Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30% After a median follow-up of 61.4 months, treatment with XTANDI (enzalutamide) plus ADT was associated with a 66% probability of survival at five years compared to 53% probability of survival with placebo plus ADT XTANDI (enzalutamide) is the first and only androgen receptor inhibitor to demonstrate an overall survival... Read more
First results to be presented in two ASCO oral presentations Data in both combinations demonstrate high response rates TARRYTOWN, N.Y., May 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with relapsed/refractory (R/R) multiple... Read more
Nucala is the only approved biologic studied in a wide COPD population with an eosinophilic phenotype characterized by blood eosinophil count (BEC) starting at 150 cells/μL Approval based on the positive MATINEE and METREX phase III trials MATINEE data included reduction of exacerbations leading to hospitalization and/or emergency department visits Nearly 70% of patients in the US who are inadequately controlled on inhaled triple therapy have a BEC ≥150 cells/μL... Read more
With all doses of FDA-approved Wegovy® fully available nationwide, it is illegal under US compounding laws to make or sell knockoff "semaglutide" drugs, with rare exceptions New, one-time $199 first-month offer for Wegovy® available through June 30, 2025; offer designed to help new self-paying patients previously prescribed unapproved "semaglutide" start on FDA-approved Wegovy® "Choose the Real Thing" campaign launching to raise awareness about the dangers of knockoff... Read more
The authorization in Australia is for adult patients who are Apolipoprotein E-ε4 heterozygotes or non-carriers INDIANAPOLIS, May 21, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for Kisunla (donanemab), an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in... Read more
Insmed Presented 11 Abstracts at ATS 2025 from Across Its Respiratory Portfolio, Including Data on ARIKAYCE®, TPIP and Health Economics and Outcomes Research BRIDGEWATER, N.J., May 21, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, presented 11 new abstracts at the American Thoracic... Read more
CAMBRIDGE, Mass. / May 21, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following update related to ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy. We have received feedback from the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) that dosing may continue uninterrupted... Read more
CAMBRIDGE, MA / ACCESS Newswire / May 21, 2025 / Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational... Read more
ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study If approved, DARZALEX FASPRO® would be the first treatment to potentially delay or prevent progression to multiple myeloma RARITAN, N.J., May 20, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (6-2) in favor of the benefit-risk profile... Read more
Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the Phase III STARGLO study There is an urgent need for effective, immediately available therapies that are broadly accessible to people with transplant-ineligible R/R DLBCL This first-of-its-kind Columvi combination could provide a much-needed, off-the-shelf and fixed-duration treatment option for patients who face poor prognosi... Read more
NEW YORK / May 19, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced it has entered into an exclusive global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK), a leading Chinese biopharmaceutical company, for the development, manufacturing and commercialization of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, currently undergoing several clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological... Read more
AIRSUPRA demonstrated a 47% reduction in the risk of severe exacerbations in mild asthma compared with albuterol alone Full results published in the New England Journal of Medicine and presented at ATS 2025 International Conference WILMINGTON, Del. / May 19, 2025 / Business Wire / Positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, AIRSUPRA (albuterol/budesonide), demonstrated statistically significant... Read more
Purchase is subject to bankruptcy court and regulatory approvals Regeneron will prioritize the privacy, security and ethical use of 23andMe’s customer data; stands ready to work with independent, court-appointed Customer Privacy Ombudsman Planned purchase to strengthen Regeneron’s ongoing leadership in genetics-guided research and drug development to help people with serious diseases TARRYTOWN, N.Y., May 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals,... Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / May 19, 2025 / Business Wire / The first patient has been dosed in the IDeate-Esophageal01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following treatment with a platinum-containing systemic therapy and an immune checkpoint... Read more
