Results showed the benefits of early initiation of WINREVAIR within the first year after PAH diagnosis HYPERION results were presented today at ERS 2025 and simultaneously published in the New England Journal of Medicine RAHWAY, N.J. / Sep 30, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 HYPERION trial evaluating WINREVAIR™...Read more
Expansion increases biologics manufacturing for immunology and oncology medicines Milestone marks progress on AbbVie's long-term commitment to U.S. manufacturing Furthers longstanding commitment to AbbVie's Massachusetts sites and workforce NORTH CHICAGO, Ill., Sept. 30, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the start of construction of a $70 million expansion at its AbbVie Bioresearch Center (ABC) in Worcester,...Read more
Company Announcement Genmab to acquire Merus for USD 97.00 per share in an all-cash transaction representing a transaction value of approximately USD 8.0 billion Proposed acquisition adds petosemtamab, a late-stage asset with two Breakthrough Therapy Designations, to Genmab’s portfolio Transaction anticipated to be accretive to EBITDA by end of 2029 Genmab to host a conference call today at 1:00 PM CEST / 12:00 PM BST / 7:00 AM...Read more
Treatment with Vutrisiran Led to 37- 49% Lower Rates of Gastrointestinal Events, a Multisystem Manifestation of ATTR-CM, Across Multiple Treatment Groups, Compared to Placebo Additional Analyses Reinforce Vutrisiran’s Safety and Efficacy Profile as a Monotherapy and Illustrate Consistent Benefit from Treatment with Vutrisiran Across a Range of Patients’ Baseline Health Status and Quality of Life Findings Presented at the Heart Failure...Read more
Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s ENHERTU in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting Results from the DESTINY-Breast05 and DESTINY-Breast11 trials will be presented at ESMO 2025 in a Presidential Symposium WILMINGTON, Del. / Sep 29, 2025 / Business Wire / Positive high-level results from a planned interim analysis...Read more
The list price will be consistent with the United States to reflect the value of the innovation AbbVie is committed to ensuring that developed nations fully recognize the value of our medicines in improving patient outcomes, consistent with the level of recognition in the United States NORTH CHICAGO, Ill., Sept. 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced plans to launch ELAHERE® (mirvetuximab...Read more
TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children six years and older, weighing at least 40 kg Approval was based on PROTOSTAR study, which showed pediatric patients receiving TREMFYA® achieved high levels of skin clearance vs. placebo at Week 16 HORSHAM, Pa., Sept. 29, 2025...Read more
New state-of-the-art active pharmaceutical ingredient (API) facility will manufacture immunology, oncology and neuroscience medicines Facility expected to be fully operational and serving patients by 2027 Milestone marks progress on AbbVie's long-term commitment to U.S. manufacturing NORTH CHICAGO, Ill., Sept. 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the start of construction of its new active...Read more
TOKYO and CAMBRIDGE, Mass., Sept. 28, 2025 (GLOBE NEWSWIRE) -- 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 humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab) has been approved for once every...Read more
AstraZeneca Direct is designed to offer greater convenience WILMINGTON, Del. / Sep 26, 2025 / Business Wire / AstraZeneca today announces the launch of AstraZeneca Direct, an online platform designed to create a simple, convenient way for eligible patients to access their prescribed medications at a transparent cash price with home delivery. AstraZeneca Direct will support people living with chronic conditions such as asthma, diabetes,...Read more
Submission supported by data from the Phase 3 TEMPO program that demonstrated symptomatic improvement across the Parkinson's disease spectrum Positive results across all three Phase 3 TEMPO trials reinforce the potential of tavapadon, a novel selective dopamine D1/D5 receptor partial agonist, in Parkinson's disease If approved, tavapadon will enhance AbbVie's leadership in Parkinson's disease by providing patients with a once...Read more
MORRISTOWN, N.J., Sept. 26, 2025 /PRNewswire/ -- Sanofi US today announces a broad expansion of its Insulins Valyou Savings Program by offering a 30-day supply of any Sanofi insulin for $35 to all patients in the US with a valid prescription. The program, first created for people without health insurance, will be available to all Americans regardless of insurance status, including those with commercial insurance or Medicare, to ensure...Read more
FDA approval extends the indication of Evkeeza to treat younger patients with homozygous hypercholesterolemia (HoFH) HoFH is an inherited condition characterized by extremely high levels of low-density lipoprotein cholesterol (LDL-C) Initial Evkeeza approval based on placebo-controlled trial showing Evkeeza, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need...Read more
