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Surmodics

List of Big Pharma Stocks

Company
Last Trade
Change
Volume
Shares Out
Market Cap
US$ 888.71
2.72 0.31
1.32M
950.40M
US$ 844.630B
US$ 142.02
1.03 0.73
1.38M
4.45B
US$ 631.970B
US$ 148.65
0.87 0.59
3.74M
2.41B
US$ 358.250B
US$ 129.59
-0.08 -0.06
4.44M
2.53B
US$ 327.860B
US$ 170.66
-1.47 -0.85
2.97M
1.77B
US$ 302.070B
US$ 78.84
0.27 0.34
2.14M
3.10B
US$ 244.390B
US$ 35.50
0.27 0.77
392,947
6.38B
US$ 226.490B
US$ 105.12
-0.62 -0.59
504,365
2.04B
US$ 214.440B
US$ 309.89
0.00 0.00
2.39M
536.44M
US$ 166.240B
US$ 27.62
-0.12 -0.43
15.59M
5.67B
US$ 156.600B
US$ 466.62
-4.76 -1.01
846,138
258.05M
US$ 120.410B
US$ 46.97
0.12 0.26
3.81M
2.50B
US$ 117.420B
US$ 1.00
9.50 0.91
343,321
108.37M
US$ 114.210B
US$ 69.92
1.43 2.09
12.30M
1.25B
US$ 87.400B
US$ 41.15
0.11 0.27
6.15M
2.03B
US$ 83.520B
US$ 40.28
-0.48 -1.18
1.46M
2.04B
US$ 82.170B
US$ 134.42
0.02 0.01
1.79M
383.24M
US$ 51.520B
US$ 12.65
0.04 0.32
613,945
3.14B
US$ 39.710B
US$ 222.56
-3.02 -1.34
562,377
145.60M
US$ 32.400B
US$ 7.00
0.01 0.14
52,252
3.93B
US$ 27.510B
US$ 163.00
5.60 3.56
420,949
126.49M
US$ 20.620B
US$ 84.48
-1.40 -1.63
362,594
240.99M
US$ 20.360B
US$ 17.00
-0.06 -0.35
2.56M
1.13B
US$ 19.200B
US$ 158.36
2.82 1.81
64,726
113.43M
US$ 17.960B
US$ 9.55
0.16 1.70
3,194
1.79B
US$ 17.090B
US$ 25.97
0.09 0.35
187,663
642.30M
US$ 16.680B

Latest Big Pharma Stock News


Takeda's HyQvia® Approved as Replacement Therapy for Primary Humoral Immunodeficiency and Secondary Humoral Immunodeficiency in Pediatric Patients 2 years of Age and Older

HyQvia®, which may be administered at home, will provide children and adolescents living with immunodeficiencies with a new treatment option TORONTO, June 21, 2024 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that Health Canada has expanded the marketing authorization (NOC) for HyQvia® (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement therapy for primary humoral immun... Read more


European Medicines Agency Validates Bristol Myers Squibb’s Application for Subcutaneous Nivolumab

Validation is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of Opdivo to evaluate and demonstrate noninferior pharmacokinetics and efficacy vs. its intravenous formulation Application seeks approval for subcutaneous nivolumab formulation to treat multiple Opdivo adult solid tumor indications in the European Union PRINCETON, N.J. / Jun 21, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the... Read more


Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA® (guselkumab) for the treatment of moderately to severely active Crohn's disease

Submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs TREMFYA® is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) induction, and has the potential to be the first in its class to offer the option of both SC and IV induction therapy in Crohn's disease GALAXI includes data demonstrating superior outcomes for TREMFYA® versus STELARA® (ustekinumab)... Read more


Gilead Sciences’ Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention

First Phase 3 HIV Prevention Trial Ever to Show Zero Infections  Independent Data Monitoring Committee Recommended That Gilead Stop the Blinded Phase of the PURPOSE 1 Trial at Interim Analysis and Offer Open-Label Lenacapavir to All Participants  FOSTER CITY, Calif. / Jun 20, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s... Read more


Roche launches new highly-sensitive test to more easily diagnose patients who may have B-cell lymphoma

