The marketing authorization for SKYRIZI® (risankizumab) marks its fourth approved indication in the European Union The approval is supported by data from two pivotal Phase 3 trials: The INSPIRE induction trial1 and COMMAND maintenance trial2 In both trials, SKYRIZI achieved the primary endpoint of clinical remission (per Adapted Mayo Score*) and key secondary endpoints, including mucosal healing** and histologic endoscopic mucosal...Read more
Bagsværd, Denmark, 25 July 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy® (semaglutide 2.4 mg) label to reflect data from the SELECT cardiovascular outcomes trial, demonstrating a risk reduction of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart...Read more
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9) after up to four years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients. NEW YORK / Jul 25, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that the European Commission...Read more
New 5-Year Clinical and Real-World Data Reinforce Biktarvy® as a Long-Term Treatment Option for a Diverse Range of People with HIV, Including Those with Comorbidities Investigational, Once-Daily, Once-Weekly and Twice-Yearly Dosing Frequencies Across Administration Methods Aim to Expand Options, Advance Public Health and Help Address Unmet Needs in HIV Treatment FOSTER CITY, Calif. / Jul 25, 2024 / Business Wire / Gilead...Read more
Reports Second-Quarter Diluted EPS of $0.77 on a GAAP Basis, a Decrease of 32.5 Percent; Adjusted Diluted EPS of $2.65, a Decrease of 8.9 Percent; These Results Include an Unfavorable Impact of $0.52 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $14.462 Billion, an Increase of 4.3 Percent on a Reported Basis and 5.6 Percent on an Operational Basis Second-Quarter...Read more
Strong underlying growth supports FY 2024 guidance upgrade, with both Total Revenue and Core EPS now expected to increase by a mid teens percentage at CER1 CAMBRIDGE, United Kingdom / Jul 25, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary H1 2024 % Change Q2 2024 % Change $m Actual CER $m Actual CER - Product...Read more
Enrollment acceleration drives earlier-than-anticipated data availability for this potentially best-in-class IBD treatment Topline results for both UC and CD now anticipated in Q4 2024 Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug (anti-TL1A) for moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD) patients PARSIPPANY, N.J. & PARIS / Jul 25, 2024 / Business Wire / Teva...Read more
$478 million in second quarter global net product sales First CIDP patients treated with VYVGART® Hytrulo following June 21st FDA approval On track to begin four additional registrational studies across efgartigimod and empasiprubart by end of 2024 Management to host conference call today at 2:30 PM CET (8:30 AM ET) Regulated Information – Inside Information July 25, 2024 7:00 AM CET - Amsterdam, the Netherlands – argenx SE...Read more
Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis NEW YORK / Jul 24, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A. The AFFINE study...Read more
PURPOSE 1 Data Showed Zero Infections and 100% Efficacy and Superiority of Lenacapavir to Background HIV Incidence and Daily Truvada® for PrEP If Approved, Lenacapavir Would be the First and Only Twice-Yearly PrEP Choice and Could Address Critical Gaps in Uptake and Adherence for Individuals Who Need or Want PrEP Gilead Commits to Prioritizing Swift Access and Enabling Efficient Paths for Regulatory Approval of Lenacapavir...Read more
Time-limited reimbursement (TLR) recommendation is a new Canada's Drug Agency (CDA) review process whereby a temporary recommendation is issued based on a phase II clinical data assessment, and the final recommendation is contingent upon a future reassessment of additional evidence (i.e., phase III clinical data)1. The positive CDA TLR recommendation recognizes the clinical efficacy of EPKINLY based on phase II data (EPCORE NHL-1),...Read more
Clesrovimab met all primary safety and efficacy endpoints RAHWAY, N.J. / Jul 23, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease....Read more
$800 million investment in New Jersey supports global growth and expansion with technologically advanced manufacturing capacity and clinical development capabilities for novel cancer medicines HOPEWELL, N.J. / Jul 23, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the opening of its flagship U.S. facility in Hopewell, N.J., at the Princeton West Innovation...Read more
Co-Founder and Co-Chairman of The Carlyle Group brings multi-industry investor experience and global policy expertise, replacing retiring director Stephen Berenson Co-founder and director Robert Langer also to retire from the Moderna Board; recruitment efforts ongoing for his replacement CAMBRIDGE, MA / ACCESSWIRE / July 23, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that David M. Rubenstein, Co-Founder and Co-Chairman of...Read more
Phase 4 SPRAVATO® monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at least 4 weeks Monotherapy submission builds on more than a decade of research, 31 clinical trials and more than five years of real-world use that reinforce the safety and efficacy of SPRAVATO® TITUSVILLE, N.J., July 22, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the submission of a...Read more
