Merck is a global healthcare company that develops medicines, vaccines, and animal health products. It advances long-term health by conducting research and development to create new treatments for diseases such as cardiovascular disease, diabetes, and cancer, then brings these medicines to patients, healthcare professionals, and institutions worldwide. The company’s products work by undergoing scientific discovery, clinical testing, and regulatory approval before being manufactured and sold or distributed through patient assistance programs. What sets Merck apart is its large, diversified portfolio across human medicines, vaccines, and animal health, along with a strong emphasis on R&D, global reach, and support services like Merck Connect and Merck Manuals that provide professional resources. Merck’s goal is to tackle major health threats by applying science to discover and deliver therapies that improve patient outcomes and public health across the globe.
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1891
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Halozyme wins injunction stopping manufacture and sale of Merck's Keytruda SC in multiple European markets. Oct 07, 2026, 08:30 ET SAN DIEGO, Oct. 7, 2026 /PRNewswire/ - Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") announced today that the specialized Dutch patent court of the Hague has found Merck to be infringing one of its MDASE patents, EP 2,797,622 (EP622) and ordered Merck's central European Market Authorization Holder and worldwide packaging and distribution hub MSD BV to refrain from manufacturing, having manufactured, offering, placing on the market and using, or importing or stocking for these purposes, Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands. The injunction also forbids MSD to facilitate infringement by its affiliates, including by allowing the use of its European Marketing Authorization. The court also rejected Merck's arguments that EP622 patent is invalid. "We're very pleased the Dutch court recognized the validity and infringement of Halozyme's MDASE patent EP622 and granted an injunction halting Merck's launch of Keytruda SC in multiple European markets. The MDASE technology was developed through years of rigorous research to enable rapid, high-volume subcutaneous drug delivery," said Mark Snyder, Chief Legal Officer of Halozyme. Importantly, patients who want to use Keytruda will still have access to the IV version of Keytruda, which is not covered by Halozyme's patent or the court's injunction order. The Dutch proceedings are part of Halozyme's global enforcement of its MDASE(TM) patents against infringement by Merck's Keytruda SC. Halozyme previously sued Merck in Germany and was granted a preliminary injunction on December 4, 2025, stopping Merck's launch of Keytruda SC in Germany. Halozyme has also sued Merck for patent infringement in U.S. federal district court in New Jersey. In that case, Halozyme alleges the subcutaneous formulation of Keytruda, which is being marketed in the U.S. as QLEX, infringes 15 patents that Halozyme filed beginning in 2011 to protect its MDASE(TM) technology. The patents at issue arise from Halozyme's extensive research into nearly 7,000 modifications to human hyaluronidases. Among their uses, these hyaluronidases pioneered by Halozyme provide a mechanism for the rapid SC administration of therapeutic drugs. Halozyme's comprehensive studies and innovations were a significant advancement to the field of human-derived hyaluronidases. The MDASE(TM) patents are not included in Halozyme's ENHANZE(R) licensing program and are distinct from its ENHANZE(R) patents. Therefore, the outcome of the global enforcement of its MDASE(TM) patents against Merck will not impact the ability of any licensee to use ENHANZE(R), or the license fees for use of ENHANZE(R) patents. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE(R) drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE(R) has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, Merus N.V., GSK, and Incyte. Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon(TM) and Surf Bio's hyperconcentration technology, recently renamed as Aerocon(TM). Hypercon(TM) is an innovative microparticle technology expected to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at-home and healthcare-provider settings. Aerocon's polymer-based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. Together, Hypercon(TM) and Aerocon(TM) complement ENHANZE(R) by enabling creation and delivery of highly concentrated biologics. The Hypercon(TM) technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly, argenx, Vertex Pharmaceuticals and Oruka Therapeutics. Halozyme also develops, manufactures and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex(R) and XYOSTED(R), partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of Halozyme's ENHANZE(R) and MDASE(TM) drug delivery technologies, the possible method of action of these technologies, their potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of these technologies including facilitating more rapid delivery of high-volume injectable medications through subcutaneous delivery and potentially easing the treatment burden for patients and improving patient outcomes. These forward-looking statements include statements with respect to the decision of a Dutch court to order MSD BV