KIRKLAND, QC, Dec. 8, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the province of Saskatchewan has added CAPVAXIVE®, a 21-valent pneumococcal conjugate vaccine, to its publicly funded adult immunization program. This addition supports increased access to pneumococcal immunization for eligible adults in accordance with the provincial eligibility criteria. CAPVAXIVE® is approved by Health Canada for adults... Read more
In addition to meeting the primary endpoint of non-inferiority for overall response rate (ORR) in the BRUIN CLL-314 study, pirtobrutinib achieved a numerically higher ORR of 87.0% compared to 78.5% for ibrutinib in the intent-to-treat (ITT) population Progression-free survival data were immature but trended in favor of pirtobrutinib with a 43% reduction of the risk of disease progression or death in the ITT population, and the treatment-naïve subgroup, which... Read more
All three dose groups (50 mg, 100 mg and 200 mg) showed impressive monotherapy efficacy, with VGPR+ (very good partial response or better) of ≥70% despite limited follow-up; evidence shows that these responses are expected to deepen over time Across all dose groups, 95% (19 of 20 patients) of all evaluable VGPR+ patients achieved minimal residual disease negative status Data featured in an ASH oral presentation; LINKER-MM4 is the first clinical trial to evaluate a... Read more
The Company plans to initiate a Phase 3 program evaluating INCA033989 in essential thrombocythemia (ET) patients with all types of CALR mutations in mid-2026, following alignment with regulators Updated safety and efficacy data for INCA033989 in ET, and new data in myelofibrosis (MF), will be presented at the upcoming 2025 ASH Annual Meeting WILMINGTON, Del. / Dec 07, 2025 / Business Wire / Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration... Read more
Trial demonstrated treatment with fixed duration EPKINLY plus rituximab and lenalidomide (EPKINLY+ R2) resulted in statistically significant and clinically meaningful reduction in the risk of disease progression or death and overall response compared to R2 alone EPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific-based therapy for follicular lymphoma in the second-line setting Results of EPCORE FL-1 simultaneously... Read more
Findings from the Phase 3 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition and published in Blood NEW YORK / Dec 06, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today presented results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI® (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors. The results demonstrated the superiority of HYMPAVZI in improving key bleeding outcomes... Read more
Selective Treg modulator gotistobart (BNT316/ONC-392) showed a reduction in the risk of death by more than half compared to standard of care chemotherapy and a manageable safety profile in the first of two stages of the global Phase 3 trial PRESERVE-003 in patients with squamous non-small cell lung cancer (“sqNSCLC”) who have progressed on prior immunotherapy plus chemotherapy Median OS with gotistobart has not been reached at almost 15 months of follow-up, compared... Read more
96% Overall Response Rate, 74% Stringent Complete Response/Complete Response, and 95% Minimal Residual Disease Negativity Observed at a Median 15.9-months of Follow-up, with Responses Continuing to Deepen Over Time Observed Safety Profile is Predictable and Manageable to Date; No Delayed Neurotoxicities or Immune Effector Cell-Associated Enterocolitis across Phase 1 and 2 (iMMagine-1) Studies Data from Investigational Agent Anito-cel Support Planned 2026 Launch in the... Read more
Follow-up data from CARTITUDE-4 show at least 80 percent of as-treated standard-risk patients remained progression and treatment-free following a single infusion as early as second line Data suggest stronger immune fitness in earlier lines may be associated with longer progression free survival ORLANDO, Fla., Dec. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today updated results from the Phase 3 CARTITUDE-4 study supporting durable tr... Read more
Viatris to Receive $400 Million in Cash and $415 Million in Equity Shares of Biocon Limited Transaction Accelerates the Expiration of Biosimilars Non-Compete Restrictions PITTSBURGH, Dec. 6, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) today announced that it has entered into definitive agreements with Biocon Limited ("Biocon") for the sale of Viatris' equity stake in Biocon Biologics Limited ("Biocon Biologics"). Under the definitive agreements, Biocon will... Read more
New data from Cohort 4 of the SunRISe-1 study show more than 95 percent of patients remained progression free at one year, with more than 92 percent not undergoing bladder removal Patients with this type of bladder cancer have limited choices beyond radical cystectomy, highlighting the need for newer therapies for bladder preservation RARITAN, N.J., Dec. 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today that new data from the investigational... Read more