The Application is based on Phase 3 CheckMate -9DW trial results demonstrating improved survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population PRINCETON, N.J. / Jul 19, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy®...Read more
SPACE pediatric Phase 3 study met its primary end point for efficacy with a significantly greater reduction in Monthly Migraine Days compared to placebo Efficacy is consistent with AJOVY (fremanezumab) pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed Full data to be presented at a medical meeting later in 2024 TEL AVIV, Israel / Jul 18, 2024 / Business Wire / Teva Pharmaceutical...Read more
Two-year Phase III data presented at ASRS 2024 show Susvimo’s potential as an alternative to eye injections to treat diabetic macular edema (DME) and diabetic retinopathy (DR) Safety data were consistent with the known safety profile for Susvimo in people with DME and DR Additionally, the FDA has accepted the filing application for Susvimo in DME and DR based on one-year Pagoda and Pavilion study data Susvimo is a...Read more
2024 Second-Quarter reported sales growth of 4.3% to $22.4 Billion with operational growth of 6.6%* and adjusted operational growth of 6.5%*. Adjusted operational growth excluding COVID-19 Vaccine of 7.1%* 2024 Second-Quarter Earnings per share (EPS) of $1.93 decreasing by 5.9% due to one-time special charges and adjusted EPS of $2.82 increasing by 10.2%* Significant new product pipeline progress including TREMFYA IBD and subcutaneous...Read more
After four weeks of treatment, CT-996 demonstrated clinically meaningful weight loss of -7.3% (weight loss in placebo -1.2%; p < 0.001)1 Pharmacokinetic data supports a once-daily oral dosing regimen for CT-9961 The safety and tolerability profile was consistent with other oral GLP-1 receptor agonists and no unexpected safety signals were observed1 SOUTH SAN FRANCISCO, Calif. / Jul 17, 2024 / Business Wire /...Read more
First and only NMPA-approved subcutaneous injectable FcRn blocker for gMG patients in China Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study July 16, 2024 6:30am CET - Amsterdam, the Netherlands — argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA)...Read more
Approximately 200 people with certain rare CF mutations are now eligible for TRIKAFTA® TORONTO, July 15, 2024 /CNW/ - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Health Canada has granted Marketing Authorization for the expanded use of PrTRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have a mutation in the...Read more
Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26-week steroid taper regimen achieved the primary endpoint of sustained remission from week 12 through week 521 The safety profile of upadacitinib in patients with GCA was generally consistent with that in approved indications1 NORTH CHICAGO, Ill., July 12, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has...Read more
Clinical evaluation of several modified release once-daily formulations of danuglipron resulted in encouraging pharmacokinetic data for several candidates with one showing the most favorable profile The company plans to conduct dose optimization studies with a focus on the preferred formulation to inform the registration enabling studies NEW YORK / Jul 11, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that based on...Read more
GSK supports annual flu immunization by getting FLULAVAL and FLUARIX to patients in advance of flu season PHILADELPHIA / Jul 11, 2024 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its trivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2024-25 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug...Read more
NM26 is a Phase 2-ready, first-in-class bispecific antibody targeting two clinically proven pathways in atopic dermatitis (AD) The Company is leveraging a multi-pathway approach to transform treatment in atopic dermatitis and other immune-mediated diseases NEW BRUNSWICK, N.J. / Jul 11, 2024 / Business Wire / Johnson & Johnson1 (NYSE: JNJ) announced today that it has successfully completed the acquisition of Yellow Jersey, a...Read more
Bagsværd, Denmark, 10 July 2024 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus. In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed....Read more
Acquisition delivers industry-leading portfolio, scientific and research capabilities, for enhanced customer benefits RAHWAY, N.J. / Jul 09, 2024 / Business Wire / Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the completion of its acquisition of the aqua business of Elanco Animal Health Incorporated (NYSE:...Read more
CAMBRIDGE, MA AND OSAKA, JAPAN / ACCESSWIRE / July 8, 2024 / Moderna, Inc. (Nasdaq:MRNA) and Mitsubishi Tanabe Pharma Corporation today announced that the companies have entered into a joint agreement regarding the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Japan, including Moderna's COVID-19 vaccine, Spikevax®. Under the agreement, Moderna will handle the manufacturing, sales, medical education and distribution of...Read more
Acquisition to expand Lilly's immunology pipeline with oral integrin therapies INDIANAPOLIS and WALTHAM, Mass., July 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Morphic Holding, Inc. (NASDAQ: MORF) today announced a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for treatment of serious chronic diseases. Morphic's lead program is a...Read more
