Moderna goes on the patent offensive; Pablo Legorreta doubles down; Is a biotech recovery on the way?; 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.
Another round of major medical conferences is upon us, and Kyle LaHucik is in Barcelona, bringing us live coverage from the European Society of Cardiology Congress. We’ll be posting updates on our website throughout the weekend.
Moderna goes on the patent offensive
Moderna said in March it would begin enforcing its Covid-19 vaccine patents in wealthy countries. In an aggressive move, it is suing Pfizer and BioNTech over their mRNA shot, alleging that their rival Covid-19 vaccine copied parts of Moderna’s vaccine technology that it had patented between 2010 and 2016, when it was developing an mRNA vaccine for MERS. Consider Pfizer “surprised” — while a legal scholar believes that Moderna’s previous pledge about patent enforcement could be key here.
Investors have pulled back from the biotech industry in recent months. But not Pablo Legorreta, who quietly pioneered a drug development niche that’s in demand. His company, Royalty Pharma, is doubling down on its specialty investment strategy with plans to deploy $10 billion to $12 billion in capital in the next five years, up from a $7 billion forecast two years ago. Legorreta, who keeps a low profile and rarely grants interviews, told Endpoints features editor Jared Whitlock that these beefed-up plans stem from the sector’s large capital needs both in the immediate and distant future.
Is a biotech recovery on the way?
The Covid impact — escalating the biotech industry’s mission to bring new treatments and vaccines to the world in record time — led to a “sugar high,” and the subsequent crash has been weighing on dozens of drug developers. But signs of a recovery are on the way, Kyle LaHucik reports, thanks to a series of positive clinical trial readouts, acquisitions, drug approvals and the popular data-to-financing train. In a somewhat brave move, Third Harmonic, the Atlas-backed startup led by Natalie Holles, is testing the IPO waters.
The monkeypox pipeline
Two years after biotech and pharma sprung to action to create vaccines and therapies in record time for the rapidly circulating Covid-19 pandemic, a handful of drug developers and vaccine makers are considering their role in preventing and treating future cases of the WHO’s latest public health emergency: monkeypox. They include Vir, Moderna, Gilead — all players in the Covid-19 race — and others like NightHawk Biosciences, Blue Water Vaccines and Tonix Pharmaceuticals. In the meantime, regulators are working with Bavarian Nordic to assess whether some expired doses of its Jynneos vaccine can still be used.
Gene therapies and how to pay for them
As the European Commission’s approval of BioMarin’s hemophilia A gene therapy, Roctavian, marks the second OK for expensive gene therapies for blood disorders in recent days (after bluebird’s Zynteglo), their price tags are shining a spotlight on outcomes-based pricing deals as both companies look to leverage the strong efficacy and durability of their therapies. But experts point out that such deals are often secretive. Roctavian will cost $1.5 million while Zynteglo carries a $2.8 million sticker.
Navigating vaccination slumps
It’s been a tough couple of years for traditional vaccine makers. While the Covid-19 pandemic spurred a flurry of innovation and turned a white-hot spotlight on the footrace for Covid vaccine approvals, routine vaccination rates plummeted. Judy Stewart, GSK’s head of vaccines in the US, has weathered vaccine industry ups and downs long before the Covid-19 pandemic. She recently spoke with Endpoints MarketingRx editor Beth Snyder Bulik about GSK’s efforts before and during Covid as well as pharma’s latest drive for data and innovations through partnerships and acquisitions to help keep vaccinations at the top of the mind.
- Pfizer wasn’t the first — or only — company that wanted to buy Global Blood Therapeutics. In fact, Pfizer elbowed a rival bidder throughout two months of intense negotiations almost right down to the last minute, according to details revealed in a new SEC filing. But ultimately, after four proposals and a phone call from Pfizer CEO Albert Bourla to GBT chief Ted Love, it was Pfizer that won the bidding war, sealing the deal at $68.5 per share — or $5.4 billion.
- Two Mondays have come and gone without Merck’s hotly-rumored takeover of Seagen, keeping observers waiting. And according to a new Bloomberg report, that’s because the two sides have yet to agree on a price, stalling talks. While previous reports say Merck could be looking at a $40 billion bid, a recent loss in its patent dispute with Daiichi Sankyo could affect Seagen’s valuation.
