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...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...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...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...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...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...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...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...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...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,...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...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...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...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...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:...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...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...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...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...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...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...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...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...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...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...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/...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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®)...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...Read more
PRINCETON, N.J. / Mar 28, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE clinical trial program evaluating Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease. The study did not meet its primary endpoint of clinical remission at Week 12. The safety profile of Zeposia...Read more
Efficacy and Safety Profile of Once-Daily Vemlidy Demonstrated in Children Six Years of Age (Weighing at Least 25kg) and Older FOSTER CITY, Calif. / Mar 28, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic...Read more
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results and represents the sixth approval for KEYTRUDA in lung cancer in Europe RAHWAY, N.J. / Mar 28, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in...Read more
Announces next-generation COVID-19 vaccine candidate as fourth respiratory vaccine to successfully meet its Phase 3 endpoints Expects two more Phase 3 readouts in 2024, including combination vaccine against flu and COVID-19, and vaccine against CMV Announces positive clinical trial data from three new vaccines against viruses that cause significant burden (Epstein-Barr virus, Varicella-Zoster virus, norovirus) and advances programs...Read more
WINREVAIR is a breakthrough biologic for this rare, progressive disease WINREVAIR on top of background therapy significantly improved exercise capacity and multiple important secondary outcome measures compared to background therapy alone RAHWAY, N.J. / Mar 26, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved...Read more
cTTP is an Ultra-rare Blood Clotting Disorder Associated with Life-Threatening Acute Events and Debilitating Chronic Symptoms ADZYNMA (apadamtase alfa /cinaxadamtase alfa) is the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for People with cTTP OSAKA, Japan & CAMBRIDGE, Mass. / Mar 26, 2024 / Business Wire / Takeda (TSE: 4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare has...Read more
mRNA-1283 induced a more robust immune response compared to Spikevax® COVID-19 vaccine, mRNA-1273.222 Next-generation mRNA vaccine design offers the potential of longer shelf life and storage advantages, and paves the way for combination vaccine against influenza and COVID-19, mRNA-1083 CAMBRIDGE, MA / ACCESSWIRE / March 26, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that mRNA-1283, the Company's next-generation COVID-19...Read more
Bagsværd, Denmark, and Hannover, Germany, 25 March, 2024 – Novo Nordisk and Cardior Pharmaceuticals today announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. Cardior is a leader in the discovery and development of therapies that target RNA as a means to prevent, repair and reverse...Read more
First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+ NMOSD the potential to live relapse-free Unprecedented relapse risk reduction observed in CHAMPION-NMOSD trial underscores how ULTOMIRIS may redefine patient journey for rare neurological disease WILMINGTON, Del. / Mar 25, 2024 / Business Wire / ULTOMIRIS® (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5...Read more
TARRYTOWN, N.Y., March 25, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued Complete Response Letters (CRLs) for the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy. The only...Read more
The full approval of ELAHERE is based on the confirmatory MIRASOL Phase 3 trial that supports the medicine as a potential new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC) Data show that ELAHERE treatment resulted in an overall survival benefit and reduced the risk of cancer progression by 35% ELAHERE represents AbbVie's first approved solid tumor treatment following the recent...Read more
Acquisition Reinforces Gilead’s Leadership in Developing Innovative Therapies For Challenging Liver Diseases FOSTER CITY, Calif. / Mar 22, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for approximately $4.3 billion in total equity value. The addition of CymaBay’s investigational lead product...Read more
Bagsværd, Denmark, 21 March 2024 – Novo Nordisk (NYSE: NVO) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Awiqli® (the brand name for once-weekly basal insulin icodec) for treatment of diabetes in adults. The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial...Read more
ADPKD is the most common inherited kidney disease, with no treatments currently available that address the underlying cause of disease Vertex to initiate a Phase 1 clinical trial in healthy volunteers this month ADPKD is Vertex’s 10th disease area in the clinic, further expanding the company’s pipeline of potentially transformative medicines for serious diseases BOSTON / Mar 21, 2024 / Business Wire / Vertex Pharmaceuticals...Read more