The FDA has approved updates to Susvimo, which will be available to U.S. retina specialists and patients with wet AMD in the coming weeks Susvimo offers the first alternative to regular eye injections that are standard of care for wet AMD, which impacts 1.5 million people in the U.S. and 20 million people worldwide and can cause blindness if left untreated By continuously delivering medicine to the eye through a refillable implant,...Read more
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness Designed to simplify administration, Vabysmo PFS provides retina specialists a ready-to-use option Vabysmo PFS will be available for people living with wet AMD, DME and RVO SOUTH SAN FRANCISCO, Calif. / Jul 05, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG;...Read more
SKYSCRAPER-06 evaluating tiragolumab plus Tecentriq and chemotherapy did not meet the primary endpoints of progression-free survival at primary analysis and overall survival at first interim analysis The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy compared to the comparator arm Safety was consistent with previous studies, however we intend to halt the trial due to reduced efficacy compared to the...Read more
Phase 3 PAPILLON study showed RYBREVANT® in combination with carboplatin and pemetrexed significantly improved progression-free survival, reducing the risk of disease progression or death by 60 per cent versus carboplatin and pemetrexed alone in patients with previously untreated NSCLC with EGFR exon 20 insertion mutations.1 TORONTO, July 3, 2024 /CNW/ - Johnson & Johnson (NYSE: JNJ) announced today that Health Canada,...Read more
First-in-world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life Dupixent is the first new treatment approach for COPD in more than a decade and a new option for approximately 220,000 adults in the European Union (EU) Approval represents...Read more
Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39% Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment...Read more
CAMBRIDGE, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Human Immunology Biosciences (HI-Bio™), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs). “We are very excited about the addition of felzartamab into our pipeline, further strengthening our presence in immunology with a promising...Read more
Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 EU Marketing Authorization Application (MAA) submission also validated by European Medicines Agency (EMA) BOSTON / Jul 02, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for...Read more
CAMBRIDGE, MA / ACCESSWIRE / July 2, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced a project award of $176 million through the Rapid Response Partnership Vehicle (RRPV) to accelerate the development of mRNA-based pandemic influenza vaccines. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S....Read more
CARVYKTI ® is the first and only BCMA-targeted CAR-T cell therapy approved by the U.S. FDA for the treatment of patients with multiple myeloma who have had at least one prior line of therapy RARITAN, N.J., July 2, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today positive results from a prespecified second interim analysis of the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel;...Read more
RAHWAY, N.J. / Jul 01, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Orion Corporation (“Orion”) today announced that notice has been provided of the mutual exercise of an option to convert the companies’ ongoing co-development and co-commercialization agreement for opevesostat (MK-5684/ODM-208), an investigational CYP11A1 inhibitor, and other candidates targeting CYP11A1 into an...Read more
As Previously Announced, Richard A. Gonzalez Retires as Chief Executive Officer to Become Executive Chairman Robert A. Michael Joins AbbVie Board of Directors NORTH CHICAGO, Ill., July 1, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that Robert A. Michael has assumed the role of chief executive officer (CEO) and has joined AbbVie's Board of Directors, effective today. As previously announced, Mr. Michael succeeds...Read more
NEW YORK / Jul 01, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced the election of Cyrus Taraporevala to its Board of Directors, effective immediately. Mr. Taraporevala, age 57, was also appointed to and will join the Audit Committee and Compensation Committee of Pfizer’s Board. Mr. Taraporevala served as President and Chief Executive Officer at State Street Global Advisors from 2017 until his retirement in 2022. Prior to...Read more
First-and-only FcRn blocker to demonstrate superiority in activities of daily living (MG-ADLa) over placebo when added to standard of care over 24 weeks in antibody positive patients: anti-AChR+, anti-MuSK+, anti-LRP4+ HELSINKI, June 28, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive results from the nipocalimab Phase 3 Vivacity-MG3 study in patients with generalized myasthenia gravis (gMG)....Read more
CAMBRIDGE, MA / ACCESSWIRE / June 28, 2024 / Moderna, Inc. (Nasdaq:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization in the European Union for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract...Read more
TARRYTOWN, N.Y., June 28, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL),...Read more
If approved by the European Commission, WINREVAIR will be the first activin signaling inhibitor therapy for PAH in Europe, offering a new treatment option for certain adults with this rare, progressive disease Milestone highlights Merck’s focus on global filings to expand access to WINREVAIR and commitment to patients living with PAH RAHWAY, N.J. / Jun 28, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United...Read more
If approved, epcoritamab (TEPKINLY®) will become the first and only bispecific antibody conditionally approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of prior therapy Positive CHMP opinion based on results from the Phase 1/2 EPCORE® NHL-1 study NORTH CHICAGO, Ill., June 28, 2024 /PRNewswire/...Read more
CAPVAXIVE (V116) recommended for all adults age 65 and older and for adults 19 to 64 with certain risk conditions, and for those over 65 previously vaccinated with other pneumococcal vaccines RAHWAY, N.J. / Jun 27, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices...Read more
TOKYO and CAMBRIDGE, Mass., June 27, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab) has been launched in China....Read more
The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older Recommendation is based on pre-clinical and epidemiological data showing that the JN.1-adapted monovalent COVID-19 vaccine generates an improved immune response against multiple JN.1 sublineages Doses will be ready to ship to applicable EU member states immediately upon authorization by the...Read more
Celsius' CEL383 is a potential first-in-class anti-Triggering Receptor Expressed on Myeloid Cells 1 (TREM1) antibody for the treatment of inflammatory bowel disease (IBD) NORTH CHICAGO, Ill., June 27, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today the acquisition of Celsius Therapeutics, Inc. ("Celsius"), a privately held biotechnology company pioneering new therapies for patients with inflammatory disease. Celsius'...Read more
Approval based on results from Phase 1/2 EPCORE® NHL-1 study, which demonstrated durable, clinically meaningful treatment responses in patients with challenging-to-treat R/R FL EPKINLY offers an off-the-shelf, T-cell engaging treatment option that enables treatment across practice settings to address high clinical need EPKINLY is the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory (R/R)...Read more
EPKINLY is now the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL) Bispecific antibodies are designed to induce targeted cell killing by engaging the immune system FL is considered incurable with current standard of care therapies. Many people living with FL who have relapsed or are refractory to existing...Read more
Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to one year Dupixent is the first and only treatment indicated for EoE in the U.S. for this age group TARRYTOWN, N.Y. and PARIS, June 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the New England Journal of Medicine (NEJM)...Read more
INDIANAPOLIS, June 25, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced a collaboration with OpenAI that will allow Lilly to leverage OpenAI's generative AI to invent novel antimicrobials to treat drug-resistant pathogens. Antimicrobial resistance (AMR) is one of the top public health and development threats across the global health landscape. "Our collaboration with OpenAI represents a groundbreaking step forward in the...Read more
First immunotherapy regimen before and after surgery to extend survival in bladder cancer WILMINGTON, Del. / Jun 25, 2024 / Business Wire / Positive high-level results from the NIAGARA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint...Read more
In 2024, Novo Nordisk plans to boost its current investments, aiming to allocate USD 6.8 billion towards production, a significant increase from the previous year's investment of USD 3.9 billion*. Bagsværd, Denmark, 24 June 2024 – Novo Nordisk today announced plans to invest 4.1 billion US dollars (approx 27 billion Danish kroner) to build a second fill and finishing manufacturing facility in Clayton, North Carolina, and grow its...Read more
TOFIDENCE™ complements existing portfolio of immunology biosimilars commercialized by Biogen Cambridge, Mass., June 24, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the European Commission (EC) has granted approval for TOFIDENCETM, a biosimilar monoclonal antibody referencing ROACTEMRA®1. The intravenous formulation of TOFIDENCE has been granted marketing authorization by the EC for the treatment of...Read more
Achieved 28% and 33% Reduction in Composite of All-Cause Mortality and Recurrent Cardiovascular Events in the Overall and Monotherapy Populations, Respectively Reduced All-Cause Mortality by 36% and 35% in the Overall and Monotherapy Populations, Respectively, in a Pre-Specified Secondary Endpoint Demonstrated Clinically Significant Benefits on 6-Minute Walk Test, Kansas City Cardiomyopathy Questionnaire and NYHA Class – Key Measures of...Read more
Designation is based on pre-clinical data and data from an ongoing Phase 1/2 trial for BNT324/DB-1311, with antitumor activity and a manageable safety profile demonstrated by preliminary Phase 1/2 clinical data from patients with advanced or metastatic solid tumors1,2 With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the U.S. Food and Drug Administration (“FDA”) to support...Read more
Generic Victoza® is the first-ever generic GLP-1 and supports increased demand for this category of therapies in the U.S. market. This launch adds to Teva’s continued commitment to its complex generic medicine portfolio. Liraglutide injection is indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus and reduce the risk of cardiovascular events in adults with type 2...Read more
