Boston built America's innovation engine. Now it's under attack by Trump
Back then, some of the main flashpoints related to Britain's tight grip on commerce in the colonies and taxation without representation. When the King got angry about the boisterous Boston Tea Party, he shut down Boston's port so that merchants couldn't import or export goods. That knee-capped the local economy, leading to business closures, high unemployment, shortages of food and other essentials and soaring prices. And it led the colonists to organize the First Continental Congress to plan their response.
Now, the danger to our economy comes not from abroad, but from a president who gleefully uses phrases like 'long live the king' to refer to himself.
His administration is attacking the foundations of what we have been building here since the 1630s, when Boston Latin School and Harvard College got started. That foundation tightly integrates education, smart students and professors from around the world, research and development activities, funding from the federal government and private philanthropists and experienced entrepreneurs and investors who form companies around the research projects that look most promising.
What we have built on top of that foundation has been significant both societally and financially. We have cured deadly diseases in children and adults, developed surgical anesthesia, performed the first human organ transplant, helped sequence the human genome, created the field of proton therapy for cancer treatment, and we also did some of the earliest work on the GLP-1 drugs now widely prescribed for diabetes and weight loss.
We developed radar systems that helped the Allies win World War II, and also the guidance computers that enabled Apollo spacecraft to land humans on the surface of the moon. We built some of the earliest hardware and software that allowed the ARPANET — the Internet's forerunner — to link computers together in the 1960s, sent the first email and ensured that the web has remained an open standard that everyone can benefit from. We created the first videogame, booting up an industry that now spins off revenues of more than $180 billion globally each year. An entrepreneur educated at the University of Massachusetts Lowell and working in Cambridge co-founded a startup called Android, now owned by Google, and is the world's most popular mobile operating system.
Before that, we invented the telephone. (The Scotsman Alexander Graham Bell was a Boston University professor — but not yet a U.S. citizen — when he made the earliest phone calls.)
In 2025, we're trying to do things like edit or silence the malfunctioning genes that cause diseases; help our military develop hypersonic missiles; and build a functional nuclear fusion reactor, with no carbon emissions or long-lived radioactive waste.
You get the idea; this list could go on for a whiiiiiile.
Just one industry that our university labs helped incubate here in the late 1970s, biotechnology, last year created more than $600 billion in economic activity in the U.S., and employed more than 300,000 people. Some of its early pioneers and current leaders — people like the late Henri Termeer of Genzyme and Noubar Afeyan of Flagship Pioneering — were foreigners who came to this country to advance their education.
For its part, the Trump administration asserts that it aims to cut government research funding to help bring the deficit under control — a key mission of the Department of Government Efficiency. And the administration believes that it can get universities to address antisemitism on campuses, or increase ideological diversity on faculties, only with high-pressure tactics like withholding federal funding, rescinding their ability to enroll foreign students or revoking their tax-exempt status.
Supporters of the administration may want to play out this hand of cards and see if those aims can be achieved.
But I'd make the case that what we're seeing right now is a federal government that is jackhammering away at the foundations of what makes Boston work — not to mention similar ecosystems such as Seattle, New York and Silicon Valley. It seems they are rooting for the towers atop that foundation to tumble, without truly understanding the impact that that would have on America's competitiveness. They have demolition equipment, but I'm not convinced they have a blueprint or construction equipment.
(As they wrangle with our great institutions, create anxiety around visas, and deny funding to cutting-edge researchers, you can already watch savvy countries swinging into action to attract those people.)
There is also one possible impact of the Trump administration's war on Ivy League schools that few people understand, and it has to do with the universities' nest eggs — their endowments. If federal funding gets yanked or cut, universities may tap their endowments to fill the gap. There are also proposals in Congress to potentially increase the tax rate on wealthy universities' endowments from 1.4% to as much as 21%.