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, providing diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is... Read more


Johnson & Johnson: TREMFYA® (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction

TREMFYA® Phase 3 Crohn's disease study achieves all primary and secondary endpoints SPRING HOUSE, Pa., June 20, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease.1 The study met both co-primary endpoints, achieving statistically significant... Read more


AbbVie Appoints Roxanne S. Austin as Lead Independent Director of the Board of Directors

Ms. Austin assumes role from Glenn F. Tilton, who will continue to serve as an independent director NORTH CHICAGO, Ill., June 20, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the independent directors of the board have selected Roxanne S. Austin as lead independent director, effective July 1, 2024. Ms. Austin succeeds Glenn F. Tilton, who has served as lead independent director since 2013. Mr. Tilton will continue to serve on the AbbVie Board... Read more


U.S. FDA Approves SKYRIZI® (risankizumab-rzaa) for Ulcerative Colitis, Expanding AbbVie's Portfolio Across Inflammatory Bowel Disease

Approval supported by two Phase 3 clinical trials that evaluated SKYRIZI® for the treatment of moderate to severe ulcerative colitis: a 12-week induction study, INSPIRE,1 and a 52-week maintenance study, COMMAND2 Data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, a key secondary endpoint1,2 SKYRIZI is the first IL-23 antagonist approved for both ulcerative... Read more


Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA® in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting

Favorable Findings from the Longest Public Clinical Study in CIDP Support HYQVIA as an Effective Long-Term Treatment Option for Maintaining Stable Disease Course in CIDP ADVANCE Clinical Program Reflects Takeda’s Commitment to Continued Research on the Role of Immunoglobulin (IG) Therapy for Patients with Rare Neuroimmunological Disorders OSAKA, Japan & CAMBRIDGE, Mass. / Jun 18, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced data from the Phase... Read more


Roche receives FDA clearance on its digital pathology solution for diagnostic use

The solution, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. Primary diagnosis for digital pathology enhances healthcare efficiency and helps ensure effective and timely patient care, especially in areas where access to pathologists is limited. This clearance is a foundational step in Roche's commitment... Read more


Merck: U.S. FDA Approves CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults

CAPVAXIVE (V116) is specifically designed for adults and covers serotypes responsible for approximately 84% of invasive pneumococcal disease in adults 50 years of age and older Across four Phase 3 studies, CAPVAXIVE demonstrated robust immune responses in both vaccine-naïve and vaccine-experienced adult populations RAHWAY, N.J. / Jun 17, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food... Read more


FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Carboplatin and Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma

KEYTRUDA is now the first and only anti-PD-1 therapy FDA-approved in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status Approval marks the third FDA-approved indication for KEYTRUDA in endometrial carcinoma and the 40th indication for KEYTRUDA in the US RAHWAY, N.J. / Jun 17, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today... Read more


Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome

SKYLINE Study in Dravet Syndrome Narrowly Missed its Primary Endpoint of Reduction in Convulsive Seizure Frequency and Showed Clinically Meaningful and Nominally Significant Effects in Multiple Key Secondary Efficacy Endpoints SKYWAY Study in Lennox-Gastaut Syndrome Missed its Primary Endpoint of Reduction in Major Motor Drop Seizures Soticlestat Showed a Consistent and Favorable Safety and Tolerability Profile in Both Studies Takeda Will Move Forward to Discuss the... Read more


AstraZeneca: IMFINZI® (durvalumab) plus chemotherapy approved in the US for mismatch repair deficient advanced or recurrent endometrial cancer

Approval based on DUO-E trial results, which showed IMFINZI reduced the risk of disease progression or death by 58% vs. chemotherapy WILMINGTON, Del. / Jun 17, 2024 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with carboplatin and paclitaxel followed by IMFINZI monotherapy has been approved in the US as treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).1 The approval... Read more


Johnson & Johnson: Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer

Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five-minute administration of subcutaneous amivantamab Longer overall survival, progression-free survival and duration of response also observed with subcutaneous amivantamab RARATIN, N.J., June 17, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug... Read more


AstraZeneca: CALQUENCE® (acalabrutinib) plus chemoimmunotherapy reduced the risk of disease progression or death by 27% vs. standard of care in patients with untreated mantle cell lymphoma in ECHO Phase...