In the MZL cohort of TRANSCEND FL, Breyanzi delivered deep and durable responses in 95.5% of patients while demonstrating a consistent safety profile Breyanzi is now the only CAR T cell therapy approved by the FDA for five cancer types, the most of any CD19-directed CAR T cell therapy PRINCETON, N.J. / Dec 04, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Breyanzi® (... Read more
NEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Denali Therapeutics, Inc. (Nasdaq: DNLI) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali’s lead investigational TransportVehicleTM-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License... Read more
BAY 3401016 is an investigational monoclonal antibody with potential to block a protein called Semaphorin 3A (Sema3A), which is thought to be involved in the progression of kidney damage in Alport Syndrome (AS), a rare genetic disorder Bayer explores opportunity to address high unmet medical need of patients suffering from AS and advances research efforts through close cooperation with AS patient organizations Derived from the strategic research cooperation with Evotec,... Read more
Approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL in which all patients were previously treated with a covalent BTK inhibitor This expanded indication represents a substantial increase in the number of CLL/SLL patients who may benefit from Jaypirca and aligns with the patient population endorsed by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) INDIANAPOLIS, Dec. 3, 2025 /PRNewswire/ -- Eli... Read more
Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee BMS Remains Blinded to Study Data PRINCETON, N.J. / Dec 03, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY, “BMS”) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, the company identified... Read more
Bayer revealed first results of the pediatric study from the pivotal clinical development program QUANTI for its low-dose MRI contrast agent QUANTI Pediatric evaluated the pharmacokinetics and safety of gadoquatrane in children (birth to <18) at a gadolinium dose of 0.04 mmol Gd/kg body weight, representing a dose reduction of 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight Data are part of submissions to health authorities worldwide... Read more
TOKYO and CAMBRIDGE, Mass., Dec. 2, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name: LEQEMBI®), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in cerebrospinal fluid (CSF) was... Read more
Submission based on positive BaxHTN Phase III trial results which demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension If approved, baxdrostat could be the first aldosterone synthase inhibitor to receive regulatory authorization WILMINGTON, Del. / Dec 02, 2025 / Business Wire / AstraZeneca’s New Drug Application (NDA) for baxdrostat has been accepted for Priority... Read more
Study further expands clinical development program of Bayer’s long-acting reversible intrauterine system Mirena® (levonorgestrel-releasing intrauterine system) 52 mg. Approximately 121 out of every 100,000 women develop nonatypical endometrial hyperplasia (NAEH), a benign form of endometrial thickening, each year.1 Currently, there are no approved medical treatment options for NAEH in the U.S. Mirena is globally available in more than 120 countries, and approved in... Read more
Centargo compatible with Ultravist® (iopromide), Isovue® (iopamidol), Optiray® (ioversol), Omnipaque™ (iohexol) and now, Visipaque™ (iodixanol) Follows recent FDA clearance to expand the use of compatible contrast agent presentations, adding single-dose vials in addition to Imaging Bulk Package presentations Radiology suites now have the ability to further manage contrast consumption and waste, while providing greater flexibility for those transitioning to bulk... Read more
TSRA-196 is a potential one-time treatment to precisely correct the genetic mutation underlying AATD, with Investigational New Drug filing expected by the end of the year Tessera to receive $150 million, inclusive of a cash upfront and equity investment from Regeneron; companies to share worldwide development costs and future profits 50:50 Collaboration combines Regeneron’s long-standing expertise in genetics, genetic medicines and clinical development with Tessera’s... Read more
WILMINGTON, Del. / Dec 01, 2025 / Business Wire / Incyte (Nasdaq:INCY) announces the appointment of Richard Hoffman as Executive Vice President and General Counsel effective today, December 1, 2025. In his new role, Mr. Hoffman will serve as a key member of the Executive Leadership Team and be responsible for the Company’s legal and compliance teams. “Richard joins us with a distinguished background, including many years of experience as a partner at a premier law firm,... Read more
