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Janssen-Cilag’s Lazcluze-Rybrevant Combo Receives Positive EMA Opinion for NSCLC Treatment
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Janssen-Cilag International NV, a subsidiary of the US pharmaceutical giant Johnson & Johnson (J&J; NYSE: JNJ), has announced that it has received positive opinions from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) regarding the combination of Lazcluze (lazertinib) and Rybrevant (amivantamab-vmjw). This combination therapy…
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Janssen-Cilag’s Nipocalimab Shows Promise in Phase II Study for Sjögren’s Disease
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Janssen-Cilag International NV, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), has unveiled the latest analysis results from the Phase II DAHLIAS study for nipocalimab, an investigational FcRn blocker, in adult patients with moderate-to-severe Sjögren’s disease (SjD). The study has shown that the drug significantly improved key measures of…
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J&J MedTech Secures Exclusive Distribution Deal with Responsive Arthroscopy
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Johnson & Johnson (J&J, NYSE: JNJ) MedTech, a leading player in the US medical technology sector, has announced an exclusive commercial distribution agreement with Responsive Arthroscopy Inc., an innovative medical device company specializing in sports soft tissue repair solutions. This strategic partnership is aimed at bolstering J&J MedTech’s sports medicine…
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Huadong Medicine’s Biosimilar SaiLeXin Receives First National Prescription in China
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China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has announced a significant milestone with the issuance of the first national prescription for its biosimilar drug, SaiLeXin, at the Peking University People’s Hospital. This marks a new chapter in the treatment of autoimmune diseases in China, offering patients an alternative…
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J&J MedTech Receives FDA IDE for OTTAVA Robotic Surgical System Trials
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US-based Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing its OTTAVA robotic surgical system to commence clinical trials at various sites across the United States. This approval marks a significant step…
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J&J’s Nipocalimab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease
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US-based pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its investigational drug nipocalimab. The designation is for the treatment of moderate-to-severe Sjögren’s disease (SjD), a chronic autoantibody disease with a high…
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J&J Submits Regulatory Filings for Darzalex Faspro and Subcutaneous Daratumumab
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Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of regulatory filings for its therapies Darzalex Faspro (daratumumab and hyaluronidase-fihj) to the US Food and Drug Administration (FDA) and for the subcutaneous (SC) formulation of Darzalex (daratumumab) to the European Medicine Agency (EMA). The company is seeking new indication…
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Johnson & Johnson MedTech’s Varipulse Platform Receives FDA Approval for Atrial Fibrillation Treatment
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Johnson & Johnson MedTech (J&J, NYSE: JNJ) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Varipulse platform, marking a significant advancement in the treatment of drug refractory paroxysmal atrial fibrillation (AFib). The Varipulse platform is the company’s first pulsed field…
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Huadong Medicine Co., Ltd Receives NMPA Approval for Stelara Biosimilar SaiLeXin
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab), named SaiLeXin. This development marks a significant step forward…
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J&J MedTech Completes Pilot Enrollment for OMNY-AF Study on Atrial Fibrillation Treatment
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US major Johnson & Johnson (J&J, NYSE: JNJ) MedTech has announced the completion of pilot phase enrollment for the OMNY-AF study, which is assessing the effect of its OMNY-AF platform in symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia. The single-arm, multi-center study aims to enroll up…
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Johnson & Johnson’s Akeega Approved in China as First Dual Action Tablet for mCRPC
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Johnson & Johnson (J&J, NYSE: JNJ), a leading US pharmaceutical company, has announced that China’s National Medical Products Administration (NMPA) has granted indication approval for Akeega (niraparib and abiraterone acetate), to be taken with prednisone or prednisolone, for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2…
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Johnson & Johnson’s Nipocalimab Shows Promise in Treating Adolescent Myasthenia Gravis in Phase II/III Trial
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Johnson & Johnson (J&J, NYSE: JNJ), a US pharmaceutical giant, has reported encouraging outcomes from its Phase II/III clinical trial, Vibrance-MG, which evaluated the efficacy of nipocalimab in treating adolescents with generalized myasthenia gravis (gMG) who tested positive for anti-AChR antibodies. The study successfully achieved its primary and secondary endpoints,…
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J&J Reports Q3 2024 Revenue Growth, Raises Full-Year Guidance on Strong Pipeline Progress
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Johnson & Johnson (J&J, NYSE: JNJ) has released its financial report for the third quarter of 2024, announcing revenues of USD 22.47 billion for the period, marking a 5.2% increase year-on-year in constant currency terms. This growth was comprised of USD 4.58 billion in innovative medicine sales, which expanded by…