- After spending five years on Finch Therapeutics’s microbiome platform and a partnership around drugs for inflammatory bowel disease, Takeda is now walking away from it all. Finch, which has received a total of $44 million from the pact, will also get all the data and IP generated during the collaboration.
- After picking up two drugs from a Bob Langer spinout in a deal earlier this year, Alcon is staying busy. The former Novartis subsidiary focused on eye diseases is acquiring Aerie Pharmaceuticals in a $770 million buyout to bag two approved eye drugs, Rocklatan and Rhopressa, as well as an advanced program.
- CAR-T therapies traditionally have been made using virus vectors. While CRISPR/Cas9 gene editing promised to overcome some of its limitations, combining the two technologies proved challenging. But in a new paper, researchers from UCSF describe a way to improve the efficiency of a less toxic nonviral CAR-T manufacturing method.
- Jeff Bluestone’s Sonoma Biotherapeutics is putting its cash reserves to use and entering a lease to develop an 83,000-square-foot manufacturing and R&D center in Seattle. The company’s gene modified Treg therapies, born out of the R&D lab in South San Francisco, will be made at the site.
- Armed with a $100 million grant, David Hallal’s ElevateBio will partner with the University of Pittsburgh to manufacture cell and gene therapies in Pittsburgh. The 30-year deal will have ElevateBio locate its BaseCamp and GMP manufacturing facilities in the city, with the site eventually running gene editing, induced pluripotent stem cell (iPSC) and cell, vector and protein engineering efforts.
- With its first base editing clinical trial underway for heterozygous familial hypercholesterolemia, Verve is ready to reveal its second base editing program: one going after homozygous FH, a rarer type of heart disease in which patients inherit two gene mutations that impair their liver’s ability to remove bad cholesterol. The therapy would turn off the ANGPTL3 gene permanently.
- Searching for new TCR targets as well as better ways to engage them, an immunotherapy startup emerged with technology out of Stanford and $40 million in Series A funding led by Westlake Village BioPartners, with participation from Lightspeed Venture Partners. In addition to cell therapies, 3T Biosciences believes its targets can lead to bispecifics and peptide vaccines.
- As companies small and large begin to test the waters and go mainstream with a series of different psychedelics, Freedom Biosciences — a clinical-stage company developing therapeutics using ketamine and other psychedelics — netted itself $10.5 million in seed financing. Founded by a longtime expert in the field, Freedom says its candidate is different from other ketamine-based products on the market simply due to the efficacy duration.
- Allergan never steered the depression drug it scored from a $560 million acquisition of Naurex to approval, instead taking a $2.5 billion writedown following successive Phase III failures. But the founders and crew at Naurex are convinced this class of drugs — not the same one but next-generation renditions — still has potential, grabbing it from AbbVie’s shelves. And they’re coming out of stealth with the startup, Gate Neurosciences, now.
- A trio of Novartis vets is coming out of stealth with their idea of leveraging Akt inhibitors, typically used to treat cancers, for rare diseases that cause blood vessel malformations. Vaderis Therapeutics, their Medicxi-backed startup, is ready to take a lead drug into the clinic for an 80-patient proof-of-concept study.
- As mRNA takes a more prominent perch, European biotech eTheRNA raised $39 million to further develop its platform. The Series B2 features two big-name investors: Moderna co-founder Kenneth Chien and ex-Bayer and Thermo Fisher CEO Marijn Dekkers. Both of them are joining the biotech’s board of directors.
- Riding on the slowly bubbling field of targeted radiation therapy and going after a broader metastatic prostate cancer indication, Australian biotech AdvanCell hopes to address a key problem in targeted radiation therapy — radioisotope supply — and now it has an additional $12.4 million to back its idea.
- In the field of radioligand therapy, PSMA, an antigen overexpressed in prostate cancer cells, has loomed large. But Aktis Oncology is staying away from it while trying to develop drugs against a myriad of other cancers. And now, the MPM-backed biotech has an additional $84 million to develop that portfolio and build out its radioisotope supply.
- UK-based biotech Mereo BioPharma is facing some heat from one of its principal shareholders who are looking to make several changes to the biotech’s board amid some recent roadblocks for the company. Rubric Capital Management, a New York-based capital firm, wants to replace four of the current board directors. But Mereo isn’t obliging easily.
