Pharma News

Amgen announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of KYPROLIS® (carfilzomib), melphalan and prednisone (KMP) versus Velcade® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 - 1.10). While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 - 1.64). Neither result was statistically significant.

Amgen and UCB  announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Pain Therapeutics, Inc.  announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug application (NDA) for REMOXY ER (oxycodone capsules CII).  The CRL informs that REMOXY ER cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.

Janssen Research & Development, LLC announced that a supplemental New Drug  Application (sNDA) for ibrutinib (IMBRUVICA ® ) has been submitted to the U.S. Food and  Drug Administration (FDA) for the treatment of patients with marginal zone lymphoma  (MZL) who require systemic therapy. The filing is based on data from the multi-center, open-  label Phase 2 PCYC-1121 trial assessing the use of ibrutinib, a BTK inhibitor, in patients  with MZL who have received at least one prior therapy.

Janssen Biotech, Inc., announced that the U.S. Food and Drug Administration (FDA) has  approved STELARA ® (ustekinumab) for the treatment of moderately to severely active  Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment  with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis  factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF  blockers. STELARA ® is the first biologic therapy for Crohn’s disease targeting interleukin  (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses. 

Leading the way in becoming an inspirational model for pharmaceutical sector, Gujarat has evolved into a hub for major pharmaceutical companies. Many investment-friendly initiatives and growth propelling policies in industries such as pharmaceutical & biotechnology, textile, auto, gems & jewellery, IT, maritime & port and engineering are significantly driving growth for the state.

Marksans Pharma Limited announces that USFDA has granted approval for an Abbreviated New Drug Application (ANDA) for Loratadine Liquid Filled Capsules 10 mg.

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. AMJEVITA is Amgen's first biosimilar to receive regulatory approval.

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