First and only BTK inhibitor to demonstrate favorable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting WILMINGTON, Del. / Jun 16, 2024 / Business Wire / Positive results from the ECHO Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and showed a favorable trend... Read more


Regeneron Pharmaceuticals: Updated Linvoseltamab Data Showcase Continued Deepening of Responses in Patients with Heavily Pre-Treated Multiple Myeloma

At 14-months median follow-up in the pivotal trial, 50% of patients achieved a complete response or better and a 71% overall response rate, as presented in an EHA oral presentation and simultaneously published in the Journal of Clinical Oncology Also presented at EHA, a retrospective study of patient outcomes that compared investigational linvoseltamab to real-world standard-of-care treatment in clinical practice TARRYTOWN, N.Y., June 16, 2024 (GLOBE NEWSWIRE) --... Read more


Genentech’s Phase III STARGLO Study Demonstrates Columvi Significantly Extends Survival in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

The study met its primary endpoint of overall survival with a 41% reduction in the risk of death in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with Columvi plus chemotherapy This Columvi combination could provide a much-needed off-the-shelf treatment option for people with transplant-ineligible R/R DLBCL Data were featured in the congress Press Briefing and presented today in the Plenary Abstracts Session at EHA 2024 as a l... Read more


Johnson & Johnson: Late-breaking results show nipocalimab significantly improves Sjögren's disease activity in a Phase 2 study

Patients who received nipocalimab 15 mg/kg demonstrated a greater than 70 percent relative average improvement on the primary endpoint compared to patients who received placebo Sjögren's disease is a chronic, debilitating, and prevalent autoantibody disease with no approved advanced treatments VIENNA, June 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announces patients treated with nipocalimab demonstrated statistically significant (P=0.002) and clinically... Read more


Amgen: FDA Approves BLINCYTO® (blinatumomab) In CD19-Positive Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL) in the Consolidation Phase

BLINCYTO® Added to Multiphase Consolidation Chemotherapy Reduced Risk of Death by 58% Showing Superior Overall Survival Versus Chemotherapy Alone First and Only Bispecific T-cell Engager (BiTE®) Therapy for Consolidation Treatment Regardless of Measurable Residual Disease (MRD) Status THOUSAND OAKS, Calif., June 14, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved BLINCYTO® (blinatumomab)... Read more


Pfizer: ELREXFIO™ Shows Median Overall Survival of More Than Two Years in People with Relapsed or Refractory Multiple Myeloma

Patients in MagnetisMM-3 demonstrated a median overall survival (OS) of 24.6 months, with median progression-free survival (PFS) of 17.2 months NEW YORK / Jun 14, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced detailed overall survival (OS) results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM). The study demonstrated a median OS of 24.6 (95% CI,... Read more


Takeda Signs Option Agreement with Ascentage Pharma to Enter into Exclusive Global License for Olverembatinib, a Third-Generation BCR-ABL Tyrosine Kinase Inhibitor (TKI)

Takeda to Receive Exclusive Option to License Global Rights to Olverembatinib in All Territories Outside of Mainland China, Hong Kong, Macau, Taiwan and Russia Olverembatinib Has the Potential to Address Significant Unmet Need for Patients with Chronic Myeloid Leukemia Following Treatment with Currently Approved TKIs Ascentage Pharma to Advance Late-Stage Clinical Development of Olverembatinib Prior to Potential Exercise of the Option to License OSAKA, Japan &... Read more


Johnson & Johnson: TALVEY® (talquetamab-tgvs) demonstrates highly durable, longer-term responses in patients with relapsed or refractory multiple myeloma

24-month overall survival rate of 67 percent achieved with TALVEY® 0.8 mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 study MADRID, June 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that long-term data from the Phase 1/2 MonumenTAL-1 study showed that with 20 to 30 months of median follow-up, triple-class-exposed patients with relapsed or refractory multiple myeloma (RRMM) who were treated with TALVEY® (talquetamab-tgvs) maintained... Read more


