Lilly Covid drug trial : Eli Lilly and Company has enrolled the first patient in a phase 3 randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of baricitinib in hospitalized adults with COVID-19. Baricitinib is an oral JAK1/JAK2 inhibitor, which was licensed by Lilly from Incyte. Marketed as OLUMIANT, baricitinib has approval in […]
AbbVie said that RINVOQ (upadacitinib, 15 mg, once daily) has met the primary endpoint and key secondary endpoints in the SELECT-CHOICE phase 3 trial in a certain population of rheumatoid arthritis patients. RINVOQ met the primary endpoint of non-inferiority compared to Bristol Myers Squibb’s ORENCIA (abatacept) on change from baseline in Disease Activity Score 28 […]
Actemra coronavirus clinical trial : Genentech has been given approval by the US Food & Drug Administration (FDA) to undertake the phase 3 COVACTA trial to assess the safety and efficacy of intravenous Actemra (tocilizumab) along with standard of care in hospitalized adults having severe COVID-19 pneumonia. The Roche subsidiary will carry out the randomized, […]
Global investment firm Blackstone has announced the acquisition of AYUMI Pharmaceutical, a leading Japanese specialty pharma company, marking its first controlling private equity investment in Japan. The deal was made through Blackstone-managed private equity funds, though the purchase price remains undisclosed. Blackstone’s Strategic Move into Japan’s Pharma Sector Blackstone’s acquisition of AYUMI Pharmaceutical represents a […]
Amgen Inc. has officially submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & Johnson’s REMICADE (infliximab). This submission marks a significant milestone in Amgen’s efforts to expand its biosimilar portfolio. ABP 710: A Biosimilar to Infliximab ABP 710 is being developed […]
Mylan has officially launched Hulio, its biosimilar to AbbVie’s Humira (adalimumab), across major European markets. This launch follows the European Commission’s recent approval of Hulio for all indications of the reference product. Hulio will be accessible to patients in Europe as soon as possible, thanks to a partnership between Mylan and Fujifilm Kyowa Kirin Biologics. […]
In a significant advancement for biopharmaceuticals, Novartis’ division Sandoz has secured approval from the European Commission (EC) for Hyrimoz (adalimumab), a biosimilar to AbbVie’s Humira. This approval encompasses all indications of the reference drug, including treatment for rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis, and ulcerative colitis, marking a pivotal step in broadening access to […]