An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor In the Phase 3 EMBER-3 trial, Inluriyo monotherapy reduced the risk of progression or death by 38% versus endocrine therapy among patients with ESR1-mutated MBC INDIANAPOLIS, Sept. 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and...Read more
ADALAT® XL® (nifedipine extended-release tablets) first received market authorization in Canada in 1995 and is indicated for the management of chronic stable angina and the management of mild to moderate essential hypertension. MISSISSAUGA, Ontario / Sep 25, 2025 / Business Wire / Bayer Canada is pleased to announce a new partnership with Mint Pharmaceuticals Inc. for the distribution of ADALAT® XL® 30 mg tablets1 in Canada. This...Read more
Food and Drug Administration granted Breakthrough Therapy Designation for povetacicept in IgA nephropathy; on track to file for accelerated approval in the U.S. in H1 2026 if 36-week interim analysis data positive Enrollment completed for interim analysis cohort of AMPLITUDE global Phase 2/3 trial evaluating inaxaplin in APOL1-mediated kidney disease; potential to file for accelerated approval in the U.S. if 48-week interim...Read more
Expanded access provides an additional treatment option for those with chronic migraine. AbbVie is dedicated to people living with this debilitating disease and continues its commitment by providing multiple treatments and programs for these individuals. MONTREAL, Sept. 25, 2025 /CNW/ - AbbVie (NYSE: ABBV) announced today that the RAMQ has listed QULIPTA® in their formulary for the prevention of chronic migraine and episodic...Read more
Eliquis Offered to Cash-Paying Patients at More Than 40% Discount to Current List Price, Sotyktu at More Than 80% Discount to Current List Price PRINCETON, N.J. / Sep 25, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced an expansion of its direct-to-patient offerings, providing eligible U.S. patients with steeply discounted prices for Eliquis® (apixaban) and Sotyktu® (deucravacitinib). Eligible cash-pay patients...Read more
The Moderna Innovation and Technology Centre in Harwell, Oxfordshire is now fully operational and Moderna is licensed to supply British-made COVID-19 vaccines to the UK population The facility marks a cornerstone of Moderna's ten-year strategic partnership with the UK Government, designed to strengthen health resilience and drive economic growth CAMBRIDGE, MA / ACCESS Newswire / September 24, 2025 / Moderna, Inc. (NASDAQ:MRNA) today...Read more
TOKYO and CAMBRIDGE, Mass., Sept. 24, 2025 (GLOBE NEWSWIRE) -- 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 Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name,...Read more
Based on DESTINY-Breast09 Phase III trial results which showed ENHERTU plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP with a median progression-free survival of greater than three years If approved, AstraZeneca and Daiichi Sankyo’s ENHERTU-based treatment approach would move into the 1st-line HER2-positive metastatic setting with potential to become a new standard of care WILMINGTON, Del. / Sep 24,...Read more
CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company’s supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA). The FDA letter requested an update to the technical information be included in the Chemistry Manufacturing...Read more
The new Houston site, Lilly's eighth U.S. manufacturing facility announced since 2020, will focus on domestic production of small molecule synthetic medicines Company plans to create 4,615 manufacturing and construction jobs INDIANAPOLIS, Sept. 23, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that it plans to build a new $6.5 billion manufacturing facility at Generation Park in Houston, Texas. This...Read more
Preliminary analysis showed the 2025-2026 formula of mNEXSPIKE generated greater than a 16-fold increase in LP.8.1-neutralizing antibodies across age groups Both of Moderna's COVID-19 vaccines for the 2025-2026 season have demonstrated strong immune responses against today's top circulating COVID-19 strains CAMBRIDGE, MA / ACCESS Newswire / September 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary...Read more
PRINCETON, N.J. / Sep 23, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD™), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or refractory multiple myeloma (RRMM) demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity...Read more
SKINVIVE® to launch in 35 additional markets worldwide from September taking the total to 57 international launches in 2025. Research highlights 94% of people want to improve facial skin quality1*, with deep hydration valued across all ages worldwide2. SKINVIVE® is the longest lasting hydrating injectable on the market, delivered in one treatment.3,4,† AMWC Dubai agenda spotlights multimodal approach to skin quality, following the...Read more
