Upadacitinib demonstrated superiority versus dupilumab in primary endpoint of simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1) at Week 161 LEVEL UP, a Phase 3b/4 head-to-head study, compared upadacitinib to dupilumab for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis who had inadequate response to systemic therapy or when use of those therapies was inadvisable1 The safety... Read more
Performance Reflects Execution and Actions to Strengthen the Company's Long-Term Growth Profile First Quarter Revenues were $11.9 Billion, increasing 5% (+6% Adjusting for Foreign Exchange) Growth Portfolio Revenues were $4.8 Billion, increasing 8% (+11% Adjusting for Foreign Exchange) Strengthened Long-Term Growth Profile Through Completion of Karuna Therapeutics, RayzeBio, Mirati Therapeutics, and SystImmune Transactions Including the One-Time Net Impact of... Read more
Mammoth’s proprietary ultracompact CRISPR-based gene editing platform and Regeneron’s proprietary delivery technologies set to advance in vivo programs in multiple tissue and cell types Mammoth to receive $100 million total upfront payment and equity investment from Regeneron at signing TARRYTOWN, N.Y., April 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Mammoth Biosciences, Inc., today announced a collaboration to research, develop... Read more
Sales Reflect Continued Strong Growth in Oncology and Vaccines Total Worldwide Sales Were $15.8 Billion, an Increase of 9% From First Quarter 2023; Excluding the Impact of Foreign Exchange, Growth Was 12% KEYTRUDA Sales Grew 20% to $6.9 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 24% GARDASIL/GARDASIL 9 Sales Grew 14% to $2.2 Billion; Excluding the Impact of Foreign Exchange, Sales Grew 17% GAAP EPS Was $1.87; Non-GAAP EPS Was $2.07; GAAP and... Read more
Very strong revenue and EPS growth in the first quarter coupled with exciting pipeline delivery CAMBRIDGE, United Kingdom / Apr 25, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary Q1 2024 % Change $m Actual CER1 - Product Sales 12,177 15 18 - Alliance Revenue 457 59 &nb... Read more
Generative AI will help advance Moderna's broad and diverse portfolio to maximize the Company's impact on patients Moderna embeds OpenAI's generative AI tools throughout its organization and sees early success with broad adoption of ChatGPT Enterprise CAMBRIDGE, MA AND SAN FRANCISCO, CA / ACCESSWIRE / April 24, 2024 / Moderna, Inc. (NASDAQ:MRNA) and OpenAI today announced their ongoing collaboration to co-innovate with a shared vision of AI's transformative potential... Read more
Comprehensive development program, including three Phase 3 clinical trials, demonstrated benefit of tislelizumab for patients with treatment-naïve and relapsed NSCLC Decision represents tislelizumab’s second approval in the region BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Apr 23, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved... Read more
Vertex obtains an exclusive license to TreeFrog's C-StemTM manufacturing technology in type 1 diabetes TreeFrog and Vertex to collaborate on scale-up of fully differentiated, insulin-producing pancreatic islet cells BOSTON and BORDEAUX, France, April 23, 2024 /CNW/ -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and TreeFrog Therapeutics today announced that Vertex has obtained an exclusive license to TreeFrog's proprietary cell manufacturing... Read more
EMBLAVEO® is the first β-lactam/β-lactamase inhibitor antibiotic combination approved in the European Union for treating serious infections in adult patients caused by multidrug-resistant Gram-negative bacteria, including metallo-β-lactamase-producing bacteria EMBLAVEO® was reviewed under European Medicines Agency accelerated assessment procedure, used when a pharmaceutical product is of major interest for public health and therapeutic innovation NEW YORK / Apr... Read more
CAMBRIDGE, MA / ACCESSWIRE / April 22, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced a contract with the Ministry of Health in Brazil (Ministério da Saúde) to supply its mRNA COVID-19 vaccine as an integral part of Brazil's 2024 national vaccination campaign against COVID-19. This contract follows the Brazilian Health Regulatory Agency's (ANVISA) approval of Moderna's COVID-19 vaccine in March 2024, which encodes the spike protein of the XBB.1.5 sublineage of SARS-CoV-2... Read more
Bristol Myers Squibb will utilize Cellares’ proprietary Cell Shuttle, a next-generation end-to-end, fully automated cell therapy manufacturing platform, for the clinical and commercial-scale manufacturing of select CAR T cell therapies Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO), will allocate multiple Cell Shuttles and its fully automated, high-throughput Cell Q systems across its IDMO Smart Factories in the U.S., EU and... Read more
