RINVOQ is the first and only oral Janus kinase (JAK) inhibitor approved in the European Union (EU) to treat adult patients with giant cell arteritis (GCA) The approval is supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that RINVOQ achieved the primary endpoint of sustained remission* and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete...Read more
EPYSQLI® (eculizumab-aagh) is now available to patients living with difficult-to-treat rare diseases like paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive EPYSQLI will be available at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris® (eculizumab), making it one of the greatest...Read more
If approved for an expanded pediatric indication, AJOVY would be the first calcitonin gene-related peptide (CGRP) antagonist for migraine prevention in adults and episodic migraine prevention in pediatric patients, addressing the high unmet need for effective treatments AJOVY is currently the only anti-CGRP treatment for migraine prevention in adults in the U.S. that is available in both quarterly and monthly dosing options1 These...Read more
TREMFYA® demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b study Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA® as a first-line treatment option for patients with active psoriatic arthritis SPRING HOUSE, Pa., April 4, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today...Read more
Breakthrough CD19+ B-Cell Targeted Therapy Delivered an 87% Reduction in the Risk of Flares Versus Placebo UPLIZNA Shown to Deliver Corticosteroid-Free, Flare-Free, Complete Remission for Patients in the MITIGATE Trial Advances Amgen's Leadership in CD19 Directed, B-Cell Depletion Therapies for Serious Autoimmune Diseases Including NMOSD, IgG4-RD and gMG THOUSAND OAKS, Calif., April 3, 2025 /PRNewswire/ -- Amgen...Read more
Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program1 Phase III data showed Vanrafia achieved proteinuria reduction of 36.1% (P<0.0001) vs. placebo with improvements seen at Week 6 and sustained through Week 36 and favorable safety1,2 IgAN is a progressive, rare kidney disease; up to 50% of patients with persistent...Read more
MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to people living with relapsing multiple sclerosis The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression High dose was well tolerated with an overall comparable safety profile to Ocrevus IV 600 mg and no new safety signals...Read more
Company plans to submit for regulatory approval later this year SAN RAFAEL, Calif., April 2, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the Phase 3 PEGASUS trial evaluating PALYNZIQ® (pegvaliase-pqpz) met its primary efficacy endpoint, demonstrating a statistically significant lowering in blood Phe levels in adolescents aged 12-17 with phenylketonuria (PKU) compared to diet alone....Read more
Advances Company’s industry-leading portfolio in mental health with addition of CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive therapy and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, has potential to become a new standard of care...Read more
CAMBRIDGE, Mass., April 02, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer’s disease. Fast Track designation is intended to facilitate the development and expedite the review of investigational drugs that treat serious...Read more
MINNEAPOLIS, April 2, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced an expansion of the longstanding partnership between its spatial biology brand, Advanced Cell Diagnostics (ACD), and Leica Biosystems, a global leader in anatomic pathology solutions. The expanded spatial multiomic collaboration now includes automation of ACD's new RNAscope™ Multiomic LS Assay and protease-free workflows on Leica's BOND RX...Read more
ABRYSVO is the first and only RSV vaccine approved in the European Union (EU) for non-pregnant adults aged 18-49 NEW YORK / Apr 01, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of...Read more
More than 92% of schizophrenia patients taking TEV-'749 in the SOLARIS survey were satisfied or very satisfied with the initiation regimen, dosing schedule and trial medication1 New data from UZEDY® (risperidone) evaluated predictors of response in schizophrenia with efficacy observed across patient demographic and clinical characteristics in the Phase 3 RISE trial Teva continues its commitment to generating clinical insights that...Read more
New late-breaking clinical trial data presented at ACC and published simultaneously in JACC show benefit of investigational medicine AZD0780 on top of standard of care WILMINGTON, Del. / Mar 31, 2025 / Business Wire / Positive results from the PURSUIT Phase IIb trial for AstraZeneca’s AZD0780 demonstrated a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care...Read more
