Tags : Indications

Merck’s Brenzys (etanercept, biosimilar) Receives Health Canada Approval for Multiple

Shots: Health Canada has approved Brenzys for new indications that include adults & pediatric patients (4-17yrs.) with PsO who are candidates for systemic therapy/ phototherapy, adult patients with PsA, and patients aged 4-17yrs. with JIA The clinical efficacy and safety studies conducted in patients with RA demonstrate clinical comparability between Brenzys and the reference product. […]Read More

Roche Reports the US FDA’s Acceptance of sBLA for Xolair

Shots: The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21 The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA) If approved, Xolair’s […]Read More

Amgen and Allergan’s Kanjinti (biosimilar, trastuzumab) Receive the US FDA’s

Shots: The FDA’s approval is based on the totality of evidence which includes extensive comparative analytical, pharmacokinetic and clinical data demonstrating that Kanjinti is highly similar and have no clinical differences from Roche’s Herceptin Kanjinti is the second biosimilar from Amgen and Allergan’s collaboration and third biosimilar from the Amgen’s portfolio to receive FDA’s approval […]Read More

Merck’s Keytruda(pembrolizumab) Receives 5 Approvals from PMDA, Japan across 3

Shots: •      Out of 5 approvals three are for NSCLC patients, one for Melanoma and one for Microsatellite Instability-High (MSI-H) solid tumor patients •      Keytruda got approved as monotherapy in 1L PD-L1 positive NSCLC patients based on Keynote-042, one in 1L non-squamous patients in combination with pemetrexed and PT-CT based on keynote-189 and another for […]Read More