- After raising heaps of capital during the first two years of the Covid-19 pandemic to help biopharmas shift to virtual clinical studies, a few decentralized clinical trials providers have conducted layoffs in recent months as they adjust business priorities, Endpoints learned. That includes privately held Medable, which disclosed a $304 million Series D last October, and Science 37, which also began trading last October after a SPAC merger.
- Following more than 50 years of government service, Anthony Fauci will step down in December as chief medical advisor to President Joe Biden, director of the NIH’s National Institute of Allergy and Infectious Diseases and chief of his NIAID lab on immunoregulation. But he also emphasized that he’s not retiring.
- After some repositioning — and a $126 million financing round to take it down that direction — Singapore’s Tessa Therapeutics has found a new captain to steer the ship. Thomas Willemsen is jumping from Takeda, where he was most recently SVP, Asia-Pacific, to spearhead Tessa’s drive to develop new CAR-T therapies, including both autologous and off-the-shelf ones.
- Austin, TX-based Aeglea BioTherapeutics announced it was undertaking a corporate restructuring and reducing headcount in an attempt to focus on now-lead candidate AGLE-177, for a rare genetic disease. Amid the changes, president and CEO Anthony Quinn stepped down from all positions, leaving general counsel Jim Kastenmayer in charge in the interim.
- Kerry Blanchard resigned as Everest Medicines’ CEO and a member of the board of directors, effective immediately. After spending nearly 17 years at Eli Lilly where he rose to the rank of VP, Blanchard spent three years as a top executive for other Chinese pharmas before heading up Everest. He led the company’s IPO, dealmaking and development strategy, recently culminating in the sale of Trodelvy regional rights back to Gilead for $280 million upfront.
- Just two days after securing FDA approval for the first gene therapy for a chronic condition, bluebird bio’s chief regulatory officer was on to her next journey. After an 11-year career at bluebird, Anne-Virginie Eggimann moved over to Tessera Therapeutics, the Flagship-incubated biotech that recently attracted former AbbVie vice chair Michael Severino as CEO.
- Bay Area biotech Atara Biotherapeutics submitted WARN notices to California that it plans to lay off 77 employees at three different sites within the state as part of a slimming plan that the biotech discussed at its Q2 earnings call earlier this month. The cell therapy player says by reducing the cash burn, it hopes to become a leaner organization centered on R&D.
- After wrestling with the Sandoz problem for several years, Novartis CEO Vas Narasimhan finally decided to go with a spinout of the generics giant as a separate company. The pharma giant says it will set up Sandoz as an independent company in H2 2023 after navigating the separation through regulators. But despite a large portfolio and a pipeline of 15 biosimilars, its weak financial performance means Sandoz will have an uncertain reception on its own.
- Takeda scored a landmark approval for its dengue vaccine, the first step in cracking open a potential blockbuster market and proving it can sidestep the disaster Sanofi experienced with Dengvaxia. Indonesia approved the vaccine, formerly known as TAK-003 and now branded Qdenga, for the prevention of dengue disease regardless of prior dengue exposure.
- As J&J and AbbVie duke it out with AstraZeneca and other BTK competitors in chronic lymphocytic leukemia, the partners are celebrating a first for Imbruvica in a pediatric population. The drug was approved as a second-line treatment for chronic graft versus host disease in children one year and older.
- Incyte nabbed its second approval from federal regulators for cancer drug pemigatinib, branded as Pemazyre — as the potential for even more indications awaits. The FDA approved Pemazyre under priority review for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement, an extremely rare cancer subtype.
- Novartis suspended dosing in a Huntington’s disease study after safety signals emerged, sparking concerns that the drug, branaplam, may be causing peripheral neuropathy. The worrying findings include changes in a biomarker suggesting neuronal damage and neurological exams, as well as numbness or tickling sensations reported by patients.
- The 50-year race to develop an RSV vaccine turned a corner with Pfizer unveiling promising pivotal data for its bivalent RSV vaccine candidate, promising to take the data to the FDA ahead of several rivals in a market that could stretch to $10 billion by 2030. Pfizer said the candidate demonstrated vaccine efficacy of 66.7% in a Phase III trial.
