02/28/2025 11:21
Delta-Fly Pharma, Inc.: Progress of Development Status of the Combination Study of DFP-10917 with Venetoclax

Following to the previous information on Dec. 9th. in 2024, we are excited to share our latest development status. Regarding the Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (VEN) in patients with acute myeloid leukemia (AML) in second-line therapy (NCT06382168), the Data Management Committee (DMC) has approved the tolerability of all six patients in the Phase I (dose finding) portion of the Phase I/II study, and we are moving to the Phase II portion of the trial for ...

02/28/2025 12:00
SINOVAC Announces New Board Pursuant to Privy Council Judgment and Order

Sinovac Biotech Ltd. (NASDAQ:SVA) ("SINOVAC" or the "Company"), a leading provider of biopharmaceutical products in China, today announced that SINOVAC has received on February 8, 2025 a formal court order (the “Order”) from the Privy Council following the previously announced Privy Council Judgment (the “Judgment”) which ruled, among others, that (i) the slate of nominees proposed by a group of shareholders at the 2018 Annual General Meeting was rightfully elected to the board of directors of ...

02/28/2025 12:22
Vertex Receives CHMP Positive Opinion for Expanded Label for KAFTRIO® in Combination With Ivacaftor for People With Cystic Fibrosis to Include Rare Mutations

Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for the treatment of people with cystic fibrosis (CF) aged 2 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. “We are thrilled by the po...

02/28/2025 13:00
ENHERTU® Recommended for Approval in the EU by CHMP for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following at Least One Endocrine Therapy

Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine ...