Eli Lilly and Co. and ARMO BioSciences Inc. announced a definitive agreement for Lilly to acquire ARMO for $50 per share, or approximately $1.6 billion, in an all-cash transaction.
FDA approved Kymriah (tisagenlecleucel) suspension for intravenous infusion for its second indication – the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
The FDA granted regular approval to Tafinlar (dabrafenib) and Mekinist (trametinib) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node, following complete resection.
Regeneron Pharmaceuticals Inc. and Sanofi today announced the FDA has accepted for priority review the Biologics License Application for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or patients with locally advanced CSCC who are not candidates for surgery.
Genocea Biosciences Inc., the biopharmaceutical company developing neoantigen cancer vaccines, announced the filing of an Investigational New Drug Application with the FDA to begin a Phase I/IIa clinical program testing the safety, immunogenicity, and clinical efficacy of GEN-009, the company's lead personalized neoantigen cancer vaccine candidate.
The European Commission approved Mylotarg (gemtuzumab ozogamicin) in combination with daunorubicin and cytarabine for the treatment of patients age 15 years and above with previously untreated, de novo, CD33-positive acute myeloid leukemia, except acute promyelocytic leukemia.
Nektar Therapeutics and Takeda Pharmaceutical Co. Ltd. join a clinical collaboration to evaluate Nektar's investigational medicine, NKTR-214, with Takeda's investigational medicine, TAK-659, as a potential combination treatment regimen in multiple cancer settings.
Pfizer Inc. announced it has received a Complete Response Letter from FDA in response to the Biologics License Application for the company's proposed trastuzumab biosimilar. In the CRL, FDA highlighted the need for additional technical information.
FDA has approved Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
FDA has granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
