make up 90% of Amer­i­cans’ med­ica­tions, while near­ly 70% of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents are made out­side the US, a White House re­port says. Last week, a bill was in­tro­duced in the US House of Rep­re­sen­ta­tives that would cre­ate a na­tion­al stock­pile of APIs to pre­vent sup­ply chain short­ages in the fu­ture.

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.