Proposed acquisition to add four highly differentiated clinical-stage incretin and amylin programs to Pfizer’s pipeline Transaction valued at $47.50 per Metsera share in cash upon closing, for an initial enterprise value of $4.9 billion with a CVR of up to $22.50 per share in additional payments Pfizer to host a public webcast at 8 am EDT today NEW YORK / Sep 22, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) and Metsera, Inc....Read more
SAN DIEGO, Sept. 22, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new data from the Phase 2 SAVITRI™ study, which showed statistically significant and clinically meaningful improvement in depression severity at Day 28 and Day 56 with once-daily oral administration of 1 mg osavampator (NBI-1065845). In recognition of the data presentation, Neurocrine was honored with the...Read more
First investigational allogeneic pluripotent stem cell derived therapy pivotal Phase III clinical trial exPDite-2 with bemdaneprocel started Phase II gene therapy trial REGENERATE-PD with AB-1005 initiated randomizing participants in United Kingdom and Poland, with Germany following shortly and ongoing in the USA Parkinson’s disease second most common and fastest growing neurodegenerative disease affecting more than 10 million people...Read more
WILMINGTON, Del. / Sep 22, 2025 / Business Wire / Incyte (Nasdaq:INCY) announces that Dave Gardner has been appointed Executive Vice President and Chief Strategy Officer (CSO) effective today, September 22, 2025. In his new role, Mr. Gardner will serve as a key member of the Executive Leadership Team and be responsible for the Company’s strategy and business development. "Dave possesses a unique combination of business acumen, scientific...Read more
evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in ITT and ESR1-mutated populations in the post-CDK inhibitor setting, compared with standard of care plus everolimus The all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observed evERA is the first positive...Read more
Recommendation for adults and adolescents based on Phase 3 trials showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo If approved, Dupixent would be the first targeted medicine in over a decade indicated for CSU in the European Union (EU) TARRYTOWN, N.Y. and PARIS, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines...Read more
Through Week 56 in the SOLARIS trial, there were no suspected or confirmed post-injection delirium/sedation syndrome (PDSS) events observed with olanzapine LAI (TEV-'749) and its long-term systemic safety profile was consistent with other olanzapine formulations1 Additional new data comparing initiation of UZEDY® (risperidone) versus Invega Sustenna® (paliperidone palmitate) in hospitalized patients found that UZEDY was associated with...Read more
TREMFYA® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn's disease TREMFYA® achieved significant rates of clinical remission and endoscopic improvement versus placebo at Week 12 with a subcutaneous induction regimen, consistent with IV induction Johnson & Johnson is initiating a head-to-head study seeking to demonstrate the superiority of...Read more
CAMBRIDGE, MA / ACCESS Newswire / September 19, 2025 / Moderna announced today that the first mRNA vaccines fully manufactured in Canada are being shipped to provinces and territories. This milestone advances Canada's domestic vaccine production capacity and strengthens national health security. "The delivery of the first made-in-Canada mRNA vaccines to provinces and territories across the country marks a major milestone in our...Read more
If approved by the European Commission, ENFLONSIA will be the first and only RSV preventive option in Europe for administration to infants using the same dose regardless of weight RAHWAY, N.J. / Sep 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the...Read more
100 percent of evaluable patients achieved minimal residual disease (MRD) negativity following induction therapy in updated results from the Phase 2 MajesTEC-5 study TORONTO, Sept. 19, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced that an investigational immune-based induction regimen with TECVAYLI® (teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) demonstrated meaningful clinical...Read more
KEYTRUDA QLEX is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute RAHWAY, N.J. / Sep 19, 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 QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for...Read more
Opzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis (AD) Phase 3 data supporting the approval show that treatment with Opzelura resulted in significant efficacy, with no new safety concerns identified This milestone marks the third U.S. approval for Opzelura, which is now indicated to treat mild to moderate AD in non-immunocompromised patients 2+ years of age and nonsegmental vitiligo in...Read more
First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. Expands access to advanced testing with a fully automated, standardized workflow on the cobas® i 601 analyzer Marks an important step in broadening the clinical utility of mass spectrometry testing across routine labs INDIANAPOLIS, Sept. 18, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:...Read more