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Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
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Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
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Johnson & Johnson’s KLK2-CD3 Bispecific Antibody JNJ-78278343 Advances in Prostate Cancer Clinical Trials
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JNJ-78278343, a KLK2-CD3 bispecific antibody, is currently in Phase I clinical trials globally. According to data released by Johnson & Johnson (J&J, NYSE: JNJ), this drug targets kallikrein-related peptidase 2 (KLK2), an antigen highly expressed in prostate cancer, and binds to CD3 on T cells to activate them, inducing an…
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Johnson & Johnson’s Darzalex Combo Therapy Gets EMA Nod for Multiple Myeloma, Aims to Set New Standard
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Johnson & Johnson (NYSE: JNJ) has taken a significant step in expanding its oncology portfolio with a market filing to the European Medicines Agency (EMA) for its drug Darzalex (daratumumab). The application seeks an indication extension for the subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, lenalidomide, and dexamethasone…
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J&J’s Carvykti Shows 45% Reduced Risk of Death in Multiple Myeloma Patients, Landmark Trial Data Reveals
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Johnson & Johnson (J&J, NYSE: JNJ), a U.S.-based healthcare conglomerate, has released new clinical trial data for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel). The data reveals long-term overall survival (OS) for the therapy’s use as a second-line treatment for multiple myeloma (MM). The three-year…
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Johnson & Johnson Reportedly Winding Down Cardiovascular and Metabolic Pharma Unit
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Johnson & Johnson (J&J; NYSE: JNJ), a healthcare giant in the U.S., is reportedly winding down its cardiovascular and metabolic pharmaceutical unit, as reported by Endpoints News. Insiders have indicated that J&J has issued notices to its sales, marketing, and medical affairs teams this week. The company has acknowledged the…
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Janssen and Yuhan Halt Development of Next-Gen EGFR Inhibitor for NSCLC
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Yuhan, a South Korean pharmaceutical company, and its partner Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (J&J; NYSE: JNJ), have reportedly decided to halt the development of a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for non-small cell lung cancer (NSCLC). This strategic…
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J&J’s Rybrevant Secures FDA Approval for EGFR/c-MET Non-Small Cell Lung Cancer Treatment
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Johnson & Johnson (J&J; NYSE: JNJ)has announced that the US Food and Drug Administration (FDA) has granted approval for its EGFR/c-MET bispecific antibody, Rybrevant (amivantamab-vmjw), in combination with standard chemotherapy, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor…
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Johnson & Johnson’s Tremfya Gains FDA Approval for Ulcerative Colitis Treatment
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Johnson & Johnson (NYSE: JNJ) announced today that the US Food and Drug Administration (FDA) has granted approval for Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). With this approval, Tremfya stands out as the sole fully-human, dual-acting monoclonal antibody that not only…
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Johnson & Johnson Submits Second NDA for Nipocalimab to Treat Generalized Myasthenia Gravis
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Johnson & Johnson (NYSE: JNJ), a leading healthcare company based in the U.S., has reported a second New Drug Application (NDA) filing for its FcRn blocker, nipocalimab. The company has submitted the application to the European Medicines Agency (EMA) for the treatment of adults with generalized myasthenia gravis (gMG) who…
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Biocon Biologics Resolves Patent Dispute with J&J, Secures Market Entry for Biosimilar Stelara
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Biocon Biologics Ltd, the biosimilars division of Indian pharmaceutical company Biocon Ltd (BOM: 532523, NSE: BIOCON), has announced the signing of a comprehensive settlement and licensing agreement with Janssen Biotech Inc. and its parent company, Johnson & Johnson (J&J; NYSE: JNJ). This agreement resolves a patent dispute over Bmab 1200,…
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J&J Files NDA for FcRn Blocker Nipocalimab, Targets Myasthenia Gravis Market
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US-based Johnson & Johnson (NYSE: JNJ) has made a global first New Drug Application (NDA) filing with the US FDA for its FcRn blocker nipocalimab. The drug’s initial indication is anticipated to be for the treatment of adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies. This…
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Johnson & Johnson China’s Cardiovascular and Professional Solutions Division Head, Kevin Chen, Resigns for New Opportunities
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Johnson & Johnson (J&J, NYSE: JNJ), a leading US multinational conglomerate, has announced the resignation of Kevin Chen from his role as General Manager and Head of External Affairs and Market Access for the Cardiovascular and Professional Solutions division of J&J MedTech in China. Chen is pursuing “external development opportunities,”…
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J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
