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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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Bio-Thera Solutions’ BAT2094 Wins NMPA Nod for Acute Coronary Syndrome Treatment
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug BAT2094 (Betagrin). The drug is indicated for use in patients with acute coronary syndrome who are undergoing percutaneous…
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Takeda’s CEO Weber Eyes Further Partnerships with Chinese Biotechs Amid Innovation Surge
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Takeda Pharmaceutical Co., (TYO: 4502, NYSE: TAK), a leading Japanese pharmaceutical company, is actively seeking potential partnerships with Chinese biotech firms, according to CEO Christophe Weber in a recent Bloomberg interview. Weber highlighted that despite finalizing two recent agreements with Chinese companies, Takeda is still “very open” to further collaborations,…
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Luye Pharma’s Manufacturing Facility Passes FDA Inspection for Paliperidone Palmitate Product
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Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that it has successfully passed the Pre-Approval Inspections (PAI) by the U.S. Food and Drug Administration (FDA) for its manufacturing facility producing paliperidone palmitate extended-release injectable suspension (LY03010). The inspection was completed without any Form 483 Inspectional Observations, indicating…
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Sirnaomics’ STP707 Shows Promising Results in Phase I Pancreatic Cancer Trial
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Sirnaomics Ltd (HKG: 2257), a biopharmaceutical company, has announced the successful completion of a Phase I clinical study for its small interfering RNA (siRNA) drug candidate, STP707, which has shown good safety and preliminary signs of activity in pancreatic cancer. The dose-escalation study was conducted across 11 cancer clinics in…
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Genmab and AbbVie’s Epcoritamab Earns FDA Accelerated Approval for Follicular Lymphoma
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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
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Novo Nordisk Plans Cautious Wegovy Launch in China to Preserve Global Supply
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Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a leading healthcare company, has reportedly planned a cautious market launch for the anti-obesity drug Wegovy (semaglutide) in China following its recent approval. The strategy is aimed at preserving manufacturing capacity and maintaining the stability of global supply chains, according to Maziar Mike Doustdar,…
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Hybio Pharmaceutical Gets FDA Nod for Tirzepatide Raw Materials in DMF Filing
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received a Drug Master File (DMF) First Adequate Letter from the U.S. Food and Drug Administration (FDA) for its tirzepatide raw materials. Tirzepatide, a first-to-market dual GIP/GLP-1 receptor agonist, has been approved in the U.S.…
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Abbisko Therapeutics Presents Positive Phase II Results for HCC Treatment at ESMO-GI
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotech company, has announced the presentation of Phase II study results for its irpagratinib in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) at the 2024 ESMO-GI annual meeting. Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko,…
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Dizal Pharmaceutical’s Golidocitinib Breaks Record with Rapid Market Launch in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has seen its drug golidocitinib go from marketing approval to first prescriptions in a record time of just two days in China. This marks a significant milestone, as golidocitinib is the first and only approved Janus kinase 1…
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HighTide Therapeutics Completes Enrollment for Two Phase III Trials of T2DM Drug Candidate HTD1801
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HighTide Therapeutics Inc., (HKG: 2511), a biopharmaceutical company based in China, has announced the completion of patient enrollment for two Phase III clinical studies of its drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) for the treatment of type 2 diabetes (T2DM). The studies include the multi-center, randomized, double-blind, placebo-controlled SYMPHONY-1, which…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment…
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Harbour BioMed Resubmits Biological License Application for Batoclimab in China
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Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands, and Suzhou, China, has announced the resubmission of a biological license application (BLA) to China’s National Medical Products Administration (NMPA) for its drug candidate batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). Batoclimab…
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Antengene’s Xpovio Included in South Korea’s NHIS Reimbursement Drug List
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that South Korea’s National Health Insurance Service (NHIS) has included its drug Xpovio (selinexor) in the medical insurance reimbursement drug list, effective from July 1, 2024. The drug is indicated for the treatment of adult patients with…
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Bio-Thera Solutions’ BAT1806 Biosimilar Receives European Commission Approval
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received market approval from the European Commission (EC) for BAT1806, a biosimilar version of Roche Holding AG’s (OTCM: RHHBY) Actemra/RoActemra (tocilizumab). BAT1806 is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,…
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Novartis’s Scemblix STAMP Inhibitor for CML Accepted for Review by China’s NMPA
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its market filing for Scemblix (asciminib) accepted for review by China’s National Medical Products Administration (NMPA). Scemblix is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor, which is filed for the treatment of chronic myeloid leukemia (CML). As the world’s…
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Novo Nordisk’s Ocedurenone Misses Primary Endpoint in Chronic Kidney Disease Trial
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Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a Danish pharmaceutical company, has announced that its pipeline candidate ocedurenone has failed in a Phase III trial for chronic kidney disease (CKD). The drug did not meet the primary endpoint in the CLARION-CKD study, leading to the cancellation of its development for CKD.…
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Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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Moderna’s RSV Vaccine Efficacy Wanes to 50% After 18 Months, Shares Slide
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Moderna Inc. (NASDAQ: MRNA), a U.S.-based biopharmaceutical company, has announced long-term efficacy data for its recently approved respiratory syncytial virus (RSV) vaccine, mResvia, showing a decline in effectiveness to approximately 50% after 18 months. This is notably lower than the efficacy rates of RSV vaccines from competitors GSK and Pfizer,…
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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…