TOKYO, April 22, 2024 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK, President and CEO; Christophe Weber, "Takeda"), Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), and Sumitomo Mitsui Banking Corporation (President & CEO: Akihiro Fukutome, "SMBC") today announced that the three companies signed a master agreement on April 22, 2024, to establish a joint venture company. The new company will be dedicated to... Read more
Approval is based on the Phase 3 KEYNOTE-859 Trial KIRKLAND, QC, April 19, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric... Read more
ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease OSAKA, Japan & CAMBRIDGE, Mass. / Apr 18, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately... Read more
Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC) This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy The National Comprehensive Cancer Network® (NCCN®) Guidelines... Read more
Results from the Phase 3 SELECT-GCA study showed 46 percent of patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ®; 15 mg) with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared to 29 percent of patients receiving placebo with a 52-week steroid taper regimen1 The safety profile in GCA was generally consistent with that in approved indications, and no new safety signals were identified... Read more
Rolling submission for suzetrigine moderate-to-severe acute pain NDA granted by FDA; first module submitted and on track to complete filing this quarter Successful completion of end-of-phase 2 FDA meeting for pain associated with diabetic peripheral neuropathy (DPN); Phase 3 program to initiate in 2H 2024 Breakthrough Therapy designation for pain associated with DPN granted by FDA Enrollment of Phase 2 study in patients with painful lumbosacral radiculopathy... Read more
Tirzepatide achieved a mean apnea-hypopnea index reduction of up to 63% (about 30 fewer events per hour), meeting all primary and key secondary endpoints in two phase 3 clinical trials Tirzepatide meaningfully improved sleep apnea symptoms in those with moderate-to-severe OSA and obesity with and without PAP therapy, and based on these results Lilly plans to submit these data for global regulatory reviews INDIANAPOLIS, April 17, 2024 /PRNewswire/ -- Eli Lilly and... Read more
Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks The twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations U.S. FDA and EMA accepted filings based on the data from OCARINA II, with EU... Read more
Longest survival follow-up ever reported for immunotherapy treatment in this setting WILMINGTON, Del. / Apr 16, 2024 / Business Wire / Updated exploratory results from the TOPAZ-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care chemotherapy demonstrated a clinically meaningful long-term overall survival (OS) benefit at three years for patients with advanced biliary tract cancer (BTC). These results from TOPAZ-1, which... Read more
2024 First-Quarter reported sales growth of 2.3% to $21.4 Billion with operational growth of 3.9%* and adjusted operational growth of 4.0%* Adjusted operational growth excluding COVID-19 Vaccine of 7.7%* 2024 First-Quarter Earnings per share (EPS) increased to $2.20 and adjusted EPS increased to $2.71 or 12.4%* Company increasing the midpoint for Full-Year 2024 operational sales5 and adjusted operational EPS guidance NEW BRUNSWICK, N.J. / Apr 16, 2024... Read more
APPLAUSE-IgAN is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with IgAN1 IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide2; complement activation is a key driver of glomerular inflammation in IgAN3,4 There is a need for effective, targeted therapies for IgAN2,5; up to 30% of patients with persistent proteinuria (≥1 g/day)... Read more
Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma Data from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meeting SOUTH SAN FRANCISCO, Calif. / Apr 15, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the Phase III... Read more
Interim analysis of an ongoing 156-week extension study supports long-term safety, tolerability and efficacy of atogepant 60 mg to prevent chronic and episodic migraine Seventy percent of subjects achieved ≥50% reduction in monthly migraine days at Weeks 13-16 and this was consistent during the 48 weeks of open-label treatment Findings will be showcased in an oral presentation at the American Academy of Neurology (AAN) Annual Meeting Scientific Platform Session for... Read more
Additional indication for pediatric patients with severe eosinophilic asthma WILMINGTON, Del. / Apr 11, 2024 / Business Wire / AstraZeneca’s FASENRA® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype.1 FASENRA was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma (SEA) in patients aged... Read more