Vertex Pharmaceuticals Presents Positive Long-Term Data On CASGEVY™ (exagamglogene autotemcel) at the 2024 Annual European Hematology Association (EHA) Congress

Results from CLIMB-111, -121 and -131 accepted for oral presentation Data from these trials, with the longest follow-up of more than five years, demonstrate transformative, consistent and durable benefit of CASGEVY™ Safety profile consistent with busulfan conditioning and autologous hematopoietic stem cell transplant BOSTON / Jun 14, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced longer-term data for CASGEVY™ (exagamglogene... Read more


Bristol-Myers Squibb: U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Patients with NTRK-Positive Locally...

Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors, demonstrating clinically meaningful response rates in the TRIDENT-1 trial1 This accelerated approval marks the second indication for Augtyro in the U.S.1 PRINCETON, N.J. / Jun 13, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated... Read more


AbbVie and FutureGen Announce License Agreement to Develop Next-Generation Therapy for Inflammatory Bowel Disease

Global license agreement to focus on the development of FG-M701, a TL1A antibody, for the treatment of inflammatory bowel disease (IBD) NORTH CHICAGO, Ill. and BEIJING, June 13, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and FutureGen Biopharmaceutical (Beijing) Co., Ltd. today announced a license agreement to develop FG-M701, a next generation TL1A antibody for the treatment of IBD currently in preclinical development. FG-M701 is a fully human monoclonal antibody targeting... Read more


Moderna Announces Positive Phase 3 Efficacy Data for mRNA-1283, the Company’s Next Generation COVID-19 Vaccine

mRNA-1283 met its primary vaccine efficacy endpoint in a Phase 3 trial, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax® in participants 12 years of age and older Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older CAMBRIDGE, MA / ACCESSWIRE / June 13, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1283, an investigational next-generation COVID-19 vaccine,... Read more


AstraZeneca: FARXIGA approved in the US for the treatment of pediatric type-2 diabetes

US patients aged 10 years and older can now benefit from FARXIGA for type-2 diabetes Approval based on results from T2NOW, one of the largest pediatric type-2 diabetes Phase III trials to date WILMINGTON, Del. / Jun 12, 2024 / Business Wire / AstraZeneca’s FARXIGA® (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older.1 The FDA approval was... Read more


Pfizer Provides Update on Phase 3 Study of Investigational Gene Therapy for Ambulatory Boys with Duchenne Muscular Dystrophy

NEW YORK / Jun 12, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that CIFFREO, a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo.... Read more


Regeneron Pharmaceuticals: Kevzara® (sarilumab) Approved by FDA for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Approval in patients with pJIA weighing 63kg or greater adds to Kevzara’s position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis and polymyalgia rheumatica TARRYTOWN, N.Y. and CAMBRIDGE, MA, June 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of patients weighing... Read more


AstraZeneca: TAGRISSO® (osimertinib) granted Priority Review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

Decision based on LAURA Phase III trial results which extended median progression-free survival by more than three years TAGRISSO also granted Breakthrough Therapy Designation in US in this setting WILMINGTON, Del. / Jun 10, 2024 / Business Wire / AstraZeneca’s supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable, Stage III epidermal growth... Read more


Moderna Announces Positive Phase 3 Data for Combination Vaccine Against Influenza and COVID-19

mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older CAMBRIDGE, MA / ACCESSWIRE / June 10, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints,... Read more


FDA Accepts Eisai's Filing of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease

TOKYO and CAMBRIDGE, Mass., June 9, 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 the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing.... Read more


Eli Lilly's tirzepatide was superior to placebo for MASH resolution, and more than half of patients achieved improvement in fibrosis at 52 weeks

SYNERGY-NASH results were presented at the European Association for the Study of the Liver Congress 2024 and simultaneously published in The New England Journal of Medicine INDIANAPOLIS, June 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced detailed results from SYNERGY-NASH, a phase 2 study of 190 patients, with or without type 2 diabetes, to evaluate the investigational use of tirzepatide in adults with biopsy-proven metabolic dysfunction-associated... Read more