SKYRIZI® (risankizumab), an IL-23 inhibitor, received two consecutive positive reimbursement recommendations by Canada’s Drug Agency (CDA-AMC) for inflammatory bowel diseases, initially for Crohn’s disease (CD) and now for ulcerative colitis (UC), supported by evidence from pivotal phase 3 clinical trials including MOTIVATE, ADVANCE, FORTIFY (for CD), and INSPIRE, COMMAND (for UC).1,2 AbbVie concludes letter of intent (LOI) with the pan-Canadian Pharmaceutical Alliance... Read more
Based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of progression, recurrence or death and a 22% reduction in the risk of death for the IMFINZI regimen vs. chemotherapy alone WILMINGTON, Del. / Nov 26, 2025 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients... Read more
Following the positive opinions of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorizations for Teva’s biosimilars PONLIMSI and DEGEVMA expanding access to important bone health treatments across Europe These approvals mark another significant milestone in Teva’s strong biosimilars portfolio, in line with Teva's Pivot to Growth Strategy The approvals underscore Teva’s commitment to broadening access... Read more
LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start of therapy to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Nov. 25, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher,... Read more
Approval based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo In the EU, there are approximately 270,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite standard-of-care antihistamine treatment Dupixent, which inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation, is now approved for patients across seven chronic, inflammatory diseases in the... Read more
In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% of patients achieving complete response Breyanzi demonstrated sustained clinical benefit, with 50.8% of patients still in response at 24 months based on TRANSCEND MCL trial results PRINCETON, N.J. / Nov 24, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to Breyanzi® (lisocabtagene maraleucel; liso-cel), a C... Read more
Oral macrocyclic peptides have the potential to offer biologic-like efficacy and safety in a convenient oral format Collaboration further advances Biogen’s immunology strategy by broadening its early-stage pipeline and incorporating an additional clinically validated modality into its expanding immunology capabilities CAMBRIDGE, Mass. and TORONTO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Dayra Therapeutics today announced a research collaboration... Read more
OCEANIC-STROKE demonstrates superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor Bayer will globally engage with health authorities in preparation for the submission of marketing authorization applications and looks forward to presenting... Read more
PADCEV plus Keytruda is the first and only approved perioperative treatment regimen that can significantly improve survival over current standard of care (surgery alone) in cisplatin-ineligible patients with muscle-invasive bladder cancer Approval is based on unprecedented data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression or death and a 50% reduction in the risk of death compared to surgery alone Represents... Read more
Represents the first PD-1 inhibitor plus ADC regimens for this patient population RAHWAY, N.J. / Nov 21, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued... Read more
New capacity at AstraZeneca’s Fredrick and Gaithersburg facilities will accelerate production of cancer, rare and chronic disease medicines Fourth major US manufacturing investment announced this year, advancing AstraZeneca’s historic $50 billion commitment to medicines manufacturing and R&D WILMINGTON, Del. / Nov 21, 2025 / Business Wire / AstraZeneca today announces plans to invest $2 billion to expand its long-standing manufacturing footprint in Maryland.... Read more
Published, peer-reviewed narrative review in CNS Spectrums compiles pharmacologic, pharmacokinetic and clinical data of VMAT2 inhibitors to highlight important differences between treatments Review presents distinctive profile of INGREZZA, including selective VMAT2 targeting, simplified dosing without required titration and robust clinical data across diverse patient populations and concludes that VMAT2 inhibitors are not clinically interchangeable Publication provides... Read more
Following Priority Review, the U.S. FDA granted HYRNUO® (sevabertinib) approval for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. WHIPPANY, N.J. / Nov 20, 2025 / Business Wire / Bayer announced today that the U.S. Food and Drug Administration... Read more
KIRKLAND, QC, Nov. 20, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that it has successfully completed negotiations with the pan‑Canadian Pharmaceutical Alliance (pCPA) for WINREVAIR® (sotatercept). The pCPA negotiates on behalf of the provinces, territories, and federal drug programs serving as a critical step in bringing WINREVAIR® closer to public reimbursement. WINREVAIR® is indicated in combination with... Read more
