Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While Eu­ro­pean com­pa­nies, in­clud­ing BioN­Tech, are fo­cused on in­creas­ing vac­cine ac­cess to African coun­tries by set­ting up vac­cine man­u­fac­tur­ing fa­cil­i­ties, the Eu­ro­pean Union is look­ing west­ward to Latin Amer­i­ca and the Caribbean.

Speak­ing at a press con­fer­ence with Span­ish Prime Min­is­ter Pé­dro Sanchez, EU Com­mis­sion pres­i­dent Ur­su­la von der Leyen said that the EU is launch­ing a new ini­tia­tive for vac­cines and med­i­cines man­u­fac­tur­ing in Latin Amer­i­ca, to get drugs to Latin Amer­i­ca and the Caribbean faster.

“We have learned dur­ing the Covid-19 pan­dem­ic that we can re­ly on each oth­er. The Eu­ro­pean Union is the world’s largest ex­porter of Covid-19 vac­cines. For in­stance, we shipped 237 mil­lion dos­es to Latin Amer­i­can and Caribbean coun­tries, and we are al­so to­geth­er with a lead­ing donor. The Eu­ro­pean Union do­nat­ed 475 mil­lion dos­es to our part­ners across the world,” von der Leyen said at the press con­fer­ence.

How­ev­er, in or­der to pre­pare for fu­ture pan­demics, many coun­tries must ramp up their ca­pac­i­ty to man­u­fac­ture and ad­min­is­ter vac­cines, she said.

The health part­ner­ship that the EU is launch­ing will con­tain three build­ing blocks to cre­ate more re­silient health sys­tems in Latin Amer­i­ca and the Caribbean.

“The first one is we want to get the pri­vate sec­tor from both sides in­to the game,” she said. “We will need sig­nif­i­cant in­vest­ments to strength­en the vac­cine man­u­fac­tur­ing ca­pac­i­ties and sup­ply chains. And this is why we will or­ga­nize match-mak­ing events be­tween the Eu­ro­pean Union and Latin Amer­i­can busi­ness­es start­ing this au­tumn so that they get to know each oth­er, and we are work­ing to­geth­er on new fi­nan­cial mech­a­nisms of course to sup­port these in­vest­ments in health and phar­ma­ceu­ti­cals in the re­gion.”

The sec­ond step is about shar­ing tech­nolo­gies and knowl­edge, as the EU will look to build bridges be­tween re­gion­al uni­ver­si­ties, re­search cen­ters and sci­en­tists.

For ex­am­ple, von der Leyen said that they will work to­geth­er un­der Hori­zon Eu­rope, a ma­jor re­search fund­ing pro­gram, to act as a bridge be­tween the re­searchers and the uni­ver­si­ties from both sides and joint health re­search projects sup­port­ed by funds from the EU.

The third pil­lar re­lates to the man­u­fac­tur­ing of vac­cines, as von der Leyen said that the EU will step up co­op­er­a­tion be­tween their dif­fer­ent agen­cies such as the EMA, the ECDC and CARA to link with part­ners in Latin Amer­i­ca for a more stream­lined reg­u­la­to­ry process for vac­cines pro­duced in the re­gion.

The part­ner­ship is be­ing fi­nan­cial­ly sup­port­ed by part­ners in­clud­ing the In­ter-Amer­i­can De­vel­op­ment Bank, with Team Eu­rope in­vest­ing 890 mil­lion eu­ros ($935 mil­lion) in health projects in Latin Amer­i­ca and the Caribbean. This in­cludes con­tri­bu­tions from ac­tors such as the Span­ish Agency for In­ter­na­tion­al De­vel­op­ment Co­op­er­a­tion, with more sup­port to come on board in the fu­ture, von der Leyen said.

The EU is al­so defin­ing fi­nan­cial sup­port to the biotech sec­tor in Cu­ba and Mex­i­co, as well as ex­plor­ing op­tions for sup­port in Chile, Cos­ta Ri­ca, Uruguay and Colom­bia.

How­ev­er, at the con­fer­ence, no strict time­line was giv­en for when these ini­tia­tives take off.

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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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.

Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

Fujifilm’s spending spree into its CDMO arm is not slowing down.

The multinational announced on Wednesday that it will invest $1.6 billion to enhance and expand the cell culture manufacturing services of the CDMO arm of the Japanese conglomerate Fujifilm Diosynth.

The investment will enhance Fujifilm Diosynth Biotechnologies’ sites in Hillerød, Denmark, and College Station, TX. The investment is expected to create approximately 450 jobs across both facilities.

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.

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.