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Gilead to halt Phase 3 study of magrolimab combination in higher-risk MDS
The Phase 3 ENHANCE trial is a randomised, double-blind study that was intended to assess the combination of magrolimab plus azacitidine as first-line treatments for higher-risk MDS
GC Biopharma receives approval for GC FLU quadrivalent vaccine in Egypt
The company intends to further extend its global reach, which has been focused on Southeast Asia and Latin America, to the Middle East and Africa by taking advantage of this EDA approval
EU health regulator supports Pfizer’s Abrysvo vaccine for infants, older adults
EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the approval based on the data from two randomised, placebo-controlled, pivotal trials
Mabwell Announces the NMPA Approval of Novel B7-H3 ADC (7MW3711) for IND
7MW3711 is developed by Mabwell’s next-generation antibody-drug conjugate platform IDDC
ADC Therapeutics Announces Plan to Discontinue the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients
Following a meeting yesterday, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the trial for new patient enrollment but will allow patients already on therapy who are deriving clinical benefit to remain on therapy after being reconsented
Daiichi Sankyo receives FDA approval for Vanflyta to treat FLT3-ITD positive AML
The FDA approval was based on the data from the QuANTUM-First trial in which the Vanflyta combination reduced the risk of death by 22% in comparison to standard chemotherapy alone
Recludix and Sanofi partner to advance STAT6 in multiple I&I indications
The deal will give $125m to Recludix Pharma in near-term payments from the French pharmaceutical firm in addition to a potential $1.2bn in research, regulatory, and sales milestone payments
Thermo Fisher Scientific Introduces New Reproductive Health Assays to Accelerate Fertility Research
Combined with the Ion Torrent Genexus Integrated Sequencer, new assays deliver valuable genomic insights in the field of aneuploidy analysis
Sandoz announces plans to build a Biosimilar Technical Development Center in Slovenia to support future growth of biosimilar pipeline
Planned investment of approximately USD 90 million to build a state-of-the-art Sandoz Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026
Gilead Announces $8m in Grant Funding for Viral Hepatitis Relink Program in the US
Funding Will Support the Re-Engagement of Diagnosed but Untreated People Living with HCV and HBV in the United States into Care