U.S. FDA Grants Brukinsa Approval in Waldenström’s Macroglobulinemia
BeiGene Ltd.’s Brukinsa (zanubrutinib) received approval from the U.S. Food and Drug Administration for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
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Bristol Myers Squibb Receives European Commission Approval for Abecma
The European Commission granted Conditional Marketing Authorization for Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel) – a first-in-class B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy – for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Medable Opens New EMEA Headquarters in Dublin; Expands European Presence to Grow Market for Decentralized Clinical Trials
Medable Inc., a leading cloud platform for patient-centered drug development, announced the first stage of the company’s European expansion plans with a new EMEA headquarters in Dublin.
Opdivo in Combination with Cabometyx Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced RCC
Bristol Myers Squibb and Exelixis announced results from new analyses from the pivotal Phase 3 CheckMate -9ER trial, demonstrating clinically meaningful, sustained efficacy benefits as well as quality of life improvements with the combination of Opdivo (nivolumab) and Cabometyx (cabozantinib) compared to sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC).
W2O Acquires Swoop and IPM.ai
Global health innovation leader W2O announced the acquisitions of tech-enabled companies Swoop and IPM.ai, further accelerating what is expected to be the company’s 20th consecutive year of double-digit revenue growth.
FDA Approves Ocrevus Shorter 2-Hour Infusion for Relapsing and Primary Progressive MS
The U.S. Food and Drug Administration approved a shorter two-hour infusion time for Roche Group member Genentech’s Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions.
U.S. FDA Grants Priority Review for Pfizer’s 20vPnC
The U.S. Food and Drug Administration accepted for priority review Pfizer Inc.’s Biologics License Application (BLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
New Data Reinforce Long-Term Benefit of Venclexta-Based Combination for Relapsed or Refractory CLL
Roche Group member Genentech announced that new data from the pivotal Phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta (venetoclax)-based combinations in certain people with chronic lymphocytic leukemia (CLL) and provide more evidence on the potential value of minimal residual disease.
FDA Approves Keytruda for Triple‑Negative Breast Cancer
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-approved test.
Envision Pharma Group Acquires Two Labs
Envision Pharma Group, a leading global technology-enabled scientific communications company, announced the acquisition of Two Labs, an industry-leading provider of integrated and customized commercial solutions to the pharmaceutical and biotechnology sector.
