-
Janssen-Cilag Submits for IMBRUVICA Indication Extension in Untreated Mantle Cell Lymphoma
•
Janssen-Cilag International NV has announced the submission seeking approval for an indication extension of IMBRUVICA (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). The extended indication is for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell…
-
XtalPi’s AI Platform XtalFold Secures Licensing Deal with Janssen Biotech, Enhancing Biologics Discovery
•
XtalPi (QuantumPharm, HKG: 2228) a leading AI-driven drug discovery firm based in Shenzhen and known as QuantumPharm Inc. (HKG: 2228), has announced a significant licensing agreement with Janssen Biotech, Inc., a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), for its proprietary AI platform, Ailux Biologics’ XtalFold. This platform, recognized…
-
Xtalpi Inc. Makes a Splash with HKD 1.13 Billion IPO on Hong Kong Stock Exchange
•
XtalPi (QuantumPharm, HKG: 2228) has successfully conducted an initial public offering (IPO) on the Hong Kong Stock Exchange, raising HKD 1.13 billion (USD 144.5 million). The shares of Xtalpi, listed under the ticker symbol 02228, were priced at HKD 6.03 per share. Xtalpi is a pioneer in utilizing quantum physics-based…
-
Janssen’s Rybrevant Combo Meets Primary Endpoint in Advanced NSCLC Study
•
Janssen, a subsidiary of Johnson & Johnson (J&J; NYSE: JNJ), has released an update on a late-stage study for its bispecific antibody (BsAb) Rybrevant (amivantamab). The study investigated the combination of Rybrevant with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy in treating advanced or metastatic non-small cell lung cancer (NSCLC)…
-
HHS Releases List of 10 Drugs for Medicare Price Negotiations Starting 2026
•
The Department of Health and Human Services (HHS) in the US has released a list of the first 10 medicines that will be subject to a novel mechanism for negotiating drug prices under the Medicare health insurance program starting from the 2026 period onwards. The institution plans to publish the…
-
Janssen Submits Indication Extension Application for Balversa in Urothelial Carcinoma Treatment
•
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has submitted an indication extension application to the US Food and Drug Administration (FDA) for its FGFR kinase inhibitor Balversa (erdafitinib). The application seeks to expand the use of Balversa as a treatment for locally advanced or metastatic urothelial carcinoma…
-
Janssen Submits Rybrevant for FDA Review as First-Line NSCLC Treatment
•
Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has submitted an additional indication for review with the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Rybrevant (amivantamab). The submission seeks approval for Rybrevant in combination with carboplatin and pemetrexed as a first-line treatment for locally advanced or…
-
European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
•
The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary, Janssen, for its innovative GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This first-in-class treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have shown disease progression after at least three prior…
-
J&J Subsidiary Janssen Wins FDA Approval for Akeega in BRCA-Positive mCRPC Treatment
•
The US Food & Drug Administration (FDA) has granted marketing approval to Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen for its oral drug Akeega (niraparib + abiraterone) in combination with prednisone. This treatment is designated for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).…
-
Janssen’s Talvey Receives FDA Accelerated Approval for Relapsed/Refractory Multiple Myeloma
•
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) announced last week that it received accelerated approval from the US Food and Drug Administration (FDA) for its first-in-class GPRC5D/CD3 bispecific antibody (BsAb), Talvey (talquetamab). This treatment is designated for adults with relapsed or refractory multiple myeloma (r/rMM) who have…
-
Janssen’s Sirturo (Bedaquiline) Expands Indication to Include Adolescents with MDR-TB
•
The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has announced that the National Medical Products Administration (NMPA) has granted another indication approval for its medication Sirturo (bedaquiline). The product is now approved for the treatment of adolescents aged 12-18 years and weighing ≥30kg with multidrug-resistant pulmonary tuberculosis (MDR-TB),…
-
Biomm Secures Late-Stage Biosimilar Candidate BAT2206 from Bio-Thera Solutions
•
Brazil-based biotechnology company Biomm (BVMF: BIOM3) has announced that it has in-licensed the late-stage biosimilar candidate BAT2206 from China’s Bio-Thera Solutions (SHA: 688177). This biosimilar candidate references Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary Janssen’s immunosuppressant Stelara (ustekinumab). The agreement builds upon a previous licensing and supply deal from 2020…
-
Jiangsu Kanion Pharmaceutical Gets FDA Approval for KYS202002A Clinical Study in Multiple Myeloma
•
China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving the green light from the US Food and Drug Administration (FDA) to conduct a clinical study for its pipeline candidate KYS202002A, focusing on recurrent/refractory multiple myeloma (R/R MM). This follows the molecule’s approval for clinical trials in China in…
-
Cellular Biomedicine Group Inc. and Janssen Biotech, Inc. Announce Global Collaboration for CAR-T Therapies
•
China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG), emerging from a merger deal in February 2021, has announced a significant global collaboration and license agreement with US firm Janssen Biotech, Inc. (Janssen). The partnership is centered on the development and commercialization of C-CAR039, an anti-CD19 and CD20 bi-specific chimeric…
-
Janssen’s Spravato Approved by NMPA for Adult Depression and Suicidal Ideation Treatment
•
Janssen’s Spravato (esketamine) has been granted approval by the National Medical Products Administration (NMPA) in China for the alleviation of depressive symptoms in adult patients with acute suicidal ideation or behavior when used in combination with an oral antidepressant. Spravato: A Novel Antidepressant with Rapid-Onset ActionSpravato marks a significant advancement…
-
Legend Biotech and Janssen Partner with Novartis on Carvykti Manufacturing and Clinical Supply
•
Legend Biotech Corporation (NASDAQ: LEGN), a China-based biotech firm, and its US partner Janssen Pharmaceutical have entered into a significant technology transfer, manufacturing, and clinical supply service agreement with Swiss pharmaceutical giant Novartis (NYSE: NVS). The agreement pertains to the co-developed CAR-T cell therapy, Carvykti (ciltacabtagene autoleucel; cilta-cel), and is…
-
Janssen Withdraws Carvykti from UK Market Amid Manufacturing Concerns
•
US-based Janssen Pharmaceutical reportedly decided to withdraw Carvykti (ciltacabtagene autoleucel; cilta-cel) from the UK market last week. The BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, which is under development globally by Janssen in partnership with China-based Legend Biotech (NASDAQ: LEGN), was being assessed by the UK’s National Institute of…
-
Biocytogen and Janssen Sign Licensing Agreement for RenLite Platform
•
Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced the signing of a non-exclusive licensing agreement with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ). The agreement grants Janssen and its affiliates a non-exclusive worldwide license to use Biocytogen’s proprietary RenLite platform and…
-
Novartis’ LNP023 and Janssen’s Tremfya on Track for Breakthrough Designations
•
The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023 and US giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Tremfya (guselkumab) are on course to obtain breakthrough therapy designations (BTDs). LNP023 is to be awarded BTD status for its use in paroxysmal nocturnal hemoglobinuria…