Treatment with ELEVIDYS for Duchenne muscular dystrophy resulted in mean protein expression of 93.87% as measured by western blot in study participants (n=6) Safety profile consistent with prior studies of ELEVIDYS and real-world experience CAMBRIDGE, Mass. / May 16, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported new results from Study 9001-103. Also known as ENDEAVOR, Study... Read more
Bagsværd, Denmark, 16 May 2025 – Novo Nordisk today announced changes to its executive leadership and Board of Directors. As per mutual agreement with the Novo Nordisk Board, Lars Fruergaard Jørgensen will step down from his role as CEO of Novo Nordisk. He will continue as CEO for a period to support a smooth transition to new leadership. A search for Lars Fruergaard Jørgensen’s successor is ongoing, and an announcement will be made in due course. In connection... Read more
Acquisition is Strong Strategic Fit for BioMarin, Adding INZ-701, a Phase 3 Enzyme Replacement Therapy Being Developed for Treatment of ENPP1 Deficiency First Pivotal Data Readout in Children Expected in Early 2026 with Potential Launch in 2027; Additional Clinical Programs to Expand to Patients of all Ages Potential First-in-Disease Treatment for ENPP1 Deficiency Conference Call and Webcast Scheduled Today at 8:45 a.m. ET SAN RAFAEL, Calif. and BOSTON, May... Read more
Approval based on results from the CheckMate-77T trial which showed perioperative Opdivo improved event-free survival compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo Opdivo is now the only PD-(L)1 inhibitor approved for both perioperative and neoadjuvant-only treatment of resectable non-small cell lung cancer in the European Union PRINCETON, N.J. / May 16, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced... Read more
Zynyz® (retifanlimab-dlwr), a PD-1 inhibitor, is now approved for the treatment of advanced squamous cell carcinoma of the anal canal (SCAC) in combination with chemotherapy and as a monotherapy Patients with SCAC treated with Zynyz achieved a statistically significant improvement in progression-free survival and improvement in overall survival WILMINGTON, Del. / May 15, 2025 / Business Wire / Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration... Read more
Study also met secondary endpoint of overall survival (OS) for patients whose tumors express PD-L1 KEYTRUDA® (pembrolizumab) plus chemotherapy (paclitaxel) with or without bevacizumab is the first immune checkpoint inhibitor-based regimen to show a statistically significant improvement in OS for ovarian cancer RAHWAY, N.J. / May 15, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-B96... Read more
EMRELIS is the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression who often face poor prognosis and have limited treatment options Lung cancer remains the leading cause of cancer-related deaths throughout the world1 NORTH CHICAGO, Ill., May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that EMRELIS™ (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S.... Read more
MORRISTOWN, N.J. and CAMBRIDGE, Mass., May 14, 2025 /PRNewswire/ -- Sanofi today announces its intention to invest at least $20 billion in the United States through 2030. The expected investment includes a significant increase in research and development spending and the allocation of billions of dollars to US manufacturing. The announcement comes as Sanofi prepares for the potential launch of numerous new first- or best-in-class medicines across many indications in the... Read more
WELIREG becomes the only approved and available treatment in the U.S. for eligible patients with advanced PPGL RAHWAY, N.J. / May 14, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally... Read more
Collaboration to leverage AbbVie's expertise in biotherapeutic drug development and commercialization together with ADARx's proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology NORTH CHICAGO, Ill. and SAN DIEGO, May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, today announced a collaboration... Read more
Approval based on efficacy and safety results from clinical studies, including longer-term functional outcomes from EMBARK global phase 3 study Company is eligible to receive up to $103.5M in near-term regulatory and commercial milestone payments CAMBRIDGE, Mass. / May 13, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the Japanese Ministry of Health, Labour, and Welfare... Read more
Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and chemotherapy 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer Congress SOUTH SAN FRANCISCO,... Read more
An investment of up to $550 million by 2030 will establish the Indianapolis site as a hub for manufacturing of Roche's continuous glucose monitoring solution. Expansion will create hundreds of jobs while also enhancing U.S. production capabilities. Increased access to diabetes management tools will help improve health outcomes for patients in the U.S. and globally. INDIANAPOLIS, May 12, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it plans... Read more