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Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United States for the combined use of its bispecific antibody Rybrevant (amivantamab) and the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). Following a priority review, the US FDA approved this dual therapy for the first-line treatment of…
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Johnson & Johnson to Acquire Israeli Cardiovascular Device Maker V-Wave for Upfront USD 600 Million
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Johnson & Johnson (NYSE: JNJ), a multinational healthcare conglomerate based in the US, has announced a definitive agreement to acquire V-Wave Ltd, an innovative Israeli medical device developer. The acquisition includes an initial payment of USD 600 million, with additional potential payments of up to USD 1.1 billion tied to…
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Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
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NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone with the US FDA’s approval of its bispecific antibody Rybrevant (amivantamab) in combination with the tyrosine kinase inhibitor (TKI) Lazclude (lazertinib). The priority review has led to a green light for the combined use of…
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Johnson & Johnson to Acquire Israel’s V-Wave Ltd. in a Deal Valued Up to $1.7 Billion
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NEW YORK—Johnson & Johnson (NYSE: JNJ), a multinational healthcare giant based in the US, has announced a definitive agreement to acquire V-Wave Ltd., an innovative Israeli medical device company. The acquisition is set to bolster J&J’s MedTech segment with an upfront payment of USD 600 million and potential milestone-based payments…
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Johnson & Johnson Pursues FDA Approval for Spravato as Monotherapy for Treatment-Resistant Depression
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Johnson & Johnson (J&J, NYSE: JNJ), a leading global healthcare company, is pursuing expanded approval for its anti-depression drug Spravato (esketamine) in the U.S. by submitting a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). The application seeks to establish Spravato CIII nasal spray as…
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Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA
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Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson’s (J&J, NYSE: JNJ) Stelara (ustekinumab), an auto-immune disease…
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J&J Halts Development of Epilepsy Therapy ADX71149 After Phase II Trial Failure
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Johnson & Johnson (J&J; NYSE: JNJ), a US-based multinational medical devices, pharmaceutical, and consumer packaged goods manufacturing company, has reportedly discontinued the development of its pipeline epilepsy therapy ADX71149, according to the company’s latest Q2 2024 financials report and information from FiercePharma.com. ADX71149, a positive allosteric modulator (PAM) of metabotropic…
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Johnson & Johnson Reports Robust Q2 2024 Earnings, Bolstered by Pharma and Medtech Growth
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Johnson & Johnson (NYSE: JNJ) has reported its financial results for the second quarter of 2024, with global sales reaching USD 22.4 billion, reflecting a strong operational growth of 6.6% year-on-year, excluding currency impacts. When adjusting for COVID-19 sales, this growth rises to 7.2%. The company’s innovative medicine segment contributed…
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Johnson & Johnson Appoints Edward Zhou as Medtech China President
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Johnson & Johnson (J&J, NYSE: JNJ), a global healthcare giant, has announced the appointment of Edward Zhou as President of its Medtech division in China, effective from July 25, 2024. Zhou will report to Vishnu Karla, Chairman of Johnson & Johnson Medtech Asia Pacific. This strategic appointment comes at a…
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Johnson & Johnson’s Opsumit Faces Generic Competition with Qilu Pharmaceutical’s Entry
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Johnson & Johnson (J&J, NYSE: JNJ)’s pulmonary hypertension treatment, Opsumit (macitentan), is set to encounter intensified competition in China following the approval of a generic version by local pharmaceutical company Qilu Pharmaceutical last month. Macitentan, classified as an endothelin receptor antagonist (ERA), initially received marketing approval in the US in…
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J&J’s Rybrevant Earns First-Line NSCLC Approval in Canada, a Milestone for EGFR Exon 20 Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that Rybrevant (amivantamab) has received its first market approval in Canada. The drug is approved as a first-line treatment in combination with chemotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating epidermal growth factor receptor (EGFR) Exon…
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Johnson & Johnson’s Talvey Gets Green Light in South Korea for Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that its subsidiary Janssen Korea has received approval in South Korea for Talvey (talequetamab), a treatment for multiple myeloma (MM). The drug is indicated for monotherapy in adult patients with relapsed/refractory MM who have received at least three prior therapies, including proteasome…
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Johnson & Johnson Achieves Positive Phase III Results for Nipocalimab in Generalized Myasthenia Gravis
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Johnson & Johnson (J&J, NYSE: JNJ), a leading US-based healthcare company, has announced positive results from the Phase III trial for nipocalimab, a potential first-in-class anti-FcRn (neonatal Fc receptor) antibody, for the treatment of generalized myasthenia gravis (gMG). The company has achieved its primary endpoint and is preparing for regulatory…