- Two months after revealing the topline data — and quickly going to the market for a capital infusion of $95 million — 89bio is now presenting the mid-stage results of its high-triglyceride drug at the European Society of Cardiology Congress. In patients with severe hypertriglyceridemia, 89bio’s drug performed better than placebo. It will enter Phase III next year.
- Novo Nordisk is one step closer to unlocking a new semaglutide franchise — one it hopes can spur even better results for people with type 2 diabetes. It posted positive Phase II topline results with CagriSema, a subcutaneous combination of semaglutide and an experimental amylin analogue dubbed cagrilintide, suggesting “numerically higher” reductions in blood sugar levels and body weight than either drug alone.
- Just a month after bringing out the budget axe, PACT Pharma is now showing more of what it has planned next. The company’s sole clinical trial has now been suspended. According to clinicaltrials.gov, the pause is due to a “business decision,” with CEO Scott Garland noting via email that the company is adding a new focus on targeting shared neoantigens, planning to put a program in the clinic next year.
- The UK-based Oxford University researchers behind the successful Covid-19 treatment trial RECOVERY are back again, this time cobbling together a randomized controlled trial to see if Siga Technologies’ smallpox treatment Tpoxx (tecovirimat) is safe and effective for monkeypox. The NIH plans to launch a similar trial in the US next week.
- GSK called on the US Supreme Court not to revive its case against Teva Pharmaceuticals regarding so-called “skinny” generic drug labels, where certain indications are carved out so generics can come to market more quickly. The case at hand involves GSK’s win over Teva in a long-running battle over the generic giant’s skinny label for GSK’s beta-blocker Coreg.
- A longtime Kadmon consultant pleaded guilty to a single count of securities fraud in connection to more than $360,000 in profits he made trading on insider knowledge of the company’s impending $1.9 billion Sanofi buyout. Frank Glassner was arrested back in May.
- A California federal appeals court let AbbVie off the hook from a whistleblower lawsuit alleging the company held fraudulent patents on two Alzheimer’s drugs, therefore overcharging Medicare. The case traces back to a complaint filed by patent lawyer Zachary Silbersher back in 2018 against Allergan, which was later acquired by AbbVie.
- A couple months after Bristol Myers Squibb brought its patent fight with Gilead’s Kite unit to the Supreme Court, Gilead is now making the argument that the petition should be denied because it challenges more than 50 years of precedent. The dispute dates back to 2017, before Juno was acquired by Celgene and then got swallowed by Bristol Myers Squibb.
- The manufacturer of a generic tablet used in medication abortions withdrew its case against Mississippi state requirements that restricted access to abortions. GenBioPro, which filed the original suit in 2020, attributed the decision to “the changed national landscape.”
- Weeks after snapping up the chronic kidney disease drug Velphoro in its $11.7 billion Vifor buyout, CSL pulled in a court win that gives it at least a few more years on the market without competition from Teva. A judge rude that Teva’s generic candidate for Velphoro — which has yet to be approved — would infringe on a patent held by what is now part of CSL Vifor.
- Indivior isn’t getting out of its class action Suboxone lawsuit without a trial, a federal judge ruled. Its two motions for a summary judgment were dismissed in a case alleging the company committed a “product hop” scheme to prevent generic competition to its opioid addiction treatment Suboxone by switching to the sublingual film and withdrawing pills.
- A House subcommittee focused on the pandemic released another scathing report detailing the extent to which the White House injected politics into a time-sensitive situation. The 69-page report found that the Trump White House “exerted extreme and inappropriate pressure” on FDA and former FDA commissioner Stephen Hahn to not only reauthorize hydroxychloroquine’s EUA, but deliver misleadingly positive news about convalescent plasma.
- Usage of Pfizer’s Covid-19 treatment Paxlovid has spiked across the US in recent months, with more than 2 million courses administered during this latest Omicron wave since June. But a new observational study published in NEJM found that Paxlovid only worked to avoid hospitalization among patients 65 years of age or older, with no evidence of benefit found in younger adults.
- Three months after bringing on a new CEO, Inovio reached a settlement with investors over accusations that it exaggerated progress on its Covid-19 vaccine candidate. The biotech, once claiming to be at the heart of Operation Warp Speed, agreed to shell out $44 million in a mix of cash and stock to end a class action lawsuit.