to refrain from manufacturing, having manufactured, offering, placing on the market and using, or importing or stocking for these purposes, Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands, and forbidding MSD BV to facilitate infringement by its affiliates, including by allowing the use of its European Marketing Authorization, the decision of a German court to issue a preliminary injunction ordering Merck to refrain from distributing and offering Keytruda SC in Germany, and statements with respect to the strength and validity of Halozyme's intellectual property. These forward-looking statements also include statements with respect to Halozyme's patent infringement suit against Merck Sharp & Dohme LLC, to enforce Halozyme's patent rights, including Halozyme's allegation that Merck's SC Keytruda infringes multiple Halozyme patents and Halozyme's belief that the outcome of the lawsuit will not impact its ENHANZE(R) licensing program or the revenues Halozyme receives from ENHANZE(R) licensees. These forward-looking statements involve risks and uncertainties beyond Halozyme's control that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors and Halozyme can offer no assurance with respect to such forward-looking statements and cautions the reader not to place undue reliance on these forward-looking statements. In particular, there can be no assurance as to developments related to the litigation referred to in this press release, the outcome of the litigation or any remedies that could be awarded in connection with the litigation. Actual results could also differ materially from expectations contained in this press release as a result of other risks and uncertainties including those related to future decisions by Dutch courts with respect to the decisions of the Dutch court referred to in this press release, the courts in Germany with respect to the preliminary injunction referred to in this press release, the strength, enforceability and validity of our patents, future revenues and the cost of litigation. These and other factors that may result in material differences from the forward-looking statements contained in this press release are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] SOURCE Halozyme Therapeutics, Inc.
Tempus enters multiyear collaboration with Moderna, Merck aimed at commercializing cancer drug. Published on 10/07/2026 at 09:26 am EDT - Modified on 10/07/2026 at 09:27 am EDT By Kelly Cloonan Tempus is doubling down on its work with Moderna and Merck under a new multiyear collaboration to support the potential commercialization of a cancer drug. The healthcare-technology company said Wednesday the collaboration will focus on intismeran autogene, a therapy being evaluated in combination with Merck's Keytruda in patients with completely resected stage IIB-IV melanoma and other cancer types. Moderna and Merck are jointly developing intismeran autogene. As part of the collaboration, Tempus will manage the collection and transfer of tumor tissue and blood samples required for next-generation sequencing, the company said. The collaboration expands work that Tempus initiated with Moderna and Merck last year. Moderna said working with Tempus will allow it to use the company's commercial footprint and advanced sequencing capabilities to help it provide individualized neoantigen therapies at scale. "Bringing an individualized therapy like intismeran autogene from clinical development toward potential commercialization requires a seamless, highly reliable diagnostic network," said Said Francis, Moderna's chief business officer and general manager, individualized neoantigen therapies. Write to Kelly Cloonan at [email protected] (END) Dow Jones Newswires 10-07-26 0925ET (C) Dow Jones - 2026
Halozyme prevails in patent fight with Merck; Enliven readies anticipated leukemia trial. A Dutch court barred Merck from selling subcutaneous Keytruda in several European countries. Elsewhere, an Insmed executive ended a seven-year run and two startups secured venture cash. Published Oct. 7, 2026 By BioPharma Dive staff Today, a brief rundown of news involving Merck & Co. and Enliven Therapeutics, as well as updates from Insmed, KymaThera and RougeTx that you may have missed. A Netherlands court has blocked sales of Merck & Co.'s subcutaneous cancer immunotherapy Keytruda Qlex in eight European countries by siding with Halozyme in an intellectual property dispute. According to Halozyme, the court ruled that Merck's drug infringed on patents covering a Halozyme technology capable of rapidly delivering large biologic molecules through under-the-skin injections. The Netherlands case is part of a broader offensive by Halozyme, which won a legal proceeding in Germany and is challenging Merck in a U.S. court. Unlike Merck, Bristol Myers Squibb and Roche both partnered with Halozyme to develop subcutaneous versions of their cancer immunotherapies Opdivo and Tecentriq. The decision announced Wednesday "strengthens [Halozyme]'s position and could improve the potential path toward a future license or other economic resolution," wrote TD Cowen analyst Brendan Smith in a client note. - Jonathan Gardner Enliven Therapeutics has aligned with the Food and Drug Administration on the design of a late-stage study for its experimental chronic myeloid leukemia drug relcobatinib. Enliven's drug blocks the expression