TOKYO and CAMBRIDGE, Mass., July 26, 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval (MAA) for the humanized anti-soluble... Read more
Results Underscore Continued Progress on Commercial Execution, Driving the Growth Portfolio and Pipeline Advancement Second Quarter Revenues were $12.2 Billion, increasing 9% (+11% Adjusting for Foreign Exchange) Growth Portfolio Revenues were $5.6 Billion, increasing 18% (+21% Adjusting for Foreign Exchange) GAAP EPS was $0.83 and Non-GAAP EPS was $2.07; Includes Net Impact of $(0.04) Per Share for GAAP EPS and Non-GAAP EPS Due to Acquired IPRD Charges and Licensing... Read more
Opinion granted based on positive overall survival and progression-free survival results from the Phase 3 KEYNOTE-A39 trial Positive opinion marks step forward for a potential new first-line standard of care for the treatment of patients with this disease in Europe RAHWAY, N.J. / Jul 26, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products... Read more
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 healing†,1,2 NORTH CHICAGO, Ill.,... 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 attack (myocardial infarction)... 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 (EC) has granted conditional marketing... 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 Sciences, Inc. (Nasdaq: GILD) today... 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 Global Net Revenues from the Immunology... 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 Sales 24,629... 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 Pharmaceuticals, a U.S. affiliate of 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 (Euronext & Nasdaq: ARGX),... 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 achieved its primary objective of non-... 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 for PrEP in High-Incidence, Res... 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), and benefits of subcutaneous administration... 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. In the trial, clesrovimab met... 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 Campus, which houses state-of-the-art... 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 The Carlyle Group, will join Moderna's... 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 supplemental New Drug Application (sNDA)... 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® (ipilimumab) as a potential first-line... 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 Industries Ltd. (NYSE and TASE: TEVA)... 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 unique therapeutic approach that... 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 filings, RYBREVANT subcutaneous filing,... 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 / Genentech, a member of the Roche Group... 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) approved the Biologics License... 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 cystic fibrosis transmembrane conductance... 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 submitted applications for a new indication... 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 results from the ongoing pharmacokinetic... 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 Administration (FDA). In February 2024,... 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 demerged subsidiary of Numab Therapeutics... 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. Novo Nordisk is evaluating the... 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: ELAN). The completion of this acquisition... 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 its mRNA respiratory vaccines. Both... 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 selective oral small molecule inhibitor... 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, Susvimo is the first and only approved... 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; OTCQX: RHHBY) announced today the U.S.... 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 comparator arm SOUTH SAN FRANCISCO,... 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, through a Priority Review, has issued... 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 the sixth approved indication for... 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 with Kisunla in 12 months Once-monthly... 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 late-stage therapeutic candidate... 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 investigational once-daily vanzacaftor/t... 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. Department of Health and Human Services... 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; cilta-cel) compared to standard... 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 exclusive global license for Merck. “We... 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 Richard A. Gonzalez, who has served... 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 joining State Street, he held numerous... 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). Patients treated with nipocalimab plus... 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 disease caused by RSV infection. Following... 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), after two or more lines of systemic... 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 States and Canada, announced today... Read more
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