TIVDAK® is the first and only antibody-drug conjugate (ADC) approved to treat recurrent or metastatic cervical cancer with disease progression on or after systemic therapy In the global Phase 3 innovaTV 301 clinical trial TIVDAK demonstrated superior overall survival compared to chemotherapy TIVDAK is approved for the treatment of recurrent or metastatic cervical cancer in the European Union, United States and Japan COPENHAGEN,...Read more
Based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death vs. neoadjuvant chemotherapy alone WILMINGTON, Del. / Mar 31, 2025 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been...Read more
Positive opinion for first-line treatment of extensive-stage small cell lung cancer based on results of RATIONALE-312 study demonstrating statistically significant overall survival benefit for TEVIMBRA in combination with chemotherapy SAN CARLOS, Calif. / Mar 31, 2025 / Business Wire / BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today...Read more
CAMBRIDGE, MA / ACCESS Newswire / March 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Australian Therapeutic Goods Administration (TGA) has granted approval for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to prevent lower respiratory tract disease caused by RSV infection in adults aged 60 years and older.1 mRESVIA's approval marks a significant milestone as it is the first mRNA vaccine in...Read more
In Phase 2 ALPACA results, lepodisiran significantly reduced levels of genetically inherited cardiovascular risk factor, with some patients sustaining reductions for nearly 1.5 years These data were presented at the American College of Cardiology 2025 Scientific Sessions and simultaneously published in the New England Journal of Medicine (NEJM) INDIANAPOLIS, March 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today...Read more
New Data Follow Recent U.S. FDA Approval of AMVUTTRA® (vutrisiran) as First RNAi Therapeutic to Reduce Cardiovascular Death, Cardiovascular Hospitalizations and Urgent Heart Failure Visits in Patients with ATTR-CM Vutrisiran Favorably Impacted Echocardiographic Systolic and Diastolic Function Vutrisiran Treatment Led to Maintenance or Improvement in Functional Capacity, Health Status, and Quality of Life, Compared to Placebo Benefits...Read more
Ozempic® improved maximum walking distance by 13% vs placebo in adults with type 2 diabetes and peripheral artery disease (PAD) in the phase 3 STRIDE trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in The Lancet2. Approximately 230 million people globally have PAD, a severe form of atherosclerotic cardiovascular...Read more
Qfitlia Becomes the Sixth Alnylam-Discovered RNAi Therapeutic Approved by U.S. FDA and First and Only to Treat Hemophilia A or B With or Without Inhibitors CAMBRIDGE, Mass. / Mar 28, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today highlighted the significance of the U.S. Food and Drug Administration’s (FDA) approval of Qfitlia™ (fitusiran), the sixth Alnylam-discovered...Read more
VX-264 Phase 1/2 enrollment and dosing complete in Parts A and B: VX-264 was generally safe and well tolerated; efficacy data are not supportive of further clinical advancement Zimislecel (VX-880) pivotal trial on track to complete enrollment and dosing in H1 2025; Vertex expects to submit marketing applications to global regulators in 2026 Continue to progress multiple novel, research-stage immunoprotective approaches BOSTON / Mar...Read more
Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils Approval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth approved indication for chronic diseases with underlying type 2 inflammation TARRYTOWN, N.Y. and PARIS, March 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)...Read more
Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo If approved by the European Commission, the perioperative regimen would be the company’s second Opdivo-based regimen available for the treatment of resectable non-small cell lung cancer in the European Union PRINCETON, N.J. / Mar 28, 2025...Read more
Recommendation is based primarily on results from the Phase 3 CheckMate -67T trial which demonstrated noninferiority in the co-primary endpoints of Cavgd28 and Cminss and consistent efficacy in the secondary endpoint of overall response rate for the subcutaneous formulation of Opdivo vs. its intravenous formulation A decision on the EU Opdivo extension of marketing authorization is expected by June 2, 2025 PRINCETON, N.J. / Mar 28,...Read more
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy A time and motion descriptive analysis shows nearly 50% reductions in patient chair and treatment room time, and in total active healthcare professional time related to treatment...Read more