RAHWAY, N.J. / Mar 21, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYLYNK-006 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic...Read more
Development of next-generation sequencing companion diagnostics (CDx) Goal is to help increase patient access to Bayer’s precision cancer therapies by offering decentralized genomic testing and rapid turnaround time BERLIN & CARLSBAD, Calif.--(BUSINESS WIRE)--Bayer AG and Thermo Fisher Scientific Inc. today announced a collaboration to develop next-generation sequencing (NGS)-based companion diagnostic assays (CDx) together. These...Read more
Abecma demonstrated superiority over 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 with mostly low-grade and transient occurrences of cytokine release syndrome and neurotoxicity Approval reinforces Bristol Myers Squibb’s commitment to bring the transformative potential of cell therapy into earlier lines of treatment PRINCETON N.J. /...Read more
Opdivo plus Yervoy demonstrates statistically significant and clinically meaningful improvement in overall survival compared to investigator’s choice of sorafenib or lenvatinib PRINCETON, N.J. / Mar 20, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular...Read more
Advanced oncology pipeline in mid- and late-stage with plans to have ten or more potentially registrational oncology trials running by the end of 2024 Aiming for first oncology launch in 2026 and ten indication approvals by 2030 as part of BioNTech's strategy to develop combinatorial and synergistic therapeutic approaches Entered strategic collaborations with Biotheus, DualityBio, Medilink and OncoC4 to complement clinical oncology...Read more
ICLUSIG Becomes the First and Only Targeted Treatment Approved in the U.S. for Frontline Ph+ Acute Lymphoblastic Leukemia (ALL) in Combination with Chemotherapy First FDA Approval in Ph+ ALL Based on Novel Primary Endpoint of Minimal Residual Disease (MRD)-negative Complete Remission (CR) Accelerated Approval Based on Data from the Phase 3 PhALLCON Trial, in which ICLUSIG Demonstrated Superiority in MRD-negative Complete Remission Rates...Read more
OASIS 3 study provides additional supporting efficacy data as well as long-term safety data of elinzanetant, complementing positive topline results of OASIS 1 and 2 studies Bayer will submit data from OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause Elinzanetant is the first dual...Read more
Results from multiple Phase 3 trials of V116 and a real-world evidence study of pneumococcal serotypes presented at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults RAHWAY, N.J. / Mar 19, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced...Read more
Includes actinium-based clinical-stage radioconjugate targeting PSMA for prostate cancer, pipeline of radioconjugates and state-of-the-art R&D and manufacturing facilities WILMINGTON, Del. / Mar 19, 2024 / Business Wire / AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The acquisition marks a...Read more
KarXT, Karuna’s Lead Asset, Is a Potential First-in-Class Treatment for Schizophrenia with Multi-Billion Dollar Sales Potential Across Multiple Indications PRINCETON, N.J. / Mar 18, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that it has successfully completed its acquisition of Karuna Therapeutics, Inc. (“Karuna”). With the acquisition's completion, Karuna shares have ceased trading on the Nasdaq Global...Read more
Dostarlimab-gxly plus chemotherapy is the only immuno-oncology combination to show statistically significant and clinically meaningful overall survival (OS) in the overall population 31% reduction in risk of death and 16.4-month improvement in median OS observed with dostarlimab-gxly plus chemotherapy versus chemotherapy in the overall population 37% reduction in risk of disease progression or death and 6-month improvement in median...Read more
The supplemental Biologics License Application for Abecma in this indication remains under review with the FDA; Abecma has been approved in Japan and Switzerland and received a positive CHMP Opinion by the European Medicines Agency based on KarMMa-3 PRINCETON, N.J. & CAMBRIDGE, Mass. / Mar 15, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the U.S. Food and Drug...Read more
KEYTRUDA plus CRT is the first immunotherapy-based regimen to demonstrate a statistically significant improvement in OS in these patients RAHWAY, N.J. / Mar 15, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT)...Read more
Breyanzi offers a personalized treatment option delivered as a one-time infusion that provides deep and durable responses for patients with relapsed or refractory CLL or SLL who have historically had no standard of care In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with...Read more
Results from the global, Phase 3 RATIONALE 302 trial showed TEVIMBRA prolonged the survival of patients who received prior systemic treatment compared to chemotherapy Approval represents the first indication in the U.S. for TEVIMBRA BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Mar 14, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S....Read more
Pre-Specified Interim Analysis Shows Positive Safety and Efficacy Results; Mezagitamab Safe and Well Tolerated Takeda Intends to Initiate a Global Phase 3 Trial of Mezagitamab in Patients with Primary Immune Thrombocytopenia in Fiscal Year 2024 Late-Stage Pipeline Continues to Gain Momentum With Five New Molecular Entities in Phase 3 Development in Fiscal Year 2024 OSAKA, Japan & CAMBRIDGE, Mass. / Mar 13, 2024 / Business Wire /...Read more
THARROS is the first-ever prospective trial to investigate the potential of an inhaled triple therapy to reduce cardiopulmonary events, a key driver of mortality, in COPD First patients dosed in ATHLOS Phase III trial assessing impact of BREZTRI on integrated cardiopulmonary parameters associated with health status and survival in patients with COPD WILMINGTON, Del. / Mar 13, 2024 / Business Wire / AstraZeneca today announced the...Read more
PREVENAR 20® (20-valent Pneumococcal Conjugate Vaccine) offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally1,2,3,4,5,6,7,8 NEW YORK / Mar 13, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has...Read more
