Tags : sBLA

Janssen Reports sBLA Submission to the US FDA for Darzalex

Shots: The sBLA submission is based on P-III ANDROMEDA study assessing Darzalex Faspro (SC) + bortezomib, cyclophosphamide, and dexamethasone (D-VCd) vs VCd as monothx. in 388 patients with newly diagnosed (AL) amyloidosis The study resulted in meeting its 1EPs overall hematologic complete response rate. The sBLA is being reviewed under the FDA’s RTOR program and […]Read More

Kite Reports sBLA Submission to the US FDA for Yescarta

Shots: The sBLA submission is based on an ongoing P-II ZUMA-5 study assessing single infusion of Yescarta in ~160 patients (≥18 yrs.) with r/r indolent NHL of either FL or marginal zone lymphoma subtypes, prior treated with 2L therapies, including an anti-CD20 mAb combined with an alkylating agent The 1EPs of the study is ORR […]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

AbbVie Reports the US FDA’s Acceptance of BOTOX’s sBLA for

Shots: The US FDA has accepted the Allergan’s sBLA to expand the BOTOX prescribing information for treating detrusor (bladder muscle) overactivity associated with an underlying neurologic condition in pediatric patients aged 5 -17yrs who have an inadequate response to or are intolerant of, or for any reason unwilling to continue anticholinergic medication The sBLA is […]Read More

The US FDA Extends Review of sBLA of Ofatumumab (OMB157)

Shots: Novartis reported that the US FDA has extended its review of sBLA for ofatumumab (OMB 157) to treat patients with RMS. The company anticipates the regulatory action in Sept’2020 Novartis works with the US FDA to continue the review for ofatumumab (SC) in RMS, for the approval in the US with expected EU approval […]Read More

Janssen Reports Submission of Two sBLA to the US FDA

Shots:::spohSththShots: The submissions are based on P-III GO-VIVA study involves assessing of SIMPONI ARIA in 127 patients aged 2-17yrs. with active pJIA having arthritis in 5or more joints, despite current treatment with methotrexate for at least two mos. The focus of the study is to evaluate PK safety & efficacy of the therapy in pediatric […]Read More

Merck & Co. Reports the Resubmission of sBLA to the

Shots: The company resubmits the sBLA to the FDA for updating the dosing frequency for Keytruda, to include a 400mg dose infused over 30mis q6w, in addition to the currently approved dose of 200mg q3w Merck has filed the resubmission addressing the Complete Response Letter issued in Febr’2020 and filed sBLA across all indications of […]Read More

Roche Reports the FDA and EMA’s Acceptance of sBLA for

Shots: The US FDA has accepted the sBLA and EMA has validated the application for a 2hrs. Ocrevus (ocrelizumab) infusion time, administered twice yearly for RMS and PPMS The sBLA is based on ENSEMBLE PLUS study, which demonstrated comparable frequency and severity of IRRs for a 2hrs. OCREVUS infusion time vs the currently approved 3.5hrs […]Read More