New tools to connect with independent in-person and telehealth providers specializing in Alzheimer's disease are designed to increase capacity and reduce delays in diagnosis INDIANAPOLIS, March 27, 2025 /PRNewswire/ -- Eli Lilly and Company (LLY) has expanded its LillyDirect digital healthcare platform to offer connections to independent in-person and telehealth options for people in the U.S. living with Alzheimer's disease, the...Read more
TIVDAK® is the first and only antibody-drug conjugate (ADC) approved for patients with advanced or recurrent cervical cancer in Japan Approval is based on results from the global Phase 3 innovaTV 301 trial, in which TIVDAK demonstrated superior overall survival compared to chemotherapy Rising cervical cancer incidence and mortality rates in Japan signify need for new treatment options COPENHAGEN, Denmark / Mar 27, 2025 / Business...Read more
EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults RAHWAY, N.J. / Mar 26, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae...Read more
Median overall survival not yet reached with projected improvement of more than one year versus osimertinib RARITAN, N.J., March 26, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study. Head-to-head comparison data versus osimertinib showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™...Read more
In LAURA Phase III trial, TAGRISSO continues to demonstrate improved overall survival trend in unresectable, Stage III setting SAVANNAH and ORCHARD Phase II trials show the addition of savolitinib or datopotamab deruxtecan-dlnk to TAGRISSO upon disease progression demonstrates strong clinical activity WILMINGTON, Del. / Mar 25, 2025 / Business Wire / New study results presented at the European Lung Cancer Congress (ELCC) 2025, March...Read more
Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 years Over half of all women experience a uUTI in their lifetime, with approximately 30% suffering from a recurrent episode Approval based on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials PHILADELPHIA / Mar 25, 2025 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa...Read more
RAHWAY, N.J. / Mar 25, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”), a global pharmaceutical company focused on scientific and technological innovation, today announced that the companies have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a), or Lp(a), inhibitor...Read more
Guangdong, China and Bagsværd, Denmark, 24 March 2025 –The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) today announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United Bio-Technology (Hengqin) Co., Ltd. (United Biotechnology), have entered into an exclusive license agreement for UBT251, a triple agonist of the receptors for GLP-1, GIP, and glucagon in early-stage clinical...Read more
Investment builds on almost 140-year legacy of improving and saving lives and supporting American jobs Includes four planned new manufacturing facilities, with ground-breaking today in North Carolina on $2 billion+ facility Total Company U.S. economic impact estimated to be more than $100 billion per year NEW BRUNSWICK, N.J. / Mar 21, 2025 / Business Wire / Today, Johnson & Johnson (NYSE: JNJ) (the “Company”), healthcare’s...Read more
Phase III study showed sustained proteinuria reduction at one year with favorable safety1 Fabhalta is the only oral alternative complement pathway inhibitor thought to target the underlying cause of C3G1-3 C3G is an ultra-rare kidney disease typically diagnosed in young adults and often progresses to kidney failure2-4 Novartis continues to advance multiple kidney disease treatments with high unmet need, compounding capabilities and...Read more
Novel Mechanism of Action Delivers Rapid Knockdown of Transthyretin, Addressing the Disease at its Source Proven Consistency of Effect on Cardiovascular Outcomes, Function, and Quality of Life in ATTR-CM Population Representative of Today’s Patients Only Therapeutic Approved in the U.S. to Address Both Cardiomyopathy and Polyneuropathy Manifestations of ATTR Amyloidosis Alnylam Offers Multiple Programs to Support Broad and Seamless...Read more
TREMFYA® is the only IL-23i to demonstrate clinical remission and endoscopic response, both at one year, with a fully subcutaneous induction regimen Supported by data from the GALAXI study, TREMFYA® is the only IL-23i to show superiority versus STELARA® in all pooled endoscopic endpoints within a double-blinded registrational trial TREMFYA® approval in Crohn's disease builds upon recent ulcerative colitis FDA approval,...Read more