Participants achieved an average weight loss of 20.2% with Zepbound vs. 13.7% with Wegovy In key secondary endpoints, Zepbound was superior to Wegovy across all weight reduction targets and waist circumference reduction INDIANAPOLIS, May 11, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from SURMOUNT-5, a Phase 3b open-label clinical trial, evaluating the safety and efficacy of Zepbound (tirzepatide), a dual GIP and GLP-1... Read more
Patients lived significantly longer without high-risk disease recurrence or progression after one year of IMFINZI treatment plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy vs. BCG alone WILMINGTON, Del. / May 09, 2025 / Business Wire / Positive high-level results from the POTOMAC Phase III trial showed one year of treatment with AstraZeneca’s IMFINZI® (durvalumab) plus standard-of-care BCG induction and maintenance therapy demonstrated a st... Read more
Data Consistent Across All Patient Subgroups, Including Demographic Subgroups, by Baseline Androstenedione Levels and by Baseline Glucocorticoid Dose Findings to be Presented at the 2025 Joint Congress of the European Society for Paediatric Endocrinology and the European Society of Endocrinology SAN DIEGO, May 8, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced new results from subgroup analyses of the Phase 3 C... Read more
Portfolio Receipts growth of 17% to $839 million; Royalty Receipts growth of 12% Net cash provided by operating activities of $596 million Raised full year 2025 guidance: Portfolio Receipts expected to be $2,975 to $3,125 million NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today reported financial results for the first quarter of 2025 and raised full year 2025 guidance for Portfolio Receipts. “Our business momentum continued in... Read more
ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of $92.8 Million for the First Quarter of 2025, Reflecting 23% Growth Over the First Quarter of 2024 NDA for Brensocatib in Patients with Bronchiectasis Remains on Track, with a PDUFA Target Action Date of August 12, 2025 Phase 2b Study of TPIP in Patients with PAH Completed; Topline Data Expected in June 2025 Enrollment Completed for Phase 2b BiRCh Study of Brensocatib in Patients with CRSsNP; Topline... Read more
Delivers Total Revenues in Line With Expectations Demonstrating Strength of the Base Business Makes Significant Pipeline Progress With Three Positive Phase 3 Data Readouts Returns More Than $450 Million in Capital to Shareholders Year-to-Date and Reaffirms 2025 Capital Allocation Priorities PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) today reported first quarter 2025 financial results and reaffirmed its 2025 outlook[1]. Executive... Read more
Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety Endpoints Results Demonstrated Potential Best-In-Class Patch Performance New Drug Application Submission to U.S. FDA Anticipated in the Second Half of 2025 PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive results of its Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and... Read more
Merck Animal Health unveils its largest economic development project in recent history RAHWAY, N.J. / May 08, 2025 / Business Wire / Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), and Kansas Governor Laura Kelly jointly announced today the $895 million expansion of Merck Animal Health’s manufacturing facility in De Soto, Kansas. The $895 million capital expansion... Read more
All Primary and Secondary Endpoints Were Met in Both Phase 3 Studies In Both Acute Pain Models, MR-107A-02 Demonstrated Statistically Significant and Clinically Meaningful Improvement in Pain Compared to Placebo, Significant Reduction in Opioid Usage and Superior Pain Control Versus the Opioid Arm Targeting New Drug Application Submission to U.S. FDA by End of 2025 PITTSBURGH, May 8, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today... Read more
Core Revenue Growth of 7.4% at Actual Exchange Rates (AER), + 2.8% at Constant Exchange Rate (CER) in FY2024 Core Operating Profit Growth of 4.9% at CER with Efficiency Program Driving Cost Savings Up to Six New Molecular Entities in Phase 3 Development in FY2025 with Three Phase 3 Data Readouts Recently Completed or Anticipated FY2025 Outlook for Broadly Flat Revenue and Core Profit Reflecting Product Momentum and Increasing Investment in New Launch Preparation Proposed... Read more
$790 million in first quarter global product net sales First patients treated with VYVGART Hytrulo pre-filled syringe for self-injection in US and Germany CIDP global expansion with positive CHMP opinion for VYVGART-SC (vial and pre-filled syringe) in EU Management to host conference call today at 2:30 PM CET (8:30 AM ET) May 8, 2025, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed... Read more
AstraZeneca and Daiichi Sankyo’s ENHERTU followed by THP showed an improved safety profile vs. standard of care First Phase III trial to demonstrate benefit of ENHERTU in early breast cancer WILMINGTON, Del. / May 07, 2025 / Business Wire / Positive high-level results from the DESTINY-Breast11 Phase III trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically... Read more