Why does that matter? Endowment money often gets handed to venture capital firms so that they can fund startup companies — the next Moderna, HubSpot, Wayfair or Vertex. So increasing the pressure on university endowments could reduce the money venture capitalists have to support new company formation — a key ingredient of the U.S.' economic vitality. The 'acute issue,' says Boston venture capitalist Michael Greeley, 'is simply not knowing what endowments will be called on to fund' at universities, which could suck money out of the venture capital system.
'In 1775, the proud New Englanders stood strong, threw down their plowshares and confronted the totalitarian threat, even though they knew the battle would be long,' wrote Don Ingber, director of the Wyss Institute, a research lab at Harvard, in a recent blog post. This time, instead of taxation without representation, Ingber says one of the central issues is 'cessation [of government funding for university research] without justification.'
To help highlight the role that academic research plays in the economy, the Greater Boston Chamber of Commerce this month rebooted a coalition of nearly fifty other chambers that it originally started during the first Trump administration, Business for Federal Research Funding. Research, says James Rooney, CEO of the Greater Boston Chamber, 'creates jobs — blue and white collar jobs — all over the country, in every state."
But aside from elected officials like Gov. Maura Healey and Senate President Karen Spilka, and university leaders like Harvard's Alan Garber and Danielle Holley of Mount Holyoke College, it's hard to find evidence of private sector leaders using their megaphones to speak out, or organizing to defend the education, research and innovation-driven economy we have been building here over nearly 400 years. It's an engine of progress that has, quite literally, won wars, cured terrible diseases and shaped the technology we use and how we communicate.
'Too many leaders in the private sector are worried about retribution that could harm their businesses,' observes John Maraganore, a longtime biotech industry executive and co-founder of Alnylam Pharmaceuticals in Cambridge.
Understood. But in the two-and-a-half centuries since we helped spark the American Revolution, have we turned into a state populated by meek worriers?
Or are we still willing to act to defend what we hold dear?
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Newsweek
29 minutes ago
- Newsweek
Putin Loses Influence in Backyard
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. His absence from World War II commemorations in Moscow was enough of a snub to Vladimir Putin, but Azerbaijani President Ilham Aliyev deepened his rift with the Russian leader by demanding Russia take responsibility for an air tragedy. Baku blames the Christmas Day crash of Azerbaijan Airlines Flight 8243 that came under fire over Grozny, Chechnya—killing 38 of the 67 on board—on a Russian Pantsir-S1 air defense system mistakenly targeting the plane amid a reported Ukrainian drone attack. Unhappy with Putin's lack of apology, Aliyev reiterated on Monday his demand for Russia to publicly acknowledge responsibility, punish those responsible, and compensate victims' families and the airline. But it is not just the plane crash that has frayed ties—tit-for-tat arrests and discontent from Baku toward Moscow's regional role as Putin remains preoccupied in Ukraine have also played their part. Azerbaijani President Ilham Aliyev, left, is seen with Russian President Vladimir Putin at the BRICS summit in Kazan, Russia, on October 23, 2024. Azerbaijani President Ilham Aliyev, left, is seen with Russian President Vladimir Putin at the BRICS summit in Kazan, Russia, on October 23, regional expert told Newsweek that ties between Azerbaijan and Russia are at their lowest point since the end of the Soviet Union. Another said Aliyev sees his country as the key shaper of the region now rather than Moscow. Ali Karimli, leader of Azerbaijan's democratic opposition, told Newsweek Aliyev had distanced himself from Moscow following the fall of Putin's ally, Bashar al-Assad in Syria, which signaled a weakening of Russian strength in the wider region. Aliyev "began to realize that Russia was not as powerful as once assumed," he said. Newsweek has contacted the foreign ministries in Russia and Azerbaijan for comment. Baku's Harsh Reaction With a shared Soviet past, fossil-fuel dominated economies and authoritarian leaders, Russia and Azerbaijan have much in common. But Moscow's invasion of Ukraine has upended Russia's regional role and Aliyev has spotted an opportunity to capitalize on Putin's tepid response to a tragic plane crash. Half a year later, tensions between the countries spilled over again following the arrests in June of dozens of Azerbaijanis in the Russian city of Yekaterinburg. The Azerbaijanis, all Russian citizens, were taken into custody in a raid as part of an inquiry into cold case murders over the previous two decades. Those