CASGEVY is the first, and only, gene editing therapy approved for the treatment of transfusion-dependent beta thalassemia (TDT) and sickle cell disease (SCD) in Europe Italy has the largest population of people living with TDT in Europe LONDON / Sep 18, 2025 / Business Wire / Vertex Pharmaceuticals (Nasdaq: VRTX) announced today a reimbursement agreement with the Italian Medicines Agency (AIFA) for eligible...Read more
Biogen to drive end-to-end development and commercialization of ThecaFlex DRx™, an investigational implantable device for intrathecal delivery of antisense oligonucleotides (ASOs) ThecaFlex DRx™ has the potential to be a new, convenient way to administer medicines to patients living with neurological disorders. CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the company has entered into a...Read more
The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for AIRSUPRA WILMINGTON, Del. / Sep 18, 2025 / Business Wire / AIRSUPRA’s US Prescribing Information now includes clinically meaningful evidence from the BATURA study in patients with mild asthma.1 The BATURA Phase IIIb trial, which evaluated severe exacerbation risk reduction, examined the efficacy of as-needed AIRSUPRA compared to...Read more
Ozempic® (once-weekly injectable semaglutide) was associated with a 23% reduced risk of heart attack, stroke and death in people with type 2 diabetes and cardiovascular disease on Medicare versus dulaglutide1 Data also highlighted Ozempic® was associated with a 26% lower risk of death versus dulaglutide1 This study is the first to directly compare these glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications in...Read more
In SURPASS-PEDS, Mounjaro met the primary and all key secondary endpoints at 30 weeks and showed sustained improvement in glycemic control and continued BMI reduction through the study's 52-week extension The safety and tolerability profile of Mounjaro was generally consistent with previous adult studies INDIANAPOLIS, Sept. 17, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from...Read more
Oral semaglutide 25 mg (the once-daily pill formulation of Wegovy®) achieved significant weight loss, with one in three study participants losing 20% or more body weight1** Oral semaglutide 25 mg also demonstrated improvements in the ability to perform everyday physical activities such as bending, standing, walking, being physically active, and improvements in cardiovascular risk factors1 Oral semaglutide 25 mg is the first oral GLP-1...Read more
Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up to 20% of women experience postpartum depressive symptoms6-11 The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPD The EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from...Read more
Complete 26-week results further demonstrate that combining semaglutide with trevogrumab (anti-GDF8/anti-myostatin) helped prevent about half of semaglutide-induced loss of lean mass, while increasing fat mass loss Numeric improvements in metabolic and lipid parameters including waist circumference, blood pressure, cholesterol, triglycerides and A1C, were observed across all treatment groups TARRYTOWN, N.Y., Sept. 17, 2025 (GLOBE...Read more
For the primary endpoint, orforglipron lowered A1C by 2.2% vs. 1.4% with oral semaglutide at the highest doses Participants taking the highest dose of orforglipron lost an average of 19.7 lbs (9.2%) vs. 11.0 lbs (5.3%) with oral semaglutide, a 73.6% relative improvement, in a key secondary endpoint The safety and tolerability of orforglipron were consistent with previous trials INDIANAPOLIS, Sept. 17, 2025 /PRNewswire/ -- Eli...Read more
Icotrokinra demonstrated superior skin clearance at Weeks 16 and 24 compared to deucravacitinib and similar adverse event rates to placebo in Phase 3 ICONIC-ADVANCE studies Icotrokinra also showed sustained skin clearance and favorable safety profile in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study Robust findings continue to demonstrate the potential of icotrokinra to disrupt the treatment paradigm to set a new...Read more
Subcutaneous administration of first-in-class biologic SAPHNELO demonstrates statistically significant and clinically meaningful reduction in disease activity WILMINGTON, Del. / Sep 17, 2025 / Business Wire / Positive high-level results from a pre-specified interim analysis of the Phase III TULIP-SC trial in patients with systemic lupus erythematosus (SLE) showed that the subcutaneous (SC) administration of AstraZeneca’s SAPHNELO®...Read more
FOP is a disease in which muscles, tendons and ligaments are progressively replaced by bone, leading to eventual incapacitation Garetosmab is the first and only treatment to demonstrate a dramatic reduction in both number and volume of abnormal bone lesions (heterotopic ossification, or HO lesions) in adults with FOP Primary endpoint was met, showing a 90% or greater reduction in new HO lesions at 56 weeks, and garetosmab also led to...Read more