Approval is based on the Phase 3 KEYNOTE-868/NRG-GY018 Trial KIRKLAND, QC, March 19, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Health Canada approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA® as a single agent, for the treatment of adult patients with primary advanced or recurrent...Read more
Sjögren's disease (SjD) is a prevalent, debilitating autoantibody disease with no FDA-approved advanced treatments The Company is actively enrolling patients in the Phase 3 DAFFODIL study This marks the fourth nipocalimab FDA Fast Track designation SPRING HOUSE, Pa., March 18, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has...Read more
Results from Phase 2 RAINFOLTM-01 trial (B1 cohort) showed that with a median on-study follow-up of 48 weeks, Rina-S 120 mg/m2 led to a confirmed objective response rate (ORR) of 55.6% and median duration of response (mDOR) was not reached Phase 2 RAINFOLTM-01 and Phase 3 RAINFOLTM-02 trials evaluating the safety and efficacy of Rina-S at 120 mg/m2 in patients with platinum resistant ovarian cancer (PROC) are actively...Read more
- Statistically significant results for primary endpoints in both STOP-HS1 and STOP-HS2 Phase 3 studies for both doses tested - Favorable safety profile, with no safety concerns - Data will support planned regulatory submission for povorcitinib in hidradenitis suppurativa (HS) worldwide - Incyte to hold an analyst and investor call on Monday, March 17, 2025 from 8:00-9:00 a.m. ET WILMINGTON, Del. / Mar 17, 2025 / Business Wire /...Read more
MONT-SAINT-GUIBERT, Belgium, March 17, 2025 (GLOBE NEWSWIRE) -- EsoBiotec SA, a biotechnology company pioneering in vivo cell therapies that has demonstrated promising early clinical activity, today announced it has entered into a definitive agreement to be acquired by AstraZeneca (LSE/STO/Nasdaq: AZN). The EsoBiotec Engineered NanoBody Lentiviral (ENaBL) platform empowers the immune system to attack cancers and could offer many more...Read more
Final data analysis from Phase 3 MIRASOL trial after 30.5-month median follow-up demonstrated 32% reduction in risk of death with ELAHERE compared to chemotherapy in folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) Data presented in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer in Seattle NORTH CHICAGO, Ill., March 15, 2025 /PRNewswire/ --...Read more
In the TRANSCEND FL trial, 97.1% of patients responded to Breyanzi, with 94.2% of patients achieving complete response* Breyanzi demonstrated sustained clinical benefit, with 75.7% of patients still in response at 18 months, and a consistent safety profile with no new safety signals observed PRINCETON, N.J. / Mar 14, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted...Read more
Patients Reported Improvement in Ability to Conduct Daily Activities with Twice-Yearly Dosing* Late-Breaking Data to be Presented at AAN 2025 THOUSAND OAKS, Calif., March 13, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the Phase 3, registrational MINT trial evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) in adults living with generalized myasthenia gravis (gMG). The results...Read more
DOR/ISL demonstrated non-inferiority and a similar safety profile to comparator antiretroviral therapies in adults with virologically suppressed HIV-1 RAHWAY, N.J. / Mar 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of positive results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir...Read more
Agreement allows for a range of potentially best-in-class therapy options as monotherapy and fixed dose combination with Roche`s lead incretin asset CT 388 Collaboration will complement Roche's portfolio in the field of cardiovascular, renal, and metabolic (CVRM) diseases Obesity is a heterogeneous disease with over 200 related comorbidities, including cardiovascular and metabolic diseases, and is expected to impact over 4 billion...Read more
Phase 1 Data Indicate Potential for Use of Once-Yearly Lenacapavir for HIV Prevention, with Plans to Launch a Phase 3 Trial in 2H 2025 Also at CROI: New PURPOSE 1 Data Showcasing Preference for Twice-Yearly Lenacapavir vs. Once-Daily Orals and In-Depth Look at Adolescent Pharmacokinetic, Safety and Efficacy Data FOSTER CITY, Calif. / Mar 11, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first data...Read more
Global Phase 3 TRANSCEND study will evaluate the efficacy and safety of felzartamab, as compared to placebo, in adults with late AMR AMR is a leading cause of kidney transplant loss, with approximately ~23k patients living with all forms of AMR in the U.S1 Felzartamab, with demonstrated proof of concept in multiple immune-mediated diseases, represents a key asset in Biogen’s late-stage immunology portfolio CAMBRIDGE, Mass., March...Read more