of a faulty gene that drives CML. It's emerging as a potential threat to Novartis' Scemblix and a therapy Merck acquired in a $6.7 billion acquisition of Terns Pharmaceuticals. The planned trial will enroll 450 people and test whether relcobatinib is superior to another drug from its class at spurring a "major molecular response," or reducing the number of diseased cells. In a client note, Jefferies analyst Maury Raycroft wrote that recent data updates from Enliven, combined with a slightly diminished outlook for Merck's drug, have improved the sentiment surrounding relcobatinib. - Jonathan Gardner Insmed Chief Financial Officer Sara Bonstein will step down from her position on Oct. 30, ending a seven-year run at the company. Insmed hasn't yet named a replacement and will begin a search for a successor, the company said Monday. Bonstein will stay on board for the next few weeks to ensure a "smooth transition" through Insmed's third-quarter results. Insmed's value has grown substantially over the course of Bonstein's tenure, as the company transitioned into a commercial-stage company with growing product sales. The company reaffirmed its full-year financial guidance on Monday. - Delilah Alvarado KymaThera has raised $80 million in a Series B round that will go toward a treatment for vascular malformations and cancers driven by PI3Kα mutations. Dubbed K-1728, KymaThera's prospect is initially being evaluated as a standalone treatment for the former condition and as part of a combination regimen in HR-positive, HER2-negative breast cancer. KymaThera expects to start Phase 1 testing in the fourth quarter. The Series B round was led by Alta Partners, and involved contributions from Foresite Capital, Venrock and J. Wood Capital, among others. The startup has now raised over $100 million in venture funding. - Delilah Alvarado RougeTx, a new biotech startup, launched with a $58 million Series A round that will help advance an experimental treatment for a rare bleeding disorder. RougeTx is working on a once-daily oral medication for hereditary hemorrhagic telangiectasia, a condition that spurs the formation of abnormal blood vessels and that's become a popular target among young drugmakers. Its prospect, RTX-001, is designed to reattach key structural support cells called pericytes to the walls of blood vessels. - Ben Fidler
New Modular method speeds up antiviral drug discovery. Scientists at Simon Fraser University's Britton Lab and biopharmaceutical firm Merck have developed a modular, light-driven chemical approach to accelerate the synthesis of nucleoside analogues - vital molecular lookalikes used in antiviral medications - reducing production timelines from months to mere weeks and generating test libraries 10 to 100 times larger than previously practical. Light-Driven method simplifies nucleoside analogue production. * What are nucleoside analogues? They are lab-made molecular lookalikes of the natural building blocks of DNA and RNA. Viruses mistakenly absorb them, which disrupts their genetic replication and stops them from reproducing. * Why does this research matter? Traditional manufacturing of these drugs requires a grueling sequence of 15 or more chemical steps, often yielding less than two percent usable product. This new method builds a versatile core piece that joins with various molecular fragments in a single visible-light-driven step. * What was achieved? Researchers successfully built a library of more than 70 analogues in weeks, identifying three compounds with promising anti-HIV activity in early cell-based assays. Overcoming the bottlenecks of traditional antiviral manufacturing. Discover more Sports news website When the COVID-19 pandemic hit, doctors turned to remdesivir, a member of the nucleoside analogue drug family. These medications are used in treating human immunodeficiency virus (HIV), hepatitis, and some cancers. Despite their importance, the arsenal for combating viral infections remains remarkably limited. This scarcity explains why new viral outbreaks cause so much alarm. For nearly a decade, the Britton Lab at Simon Fraser University has pursued faster ways for constructing these intricate molecules. In 2020, the research group published a methodology that bypassed traditional multi-step hurdles, compressing the synthesis timeline from months down to approximately one week. Now, building upon that foundational work in a study published in the journal Science, researchers partnered with scientists at Merck to introduce a modular manufacturing platform designed to transform a single, inexpensive starting material into an expansive array of finished drug candidates. Accelerating discovery through visible-light chemistry. Nucleoside analogues function by tricking cells and invading viral pathogens into incorporating fake molecular building blocks rather than authentic ones. Historically, chemists initiated this process with naturally occurring sugar molecules, executing rigid, linear sequences often exceeding 15 discrete chemical reactions to yield a single target molecule. Modifying the molecular structure to improve efficacy required restarting the entire sequence from the beginning. For instance, early manufacturing of remdesivir yielded less than two percent of the starting material as a usable drug. Discover more Real-time news updates Journalism & News Industry This