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Hinova Pharmaceuticals’ HP537 Receives CDE Approval for Clinical Study in Hematologic Malignancies
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug HP537, targeting hematologic malignancies. This development marks a significant step for Hinova Pharmaceuticals as…
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Jiangsu Hengrui’s CD79b Targeting ADC SHR-A1912 Earns FDA Fast-Track Designation for R/R DLBCL
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received Fast-Track Designation (FTD) from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC) SHR-A1912, targeting CD79b, in the treatment of recurrent/refractory diffuse large B-cell lymphoma (R/R DLBCL) in…
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Rossum Robot’s Intelligent Surgical Robot for Trauma and Spinal Surgery Clears NMPA Approval
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Rossum Robot, a Beijing-based developer of orthopedic surgical robots specializing in pelvic fracture procedures, has received marketing approval from the National Medical Products Administration (NMPA) for its intelligent small surgical robot designed for trauma and spinal surgery applications. This regulatory clearance marks a significant advancement for Rossum Robot as it…
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AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily…
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Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P receptor modulator Velsipity (etrasimod) as a treatment for patients aged 16 and older with moderately to severely active ulcerative colitis (UC). The approval applies to patients who have had an inadequate response, lost response, or…
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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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AbbVie CEO Rick González to Retire, Succeeded by Robert A. Michael
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AbbVie (NYSE: ABBV), a leading US pharmaceutical company, has announced that Rick González, who has been at the helm since the company’s separation from Abbott (NYSE: ABT) in 2013, will retire from his role as CEO. González will transition to the position of executive chairman of the board of directors,…
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Sinopharm Plans to Privatize China Traditional Medicine Holdings in a USD 2 Billion Deal
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China Traditional Medicine Holdings (HKG: 0570; China TCM) has announced that its controlling shareholder, the state-owned Sinopharm Group Co., Ltd (HKG: 1099), intends to take the company private. The proposed deal values China TCM at a price of HKD 4.6 per share, representing a 34% premium over the recent closing…