Opening highlights effort to expand U.S. manufacturing through a $1 billion investment DURHAM, N.C. / Mar 11, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the opening of a new, $1 billion, 225,000-square-foot facility dedicated to vaccine manufacturing at its Durham, North Carolina, site. This expansion of our Durham plant is a crucial component of the more than $12...Read more
Bagsværd, Denmark, 10 March 2025 – Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo. The trial included 1,206 randomised people with obesity or overweight and type 2...Read more
Phase 3 MARIPOSA study showed LAZCLUZE® plus RYBREVANT® significantly improved progression-free survival, reducing the risk of disease progression or death by 30 per cent versus osimertinib alone.1 TORONTO, March 10, 2025 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada has issued a Notice of Compliance (NOC) for LAZCLUZE® (lazertinib) in combination with RYBREVANT® (amivantamab) for the...Read more
Topline results also show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to 30.2% at Week 12 and a favorable safety profile in Phase 2b ANTHEM-UC study Clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program Icotrokinra demonstrates potential to offer therapeutic benefit and...Read more
Advanced oncology pipeline including more than 20 active Phase 2 and Phase 3 clinical trials with a strategic focus on two priority pan-tumor programs: next-generation immunomodulator candidate BNT327 and mRNA cancer immunotherapies Multiple data readouts expected in 2025 and 2026 aimed at providing clinical proof of BioNTech’s pipeline strategy and advancing the Company towards becoming a diversified multi-product oncology portfolio...Read more
Late-breaking results presented at AAD show 80% or more scalp hair coverage at Week 36 in 42.4% of adolescents receiving baricitinib 4 mg Patients treated with baricitinib 4 mg saw significant regrowth of eyebrows and eyelashes at Week 36 compared to placebo Positive data underscore Lilly's continued expansion across dermatologic conditions, with treatments that can improve outcomes for patients with the greatest...Read more
Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch Dupixent also significantly reduced oral corticosteroid and rescue medicine use compared to placebo Data support the potential of Dupixent to be the first and only targeted medicine to treat bullous pemphigoid, a skin disease with underlying type 2 inflammation;...Read more
Significantly more patients treated with Sotyktu achieved ACR and PASI response rates and had greater improvements in patient-reported quality of life compared with placebo at Week 16 Sotyktu was well-tolerated in comparison with placebo and apremilast, demonstrating safety consistent with its established clinical profile PRINCETON, N.J. / Mar 08, 2025 / Business Wire / Bristol Myers Squibb (NYSE:BMY) today announced positive data...Read more
Ongoing Studies are Evaluating Long-Term Maintenance and Durability THOUSAND OAKS, Calif., and TOKYO, March 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today announced new results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD). The...Read more
Full data from the Phase 3 TRuE-PN1 study, presented today in a late-breaking oral presentation, showed the study met all primary and key secondary endpoints Topline data from a separate Phase 3 study, TRuE-PN2, showed that while the primary endpoint did not reach statistical significance, the primary and all key secondary endpoints were in favor of ruxolitinib cream 1.5% versus vehicle These Phase 3 data will inform planned discussions...Read more
Standout combination of complete skin clearance and favorable safety profile in a once daily pill could shift treatment paradigm Nearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with investigational icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEAD Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed...Read more
MATTERHORN is first global, randomized Phase III trial to demonstrate superior event-free survival with an immunotherapy combination over standard of care in this setting IMFINZI plus chemotherapy more than doubled pathologic complete response rate in previously reported analysis of this trial in 2023 WILMINGTON, Del. / Mar 07, 2025 / Business Wire / Positive high-level results from the MATTERHORN Phase III trial showed perioperative...Read more
Approval based on results of Phase 3 CheckMate -9DW clinical trial demonstrating a statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib PRINCETON, N.J. / Mar 07, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo® (nivolumab) plus Yervoy®...Read more