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GenScript Biotech Receives Over USD 410 Million in Milestone Payments for CAR-T Therapy from Janssen Biotech
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GenScript Biotech Corporation (HKG: 1548), a Contract Research Organization (CRO) based in China, has announced that it has received a total of USD 410 million in milestone payments from Janssen Biotech, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ). These payments are part of a licensing agreement with its…
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J&J Halts Mid-Stage Trial for Tremfya in Giant Cell Arteritis Due to Efficacy Concerns
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S.-based healthcare company, has reportedly discontinued a mid-stage trial for its autoimmune drug Tremfya (guselkumab) in the treatment of giant cell arteritis, according to a report from BioSpace. An emailed statement from J&J cited “insufficient efficacy findings” as the reason for this…
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J&J’s Tecvayli Earns NMPA Approval for Relapsed or Refractory Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S. healthcare company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Tecvayli (teclistamab) for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have received three or…
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Xencor Reclaims Rights to Plamotamab After Janssen Halts Development
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Xencor Inc. (NASDAQ: XNCR), a U.S.-based biotechnology company, has announced that Johnson & Johnson (J&J, NYSE: JNJ)’s Janssen Biotech Inc. has opted not to proceed with the development of the bispecific T-cell engager plamotamab. As a result, Xencor regains exclusive global rights to the molecule, a CD20 x CD3 bispecific…
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Johnson & Johnson to Acquire Biotechnology Firm Yellow Jersey for $1.25 Billion
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare conglomerate, has entered into a definitive agreement with RTW Biotech Opportunities, a U.S. investment fund, for the acquisition of biotechnology firm Yellow Jersey. Yellow Jersey, a subsidiary of Swiss-based Numab, was previously acquired by RTW in 2021. The cash transaction, valued…
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J&J Loses US Court Case Over Asbestos in Cosmetic Products; Ordered to Pay $260 Million
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Johnson & Johnson (J&J; NYSE: JNJ) suffered a defeat in a US court this week, where a 49-year-old mesothelioma patient claimed that the company’s cosmetic products were the cause of her illness. The plaintiff alleged that J&J was aware of the presence of asbestos, a known cause of mesothelioma, in…
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J&J’s Tecvayli Shows Promising Response Rates in Multiple Myeloma Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has reported updates from a Phase I/II clinical trial for its bispecific antibody (BsAb) Tecvayli (teclistamab) in patients with relapsed or refractory multiple myeloma (r/rMM) who have received three or more prior lines of treatment. With a median follow-up of 30.4 months, the trial…
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Johnson & Johnson to Acquire Atopic Dermatitis Therapy NM26 in $1.25 Billion Deal
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare giant, has entered into a definitive agreement to acquire global rights to NM26, a first-in-class bispecific antibody (BsAb) for the treatment of atopic dermatitis (AD), from Switzerland-based Numab Therapeutics. The transaction, valued at $1.25 billion in cash, is anticipated to conclude…
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J&J’s Tremfya Meets Primary Endpoints in Phase III Crohn’s Disease Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that a Phase III trial for its dual-acting biologic Tremfya (guselkumab) has successfully met its composite co-primary endpoints in patients with moderately to severely active Crohn’s disease (CD) when compared to placebo. The study also demonstrated that the IL-23-focused subcutaneous maintenance therapy…
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Pharmaron to Sell Proteologix Stake in Upcoming Johnson & Johnson Acquisition
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Pharmaron Beijing Co., Ltd, a leading Contract Research Organization (CRO) based in Beijing (HKG: 3759; SHE: 300759), has announced the sale of its 10.21% stake in Proteologix, a US-based specialist in immune-mediated diseases. The acquisition of Proteologix is set to be completed by healthcare giant Johnson & Johnson (J&J; NYSE:…
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J&J Acquires Immune-Mediated Diseases Specialist Proteologix in a Deal Worth Up to USD 850 Million
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare giant, has announced a deal to acquire Proteologix, a US-based specialist in immune-mediated diseases, for a base purchase price of USD 850 million with additional potential milestone payments. The transaction is anticipated to be finalized by mid-2024. Proteologix is known for…
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J&J’s Erleada Plus ADT Shows 0% Biochemical Recurrence Rate in High-Risk Prostate Cancer Trial
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Phase II clinical trial for the androgen receptor inhibitor Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), successfully met its primary endpoint of biochemical recurrence (BCR) in patients with high-risk localized prostate cancer (HRLPC) following radical prostatectomy (RP). The…
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U.S. Judge Dismisses Johnson & Johnson and Bristol-Myers Squibb Lawsuits Against Drug-Pricing Provisions in Inflation Reduction Act