SAN DIEGO, Nov. 20, 2025 /PRNewswire/ -- Aspen Neuroscience, Inc., a clinical-stage biotechnology company pioneering autologous regenerative therapies, today announced the closing of a $115 million Series C financing round. This significant investment will fuel the continued clinical development of Aspen's lead program, ANPD001, for moderate to advanced Parkinson's disease. The Series C round was co-led by OrbiMed, ARCH Venture Partners, Frazier Life Sciences, and... Read more
Non-dilutive financing from premier lender bolsters strong balance sheet and provides increased flexibility Company reiterates 2025 financial guidance provided on 3Q25 earnings call and targets cash breakeven by 2028 CAMBRIDGE, MA / ACCESS Newswire / November 20, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced it has closed a five-year term loan facility for up to $1.5 billion of capital from Ares Management Credit Funds (Ares), a leading global alternative investment... Read more
First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period Monthly dosing option in all approved indications provides greater dosing flexibility for more personalized patient care TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD® (aflibercept) Injection 8 mg... Read more
Global Confirmatory Phase 3 DeLLphi-304 Trial Showed IMDELLTRA Reduced Risk of Death by 40% Compared to Chemotherapy Underscores IMDELLTRA as a Recognized Standard of Care Treatment for Patients With Extensive Stage Small Cell Lung Cancer That Has Progressed THOUSAND OAKS, Calif., Nov. 19, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment... Read more
First cohort features 7 real-world challenges across R&D, manufacturing and supply chain, commercial and medical affairs Teva's first-ever global innovation platform aims to accelerate patient impact and drive business transformation, as part of its Pivot to Growth Strategy Rise will enable startups and tech players worldwide to validate their solutions in real-world settings, scaling impact across Teva's global ecosystem including in the U.S., Europe, Israel... Read more
New capabilities strengthen U.S. production, completing Moderna's domestic end-to-end mRNA manufacturing network More than $140 million investment will create hundreds of highly skilled biomanufacturing jobs CAMBRIDGE, MA / ACCESS Newswire / November 19, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced the expansion of its U.S. manufacturing capabilities with the onshoring of Drug Product manufacturing to its existing Moderna Technology Center ("MTC") in Norwood,... Read more
Approval based on results of landmark Phase 3 C-POST trial that show Libtayo is first immunotherapy to significantly improve disease-free survival in CSCC in the adjuvant setting, reducing the risk of recurrence or death by 68% (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001) Libtayo is the current standard of care in advanced CSCC in Europe, and this approval has the potential to change the treatment paradigm for patients in an earlier setting... Read more
Investigational DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority to BIC/FTC/TAF in a Phase 3 clinical trial in treatment-naïve adults with HIV-1 infection RAHWAY, N.J. / Nov 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from the pivotal double-blind Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir... Read more
This marks the approval of the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered by a health care provider in as little as one minute RAHWAY, N.J. / Nov 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved a new subcutaneous (SC), or under the skin, route of administration and a new pharmaceutical form (solution for injection)... Read more
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapyIn the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2 with approximately 3 out of 4 patients achieving a complete r... Read more
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is the first and only bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line setting In the Phase 3 EPCORE® FL-1 trial, fixed duration EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2, with approximately three out of four patients achieving a complete response This approval marks the third indication... Read more
Non-Cystic Fibrosis Bronchiectasis (NCFB) Is a Serious, Progressive Lung Disease That Can Lead to Permanent Lung Damage BRINSUPRI Is a First-in-Disease, First-in-Class DPP1 Inhibitor Targeting Neutrophilic Inflammation BRINSUPRI Was Reviewed Under EMA's Accelerated Assessment Pathway as It Is Considered of Major Interest for Public Health BRIDGEWATER, N.J., Nov. 18, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical... Read more
WINREVAIR demonstrated a statistically significant and clinically meaningful reduction in the primary endpoint of pulmonary vascular resistance (PVR) compared to placebo, improving the ability of blood to transition through the lungs to the heart These data support proof-of-concept to inform Phase 3 development for WINREVAIR in this population RAHWAY, N.J. / Nov 18, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today... Read more