Across both STOP-HS1 and STOP-HS2, povorcitinib treatment resulted in continued clinically meaningful and statistically significant improvements for patients with active moderate to severe hidradenitis suppurativa (HS) through Week 24 At Week 24, nearly 60% of efficacy-evaluable patients among both povorcitinib treatment groups achieved HiSCR50 Additionally, patients treated with povorcitinib achieved HiSCR75 (31.0%-40.3%), HiSCR90...Read more
The investigational once-daily oral pill led to an average weight loss of 27.3 lbs (12.4%) at the highest dose at week 72 in the Phase 3 study Orforglipron demonstrated significant improvements across key cardiometabolic risk factors, supporting its potential as a treatment option for millions living with obesity INDIANAPOLIS, Sept. 16, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results...Read more
The integration of Accu-Chek SmartGuide's AI-enabled predictive CGM with the popular mySugr app delivers a simple, intuitive solution for people to manage their diabetes with greater ease. Accu-Chek SmartGuide is now available in 13 countries, with plans to accelerate access to over 30 countries across Europe, Latin America and Asia-Pacific by year-end. Real-world evidence from rollout and clinical perspectives presented at the...Read more
VELA to operate the world’s first sailing cargo trimaran powered by 100 percent wind when at sea1 to sail between Europe and the U.S. Takeda to become the first biopharmaceutical company to ship its products on VELA’s wind-powered trimaran, starting a new era of sustainable shipping in pharma OSAKA, Japan & CAMBRIDGE, Mass. / Sep 16, 2025 / Business Wire / Takeda (TSE:4502/NYSE:TAK) and VELA Transport today announced their...Read more
Preliminary analysis showed the 2025-2026 formula of Spikevax generated greater than an 8-fold increase in LP.8.1-neutralizing antibodies across age groups Clinical findings reinforce preclinical data supporting recent FDA approval of 2025-2026 formula of Spikevax CAMBRIDGE, MA / ACCESS Newswire / September 16, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary immunogenicity data for the 2025-2026 formula of...Read more
Oral semaglutide (Rybelsus®) is now the first and only oral GLP-1 RA approved for type 2 diabetes, with proven cardiovascular benefits1 This approval is based on results from the SOUL clinical trial, where oral semaglutide (Rybelsus®) reduced cardiovascular death, heart attack and stroke by 14% versus placebo, when added to standard of care, in adults with type 2 diabetes at high cardiovascular risk1 In addition, new results from SOUL...Read more
First Breakthrough Therapy Designation for Daiichi Sankyo and Merck’s raludotatug deruxtecan based on phase 1 trial and REJOICE-Ovarian01 phase 2/3 trial Second Breakthrough Therapy Designation since the start of the Daiichi Sankyo and Merck collaboration Fifteenth Breakthrough Therapy Designation granted by FDA across the oncology portfolio of Daiichi Sankyo BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 15, 2025 / Business Wire /...Read more
Results from the Phase 3 STRIDE-13 trial presented at the 6th ESCMID Conference on Vaccines Merck to share STRIDE-13 results with global regulatory authorities RAHWAY, N.J. / Sep 11, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th European Society...Read more
Rhonda Pacheco to Succeed Julie Kim, Who Was Appointed to Be Takeda’s Next CEO CAMBRIDGE, Mass. / Sep 11, 2025 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that Rhonda Pacheco, most recently group vice president of U.S. Cardiometabolic Health at Eli Lilly, will join Takeda, effective September 29, as president of Takeda’s U.S. Business Unit and will be a member of the Takeda Executive Team. Pacheco will succeed Julie...Read more
Transformation to increase speed and redirect resources to growth opportunities within diabetes and obesity, aiming at reaching millions of untreated patients Intention to reduce ~9,000 roles globally with the expectation to deliver DKK 8bn of annualised savings by the end of 2026 One-off restructuring costs of DKK 8bn leading to an updated full-year 2025 operating profit growth outlook of 4–10% at CER Bagsværd, Denmark, 10 September...Read more
First and only drug releasing system to provide extended local delivery of a cancer medication into the bladder, with 82 percent of patients achieving complete response without the need for reinduction1 Potential practice-changing treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer who have limited options before possible bladder removal RARITAN, N.J., Sept. 9, 2025 /PRNewswire/ -- Johnson &...Read more
Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development. New therapeutic options for people living with MSA, a rare and devastating neurodegenerative disorder, are urgently needed as there are no treatments available that impact disease progression. Emrusolmin is a small molecule that targets the...Read more