Company reaffirms commitment to reduce the global burden of HPV-related diseases, including certain cancers RAHWAY, N.J. / Mar 13, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today, at the EUROGIN 2024 HPV Congress, announced plans to initiate clinical development of a new investigational multi-valent HPV vaccine designed to provide broader protection against multiple HPV types....Read more
ECHELON-3 trial of ADCETRIS in combination with lenalidomide and rituximab showed significant improvement in primary endpoint of overall survival and in secondary endpoints of progression free survival and overall response rate versus lenalidomide and rituximab plus placebo, regardless of CD30 expression Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS NEW YORK / Mar 12, 2024 /...Read more
Acquisition broadens oncology pipeline with a portfolio of novel T-cell engagers including HPN328 (MK-6070), an investigational delta-like ligand 3 (DLL3) targeting T-cell engager RAHWAY, N.J. / Mar 11, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of Harpoon Therapeutics, Inc. (Nasdaq: HARP). Harpoon is now a wholly-owned subsidiary of...Read more
TARRYTOWN, N.Y., March 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH). “Many children with heterozygous...Read more
INDIANAPOLIS, March 10, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results from a first-of-its-kind study of lebrikizumab specifically designed for people with skin of color and moderate-to-severe atopic dermatitis, commonly called eczema. In this study, treatment with lebrikizumab, an investigational medicine, showed improvement in skin clearance and itch relief. These late-breaking results from a Phase 3...Read more
SPROUT 52-Week Data Demonstrate Durable Response and Consistent Safety Profile of Oral Otezla in Children with Moderate to Severe Plaque Psoriasis Late-Breaking Phase 3 Study of Otezla in Palmoplantar Pustulosis Achieves Primary and Secondary Endpoints at 16 Weeks THOUSAND OAKS, Calif., March 9, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new, 52-week results from the Phase 3 SPROUT study examining the use of...Read more
Bagsværd, Denmark, 8 March 2024 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy® based on a supplemental New Drug Application (sNDA) for the indication of reducing risks of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity and...Read more
Published results show EYLEA HD with extended 12- or 16-week dosing regimens demonstrated non-inferior vision gains to standard of care EYLEA® (aflibercept) Injection 2 mg with fixed 8-week dosing in patients with wAMD and DME in the first year EYLEA HD has shown impressive durable visual improvements and rapid and resilient fluid control with a safety profile comparable to EYLEA Extended dosing intervals with EYLEA HD have the...Read more
INDIANAPOLIS, March 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer's disease. The FDA has informed Lilly it wants to...Read more
BRUKINSA is the first and only BTK inhibitor approved across five oncology indications and the first and only approved in follicular lymphoma Approval based on positive results from ROSEWOOD trial showing BRUKINSA plus obinutuzumab achieved higher overall response rate versus obinutuzumab alone BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Mar 07, 2024 / Business Wire / BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE:...Read more
In the Phase 3 CheckMate -901 trial, Opdivo with cisplatin and gemcitabine demonstrated a statistically significant improvement in overall survival and progression-free survival compared to cisplatin-gemcitabine alone1 This is the first concurrent immunotherapy-chemotherapy combination approved for this patient population in the U.S. PRINCETON, N.J. / Mar 07, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that...Read more
Bagsværd, Denmark, 7 March 2024 – Novo Nordisk (NYSE: NVO) is today hosting a Capital Markets Day (CMD) where the company is providing a progress update on its Strategic Aspirations 2025. The day will be centred around the Strategic Aspirations. During the day, senior management presentations will cover corporate strategy and purpose & sustainability (ESG), Research and early development, Product Supply as well research and...Read more
Acquisition strengthens Johnson & Johnson’s commitment to innovation in prostate cancer and deepens pipeline of next-generation antibody drug conjugates and targeted oncologic therapeutics NEW BRUNSWICK, N.J. / Mar 07, 2024 / Business Wire / Johnson & Johnson (NYSE: JNJ) announced today it has successfully completed the acquisition of Ambrx Biopharma, Inc., a clinical-stage biopharmaceutical company with a proprietary synthetic...Read more
Week 24 Results Support Continued Development as a Potential Long-Acting Oral Combination Treatment Option in Virologically Suppressed People with HIV Novel Investigational Combination Regimen has the Potential to be the First Oral Weekly HIV Treatment, Helping to Address Unmet Needs FOSTER CITY, Calif., & RAHWAY, N.J. / Mar 06, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside...Read more
Gilead Receives Exclusive Option to License Novel Trispecific Therapeutics Resulting from the Collaboration FOSTER CITY, Calif. / Mar 06, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq:GILD) and Merus N.V. (Nasdaq:MRUS) today announced a research collaboration, option and license agreement to discover novel dual tumor-associated antigens (TAA) targeting trispecific antibodies. Gilead and Merus agreed to collaborate on the...Read more
New data from the RESPOND study show that neurofilament levels, an indicator of neurodegeneration, were reduced in nearly all study participants treated with SPINRAZA Reductions in biomarker complement previously reported RESPOND efficacy results showing improved motor function in most participants treated with SPINRAZA after gene therapy CAMBRIDGE, Mass., March 06, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced...Read more
| Company | Change | Last Trade |
|---|---|---|
| Biogen | 8.81 4.56 | $201.99 |
| BeiGene | 5.13 3.69 | $144.12 |
| Novartis | 1.07 1.10 | $98.35 |
| Moderna | 0.96 0.89 | $108.85 |
| AstraZeneca | 0.35 0.49 | $71.20 |
| Merck | 0.12 0.09 | $127.00 |
| Gilead Sciences | 0.05 0.07 | $67.08 |
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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