Rep. Anna Eshoo (D-CA) (Graeme Sloan/AP Images)

Fight over where to house ARPA-H still brews with House bil­l's pas­sage

The Biden ad­min­is­tra­tion isn’t back­ing down from its de­sire to keep a new drug ac­cel­er­a­tor, known as ARPA-H, in­side the Na­tion­al In­sti­tutes of Health.

But the House on Wednes­day passed a bill by an over­whelm­ing bi­par­ti­san ma­jor­i­ty (336 to 85) to make this new ac­cel­er­a­tor a stand­alone agency.

An­na Es­hoo (D-CA), the au­thor of the House bill, made clear that the sep­a­ra­tion from NIH is in­ten­tion­al, say­ing in a state­ment that “the House passed my ARPA-H leg­is­la­tion to cre­ate a new agency with the au­thor­i­ties and au­ton­o­my it needs to be suc­cess­ful and en­sur­ing it will be a nim­ble, dy­nam­ic, and in­de­pen­dent agency.”

Biden of­fi­cials, mean­while, re­main sup­port­ive of the bill in gen­er­al but are still push­ing for a tweak to put ARPA-H un­der the NIH um­brel­la, say­ing in a state­ment:

In or­der to suc­cess­ful­ly con­duct im­pact­ful re­search on dis­eases like can­cer or men­tal health con­di­tions, it is crit­i­cal that ARPA-H is stood up in a time­ly and ef­fi­cient man­ner. At the same time, we need to al­low this nascent agency to be nim­ble, dy­nam­ic, and adap­tive. To that end, the Ad­min­is­tra­tion sup­ports an ap­proach that pro­vides the agency with flex­i­bil­i­ty to adapt to un­fore­seen cir­cum­stances and be­lieves that lever­ag­ing the Na­tion­al In­sti­tutes of Health’s ex­ist­ing in­fra­struc­ture would pro­vide for the most ef­fi­cient ad­min­is­tra­tion of the pro­gram’s goals. The Ad­min­is­tra­tion is con­cerned by the pro­vi­sion that would en­able ARPA-H to by­pass the process for en­sur­ing that com­mu­ni­ca­tions with Con­gress are ac­cu­rate and re­flect the views of the Ex­ec­u­tive Branch.

But law­mak­ers are al­ready plot­ting ARPA-H’s au­tonomous fu­ture, with or with­out the White House’s sup­port, with 2023 fund­ing plans for $2.75 bil­lion for the ac­cel­er­a­tor, an in­crease of $1.75 bil­lion above the ini­tial $1 bil­lion, which ap­pro­pri­a­tors said will go “to ac­cel­er­ate the pace of sci­en­tif­ic break­throughs” for dis­eases like ALS, Alzheimer’s dis­ease, di­a­betes and can­cer.

Biden had ini­tial­ly re­quest­ed $6.5 bil­lion for this cur­rent­ly NIH-housed re­search out­fit, which is go­ing to mir­ror DARPA with risky in­vest­ments.

Rep. Fred Up­ton (R-MI) and oth­er Re­pub­li­cans stood be­hind the House bill too, with Up­ton say­ing, “ARPA-H can pro­vide the break­through to in­deed find cures for all these dis­eases. The pres­i­dent has signed fund­ing for this agency in­to law, now we need the bi­par­ti­san au­tho­riza­tion so the re­searchers can get to work.”

Adam Rus­sell

HHS Sec­re­tary Xavier Be­cer­ra late last month, how­ev­er, sought to for­mal­ly an­nounce the es­tab­lish­ment of the ARPA-H, known for­mal­ly as the Ad­vanced Re­search Pro­ject Agency for Health, as an en­ti­ty with­in the NIH, al­though HHS had pre­vi­ous­ly sought to keep the new re­search arm some­what in­de­pen­dent, stip­u­lat­ing that “NIH may not sub­ject ARPA-H to NIH poli­cies.”

Be­cer­ra al­so an­nounced the ap­point­ment of ARPA-H’s in­au­gur­al em­ploy­ee, Adam Rus­sell, who will serve as act­ing deputy di­rec­tor. Rus­sell, a for­mer DARPA man­ag­er and a Rhodes Schol­ar at Ox­ford, will be­gin to con­struct a new agency that has eyed big, trans­for­ma­tive work in the life sci­ences space from the be­gin­ning, con­tin­u­al­ly promis­ing “high-risk, high-re­ward re­search” on hard-to- or ex­pen­sive-to-treat dis­eases, with promis­es of “bio­med­ical and health break­throughs.”

With this new fund­ing, the Biden team still has to come up with the first di­rec­tor of ARPA-H, and where its head­quar­ters will be lo­cat­ed.

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.”

Gilead scores a $33M set­tle­ment from its cam­paign against ‘colos­sal fi­nan­cial fraud’

More than 18 months and 860 court filings later, Gilead has bagged a new settlement in its campaign against a group of companies that participated in an alleged fraud aimed at its free meds program for people at risk of HIV.

Gilead, along with healthcare clinic Well Care and execs Willie Peacock and Shajuandrine Garcia, reached a settlement worth $33 million last week. Gilead is dropping its allegations against the clinic, and the parties involved will pay their own attorney fees.

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.