Program provides access to Lilly-trained artificial intelligence to help accelerate breakthrough medicines New offering expands Lilly Catalyze360's support for early-stage drug development INDIANAPOLIS, Sept. 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the launch of Lilly TuneLab, an artificial intelligence and machine learning (AI/ML) platform that provides biotech companies access to drug...Read more
Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone In a five-year analysis, consistent efficacy was observed across histologies with especially notable benefit in the squamous patient population where median overall survival was 22.3 months TARRYTOWN, N.Y., Sept. 09, 2025 (GLOBE...Read more
THOUSAND OAKS, Calif. and TOKYO, Sept. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD). The ongoing ASCEND study, which includes approximately 2,600...Read more
CAMBRIDGE, Mass. / Sep 08, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (“Alnylam”) (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it has commenced a private offering of $500 million aggregate principal amount of convertible senior notes due 2028 (the “notes”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the...Read more
PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/BMS986545) plus chemotherapy continues to show encouraging antitumor activity in patients with extensive-stage small cell lung cancer (”ES-SCLC”), expanding evidence for its potential to set a new standard of care in first-line ES-SCLC and beyond Global interim Phase 2 data showed a 76.3% confirmed objective response rate (cORR), 100% disease control rate (DCR), a median progression...Read more
In the Phase 3 BRUIN CLL-313 study, treatment with pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival versus bendamustine plus rituximab, indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study BRUIN CLL-313 is the third positive Phase 3 study from the pirtobrutinib development program...Read more
Phase 3 clinical trial cohort of adults 65+ and 18-64 with at least one underlying risk condition shows at least a 4-fold increase in LP.8.1-neutralizing antibody titers after receiving the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula First LP.8.1 sublineage clinical findings reinforce pre-clinical data supporting recent FDA approval of 2025-2026 Formula of Pfizer-BioNTech COVID-19 Vaccine Companies have submitted these data to the...Read more
In separate cat and birch allergen-challenge trials, single doses of allergen-specific antibody blockers significantly reduced allergy symptoms compared to placebo Data from these trials will support further Phase 3 development TARRYTOWN, N.Y., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced results evaluating its first-in-class investigational allergen-blocking antibodies in...Read more
An objective response rate of 48.2% was observed with ifinatamab deruxtecan in these previously treated patients Discussions with global regulatory authorities underway BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 07, 2025 / Business Wire / Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small...Read more
FLAURA2 final overall survival analysis reinforces the favorable benefit-risk profile of this combination Results underscore TAGRISSO as 1st-line standard of care and backbone therapy in EGFRm lung cancer across stages WILMINGTON, Del. / Sep 07, 2025 / Business Wire / Positive results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) with the addition of...Read more
New data from Phase 3 PEGASUS study demonstrates a 49.7% decrease in mean blood Phe levels in adolescents aged 12-17 treated with PALYNZIQ BioMarin's planned submission to global health authorities on track for second half of 2025 SAN RAFAEL, Calif., Sept. 6, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced new data characterizing the efficacy and safety of PALYNZIQ® (pegvaliase-pqpz) for the...Read more
RYBREVANT® combination extends survival and significantly reduces common EGFR and MET resistance mutations seen with osimertinib-based treatment BARCELONA, Spain, Sept. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new analyses from the Phase 3 MARIPOSA study showing that first-line treatment with RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) significantly reduces the development of...Read more
Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand Disease (VWD) and On-Demand and Perioperative Management of Bleeding in Pediatric Patients with VWD1 VONVENDI is the Only Recombinant Von Willebrand Factor Replacement Therapy with Approved Indications in Adults and Children with VWD1 VWD, the Most Common Bleeding Disorder, Impacts More...Read more
The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in the assessment of HER2-ultralow status to identify metastatic breast cancer patients who may be eligible for treatment with ENHERTU. The VENTANA HER2 (4B5) test is also now approved to help identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA. Roche continues to break...Read more
