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Johnson & Johnson’s Tremfya Gains FDA Approval for Crohn’s Disease Treatment
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US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced receiving clearance from the US Food and Drug Administration (FDA) to market its Tremfya (guselkumab) as a treatment for moderately to severely active Crohn’s disease (CD). This IL-23 inhibitor now offers both subcutaneous (SC) and intravenous (IV) induction options…
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Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sjögren’s Disease
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US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sjögren’s disease (SjD). This designation follows the monoclonal antibody’s Breakthrough Therapy Designation (BTD) received from the agency late last year. Mechanism…
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Bio-Thera Solutions’ BAT2506 Biosimilar Accepted for Review by China’s NMPA
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that a market filing for its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in the development and commercialization of this anti-TNF alpha…
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Legend Biotech Reports Strong Q4 and Full Year 2024 Financial Results
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China-based Legend Biotech Corporation (NASDAQ: LEGN) released its Q4 and full-year 2024 financial results, highlighting significant revenue growth. In Q4, the company reported revenues of USD187 million, marking a 134.7% year-on-year increase. For the entire year, revenues surged by 120.0% to USD627 million. Carvykti’s Impact on RevenueThe BCMA-directed chimeric antigen…
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Genmab’s HexaBody-CD38 Clinical Development Halted After J&J Opt-Out
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Denmark-based Genmab A/S (NASDAQ: GMAB) announced that US giant Johnson & Johnson (J&J, NYSE: JNJ) has decided not to exercise its option to obtain a worldwide license for the development, manufacturing, and commercialization of HexaBody-CD38 (GEN3014). Consequently, clinical development of the drug will be terminated. The decision was based on…
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Johnson & Johnson Officially Launches Spravato in China for Depression Treatment
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US giant Johnson & Johnson (J&J; NYSE: JNJ) officially launched Spravato (esketamine) nasal spray in China to alleviate depressive symptoms in adult depression patients. The announcement comes after a swift approval by China’s National Medical Products Administration (NMPA) in April 2023. Spravato’s novel mechanism and rapid resultsSpravato is the first…
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GE Healthcare’s China CEO Yihao Zhang to Retire, Will Song Named Successor
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US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) announced the retirement of Yihao Zhang, president and CEO of its China operations, effective July 1, 2025. Will Song, a Johnson & Johnson veteran with over 20 years of experience, will join the company on April 1,…
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J&J MedTech Launches Locally Produced HARMONIC 7s Scalpel in China
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Johnson & Johnson MedTech, a US-based healthcare giant, announced the official launch of its HARMONIC 7s ultrasonic scalpel instrument in China, marking a milestone with local production at its Suzhou plant. Product HighlightsThe HARMONIC 7s features an innovative built-in intelligent chip and proprietary next-generation adaptive tissue algorithm (ATT), enabling continuous…
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J&J’s Tremfya Wins NMPA Approval for Crohn’s Disease Treatment
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Johnson & Johnson (J&J, NYSE: JNJ) announced that its Tremfya (guselkumab) has received marketing approval from China’s National Medical Products Administration (NMPA) for treating moderate to severe active Crohn’s disease (CD) in adults who have not responded adequately to traditional therapies or biologics. Drug ProfileTremfya, an interleukin-23 monoclonal antibody, was…
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Sandoz Launches Pyzchiva Biosimilar of J&J’s Stelara in US
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Switzerland-based Sandoz (SWX: SDZ) announced the launch of Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) autoimmune drug Stelara (ustekinumab), in the US. The drug, developed by South Korea’s Samsung Bioepis Co., Ltd., is approved for the same chronic inflammatory disease indications as the originator. Licensing DealSandoz…
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J&J’s Tremfya Meets All Endpoints in Phase III UC Study, Eyes FDA Approval for SC Induction
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U.S. pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) presented positive results from the Phase III ASTRO study of its Tremfya (guselkumab) subcutaneous (SC) induction therapy for adults with moderately to severely active ulcerative colitis (UC) at the 20th Congress of the European Crohn’s and Colitis Organization (ECCO). The data…
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Sanofi and J&J’s E. coli Vaccine Fails Phase III Study
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France-based Sanofi (NASDAQ: SNY) and US giant Johnson & Johnson’s (J&J, NYSE: JNJ) vaccine candidate for extraintestinal pathogenic E. coli failed to meet expectations in a Phase III study. An independent data monitoring committee (IDMC) determined that the vaccine was insufficiently effective at preventing invasive E. coli disease (IED) compared…
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J&J Considers Selling Stroke Care Business Cerenovus for USD1-1.5 Billion
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US giant Johnson & Johnson (J&J, NYSE: JNJ) is reportedly considering selling its stroke care business Cerenovus. According to the Financial Times, the potential deal could be worth between USD1 billion and USD1.5 billion. Background of CerenovusJ&J established Cerenovus as a neurovascular business unit in 2017. This was done through…
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Hengrui Pharma’s BD Head Dr. Chen Dong Departs for AbbVie’s External Innovation Role
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Dr. Chen Dong, Vice President and China Head of BD at Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), has recently departed from the Chinese company. He will now serve as Executive Director of External Innovation at AbbVie. Dr. Chen Dong’s Background and Contributions at HengruiDr. Chen Dong studied at Wuhan…
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Huadong Medicine’s Biosimilar SaiYueXin Seeks NMPA Approval for Crohn’s Disease
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Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin, a biosimilar version of Johnson & Johnson (J&J)’s auto-immune disease drug Stelara (ustekinumab), has been accepted for review by the National Medical Products Administration (NMPA). The Chinese firm is seeking approval for its use in…
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J&J Innovative Medicine China Appoints New General Manager and Oncology VP
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Johnson & Johnson (J&J, NYSE: JNJ) Innovative Medicine China has recently made two major appointments to its leadership team. The company has appointed a new general manager and a new vice president. New General ManagerAs of March 1, 2025, Mr. Chen Jian will take on the role of head of…
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Bio-Thera Solutions Licenses BAT2506 to Intas Pharmaceuticals for US Market
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that it has entered into a licensing agreement with Intas Pharmaceuticals Ltd., granting the Indian firm exclusive commercialization rights to its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), in the United States. Details of the AgreementUnder the terms of the…
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Bio-Thera’s Biosimilars BAT2306 and BAT2506 Accepted for Review by NMPA and EMA
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that the market filings for its biosimilars BAT2306 and BAT2506 have been accepted for review by China’s National Medical Products Administration (NMPA) and the European Medicines Agency (EMA), respectively. BAT2306 is a biosimilar version of Novartis’ (NYSE: NVS) Cosentyx (secukinumab), while BAT2506 is…
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Henlius Biotech Licenses HLX15 to Dr. Reddy’s for US and European Markets
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced a licensing deal with India-headquartered Dr. Reddy’s Laboratories Ltd. (BOM: 500124) for its HLX15, a biosimilar version of Johnson & Johnson’s Darzalex (daratumumab). Under the agreement, Dr. Reddy’s will obtain exclusive commercialization rights to the anti-CD38 monoclonal antibody (mAb), including both intravenous…
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EMA Committee Backs Subcutaneous Rybrevant for Lung Cancer Treatment
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion this week regarding the approval of a subcutaneous (SC) formulation of Johnson & Johnson’s (J&J, NYSE: JNJ) Rybrevant (amivantamab). The recommendation covers the drug’s use in combination with Lazcluze (lazertinib) for…