detained were beaten, and two brothers—the main suspects died. Azerbaijani authorities accused Russian security forces of deliberately killing their nationals. Russian cultural events in Azerbaijan were canceled, and the Baku office of the Kremlin's Sputnik news agency was raided and its employees detained. "Russia didn't expect such a harsh reaction from Baku," Konul de Moor, International Crisis Group's consulting South Caucasus analyst, told Newsweek. "Their relationship is the lowest it has ever been since Azerbaijan gained its independence." Karimli, leader of the Azerbaijan Popular Front Party and a former secretary of state whose opposition to Aliyev's rule has seen him face a travel ban and refused a passport by his country's authorities, told Newsweek the crash of Flight 8243 occurred when Aliyev was already pulling away from Moscow. At the onset of Russia's full-scale war against Ukraine, Aliyev believed Moscow would win quickly and reestablish its dominance across the post-Soviet space. On February 22, 2022— two days before the invasion—Aliyev signed a declaration in Moscow with Putin affirming a bilateral alliance between Azerbaijan and Russia. But as the war dragged on and Russia suffered repeated strategic losses, Aliyev, like many others, began to realize that Russia was not as powerful as once assumed, and was in fact becoming weaker, Karimli said. The downfall of the Assad regime in Syria further convinced Aliyev of this decline—Russia had failed to protect one of its most valued allies, he said. Aliyev also observed how Turkey and the West were rapidly filling the vacuum left by Russia's retreat, not only in Syria but across the wider region. "While Putin saw Assad's fall as a major loss, Aliyev appeared to welcome the outcome and publicly described Assad's removal as a positive development—deliberately signaling political distance from Moscow," said Karimli. "He seemed to conclude that close association with Russia might actually be more dangerous than opposing it." Ali Karimli, Azerbaijan's former secretary of state and chairman of the democratic opposition Azerbaijan Popular Front Party, is seen in this undated image. Ali Karimli, Azerbaijan's former secretary of state and chairman of the democratic opposition Azerbaijan Popular Front Party, is seen in this undated image. Supplied Nagorno-Karabakh Withdrawal Before Assad's downfall, there had already been a shift in Russia's authority in the South Caucasus, an area Moscow considers its backyard. Russian peacekeepers deployed to Nagorno-Karabakh after the 2020 Armenian-Azerbaijani war put up no resistance to Baku's blockade of the region. A Russian peacekeeping contingent left the region in 2024 ahead of schedule after not intervening in Baku's successful military operation to take full control of Nagorno-Karabakh from its separatist Armenian authorities in September 2023. Stefan Meister, head of the center for order and governance in Eastern Europe, Russia, and Central Asia at the German Council on Foreign Relations, told Newsweek that Azerbaijan winning the Second Nagorno-Karabakh War and taking over the region prompted Aliyev to see Baku as a regional player Moscow can no longer dictate to. "Aliyev considers himself as the key shaper of the new regional security order, where Russia will not play the role it played in the past," he said. "Azerbaijan is not willing to accept compromises with Russia." This comes as Moscow faces a souring of ties with another regional neighbor. Armenia did not attend the latest summit of the Moscow-led Collective Security Treaty Organization, angered by the lack of solidarity from Russia when Baku captured Nagorno-Karabakh, an operation which Meister said emboldened Aliyev's attitude to Moscow. "Aliyev did what he did without getting punished by Russia," said Meister. "He saw the relative weakness of Moscow and the unwillingness also to go into conflict with Azerbaijan because Moscow needs them." Aliyev and Armenian Prime Minister Nikol Pashinyan met in Abu Dhabi on July 10 for the first unmediated bilateral contact between the two leaders. It comes after Armenian prosecutors accused Moscow of trying to overthrow Yerevan's pro-Western government in 2024 in an alleged plot disrupted by local security forces. Armenia has since accelerated its policy of EU integration and distanced itself from the Moscow-led CSTO military alliance. Emergency specialists work at the site where Azerbaijan Airlines Flight 8243 crashed, near the western Kazakh city of Aktau, on December 25, 2024. Emergency specialists work at the site where Azerbaijan Airlines Flight 8243 crashed, near the western Kazakh city of Aktau, on December 25, with no free press, no functioning civil society, and the political opposition repressed, Azerbaijan is unlike Armenia, said Karimli adding that Aliyev may resist being in hock to Russia but he is equally unwilling to open up to the West. Azerbaijan may be strategically important to Russia but the reverse is also true with Russia a key partner for