FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

A drug man­u­fac­tur­ing fa­cil­i­ty in Mex­i­co is draw­ing the ire of the FDA af­ter it ig­nored the US reg­u­la­tor’s in­spec­tion re­quests and phone calls.

Ac­cord­ing to the warn­ing let­ter is­sued on June 13, Gliceri­nas In­dus­tri­ales re­fused a pre-an­nounced in­spec­tion dur­ing a phone call with FDA pri­or to the in­spec­tion at the com­pa­ny’s fa­cil­i­ty in Za­popan, Mex­i­co, a city next to Guadala­jara, which was planned for May 16 to May 20.

The com­pa­ny, which al­so goes by Glin­sa, is a sup­pli­er of a wide range of drug in­gre­di­ents, in­clud­ing glyc­erin, to man­u­fac­tur­ers of fin­ished drug prod­ucts. These in­clude man­u­fac­tur­ers that dis­trib­ute to the US. The let­ter made clear the im­por­tance of the in­spec­tion giv­en that the use of glyc­erin con­t­a­m­i­nat­ed with di­eth­yl­ene gly­col (DEG) has re­sult­ed in var­i­ous lethal poi­son­ing in­ci­dents over the years in var­i­ous coun­tries.

Ac­cord­ing to the FDA’s guid­ance on the sub­ject from 2007, that reg­u­la­tor has re­ceived and con­tin­ues to re­ceive re­ports about fa­tal DEG poi­son­ing of con­sumers who in­gest­ed med­i­c­i­nal syrups, such as cough syrup, that were man­u­fac­tured with DEG-con­t­a­m­i­nat­ed glyc­erin.

Ac­cord­ing to the let­ter, the com­pa­ny’s drugs are now “adul­ter­at­ed” in that they have been man­u­fac­tured, processed, packed or held in an es­tab­lish­ment that de­lays, de­nies or lim­its an in­spec­tion, or re­fus­es to per­mit en­try or in­spec­tion.

The FDA placed the com­pa­ny on Im­port Alert on June 9, and un­til the FDA is per­mit­ted to in­spect the fa­cil­i­ty and en­ters com­pli­ance, they can with­hold ap­proval of any new ap­pli­ca­tions or sup­ple­ments list­ing it as a drug man­u­fac­tur­er. In ad­di­tion, ship­ments of ar­ti­cles man­u­fac­tured at Gliceri­nas In­dus­tri­ales in­to the US that ap­pear to be adul­ter­at­ed are sub­ject to be­ing de­tained or re­fused ad­mis­sion.

In 1937, an out­break of DEG poi­son­ing oc­curred in the US, which re­sult­ed from peo­ple in­gest­ing an elixir of sul­fanil­amide that con­tained DEG as a sol­vent, re­sult­ing in 107 deaths, many of them chil­dren, which in part led to the Food Drug & Cos­met­ics Act to be passed. In late 1995 and ear­ly 1996, many chil­dren were ad­mit­ted to hos­pi­tals in Port-au-Prince, Haiti, with sud­den kid­ney fail­ure, re­sult­ing in at least 80 fa­tal­i­ties, fol­low­ing sim­i­lar poi­son­ing.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Emer Cooke, ICRMA chair (AP Photo/Geert Vanden Wijngaert)

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As regulatory agencies look to catch up on inspections amid the Covid-19 pandemic, ICMRA is unveiling several pilot programs to address industry applications and inspections.

ICMRA, which is made up of the world’s top drug regulators, is launching multiple pilot programs, including two regulatory pilots addressing facility inspections for chemistry and manufacturing controls (CMC) and post-approval change (PAC) submission assessments and related regulatory actions.

FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

A manufacturing facility belonging to the Netherlands-based API producer Fagron Group has entered the FDA’s crosshairs after an employee destroyed a cleaning log, among other violations.

One of its plants in Saint Paul, MN received a warning letter on June 14, following an inspection last November that uncovered cross-contamination concerns.

“In your response, you provided a follow-up cleaning validation report in which you only assessed the carryover of niacin swab samples but not progesterone, which was included in your initial cleaning validation,” FDA says in the letter. “The lack of progesterone (b)(4) [commercially confidential information] is concerning considering the failing residue results you provided to investigators would yield unacceptable levels of progesterone cross-contamination.”

On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Man­u­fac­tur­ing roundup: Teru­mo BCT part­ners with Bio­Bridge sub­sidiary to man­u­fac­ture cell and gene ther­a­pies; WuXi STA opens plant for HPA­PI pro­duc­tion

As the manufacturing of cell and gene therapies is ramping up and companies are starting to invest in their manufacturing capabilities, Terumo Blood and Cell Technologies have formed a partnership to stay in the game.

According to the company, it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions.

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Earlier this year, Novartis touted its radioligand as a major piece to counter competition in the cancer space. However, the physical production of its products has had anything but a smooth ride.

In May, Novartis had to suspend production of Lutathera and Pluvicto, its two primary radiotherapies. According to the company, this was done out of an abundance of caution as a result of potential quality issues identified in its manufacturing. The production suspension impacts the commercial and clinical trial supply of the products.