Alpine is a clinical stage biotechnology company focused on discovering and developing innovative, protein-based immunotherapies Alpine’s lead product, povetacicept, demonstrated best-in-class potential in patients with IgA nephropathy (IgAN); Phase 3 to initiate in H2 2024 Povetacicept holds promise as a pipeline-in-a-product, with clinical studies in additional serious diseases underway Alpine’s protein engineering and immunotherapy expertise... Read more
ABRYSVO met its trial primary endpoints in adults aged 18 to 59 with an increased respiratory syncytial virus (RSV) disease risk. The vaccine was well-tolerated and demonstrated an immune response non-inferior to adults aged 60 years and older Pfizer intends to submit these findings to regulatory agencies to seek approval of ABRYSVO in adults 18 to 59 years of age NEW YORK / Apr 09, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive top-line im... Read more
Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program PRINCETON, N.J. / Apr 08, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI® (adagrasib) in combination with cetuximab for the treatment of patients with previously... Read more
TARRYTOWN, N.Y., April 07, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the oral plenary session presentation of positive pivotal data from the Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with relapsed/refractory (R/R) multiple myeloma (MM) at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation... Read more
Study Met Primary Endpoint Demonstrating Clinically Significant Additive Reductions in Ambulatory Systolic Blood Pressure of Up to 12.1 mmHg Across Three Independent Study Cohorts at Month 3 A Single Dose of Zilebesiran Resulted in Clinically Significant Additive Reductions in Office Systolic Blood Pressure at Month 3 and in Time-Adjusted Office Systolic Blood Pressure at Month 6 Across Three Independent Study Cohorts Zilebesiran Demonstrated an Encouraging Safety and... Read more
V-INITIATE trial demonstrates that early initiation with Leqvio, prior to guideline-recommended ezetimibe, for ASCVD patients unable to achieve LDL-C goal on statin therapy alone led to significant LDL-C reduction vs. clinician-determined usual care (60% vs. 7% respectively)1 A significantly greater proportion of the ASCVD patients receiving Leqvio achieved guideline-recommended LDL-C goal vs. the usual care arm while maintaining adherence to statin treatment1... Read more
Long-term treatment with KarXT was associated with continued improvements in symptoms of schizophrenia across all efficacy measures at 52 weeks More than 75% of participants achieved >30% improvement in symptoms from baseline, as measured by the Positive and Negative Syndrome Scale (PANSS) total score, at one year Participants previously on placebo in acute trials experienced significant reduction of symptoms beginning at week two and maintained throughout treatme... Read more
KarXT demonstrated a favorable long-term metabolic profile where most patients experienced stability or improvements on metabolic parameters over 52 weeks of treatment A majority of patients (65%) experienced reductions in weight over the course of the trial, with a mean weight decrease of 2.6kg observed at one year Data show no significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks KarXT was generally... Read more
Expanded indication for this one-time infusion will provide more patients with a potential period away from their multiple myeloma treatment as early as first relapse Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with CARVYKTI® in 1-3 prior lines of therapy reduced the risk of disease progression or death by 59 percent compared to standard therapies HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:... Read more
Based on three Phase II trials of AstraZeneca and Daiichi Sankyo’s ENHERTU which showed clinically meaningful responses across a broad range of tumors ENHERTU now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers WILMINGTON, Del. / Apr 05, 2024 / Business Wire / AstraZeneca and Daiichi Sankyo's ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or... Read more
Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profile Expanded approval brings this personalized CAR T cell therapy to more patients with relapsed or refractory multiple myeloma earlier in their treatment journey as a one-time infusion offering meaningful treatment-free intervals when responding to therapy Abecma is now approved... Read more
First and only immunotherapy to demonstrate survival benefit in this setting in a global Phase III trial WILMINGTON, Del. / Apr 05, 2024 / Business Wire / Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell... Read more