On track for 30% operating profit margin by 2027 in line with our Pivot to Growth Strategy; Q1 2025 shows ninth consecutive quarter of revenue growth, excluding revenues recorded for Sanofi collaboration. Q1 2025 revenues of $3.9 billion, an increase of 5%; net of $100 million foreign exchange impact, reported revenues growth of 2%. AUSTEDO® – shows continued strong growth, with worldwide revenues of $411 million in Q1 2025, an increase of 39% in local currency terms... Read more
MINNEAPOLIS, May 7, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today reported its financial results for the third quarter ending March 31, 2025. Third Quarter FY2025 Highlights Third quarter organic revenue increased by 6% (4% reported) to $316.2 million. GAAP earnings per share (EPS) was $0.14 versus $0.31 one year ago. Delivered adjusted EPS of $0.56 compared to $0.48 one year ago. Improved pharma end market conditions, combined with strong commercial... Read more
90% of Adults with Chronic Hepatitis Delta Virus (HDV) who Achieved Undetectable HDV RNA at 96 Weeks of Treatment with Bulevirtide Remained Undetectable for Almost 2 Years After Stopping Treatment FOSTER CITY, Calif. / May 07, 2025 / Business Wire / Gilead Sciences Inc. (Nasdaq: GILD) today announced final results from the pivotal Phase 3 MYR301 study revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta virus (HDV) treated with the f... Read more
Net product revenues for the first quarter 2025 totaled $611.5 million, a 70% increase over the same quarter of the prior year ELEVIDYS net product revenue for the first quarter totaled $375.0 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $4.0 million Revised 2025 total net product revenues guidance to $2.3 to $2.6 billion Meaningfully advanced multiple clinical candidates in limb-girdle muscular dystrophy portfolio CAMBRIDGE,... Read more
INGREZZA® (valbenazine) First-Quarter 2025 Net Product Sales of $545 Million and Reaffirms 2025 Net Product Sales Guidance of $2.5 - $2.6 Billion CRENESSITYTM (crinecerfont) First-Quarter 2025 Net Product Sales of $14.5 Million with 413 Total Patient Enrollment Start Forms Initiated Phase 3 Registrational Programs for Osavampator in Major Depressive Disorder and NBI-'568 in Schizophrenia to Position for Next Phase of Growth SAN DIEGO, May 5, 2025 /PRNewswire/... Read more
Total revenue of $2.77 billion, a 3% increase compared to Q1 2024; raised the low end of total revenue guidance by $100 million to a new range of $11.85 to $12 billion Strong progress with CASGEVY®, ALYFTREK™ and JOURNAVX™ launches Povetacicept (pove) IgAN Phase 3 interim analysis (IA) cohort fully enrolled and zimislecel Phase 3 program to complete dosing this quarter, setting up potential filings in 2026; inaxaplin Phase 3 IA cohort on track to complete... Read more
TREMFYA® subcutaneous induction demonstrates significant rates of clinical remission and endoscopic improvement at Week 24 in ulcerative colitis Findings build on recent FDA-approval of both routes of administration for induction therapy with TREMFYA® in Crohn's disease SAN DIEGO, May 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction... Read more
Data from the QUASAR long-term extension study demonstrate more than 70% of patients were in clinical remission and more than 40% of patients were in endoscopic remission at Week 92 SAN DIEGO, Calif., May 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from the TREMFYA® (guselkumab) Phase 3 QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis (UC). These data are among 24 abstracts... Read more
Continued oncology pipeline advancement with a strategic focus on two priority pan-tumor programs: next-generation immunomodulator BNT327, a bispecific antibody targeting PD-L1 and VEGF-A1, and mRNA cancer immunotherapies Presented multiple clinical updates across oncology pipeline underlining BioNTech’s combination strategy in oncology with first data presented for the novel combination of BNT327 plus antibody-drug conjugates (“ADCs”) Development and commercial... Read more
WILMINGTON, Del. / May 02, 2025 / Business Wire / Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca’s fixed-dose triple-combination therapy BREZTRI AEROSPHERE (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in lung function compared with dual-combination inhaled... Read more
Revenue in Q1 2025 increased 45% to $12.73 billion driven by volume growth from Mounjaro and Zepbound. Pipeline progress included positive Phase 3 trial results for orforglipron (small molecule oral GLP-1 agonist) in Type 2 diabetes in the first of seven obesity and diabetes Phase 3 trials. Q1 2025 EPS increased 23% to $3.06 on a reported basis and increased 29% to $3.34 on a non-GAAP basis, both inclusive of $1.72 of acquired IPR&D charges. Revenue guidance reaffirmed... Read more