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In a recent legal development, a U.S. federal court judge has rejected the legal challenges brought by pharmaceutical giants Johnson & Johnson (J&J; NYSE: JNJ) and Bristol-Myers Squibb (BMS; NYSE: BMY) against the drug-price negotiations outlined in President Joe Biden’s Inflation Reduction Act (IRA). The companies had filed separate lawsuits…
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Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
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Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis,…
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J&J’s Medical Technology Sector Rises 6.3% YOY Despite China’s VBP Impact
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Johnson & Johnson (J&J; NYSE: JNJ) has reported its financial results for the first quarter of 2024, announcing global sales of USD 21.4 billion, marking a 3.9% year-on-year (YOY) increase in operational terms. Both business segments performed well, with innovative medicines seeing a 2.5% YOY rise to USD 13.6 billion.…
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Johnson & Johnson’s Xarelto Demonstrates Reduced Bleeding Risk in Atrial Fibrillation Patients Post-PCI
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Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has announced positive results from a Phase III trial, highlighting the efficacy of its anticoagulant Xarelto (rivaroxaban) in reducing the risk of clinically significant bleeding (CSB) and net adverse clinical events (NACE) or rehospitalization in adult patients with nonvalvular atrial fibrillation (AF)…
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Johnson & Johnson Acquires Shockwave Medical in a Landmark Deal to Expand Cardiovascular Portfolio
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Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has announced the acquisition of Shockwave Medical (NASDAQ: SWAV), a specialist in cardiovascular diseases, in a deal valued at approximately USD 13.1 billion. The acquisition, which is expected to close by mid-year 2024, will bring Shockwave’s innovative technologies into J&J’s medical technology…
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J&J’s Nipocalimab Fast-Tracked by FDA for Reducing FNAIT Risk in Pregnant Adults
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The US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (J&J; NYSE: JNJ) FcRn blocker nipocalimab into its fast-track program for development as a therapy to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults. This move comes after the drug was classified as…
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Johnson & Johnson MedTech Launches CPX4 PLUS Tissue Expander for Breast Reconstruction in China
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Johnson & Johnson (J&J, NYSE: JNJ) MedTech, a leading healthcare conglomerate in the US, has announced the official market launch of its CPX4 PLUS tissue expander in China. This marks the introduction of the first breast tissue-specific expander in the country, designed to benefit a greater number of breast cancer…
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Abiomed Recalls Over 66,000 Impella Heart Pumps Due to Serious Injury Risk, FDA Classifies as Class I Event
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Johnson & Johnson (J&J, NYSE: JNJ), already embroiled in lawsuits over alleged cancer risks associated with its talcum powder products, faces a new product safety scandal. The company’s medical device subsidiary, Abiomed, has initiated a recall of over 66,000 Impella left-sided heart pumps due to a risk of heart perforation…
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Boehringer Ingelheim, J&J, and Novo Holdings Invest in Asgard Therapeutics for Cancer Immunotherapy
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Germany’s Boehringer Ingelheim (BI), US-based Johnson & Johnson (J&J; NYSE: JNJ), and Denmark’s major Novo Nordisk’s controlling shareholder, Novo Holdings, have participated in a EUR 30 million (USD 32.6 million) Series A financing round for Sweden-based Asgard Therapeutics. Asgard Therapeutics specializes in in in vivo cell reprogramming for cancer immunotherapy,…
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EMA Reviews J&J’s Darzalex Subcutaneous Formulation for Newly Diagnosed Multiple Myeloma
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The European Medicines Agency (EMA) has this week received an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for a subcutaneous formulation of its anti-CD38 drug Darzalex (daratumumab). The filing seeks approval for the combination therapy with bortezomib, lenalidomide, and dexamethasone as a treatment for newly diagnosed multiple…
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J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
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The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb)…
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Celltrion’s Infliximab Biosimilar Shows Promising Long-Term Efficacy and Safety in CD and UC
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South Korean biopharmaceutical company Celltrion (KRX: 068270) has presented positive long-term efficacy and safety data for its infliximab biosimilar in the treatment of Crohn’s disease (CD) and ulcerative colitis (UC). The biosimilar offers the advantage of subcutaneous administration, providing a more convenient alternative to Johnson & Johnson’s (J&J; NYSE: JNJ)…
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FDA Authorizes Biweekly Dosing for J&J’s Tecvayli in Multiple Myeloma Treatment
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The US Food and Drug Administration (FDA) has granted authorization for a biweekly dosing regimen of Johnson & Johnson’s (J&J; NYSE: JNJ) bispecific T-cell engager (BiTE) Tecvayli (teclistamab). Tecvayli received accelerated approval in 2022 for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have undergone at…
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J&J’s Gene Therapy for X-linked Retinitis Pigmentosa Receives CDE Nod for Breakthrough Designation
