Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival for adults with previously treated, high-risk chronic lymphocytic leukemia (CLL) compared to ibrutinib.
The U.S. Food and Drug Administration granted various designations for Sanofi’s avalglucosidase alfa for Pompe disease, Sanofi’s rilzabrutinib for immune thrombocytopenia, and ViiV Healthcare’s cabotegravir for HIV prevention.
AstraZeneca’s blood cancer treatment Calquence failed to improve survival rates and prevent lung failure in patients hospitalized with symptoms of Covid-19, the drugmaker said, citing results from mid-stage trials.
Sanofi announced the acquisition of Principia Biopharma in a deal valued at about $3.68 billion as the French company continues to transform its R&D division to more heavily emphasize oncology and other lucrative programs.
Sanofi is rumored to have a $50 billion budget for mergers and acquisitions and is taking a look at U.S.-based biotech companies, including South San Francisco-based Principia Biopharma.
Sanofi’s investigational Bruton’s tyrosine kinase inhibitor SAR442168 hit the mark in a mid-stage multiple sclerosis trial.
The U.S. Food and Drug Administration approved Imbruvica (ibrutinib) in combination with Rituxan (rituximab) for chronic lymphocytic leukemia or small lymphocytic lymphoma patients who are new to therapy.
Biogen successfully fended off a patent challenge from generic company Mylan over the multiple sclerosis (MS) drug Tecfidera.
A late-stage trial failed to show that BeiGene Ltd.’s cancer treatment Brukinsa was superior to Imbruvica, a rival drug from Johnson & Johnson and AbbVie Inc., for treating WM.
AstraZeneca’s Calquence (acalabrutinib) hit the mark in a Phase III trial of previously treated patients with chronic lymphocytic leukemia (CLL).