NovoCare® Pharmacy provides direct-to-patient, convenient home shipments of all dose strengths of Wegovy® at a reduced cost of $499 per month for cash-paying patients While 90% of patients taking Wegovy ® have a co-pay of $0 to $25 per month, this offer was designed to support cash-paying patients without insurance coverage Amidst the dangers of fake or illegitimate compounded "semaglutide," NovoCare® Pharmacy offers reliable...Read more
Gazyva is the only anti-CD20 monoclonal antibody in a randomized Phase III study to demonstrate a complete renal response benefit The filing application is based on data from the Phase III REGENCY study, where Gazyva showed superiority over standard therapy alone in people with active lupus nephritis Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to...Read more
SAN DIEGO, March 5, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of investigational compound NBI-1140675 in healthy adult participants. NBI-1140675 is an investigational, oral, selective second-generation small molecule inhibitor of the vesicular monoamine transporter 2 (VMAT2) in...Read more
SKYRIZI is the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease.1 MONTREAL, March 4, 2025 /CNW/ - AbbVie (NYSE: ABBV) announced today that SKYRIZI® (risankizumab) is now available in Canada for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant...Read more
Partnership marks AbbVie's entrance into the obesity field Agreement will enable the incorporation of GUB014295, an amylin peptide discovered and developed by Gubra, into AbbVie's global infrastructure for developing and commercializing therapies for patients in need NORTH CHICAGO, Ill. and HØRSHOLM, Denmark, March 3, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Gubra A/S (CPSE:GUBRA), a company specializing in preclinical...Read more
Study met the primary endpoint, with a significantly higher proportion of clinical responders on rusfertide compared to placebo All four key secondary endpoints were met, including EU primary endpoint and patient-reported outcomes Rusfertide was generally well tolerated; no new safety findings were observed in the study NEWARK, Calif. & OSAKA, Japan & CAMBRIDGE, Mass. / Mar 03, 2025 / Business Wire / Protagonist Therapeutics,...Read more
TNKase® (tenecteplase) is the first stroke medicine approved by the FDA in nearly 30 years Single five-second intravenous bolus provides faster and simpler administration than the approved standard-of-care Genentech has developed the only two FDA-approved medicines to treat acute ischemic stroke, TNKase and Activase® (alteplase) SOUTH SAN FRANCISCO, Calif. / Mar 03, 2025 / Business Wire / Genentech, a member of the Roche Group (SIX:...Read more
First-ever head-to-head trial comparing Xolair and oral immunotherapy (OIT) Results were featured as late-breakers at the 2025 AAAAI Annual Meeting Xolair is the only U.S. FDA-approved medicine to reduce allergic reactions in children and adults with one or more food allergies SOUTH SAN FRANCISCO, Calif. / Mar 02, 2025 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new positive...Read more
mRESVIA® is Moderna's second approved product in the UK CAMBRIDGE, MA / ACCESS Newswire / February 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for mRESVIA (mRNA-1345), indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in...Read more
TOKYO and CAMBRIDGE, Mass., Feb. 28, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti-Aβ monoclonal...Read more
The positive opinion is based on results from the Phase 3 BRUIN CLL-321 trial, recently presented at the 2024 American Society of Hematology Annual Meeting BRUIN CLL-321 is the first randomized Phase 3 study in CLL ever conducted exclusively in patients previously treated with a BTK inhibitor INDIANAPOLIS, Feb. 28, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA)...Read more
TARRYTOWN, N.Y., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at...Read more
The positive opinion is based on results from the pivotal Phase 3 SELECT-GCA trial that evaluated the efficacy and safety of upadacitinib in adults with giant cell arteritis (GCA)1 The primary endpoint of sustained remission* and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure, and complete remission,† were met1 GCA is an autoimmune disease that causes...Read more
SAN DIEGO, Feb. 27, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced top-line data from a Phase 4 study, KINECT-PRO™, demonstrating clinically meaningful and sustained effects of INGREZZA® (valbenazine) capsules on the physical, social and emotional impacts experienced by patients living with tardive dyskinesia (TD), irrespective of TD severity or underlying psychiatric condition. KINECT-PRO is the...Read more