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s AAV5-hRKp.RPGR (JNJ-5340, botaretigene sparoparvovec) intraocular injectable solution is on track to receive breakthrough therapy designation (BTD). This product, an adeno-associated virus vector (AAV) based gene therapy co-developed with MeiraGTx Holdings plc, is aimed at…
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Johnson & Johnson’s Talquetamab and Daiichi Sankyo’s Enhertu Eye Priority Review in China
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J, NYSE: JNJ)’s Talvey (talquetamab) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) are on track to receive priority review statuses. Talquetamab, a bispecific GPRC5D-directed CD3 T-cell engager, is in development for the treatment of adult patients with recurrent/refractory…
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Johnson & Johnson’s Kenvue Partners with Tencent for Integrated Health Services in China
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Johnson & Johnson (J&J, NYSE: JNJ)’s consumer health spinoff Kenvue and its Chinese partner Tencent have announced an updated strategic partnership aimed at accelerating digital transformation in the healthcare sector. The collaboration will focus on the joint development of integrated online and offline health education and service solutions for patients…
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Johnson & Johnson’s Rybrevant and Lazertinib Filings Accepted for Review by CDE
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The Center for Drug Evaluation (CDE) has confirmed that Johnson & Johnson’s (J&J, NYSE: JNJ) market filings for Rybrevant (amivantamab) and lazertinib, designated as JXSS2400004 and JXHS2400009 respectively, have been accepted for review. Amivantamab-vmjw, a bispecific antibody targeting EGFR and MET, received its initial approval in May 2021 for the…
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J&J Reports Q4 and Full-Year 2023 Results with Strong MedTech and Pharmaceutical Growth
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Johnson & Johnson (J&J; NYSE: JNJ), a US major, has released its financial results for the fourth quarter and full year of 2023. Fourth-quarter global sales increased by 7.2% excluding currency impacts to USD 21.4 billion, while full-year revenues rose by 7.4% year-on-year (YOY) to USD 85.16 billion. Both the…
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J&J’s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. Balversa is indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 mutations in patients who…
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Cytokinetics Attracts Big Pharma Interest Amid Aficamten’s Phase III Success
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Cytokinetics (NASDAQ: CYTK), a specialist in cardiovascular diseases, is reportedly attracting interest from multiple Big Pharma companies keen on its promising pipeline in cardiovascular and neuromuscular diseases. Sources indicate that Novartis (NYSE: NVS) was initially leading the charge against competitors AstraZeneca (AZ, NASDAQ: AZN) and Johnson & Johnson (J&J, NYSE:…
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International Society for Cell & Gene Therapy Comments on FDA’s CAR-T Investigation
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The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the US Food & Drug Administration’s (FDA) investigation into a potential link between T-cell malignancies and CAR-T cell therapies. The FDA launched the inquiry in November following 20 reported cases of patients developing these malignancies after…
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Johnson & Johnson to Acquire Ambrx Biopharma in a Deal Valued at USD 2 Billion
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Johnson & Johnson (J&J; NYSE: JNJ), a global healthcare conglomerate, has announced its intention to acquire Ambrx Biopharma (NASDAQ: AMAM), a U.S.-based developer of antibody drug conjugates (ADCs). The deal is valued at approximately USD 2 billion in equity and carries a net cash requirement of USD 1.9 billion, with…
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J&J Shareholders Cleared to Sue Over Hidden Asbestos Risks in Talc Products
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A US federal court has granted permission for certain Johnson & Johnson (J&J; NYSE: JNJ) shareholders to initiate a class action lawsuit against the company for allegedly concealing the presence of oncogenic asbestos in its talc products. The decision, which impacts stock price events between 2017 and 2018, covers stockholders…
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Janssen Acquires Rights to Gene Therapy Botaretigene Sparoparvovec from MeiraGTx for XLRP Treatment
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Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), announced last week its acquisition of development, manufacturing, and commercialization rights for the gene therapy botaretigene sparoparvovec from MeiraGTx Holdings (NASDAQ: MGTX) for the treatment of X-linked retinitis pigmentosa (XLRP). Janssen will pay an upfront fee of USD 65…
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J&J’s Janssen Secures Exclusive Global Rights to Develop LCB84 ADC from LegoChem Biosciences
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Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical subsidiary, Janssen, has entered into an exclusive global agreement with South Korean-based LegoChem Biosciences (LCB; KOSDAQ: 141080) to develop and commercialize the antibody drug conjugate (ADC) LCB84. Under the terms of the agreement, LCB is set to receive $100 million in upfront payments…
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J&J’s Rybrevant-Lazertinib Combo Accepted for FDA Review in NSCLC
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The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J; NYSE: JNJ) application for Rybrevant (amivantamab), a bispecific antibody, in combination with lazertinib, a tyrosine kinase inhibitor (TKI), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon…