one-at-a-time paradigm contrasts sharply with contemporary pharmaceutical screening requirements, which typically demand the evaluation of thousands of related molecular candidates to isolate viable therapeutic leads. The compound collection that led to remdesivir contained roughly 1,000 candidates - a modest library by industry standards that required substantial corporate resources and many years of assembly. To prepare for future viral threats, researchers must generate and screen larger, more diverse molecular libraries as quickly as possible. The newly unveiled platform subverts traditional synthetic pathways. Instead of constructing every target molecule independently from scratch, investigators utilize an amino acid catalyst to synthesize a versatile core intermediate equipped with a chemical connector. This intermediate can be mass-produced and stockpiled. Subsequently, a single-step reaction powered by ordinary visible light couples this core to a multitude of molecular fragments, producing distinct nucleoside analogues in parallel. | Parameter | Traditional Synthesis | New Modular Platform | | Synthesis Timeline | Months to years per library | Weeks | | Reaction Steps | 15 or more sequential steps | Reduced to as few as six steps | | Library Scale | Approx. 1,000 candidates (e.g., remdesivir) | 10x to 100x larger collections | | Core Intermediate | None (built from scratch each time) | Batch-produced and stored for rapid use | Translating synthetic innovations into antiviral leads. Discover more World news coverage Sports event tickets Employing this visible-light strategy, the research team rapidly assembled a library exceeding 70 nucleoside analogues. The collection incorporated structural refinements - such as replacing standard oxygen atoms in the sugar ring with sulfur or nitrogen atoms - that typically present synthetic difficulties but can have a huge effect on biological activity. The team also engineered variants designed to get inside cells more easily, mirroring the strategies utilized by remdesivir and another drug used to treat hepatitis. While generating more than 70 molecules represents an initial proof-of-concept rather than an exhaustive industrial screening campaign, the methodology successfully transformed previously arduous synthetic routes. A compound requiring 16 separate synthetic steps under legacy methods was successfully synthesized in merely six steps using the new platform. These newly generated compounds were subsequently evaluated in cell-based assays directed by Ralph Pantophlet's laboratory at Simon Fraser University. Laboratory testing identified three standout compounds capable of blocking HIV about as effectively as some of the medications already approved to treat it. While transitioning these laboratory leads through preclinical evaluations and human clinical trials remains a long path, establishing a rapid-generation platform alters the foundational economics and timeline of antiviral drug discovery. Patients must rely on approved viral regimens. Because this research remains in the preclinical, laboratory-testing phase, these novel compounds possess no established clinical dosages, side-effect profiles, or human safety data. Patients currently managing viral infections such as HIV or hepatitis must rely exclusively on approved regimens prescribed by licensed infectious disease specialists. Unverified chemical analogues or experimental precursors must never be consumed. Individuals experiencing symptoms of acute viral illness or managing chronic infections should consult their primary care physician or local public health clinic immediately for evidence-based diagnostics and standard-of-care therapeutics. Future trajectories in antiviral preparedness. The transition from academic bench chemistry to scalable pharmaceutical manufacturing requires overcoming substantial regulatory and pharmacokinetic hurdles. While the Britton Lab platform demonstrates that generating diverse molecular libraries in weeks rather than years is chemically feasible, the path from an in vitro cell assay to a regulated clinical candidate involves extensive toxicological evaluation, pharmacokinetic profiling, and phased human trials. The open question facing the scientific community is how rapidly these accelerated synthesis platforms can be integrated into global pandemic preparedness frameworks to counter emerging pathogens before regional outbreaks escalate. References. * Science Journal: Collaborative research between Simon Fraser University and Merck.
Vaxcyte claims success in bid to beat Pfizer and Merck in lucrative vaccine market. Biotech company's pneumococcal vaccine hit primary endpoints in late-stage study. Oct. 5, 2026 General Assignment Reporter Vaxcyte said Monday that its experimental pneumococcal vaccine hit the primary endpoints in a Phase 3 clinical trial, setting up the California-based biotech to compete with Pfizer and Merck. Vaxcyte's shot, VAX-31, is designed to protect against 31 serotypes, or strains, of bacteria that can cause pneumococcal disease, including pneumonia, compared to 20 strains for Pfizer's Prevnar and 21 strains for Merck's Capvaxive. In the trial, just over 3,500 adults age 50 and older were randomized to receive VAX-31, Prevnar, or Capvaxive. Investigators then measured the strength of their antibody responses against different strains.