Amgen Submits Supplemental Biologics License Application for Prolia® (denosumab) In Glucocorticoid-Induced Osteoporosis
July 31, 2017
Amgen has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.
Imfinzi granted Breakthrough Therapy Designation by US FDA for patients with locally-advanced unresectable non-small cell lung cancer
31 July 2017
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
Amgen And Allergan Submit Biosimilar Biologics License Application for ABP 980 To US Food and Drug Administration
July 31, 2017
Amgen and Allergan plc. has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration(FDA) for ABP 980, a biosimilar candidate to Herceptin® (trastuzumab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, including ABP 980 which is the second to be submitted for FDA approval.
Acalabrutinib granted Breakthrough Therapy Designation by US FDA for the treatment of patients with mantle cell lymphoma
01 August 2017
AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.
Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan
August 01, 2017
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
U.S. FDA Approves IMBRUVICA® (ibrutinib) as First and Only Approved Treatment for Adult Patients with Chronic Graft-Versus-Host-Disease (cGVHD) After Failure of One or More Lines of Systemic Therapy
August 2, 2017
The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. IMBRUVICA is the first and only FDA-approved medication for adult patients with cGVHD, a potential consequence of an allogeneic stem cell or bone marrow transplant, which can be life-threatening and debilitating. IMBRUVICA is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.
FDA Advisory Committee Votes in Favor of Xeljanz® (tofacitinib citrate) for the Treatment of Active Psoriatic Arthritis
August 3, 2017
Pfizer Inc. has announced that the U.S. FDA Arthritis Advisory Committee (AAC) voted 10 to 1 to recommend approval of the proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis (PsA). Pfizer submitted supplemental new drug applications (sNDAs) for XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR extended release 11 mg once daily (QD) for this pending indication. The FDA decision on whether to approve tofacitinib for PsA is anticipated by December 2017.
Bristol-Myers Squibb to Acquire IFM Therapeutics to Strengthen Oncology Pipeline Focus on Innate Immunity
August 3, 2017
Bristol-Myers Squibb Company and IFM Therapeutics (IFM) have announced that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders.