PIC/S to re­sume on­site as­sess­ments for coun­tries ap­ply­ing for mem­ber­ship

While the sit­u­a­tion with Covid-19 has had an im­pact on in-per­son in­spec­tions for man­u­fac­tur­ing sites, one in­spec­tion group is look­ing to make a big re­turn to the man­u­fac­tur­ing lines.

The Phar­ma­ceu­ti­cal In­spec­tion Co-op­er­a­tion Scheme, or PIC/S, has an­nounced that they plan to restart as­sess­ments for coun­tries ap­ply­ing for mem­ber­ship. How­ev­er, ac­cord­ing to their 2022 work plan, the ex­act dates have not been de­ter­mined yet.

PIC/S ac­knowl­edged that with the pan­dem­ic and oth­er events, all as­sess­ments and re­assess­ment vis­its were put on hold in 2020-21 and on­ly a few process­es have been able to hap­pen vir­tu­al­ly. So far on­ly pre-ac­ces­sion process­es in Chi­na, Bul­gar­ia, and Sau­di Ara­bia and a re­assess­ment in New Zealand were able to go ahead.

“The ob­jec­tive for 2022 is to restart all as­sess­ments and re­assess­ments and to resched­ule all vis­its, sub­ject to pri­or­i­ties and the avail­abil­i­ty of re­sources,” the work plan said.

On the back of the open­ing, sev­er­al au­thor­i­ties have ap­plied for ac­ces­sion or pre-ac­ces­sion sta­tus and will be eval­u­at­ed this year. This in­cludes ap­pli­ca­tions for Ar­me­nia, Bul­gar­ia, Jor­dan and Sau­di Ara­bia and pre-ap­pli­ca­tions for Chi­na and Azer­bai­jan.

Due to trav­el re­stric­tions to Rus­sia, the ap­pli­ca­tion by the com­pe­tent au­thor­i­ties of Rus­sia will be frozen un­til fur­ther no­tice.

Three on-site re­assess­ments are al­so on the books in Tai­wan, In­done­sia and South Africa for lat­er this year, while New Zealand will be a vir­tu­al re­assess­ment.

PIC/S’s GMP Guide will al­so be fur­ther re­vised, in co­op­er­a­tion with the EMA’s In­spec­tors Work­ing Group (IWG) on GMDP guide­lines.

Al­so, sev­er­al re­vi­sions will be ei­ther con­tin­ued or fi­nal­ized lat­er this year. This in­cludes the GMP guide for chap­ter one re­lat­ed to phar­ma­ceu­ti­cal qual­i­ty sys­tems as well as chap­ter four and an­nex 11 re­lat­ed to doc­u­men­ta­tion and com­put­er­ized sys­tems. In 2021, the or­ga­ni­za­tion of­fered its guid­ance on on-site in­spec­tions for bio­phar­ma com­pa­nies per­form­ing man­u­fac­tur­ing (GMP) and dis­tri­b­u­tion (GDP) ac­tiv­i­ties.

This comes at a time when a re­port not­ed that the FDA com­plet­ed less than half (48%) of its reg­u­la­to­ry ac­tions for phar­ma fa­cil­i­ties des­ig­nat­ed as OAI or with an Of­fi­cial Ac­tion In­di­cat­ed, with­in 6 months of an in­spec­tion clos­ing, as the ef­fects of Covid-19 had a great ef­fect on gen­er­al over­sight at man­u­fac­tur­ing sites last year.

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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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.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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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.

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Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.