Meets 2024 Guidance for Total Revenues, Adjusted EBITDA and Adjusted EPS; Exceeds 2024 Guidance for Free Cash Flow [1] Reports 2024 Total Revenues of $14.7 Billion, U.S. GAAP Net Loss of $(634) Million, Adjusted EBITDA of $4.7 Billion, U.S. GAAP Diluted EPS Loss of $(0.53) per Share, Adjusted EPS of $2.65 per Share, U.S. GAAP Net Cash Provided by Operating Activities of $2.3 Billion, and Free Cash Flow of $2.0 Billion Including ~$650...Read more
$737 million in fourth quarter and $2.2 billion in full year global product net sales Received positive CHMP recommendation for VYVGART pre-filled syringe for gMG, enabling launch in the EU; FDA PDUFA (gMG and CIDP) on track for April 10 10 Phase 3 and 10 Phase 2 studies across pipeline ongoing in 2025, positioning for next wave of growth Recognized one-time tax benefit of $725 million related to previously unrecognized deferred...Read more
Net product revenues for the fourth quarter 2024 totaled $638.2 million, a 75% increase over the same quarter of the prior year ELEVIDYS net product revenue for the quarter totaled $384.2 million; Royalty revenue from the sales of ELEVIDYS by Roche for the quarter totaled $4.9 million Achieved GAAP and non-GAAP net income of $159.0 million and $206.0 million for the fourth quarter of 2024, respectively CAMBRIDGE, Mass. / Feb 26, 2025...Read more
Company expects to begin building four more domestic manufacturing sites this year and add 13,000 high-wage manufacturing and construction jobs in America The company's plans represent the largest pharmaceutical manufacturing investment in U.S. history INDIANAPOLIS, Feb. 26, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced at a press conference in Washington, D.C., plans to bolster its domestic medicine...Read more
TARRYTOWN, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The target action date for the FDA decision is July 30, 2025. Acceptance of...Read more
First and only next-generation oral SERD and complete ER antagonist to demonstrate 1st-line benefit in combination with widely approved CDK4/6 inhibitors WILMINGTON, Del. / Feb 26, 2025 / Business Wire / Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or...Read more
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Feb 26, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter and year ended December 31, 2024. Full year 2024 revenues rose to a record $2.88 billion, reflecting 24% growth over 2023. “I want to congratulate every Unitherian for their relentless dedication, which has allowed us to...Read more
UZEDY is currently approved in the US as a subcutaneous long-acting injectable (LAI) for use every one or two months for the treatment of schizophrenia in adults1 LAI treatment options may help address unmet needs of people living with bipolar I disorder (BP-I) BP-I filing acceptance for UZEDY represents Teva’s commitment to pursuing new advances in neuroscience PARSIPPANY, N.J. and TEL AVIV, Israel and PARIS, Feb. 25, 2025 (GLOBE...Read more
Acceptance based on results from the KEYNOTE-689 trial: the first Phase 3 trial to demonstrate significant improvement in event-free survival in the neoadjuvant and adjuvant setting for an anti-PD-1 therapy in earlier stages of head and neck squamous cell carcinoma RAHWAY, N.J. / Feb 25, 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...Read more
New 7.5 mg and 10 mg Zepbound single-dose vials now available for $499 per month via Zepbound Self Pay Journey Program 2.5 mg and 5 mg vial prices reduced INDIANAPOLIS, Feb. 25, 2025 /PRNewswire/ -- Today Eli Lilly and Company (NYSE: LLY) announced the launch of 7.5 mg and 10 mg Zepbound (tirzepatide) single-dose vials, available for $499 with the new Zepbound Self Pay Journey Program.1 Lilly also reduced the price of the 2.5 mg and...Read more
As presented at ARO, 10 of 11 children with at least one post-treatment assessment showed notable improvements in hearing Speech and development progress followed dramatic improvements in hearing in first child treated in the trial TARRYTOWN, N.Y., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced updated data for the investigational gene therapy DB-OTO from the Phase 1/2 CHORD trial...Read more
One Application Seeks European Commission Authorization; Other Application Would Facilitate Availability in Low- and Lower-Middle-Income Countries Both Applications Will Be Assessed in Parallel Under Accelerated Assessment Review Timeline Based on Potential Public Health Interest in Lenacapavir for HIV Prevention EMA Validation Follows Acceptance of U.S. Applications by FDA Under Priority Review FOSTER CITY, Calif. / Feb...Read more
| Company | Change | Last Trade |
|---|---|---|
| Astellas Pharma | 0.02 0.22 | $8.93 |
Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking’s research and development activities leverage...
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ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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