- Moderna wants people to know it’s not a typical pharma company, and its newest campaign hits that point home with a legendary sports and social change agent. Billie Jean King kicks off Moderna’s “Here’s to the Change Makers” campaign and its inaugural sponsorship of the US Open that includes a TV ad featuring tennis footage clips from the ’70s and ’80s, with a message from her today.
- How should pharma companies use the limited character space in a promotional tweet? While including risk information in the body of a post made patients more likely to recognize potential dangers, new FDA-led research suggests it also made them less likely to pursue more information. The researchers note the study results support FDA guidance on this topic.
- AbbVie is enlisting real people — including patients alongside its own employees and scientists — in unscripted social media ads under its corporate campaign “Here. Now.” The social and digital online video ads feature the people talking about AbbVie science and medicines and the personal connections for each.
- When college student Amalia developed debilitating stomach pain and eventually an inability to eat or drink, she turned to art and painting to express her pain and hopeless feelings. She was eventually diagnosed with the rare genetic disease acute hepatic porphyria — and now both Amalia and her art are featured in Alnylam Pharmaceuticals’ latest campaign for its med Givlaari, approved in 2019 to treat AHP in adults.
- Novartis’ first-ever patient DTC ad for metastatic breast cancer drug Kisqali points up the broader and more recent proliferation of mBC treatment options in general. The 15-second TV commercial features mBC patient and Kisqali user Lauren, who is a wife and mother of three girls, and talks about being the “first generation” of people who will change what it means to live with metastatic breast cancer.
- It’s “lights, camera, action” at Klick Health these days with the official opening of its own in-house production studio. Called Studio K, the full-service production setup includes a sound stage, edit suite, recording booth and green room — and it’s already booked up. The in-house studio is one of three new Klick business practices, the other two bring a new corporate branding group, Klick Brands, and a social media influencer practice called Klick Influence.
- Monica Ochapa is in her third year pursuing a doctorate of public health at the historically black university Morgan State — and one of two first-ever recipients of a new Pfizer vaccine fellowship there. The two-year program aims to create a path for more minority practitioners as leaders in vaccine medical development and translate research and analysis into real-world health solutions.
- Pfizer and BioNTech are promoting their Covid-19 vaccine Comirnaty with a focus on teens in a new national TV ad; Idorsia’s campaign for sleep med Quviviq in partnership with world-champion skier Lindsey Vonn now includes a TV commercial; Pharma ad spend drops slightly year over year, amid double-digit declines in other industries; and more news in brief feature in MarketingRx roundup.
- It’s been a little more than six months since FDA commissioner Rob Califf won Senate confirmation, and while he highlighted some of his key goals early on, he offered the agency’s latest array of top priorities in a JAMA viewpoint. At the top of the list, even as general fatigue has taken hold among the public’s perception toward the pandemic, is Covid-19, and the ongoing opioid addiction crisis, which took more than 100,000 lives in 2021.
- Although their numbers have dwindled in recent years, FDA advisory committees have been in the spotlight, and some experts are now seeking reforms to make them more useful, including a trio of leaders from Harvard. Writing in the NEJM, they call on the FDA to provide more clarity and consistency as to when it would convene an adcomm.
- Of the nearly 40 biosimilars approved to date by the FDA, only three have won the coveted interchangeability designation so far, in part because it carries additional requirements such as switching studies. But the FDA is opening the door for interchangeable biosimilars to be approved without conducting these switching studies first.
- In another key European OK, Gilead secured the first approval for lenacapavir to treat multidrug resistant HIV. The drug, branded as Sunlenca on the continent, is designed to be administered once every six months, giving Gilead a long-acting option to take on ViiV. A capsid inhibitor, it’s also been billed as the next big HIV play given its potential to both treat and prevent infection.
- One of the more anticipated H2 events will occur almost immediately after Labor Day — the unusual second adcomm for Amylyx Pharmaceuticals’ experimental ALS drug. At least one analyst is trying to read the tea leaves, and he gives the drug a 50% chance at good news at the adcomm.
- Foghorn Therapeutics’ flagship program took another hit as the FDA converted its partial clinical hold on a blood cancer drug to a full hold. The Phase I dose escalation study of FHD-286, an inhibitor of BRG1/BRM, was halted due to suspected cases of fatal differentiation syndrome cropping up, and a new data submission triggered the move.