US FDA Approves Expanded Age Indication for GSK’s AREXVY, the First Respiratory Syncytial Virus (RSV) Vaccine for Adults Aged 50-59 at Increased Risk

Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes1 Clinical development program continues to evaluate safety and immunogenicity in adults 18+ with data read-outs expected H2 2024 PHILADELPHIA / Jun 07, 2024 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention... Read more


Vertex Pharmaceuticals Presents New Data at the European Cystic Fibrosis Conference Demonstrating Significant Benefits of Treatment with TRIKAFTA®

Results from a randomized, placebo-controlled study of TRIKAFTA® in people with cystic fibrosis with rare, non-F508del CFTR mutations showed statistically significant and clinically meaningful improvements in the primary and all secondary endpoints Interim results of largest real-world study of TRIKAFTA® showed sustained improvement in lung function at three years as well as lower rates of lung transplant and death in people with cystic fibrosis, compared to pre-TRIKAFTA®... Read more


Moderna Files FDA Application for the JN.1 Targeting COVID-19 Vaccine

Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as early as August, pending regulatory approval CAMBRIDGE, MA / ACCESSWIRE / June 7, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2024-2025 formula, targeting the SARS-CoV-2 variant JN.1. "For four years, Moderna has consistently delivered vaccines that... Read more


AbbVie Announces Positive Topline Results from Phase 2 PICCOLO Trial Evaluating Mirvetuximab Soravtansine (ELAHERE®) for High Folate Receptor-Alpha (FRα) Expressing Platinum-Sensitive Ovarian Cancer

PICCOLO trial met its primary endpoint of objective response rate (ORR) Data from the study will be presented at a future medical meeting NORTH CHICAGO, Ill., June 6, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE®) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer... Read more


Moderna's Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program

Center for Biologics Evaluation and Research has chosen mRNA-3705 as one of four investigational medicines for accelerated development to address unmet medical needs for rare diseases CAMBRIDGE, MA / ACCESSWIRE / June 6, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. mRNA-3705 is an investigational... Read more


Gilead Sciences Announces New England Journal of Medicine Publication of Data that Demonstrate Bulevirtide with PegIFN Achieved Post-Treatment Undetectable HDV RNA

Phase 2b Data Presented at EASL and Published in NEJM Show Potential for Bulevirtide 10 mg in Combination with Pegylated Interferon Alfa-2a as Finite Therapy for People with Chronic Hepatitis Delta  Data Published in NEJM Demonstrate 46% of Patients Taking Bulevirtide 10 mg with PegIFN Achieved Post-Treatment Undetectable HDV RNA at Week 24  Data Presented at EASL Demonstrate Consistent Study Findings of Undetectable HDV RNA at Week 48  FOSTER CITY,... Read more


AbbVie Advances Oncology Pipeline With Start of Multiple Myeloma Phase 3 Clinical Trial for Investigational Asset ABBV-383

ABBV-383 is a B-cell maturation antigen (BCMA) bispecific antibody T-cell engager being evaluated in relapsed/refractory multiple myeloma (r/r MM) The CERVINO Phase 3 trial will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r MM who have received at least two lines of prior therapy NORTH CHICAGO, Ill., June 5, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced... Read more


Amgen Announces Positive Results For Phase 3 Registrational Trial Evaluating Uplizna® (inebilizumab-cdon) For Treatment Of Immunoglobulin G4-related Disease (IgG4-RD)

Data Show a Statistically Significant 87% Reduction in IgG4-RD Flares, With Primary and All Key Secondary Endpoints Met First Randomized, Placebo-Controlled Trial to Demonstrate Benefit in IgG4-RD THOUSAND OAKS, Calif., June 5, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive topline results from its randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial (NCT04540497) evaluating the efficacy and safety of UPLIZNA® (ineb... Read more


Gilead Sciences’ Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis

Positive Results from Two-year Interim Analysis Includes Participants from Phase 3 RESPONSE Study and are Highly Consistent with One-year Interim Analysis  Reduction in Patient-Reported Pruritus (Itching) was Rapid and Durable in Participants with Moderate to Severe Symptoms  Subset Analysis of Participants with Compensated Cirrhosis Demonstrated Clinically Meaningful Improvements in Markers of Cholestasis and Liver Injury  FOSTER CITY, Calif. / Jun... Read more