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AbelZeta Pharma Expands Janssen Partnership to Include Commercial Rights in China
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AbelZeta Pharma Inc., a Sino-US biotechnology company with operations in Rockville, Maryland, and Shanghai, China, has announced an updated global collaboration and licensing agreement with Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ). According to the revised agreement, Janssen will now secure commercialization rights to CAR-T therapies C-CAR039…
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J&J’s Carvykti Demonstrates Extended Time to Symptom Worsening in Multiple Myeloma Patients
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Johnson & Johnson (J&J; NYSE: JNJ) has released data from a Phase III study showing that its CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel), extended the median time until symptom worsening to 23.7 months in patients with relapsed and lenalidomide-refractory multiple myeloma (MM) after one to three prior lines of therapy,…
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Sanofi Eyes Blockbuster Potential with 12 Pipeline Assets, Projects EUR 10 Billion in Annual Sales by 2030
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Sanofi (NASDAQ: SNY) this week outlined its growth potential for the 2024 to 2025 period, highlighting a pipeline of 12 assets poised to achieve blockbuster status, including three projected to exceed EUR 5 billion in sales. The French pharmaceutical giant anticipates generating over EUR 10 billion in annual pharmaceutical revenues…
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J&J Forecasts 5-7% CAGR Through 2030, Driven by Innovative Medicine and Device Growth
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Johnson & Johnson (J&J; NYSE: JNJ) has presented an update on its business strategy, pipeline, and financial outlook amidst the loss of exclusivity for its blockbuster immunosuppressant Stelara (ustekinumab) in the US. The company anticipates operational sales growth of 5% to 6% in 2024 and 3% or more in 2025,…
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Johnson & Johnson Acquires Laminar for $400 Million to Enhance Heart Rhythm Solutions
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Johnson & Johnson (J&J; NYSE: JNJ) has finalized the acquisition of medical device manufacturer Laminar for $400 million, along with potential milestone payments, integrating the company into its MedTech subsidiary, specifically within Biosense Webster, a division focused on heart rhythm disorders. Laminar’s innovative technology employs rotational motion to eliminate the…
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CAR T-Cell Therapy Stocks Plunge as FDA Investigates Cancer Reports Linked to Treatments
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Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023, following an announcement from the U.S. FDA regarding an investigation into reports of patients developing cancer as a potential side effect of their treatments. The FDA’s notice highlighted that both clinical trials and post-market surveillance…
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Janssen Submits Indication Extension Application to FDA for Rybrevant in NSCLC Treatment
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has filed an indication extension application with the US Food and Drug Administration (FDA) for its bispecific antibody Rybrevant (amivantamab) in combination with chemotherapy. The treatment is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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Janssen Presents Real-World Data on Tremfya’s Efficacy in Treatment-Resistant Psoriatic Arthritis
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Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical unit, Janssen, has presented real-world efficacy data for Tremfya (guselkumab), an IL-23p19-subunit inhibitor, in the treatment of treatment-resistant active psoriatic arthritis (PsA). The data provides valuable insights into the drug’s performance in alleviating pain, improving physical function, and reducing fatigue in patients with…
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CIIE 2023: Danaher, Boehringer-Ingelheim, Merck, J&J, BeiGene, and Fosun Pharma Announce China Partnerships
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The 6th China International Import Expo (CIIE) held in Shanghai this week has been a platform for multiple companies to announce their strategic partnerships in China. Among the notable participants are Danaher (NYSE: DHR), Boehringer-Ingelheim (BI), Merck Sharp & Dohme (MSD, NYSE: MRK), Johnson & Johnson (J&J, NYSE: JNJ), BeiGene…
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Janssen’s Nipocalimab Shows Promising Results in Phase II Rheumatoid Arthritis Trial
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced the results of a Phase II trial for nipocalimab, a potential best-in-class anti-neonatal Fc (FcRn) biologic, in patients with moderate-to-severe active rheumatoid arthritis (RA) who have anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and are unresponsive to…
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GSK’s ViiV Healthcare Secures NMPA Approval for Vocabria in HIV-1 Treatment
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UK pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that its HIV joint venture, ViiV Healthcare, has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir injection). The drug is approved for use in combination with Johnson & Johnson/Janssen Pharmaceutical’s (J&J, NYSE: JNJ) Rekambys (rilpivirine long-acting injection)…
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J&J MedTech Partners with CED Medical for Neurointerventional Solutions
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Johnson & Johnson MedTech’s (J&J, NYSE: JNJ) Shanghai-based subsidiary, Johnson Johnson Medical Equipment Co., Ltd, has entered into a strategic partnership with CED Medical, a neuroscience device marker headquartered in Nantong, near Shanghai. The collaboration aims to expand market reach, promote technology, and foster innovation in the field of neurointerventional…