The Breakthrough Therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and Phase 3 SUNRAY-01 trial Updated efficacy and safety data for olomorasib will be presented at the IASLC 2025 World Conference on Lung Cancer INDIANAPOLIS, Sept. 4, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy...Read more
New Bay Area Building Marks Significant Progress as Part of $32 Billion U.S. Investment Projected to Create $43 Billion in Economic Value FOSTER CITY, Calif. / Sep 03, 2025 / Business Wire / Gilead Sciences (Nasdaq: GILD) today celebrates the groundbreaking of its new Pharmaceutical Development and Manufacturing (PDM) Technical Development Center (NTDC) at the company’s Foster City headquarters. This milestone marks continued momentum...Read more
New awareness campaign features authentic, often misunderstood, stories from people living with hidradenitis suppurativa (HS), highlighting the emotional and physical impact of the condition WILMINGTON, Del. / Sep 03, 2025 / Business Wire / Incyte (Nasdaq:INCY) announced the launch of HS TRUTHS, a new educational campaign aimed at revealing the authentic and often hidden realities of living with hidradenitis suppurativa (HS), a chronic...Read more
Data presented at 13th Society of Hematologic Oncology (SOHO) Annual Meeting NORTH CHICAGO, Ill., Sept. 3, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously,...Read more
Trial demonstrated the feasibility of treating and monitoring adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in an outpatient setting Results showed that 92% of patients with R/R DLBCL received the first full dose of epcoritamab monotherapy in an outpatient setting Adverse event profile and efficacy were consistent with previously reported studies in R/R DLBCL patients Data also demonstrated 64.3%...Read more
Agreement to explore Argo's Phase 2 ANGPTL3 in a combination trial in dyslipidemia with an option to license second-generation molecules in the pipeline License to an additional Argo siRNA candidate currently in IND-enabling studies Argo will receive an upfront payment of $160 million, an option for Profit & Loss split across multiple geographies and potential near-term equity; Argo is also eligible to receive option payment,...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 to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO:...Read more
Health Canada has approved ELAHERE®, the first novel therapy to demonstrate statistically significant and clinically meaningful improvements in overall survival (OS) compared to chemotherapy alone for patients with platinum-resistant ovarian cancer (PROC).1 ELAHERE® received approval through Health Canada's Priority Review process, based on data from the pivotal MIRASOL Phase 3 trial, establishing it as a potential new standard of care...Read more
Positive results were observed across all subgroups Study meets several key secondary endpoints with statistical significance SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Sep 02, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that its TETON-2 study evaluating the use of nebulized Tyvaso® (treprostinil) Inhalation Solution for the treatment of idiopathic...Read more
Enlicitide is the first oral PCSK9 inhibitor to demonstrate statistically significant and clinically meaningful reductions in LDL-C compared to placebo in Phase 3 trials Enlicitide had a favorable safety profile, with comparable rates of discontinuation between treatment groups RAHWAY, N.J. / Sep 02, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results...Read more
MADRID, Aug. 31, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Late breaking clinical science data, presented at the European Society of Cardiology (ESC) Congress today and simultaneously published in the New England Journal of Medicine (NEJM), finds at up to 10 years, when compared to standard care, routine use of Impella CP® in patients who have had a heart attack with cardiogenic shock leads to an absolute mortality...Read more
Compared with tirzepatide, Wegovy® (semaglutide 2.4 mg) showed a significant 57% greater reduction in the risk of heart attack, stroke or death from any cause, in people with overweight or obesity and cardiovascular disease (CVD) who stayed on treatment1 Similarly, the study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy® users compared with tirzepatide users in...Read more
| Company | Change | Last Trade |
|---|---|---|
| Eli Lilly | 35.75 4.92 | $762.27 |
| argenx | 18.52 2.58 | $737.56 |
| Alnylam Pharmaceuticals | 8.51 1.90 | $456.00 |
| Amgen | 8.23 3.00 | $282.20 |
| AbbVie | 6.77 3.03 | $229.93 |
| Merck | 5.35 6.81 | $83.93 |
| Novartis | 4.14 3.34 | $128.24 |
| Johnson & Johnson | 3.80 2.09 | $185.42 |
| AstraZeneca | 2.59 3.49 | $76.72 |
| Insmed | 2.36 1.67 | $144.01 |
| GSK | 2.06 5.01 | $43.16 |
| Roche | 1.76 4.39 | $41.81 |
| Pfizer | 1.66 6.96 | $25.51 |
| Biogen | 1.56 1.13 | $140.08 |
| Sanofi | 1.55 3.40 | $47.20 |
Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital, and pain and inflammation. Assertio has grown through...
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Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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