AbbVie: RINVOQ® (upadacitinib) Now Available for Pediatric Patients Two Years and Older with Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis

First indications of RINVOQ (upadacitinib) for pediatric patients two years of age and older1 RINVOQ is now approved for eight indications across immune-mediated inflammatory diseases1 NORTH CHICAGO, Ill., June 4, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that RINVOQ® (upadacitinib) is indicated in the U.S. for the treatment of pediatric patients two years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) as well as psoriatic... Read more


Bristol Myers Squibb Announces Opdivo (nivolumab) Plus Yervoy (ipilimumab) Significantly Improved Overall Survival Compared to Lenvatinib or Sorafenib as First-Line Treatment for Patients with Advanced...

Late-breaking data to be presented at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting Dual immunotherapy combination of Opdivo plus Yervoy demonstrated improved survival benefit compared to lenvatinib or sorafenib in this patient population Objective response rate (ORR) for Opdivo plus Yervoy was more than double that for lenvatinib or sorafenib, with median duration of response of 30 months PRINCETON, N.J. / Jun 04, 2024 / Business Wire / Bristol... Read more


Melissa Seymour to join Eli Lilly as executive vice president of Global Quality

INDIANAPOLIS, June 4, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that Melissa Seymour will join the company as executive vice president of Global Quality and member of the company's Executive Committee, effective July 22, 2024. Seymour currently serves as the chief quality officer for Bristol Myers Squibb and succeeds Johna Norton, whose retirement after 34 years of service was announced earlier this year. "As we expand global capacity to meet... Read more


Bristol Myers Squibb’s Breyanzi Demonstrates Clinically Meaningful Outcomes Across Broad Range of B-Cell Malignancies in New Data Presented at 2024 ASCO® Annual Meeting

Three-year follow-up results from TRANSFORM show ongoing event-free survival and durable responses with Breyanzi compared to standard of care Results from a subgroup analysis from mantle cell lymphoma cohort of TRANSCEND NHL 001 show Breyanzi demonstrated consistent clinical benefit regardless of number of prior lines of therapy, supporting use of Breyanzi in earlier lines of treatment Data from bridging therapy subgroup analysis of TRANSCEND FL show consistent efficacy... Read more


Kite’s Tecartus® Demonstrates Sustained Overall Survival in Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

 After More Than Four Years of Follow-up in the Pivotal ZUMA-3 Study, Median Overall Survival (OS) was 26 Months and the OS Rate was 40% at 48 Months   Survival Benefit was Seen Regardless of Age, Prior Treatment or Subsequent Allogeneic Stem Cell Transplant Status   Data Being Presented at the 2024 American Society of Clinical Oncology Annual Meeting  SANTA MONICA, Calif. / Jun 03, 2024 / Business Wire / Kite, a Gilead Company (Nasdaq:... Read more


Novo Nordisk launches national Wegovy® campaign, Power of Wegovy®

Designed to celebrate diverse, unique portrayals of individuals who partner with their healthcare professional to change the course of their weight-management journey, while educating on the clinical data of Wegovy® Reflects the power of personal journeys to address stigma, and the importance of us all working together to address excess weight and treat obesity PLAINSBORO, N.J., June 3, 2024 /PRNewswire/ -- Novo Nordisk today launched The Power of Wegovy®,... Read more


Genmab: Investigational Tisotumab Vedotin Phase 2 Data Demonstrates Encouraging Antitumor Activity in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Results from innovaTV207 evaluating tisotumab vedotin, showing 32.5% confirmed objective response rate in patients with recurrent or metastatic HNSCC, presented in a rapid oral session at 2024 ASCO® Annual Meeting HNSCC is the sixth most common cancer worldwide, with incidence rates expected to increase 30% by 2030i COPENHAGEN, Denmark / Jun 03, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today that data from the Phase 2 innovaTV 207 trial (NCT03485209)... Read more

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