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Janssen’s TAR-200 Shows High Complete Response Rate in Bladder Cancer Study
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has published data from a Phase IIb study demonstrating the efficacy of its intravesical gemcitabine delivery system, TAR-200, in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) carcinoma in situ-positive. The study results are a significant step forward in the…
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J&J Reports Strong Q3 2023 Sales Growth Amid Diverse Business Performance
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Johnson & Johnson (J&J; NYSE: JNJ) has released its Q3 2023 report, revealing impressive global sales of USD 63.7 billion for the first nine months of the year. This marks a 7.5% year-on-year (YOY) expansion in operational terms, reflecting robust performance across both of the company’s main business segments. Segment…
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J&J’s Cetrelimab and TAR-200 Gain Tacit Approvals for Bladder Cancer Trials
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The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J; NYSE: JNJ) has received two tacit clinical trial approvals for its Category 1 drug cetrelimab combined with TAR-200. The approvals are for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) patients not receiving BCG treatment, and…
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Janssen Unveils Promising Clinical Data on IL-23 Blockers for Psoriasis
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) is showcasing new clinical data this week from trials assessing the efficacy of IL-23 blockers, Tremfya (guselkumab) and JNJ-2113, in the treatment of psoriasis. The findings, derived from a late-stage study, reveal that Tremfya facilitated clear skin within 28 weeks…
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J&J’s Janssen Reports Favorable Spravato Data in Late-Stage TRD Trial
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Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, has presented tolerability and efficacy data from a late-stage trial comparing its antidepressant Spravato (esketamine nasal spray) with oral quetiapine in the treatment of treatment-resistant major depressive disorder (TRD). The trial evaluated both drugs in combination with serotonin reuptake inhibitors (SRIs). Trial…
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Janssen and Sanofi Partner for Development of First-in-Class E. coli Vaccine
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has entered into a strategic partnership with Sanofi (NASDAQ: SNY) to develop and commercialize a groundbreaking 9-valent vaccine targeting extraintestinal pathogenic Escherichia coli (ExPEC). Currently in late-stage trials, this vaccine aims to prevent invasive E. coli disease (IED) in adults…
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J&J and HHS Expand Public Health Initiative with Asha Therapeutics
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Johnson & Johnson (J&J; NYSE: JNJ) and the US Department of Health and Human Services (HHS) have welcomed biopharmaceutical company Asha Therapeutics into their joint initiative focused on public health preparedness. This collaboration aims to leverage Asha’s proprietary drug discovery platform, which is capable of designing candidates for a wide…
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South Africa’s Competition Commission Investigates J&J for MDR-TB Drug Pricing and Evergreening
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The Competition Commission of South Africa has announced an investigation into Johnson & Johnson (J&J; NYSE: JNJ) concerning allegations of profiteering on the multidrug-resistant tuberculosis (MDR-TB) drug Sirturo (bedaquiline) and employing evergreening practices to extend its patent until 2027. Investigation Details and Pricing ConcernsThe government currently pays ZAR 5,400 (USD…
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J&J Rebrands Pharmaceutical and MedTech Segments Post-Kenvue Separation
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Following the completion of its consumer healthcare unit separation as Kenvue (NYSE: KVUE) last month, Johnson & Johnson (J&J; NYSE: JNJ) has announced the rebranding of its innovative medicine and medical technology branches. The company will gradually rename its pharmaceutical segment, Janssen, to Johnson & Johnson Innovative Medicine, while its…
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AbbVie’s Skyrizi Outperforms Janssen’s Stelara in Phase III Crohn’s Disease Trial
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AbbVie (NYSE: ABBV) has announced early data from a Phase III trial that compared the IL-23 inhibitor Skyrizi (risankizumab) with Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen’s Stelara (ustekinumab) in patients with moderate-to-severe Crohn’s disease (CD) unresponsive to anti-TNF therapy. The blinded efficacy assessment revealed that Skyrizi achieved clinical…
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Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing Phase Ib/II study cohort assessing the safety and pharmacokinetics of the bispecific antibody (BsAb) Rybrevant (amivantamab) in combination with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy for the treatment of relapsed/refractory EGFR-mutated non-small cell lung…
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Sandoz Inks Deal with Samsung Bioepis for Ustekinumab Biosimilar SB17
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The Sandoz (SWX: SDZ) unit of Switzerland-based Novartis (NYSE: NVS) has announced the in-licensing of ustekinumab biosimilar SB17 from South Korea’s Samsung Bioepis. The agreement covers the markets of Canada, the European Economic Area (EEA), Switzerland, UK, and the US. The biosimilar references Johnson & Johnson (J&J; NYSE: JNJ) subsidiary…