LIVTENCITY Is the First and Only Post-Transplant Anti-CMV Treatment Approved in Japan That Targets/Inhibits UL97 Protein Kinase1 CMV Is One of the Most Common and Serious Post-transplant Infections and Can Lead to Secondary Infections and Serious Consequences, Including Loss of Transplanted Organ and Failure of Graft2,3 OSAKA, Japan & CAMBRIDGE, Mass. / Jun 24, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that...Read more
FRONTIER2 data presented at ISTH 2024 showed that up to 95% of people, who had no prior prophylaxis treatment, experienced zero treated bleeds while on Mim8 Bagsværd, Denmark, 23 June 2024 – Novo Nordisk announced results from the phase 3 FRONTIER2 trial of 254 adults and adolescents aged 12 years and over with haemophilia A, with and without inhibitors. The trial assessed both once-weekly and once-monthly prophylactic...Read more
Mezagitamab-Treated Patients Showed Rapid and Sustained Increases in Platelet Counts That Persisted 8 Weeks After the Last Dose Through to Week 161 Mezagitamab Had a Favorable Safety Profile, with No New Safety Signals1 Takeda Plans to Initiate Global Phase 3 Trial of Mezagitamab in ITP in the Second Half of FY2024 OSAKA, Japan & CAMBRIDGE, Mass. / Jun 22, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today presented positive...Read more
Approval based on results from the Phase 1/2 KRYSTAL-1 study where KRAZATI in combination with cetuximab showed an objective response rate of 34% in pretreated patients with locally advanced or metastatic CRC harboring a KRASG12C mutation1 Second FDA approval for KRAZATI - reinforcing its potential across tumor types PRINCETON, N.J. / Jun 21, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S....Read more
Approval Based on Results from Positive, Global, Phase 3 FRESCO-2 Trial FRUZAQLA (fruquintinib) is the First Novel Targeted Therapy in the EU for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status in Over a Decade OSAKA, Japan & CAMBRIDGE, Mass. / Jun 21, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved FRUZAQLA (fruquintinib) as a monotherapy indicated...Read more
In the primary endpoint, tirzepatide reduced moderate-to-severe OSA severity by up to 62.8% (about 30 fewer events per hour) In a key secondary endpoint from two clinical studies, 43.0% and 51.5% of participants taking tirzepatide at the highest dose reached the criteria for disease resolution as defined by apnea-hypopnea index and Epworth Sleepiness Scale measures Lilly submitted tirzepatide for the treatment of...Read more
All 12 patients who received the full dose of VX-880 as a single infusion demonstrated islet cell engraftment and glucose-responsive insulin production by Day 90 All patients achieved ADA-recommended target HbA1c levels <7.0% and >70% time-in-range (70-180 mg/dL), and 11 of 12 patients reduced or eliminated use of exogenous insulin 3 patients with at least 12 months of follow-up, and therefore evaluable, met the primary endpoint...Read more
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...Read more
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...Read more
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...Read more
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...Read more
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...Read more
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,...Read more
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...Read more
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...Read more
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)...Read more
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...Read more
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,...Read more
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...Read more
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...Read more
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...Read more
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...Read more
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)...Read more
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.,...Read more
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...Read more
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...Read more
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...Read more
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...Read more
| Company | Change | Last Trade |
|---|---|---|
| Regeneron Pharmaceuticals | 14.44 1.36 | $1,078.63 |
| argenx | 8.13 1.67 | $494.46 |
| Bristol-Myers Squibb | 5.18 11.44 | $50.45 |
| Vertex Pharmaceuticals | 3.00 0.61 | $495.26 |
| AbbVie | 2.99 1.64 | $185.16 |
| Moderna | 1.71 1.42 | $122.11 |
| BioNTech | 1.26 1.49 | $85.94 |
| Roche | 1.12 2.82 | $40.77 |
| Johnson & Johnson | 1.00 0.63 | $160.64 |
| GSK | 0.79 2.02 | $39.86 |
| Pfizer | 0.59 1.95 | $30.77 |
| Amgen | 0.55 0.16 | $334.85 |
| Gilead Sciences | 0.50 0.65 | $77.01 |
| Novartis | 0.39 0.35 | $110.32 |
| Teva Pharmaceutical | 0.30 1.79 | $17.10 |
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic immunoassay tests and microarrays. Surmodics is pursuing highly differentiated whole-product solutions that are designed to address...
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