Enhances Johnson & Johnson’s Ability to Transform the Treatment Landscape for Cardiovascular Disease and Continue to Improve Patient Outcomes Extends Johnson & Johnson MedTech’s Position in Highest-Growth, Innovation-Oriented Segments of Cardiovascular Intervention Accelerates Sales Growth and Accretive to Operating Margin for Both Johnson & Johnson and Johnson & Johnson MedTech Conference Call at 8:30 a.m. ET To Discuss Details of the Transaction NEW... Read more
RAHWAY, N.J. / Apr 04, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor KRAS G12C mutations and express PD-L1 (tumor proportion score [TPS] ≥50%... Read more
CAMBRIDGE, MA / ACCESSWIRE / April 3, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that interim data for a first-in-human, phase 1/2, open-label, dose optimization study and extension study, evaluating the safety and efficacy of mRNA-3927, an investigational mRNA therapy for propionic acidemia (PA), has been published in Nature. "We are excited to share the first published clinical data utilizing an mRNA therapy for intracellular protein replacement," said Kyle Holen,... Read more
Offering $200 Off the First CoolSculpting® Treatment IRVINE, Calif., April 3, 2024 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV) is announcing its second annual CoolMonth celebration featuring CoolSculpting® Elite. From April 1 through April 30, 2024, consumers can access CoolSavings promotions to help accelerate their body contouring journey. Leveraging last year's success, which saw more than 62,000 treatments during the month-long celebration1,... Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / Apr 03, 2024 / Business Wire / Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the first patient has been dosed in the REJOICE-Ovarian01 phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. The phase 2 portion of the trial will be conducted to identify the dose... Read more
Company Announcement Genmab to acquire ProfoundBio for USD 1.8 billion in cash Acquisition will give Genmab worldwide rights to three candidates in clinical development, including rinatabart sesutecan (Rina-S), plus ProfoundBio’s novel antibody-drug conjugate (ADC) technology platforms Rina-S is a novel, next-generation, potential best-in-class Topo1 ADC targeting folate receptor alpha (FRα) in development for the treatment of ovarian cancer and other solid tumors Genmab... Read more
Approval of Reblozyl is based on head-to-head, pivotal Phase 3 COMMANDS study, in which Reblozyl nearly doubled the percentage of patients achieving transfusion independence and hemoglobin increase, along with increased durability compared to epoetin alfa This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia and the first therapy to demonstrate superior efficacy vs. epoetin alfa in LR-MDS... Read more
Application based on results from the TROPION-Breast01 phase 3 trial Additional BLA under review in the U.S. for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan for patients with advanced nonsquamous non-small cell lung cancer TOKYO & BASKING RIDGE, N.J. / Apr 02, 2024 / Business Wire / Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the... Read more
Exa-cel is the first CRISPR-based gene-edited therapy to be submitted for Health Canada review TORONTO, April 1, 2024 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced its New Drug Submission (NDS) for exagamglogene autotemcel (exa-cel) has been accepted for Priority Review by Health Canada for the treatment of patients aged 12 years and older with sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) and for the treatment... Read more
45 mg once daily oral dose selected for Phase 3 Results support trial expansion to lower age group and study will now include adolescents ages 10-17 years If positive, pre-planned interim analysis at Week 48 may serve as the basis for accelerated approval in the U.S. BOSTON / Apr 01, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that inaxaplin (VX-147) has advanced into the Phase 3 portion of the global... Read more
Approval of first-in-class, oral, Factor D inhibitor based on results from pivotal ALPHA Phase III trial WILMINGTON, Del. / Apr 01, 2024 / Business Wire / VOYDEYA™ (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).1 VOYDEYA is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care ULTOMIRIS®... Read more
TOKYO and CAMBRIDGE, Mass., March 31, 2024 /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 Eisai submitted to the U.S. Food and Drug Administration (FDA) a Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing.... Read more
Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer PRINCETON, N.J. / Mar 28, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI® (adagrasib) as a monotherapy in patients with pretreated... Read more
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