- Updating guidance from 2016 on how companies can charge for investigational drugs under an IND, the FDA now tells sponsors working under expanded access that they can spread out their manufacturing, administrative or monitoring costs from the first year over the expected duration of the expanded IND or protocol, potentially easing the burden for smaller companies.
- French biotech Erytech Pharma is knocking off its plan to get FDA approval for its drug Graspa in hypersensitive acute lymphoblastic leukemia, following feedback from the regulators. Despite what it sees as positive Phase II data, the changing competitive landscape and the FDA’s request for more clinical data made it too difficult for Erytech.
- The FDA has placed a hold on the clinical trials for Swiss biotech Pharvaris’ oral drug PHA121, which aims at treating hereditary angioedema, a rare genetic condition. The regulators placed the hold after reviewing the company’s nonclinical data
- Ipsen’s palovarotene, the oft-maligned rare bone disease program it acquired from Clementia, is going to get a closer look from regulators on Halloween. The FDA scheduled an advisory committee to examine the drug on Oct. 31, setting up a showdown for a drug that once failed a Phase III test. Its decision date is slated for Dec. 29.
- Thermo Fisher opened the doors to two sites within days as part of a $650 million investment to build sites across the US, UK and China this year. The first was a $105 million, 400,000 square foot facility in Lebanon, TN, several miles east of Nashville that will produce customizable single-use bioprocessing containers and fluid transfer assembly systems for biologics, vaccine and cell and gene therapy manufacturing. The second, closer to its Massachusetts home, is a new viral vector manufacturing plant in Plainville, MA that cost about $180 million.
- Earlier this year, FDA investigators found issues at Teva Pharmaceuticals’ plant in Irvine, CA, forcing the company to padlock the doors. It ultimately decided to pull the plug on reopening it. In a WARN notice, Teva revealed that it is axing 305 jobs at the site, which has had a multitude of issues, and permanently closing it.
- The FDA’s postmarket regulations require that drug manufacturers notify the agency about any significant product quality defects in marketed products within three working days. But a new report from the agency found that of the 1,143 manufacturing sites that were eligible to submit a FAR from 2018 to 2021, almost half (49%) of the sites did not submit a report.
- Amid a scramble for more monkeypox vaccines, Grand Rapids, Michigan-based CDMO Grand River Aseptic Manufacturing landed a deal with Bavarian Nordic, to fill and finish its Jynneos vaccine. Its CEO spoke with Endpoints Manufacturing editor Tyler Patchen to explain how a relatively new player in the CDMO world landed the contract.
- As Resilience keeps up the momentum post-Series D, the biomanufacturer reeled in another partnership, this time in the Golden State. It was named by the California Institute for Regenerative Medicine as one of its initial industry resource partners to support translational and clinical phase grant applications.
- Indian generics manufacturer Morton Grove Pharmaceuticals is shuttering its Illinois site due to manufacturing issues that have built up over several years. The Department of Justice accused it of selling adulterated drugs in a lawsuit alleging the company’s syrups and nasal sprays made at the facility were not made in compliance with cGMP standards.
- Building off a previous revision in 2007, the European Commission released its latest update to its guideline on manufacturing sterile drugs. The document provides technical guidance around the intricacies of each step, and it follows the recommendation of the GMP/GDP Inspectors Working Group and the PIC/S committee to reflect changes in both regulatory and manufacturing.
- Chinese CDMO Porton Advanced Solutions managed to garner more than $80 million to continue a business expansion; Lonza expanded the range of engineering services at its Monteggio facility; ABEC, a provider of engineered solutions and services for biotech manufacturing, will invest $11 million to expand its single-use disposable container manufacturing capacity; check out the rest in our Manufacturing roundup.
- Quickly confirming reports, the US’ Public Company Accounting Oversight Board revealed it’s struck an agreement with Chinese regulatory authorities that would allow the inspection of audit reports for US-listed Chinese companies, which would save them from delisting. Now, according to SEC chair Gary Gensler, “The proof will be in the pudding.”
- A few months after a leadership shakeup, the White House’s Office of Science and Technology Policy is launching one of its most ambitious policy changes to date by making all taxpayer-funded research more accessible to the public. Agencies will have until the end of 2025 to make publications and research paid for with taxpayer dollars publicly accessible, for free, without any restriction.