Aliyev, who understands that breaking with Putin would force him to deepen ties with Europe and the United States—something he is reluctant to do, given his wish to resist democratic reforms and preserve his authoritarian grip, Karimli added. "If Putin were to break with Aliyev, he would effectively lose his last remaining ally in the South Caucasus," he said. Putin also cannot overlook Baku's strategic alliance with Turkey and pushing Russia's relationship with Azerbaijan to breaking point could strain Moscow's ties with Ankara—something the Kremlin can ill afford under current geopolitical conditions, he added. Trade relations between Moscow and Baku are still strong, as is a mutual dependency on energy exports. Linguistic ties are also tight with Russian still widely spoken in Azerbaijan and nearly half (46 percent) of the total volume of remittances paid to Azerbaijan come from Russia, where, according to official data, more than 300,000 Azerbaijanis live. But Aliyev can also benefit from portraying Azerbaijan as a strategic partner of the West in the global confrontation with Russia, especially in the energy sector. "He has a better partnering position and it's more difficult for Russia to punish Aliyev or to escalate their relations too far," said Meister. Pushing back against Russia is a good card for Azerbaijan to play with the West, de Moor said, with the prospect of investment as Baku eyes energy-related projects bypassing Russia . All this marks a shift in the position of Russia in the South Caucasus. "Russia can't treat it as its near abroad any more," added de Moor.
Yahoo
an hour ago
- Yahoo
Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention
– If Approved, Lenacapavir Would Be the First and Only Twice-Yearly HIV PrEP Option in the European Union – – Positive Opinion Also Received for EMA's EU-M4all Procedure, Designed to Facilitate Availability in Low- and Lower-Middle-Income Countries – FOSTER CITY, Calif., July 25, 2025--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company's injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The final European Commission (EC) decision is expected later this year, and, if approved, lenacapavir will be marketed in the European Union (EU) under the trade name Yeytuo®. The marketing authorization application (MAA) recommendation will now be reviewed by the EC as it evaluates lenacapavir as a potential new preventative strategy against HIV in all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. Additionally, if approved, lenacapavir will be granted one additional year of market exclusivity in the EU as a result of the new indication. The CHMP also adopted a positive EU-Medicines for all (EU-M4all) opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in low- and lower-middle-income countries (LLMICs). "This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world," said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. "Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care." Despite ongoing advances in HIV prevention, persistent social and economic factors including stigma and discrimination continue to cause disparities in PrEP use. In 2023, a total of 24,731 new HIV diagnoses were reported across 30 EU/European Economic Area countries—an increase of 11.8% compared with 2022. "These positive opinions from the CHMP are an important step toward a new HIV prevention option that could help meet the diverse needs of people across Europe and aim at helping end new HIV infections by the EU target of 2030," said Jean-Michel Molina, MD, PhD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals. "The opinions reflect the strength of the clinical evidence and the potential of long-acting innovations like lenacapavir to address real-world barriers to the use of PrEP. Expanding the range of PrEP options, in Europe and in countries around the world, is essential to making HIV prevention more accessible for people who need it most." The positive opinions were supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial (NCT04994509), data at the primary analysis showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial (NCT04925752), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, lenacapavir demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 "Breakthrough of the Year." Continued Global Regulatory Filings for Lenacapavir for HIV Prevention, Milestone Partnerships and Global Guidance Gilead is executing a global access strategy informed by health advocates and organizations that prioritizes speed and enables the most efficient paths for regulatory review, approval of and access to twice-yearly lenacapavir for PrEP. More information about Gilead's recently announced strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as updates on Gilead's access strategies in countries and regions around the world: See Gilead press release More information about the WHO's recently announced guidelines for the use of lenacapavir for PrEP: See Gilead company statement Lenacapavir for PrEP is not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. About the PURPOSE Program Gilead's landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity. The PURPOSE trials are evaluating the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents (≥35kg) who are at risk of HIV acquisition. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 "Breakthrough of the Year." U.S. Indication for Yeztugo® Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available at Truvada, Truvada for PrEP, Yeztugo, Yeytuo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website at follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on Contacts Ashleigh Koss, Mediapublic_affairs@ Jacquie Ross, Investorsinvestor_relations@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
an hour ago
- Business Wire
Gilead Receives Positive CHMP Opinions Under Accelerated Review From European Medicines Agency for Twice-Yearly Lenacapavir for HIV Prevention
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company's injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The final European Commission (EC) decision is expected later this year, and, if approved, lenacapavir will be marketed in the European Union (EU) under the trade name Yeytuo ®. The marketing authorization application (MAA) recommendation will now be reviewed by the EC as it evaluates lenacapavir as a potential new preventative strategy against HIV in all 27 EU Member States, as well as Norway, Iceland and Liechtenstein. Additionally, if approved, lenacapavir will be granted one additional year of market exclusivity in the EU as a result of the new indication. The CHMP also adopted a positive EU-Medicines for all (EU-M4all) opinion, which enables a streamlined assessment for World Health Organization (WHO) prequalification and will facilitate national regulatory evaluations in low- and lower-middle-income countries (LLMICs). 'This milestone reflects our commitment to reimagine HIV prevention in Europe and around the world,' said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. 'Lenacapavir for PrEP has the potential to become a critical tool for public health, helping to expand prevention options for people who face the highest barriers to care.' Despite ongoing advances in HIV prevention, persistent social and economic factors including stigma and discrimination continue to cause disparities in PrEP use. In 2023, a total of 24,731 new HIV diagnoses were reported across 30 EU/European Economic Area countries—an increase of 11.8% compared with 2022. 'These positive opinions from the CHMP are an important step toward a new HIV prevention option that could help meet the diverse needs of people across Europe and aim at helping end new HIV infections by the EU target of 2030,' said Jean-Michel Molina, MD, PhD, Université Paris Cité, Professor of Infectious Diseases and Head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals. 'The opinions reflect the strength of the clinical evidence and the potential of long-acting innovations like lenacapavir to address real-world barriers to the use of PrEP. Expanding the range of PrEP options, in Europe and in countries around the world, is essential to making HIV prevention more accessible for people who need it most.' The positive opinions were supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial (NCT04994509), data at the primary analysis showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada ® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial (NCT04925752), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, lenacapavir demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 'Breakthrough of the Year.' Continued Global Regulatory Filings for Lenacapavir for HIV Prevention, Milestone Partnerships and Global Guidance Gilead is executing a global access strategy informed by health advocates and organizations that prioritizes speed and enables the most efficient paths for regulatory review, approval of and access to twice-yearly lenacapavir for PrEP. More information about Gilead's recently announced strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as updates on Gilead's access strategies in countries and regions around the world: See Gilead press release More information about the WHO's recently announced guidelines for the use of lenacapavir for PrEP: See Gilead company statement Lenacapavir for PrEP is not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. About the PURPOSE Program Gilead's landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity. The PURPOSE trials are evaluating the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents (≥35kg) who are at risk of HIV acquisition. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 'Breakthrough of the Year.' U.S. Indication for Yeztugo ® Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (≥35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available at For more information about Gilead, please visit the company's website at follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
