Atara Biotherapeutics has received clearance from the US Food and Drug Administration (FDA) to initiate two phase 3 clinical studies with tabelecleucel (formerly known as ATA129) in patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD).
AbbVie says that its investigational oral JAK1-selective inhibitor upadacitinib (ABT-494) has demonstrated positive results as monotherapy in phase 3 rheumatoid arthritis study, meeting all primary and key secondary endpoints.
Regeneron Pharmaceuticals and ISA Pharmaceuticals have formed a clinical collaboration to advance ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab (REGN2810), a PD-1 (programmed cell death protein 1) antibody.
AbbVie and Roche’s Venclexta/Venclyxto (venetoclax) in combination with MabThera/Rituxan (rituximab) succeeded in a phase 3 trial in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) by meeting the primary endpoint.
Results from a phase 3 clinical trial evaluating Novartis' Kisqali (ribociclib) in premenopausal women with HR+/HER2- advanced/metastatic breast cancer demonstrated a significant treatment benefit.
AbbVie’s psoriasis drug risankizumab (150 mg) has met all the primary endpoints in the two phases of a fourth pivotal phase 3 clinical trial in patients with moderate to severe plaque psoriasis.
The National Institutes of Health (NIH) and partners have started a clinical trial to evaluate whether an experimental HIV vaccine regimen is safe and effective in prevention of HIV infection.
Revance Therapeutics has completed its End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) and has received scientific advice from the Europe Medicines Agency (EMA) regarding DaxibotulinumtoxinA for Injection (RT002) for the treatment of cervical dystonia.
Novartis and Amgen’s human monoclonal antibody erenumab has succeeded in a phase 3 study by demonstrating significant and sustained efficacy in the prevention of episodic migraine.
Japan's Takeda Pharmaceutical has started a phase 1 clinical trial of its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate, TAK-426.
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