Regulation

Momenta revises regulatory strategy for proposed Humira biosimilar

Momenta Pharmaceuticals has revised its regulatory strategy in the US for its anti-FcRn antibody M923, which is being proposed by the company as a biosimilar to Humira.

FDA fast tracks Novartis’ Zolgensma SMA gene replacement therapy

Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec-xxxx), which was formerly known as AVXS-101, has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA) Type 1.

Novartis’ Gilenya gets approval in Europe to treat children and adolescents with MS

Novartis has secured approval from the European Commission (EC) for its Gilenya (fingolimod) to treat children and adolescents, aged between 10 and 17 years, with relapsing-remitting forms of multiple sclerosis (RRMS).

Vor Biopharma secures US patent covering compositions and methods to treat haematologic malignancies

The US Patent and Trademark Office (USPTO) issued US Patent No. 10,137,155 related to Vor Biopharma's technology platform.

Teva, Celltrion get FDA nod for biosimilar to Roche’s cancer drug Rituxan

Teva Pharmaceutical and Celltrion have secured approval from the US Food and Drug Administration (FDA) for Truxima (rituximab-abbs), a biosimilar to Roche’s cancer drug Rituxan (rituximab), for three non-Hodgkin’s lymphoma indications.

Swissmedic approves fibryga to treat congenital and acquired fibrinogen deficiencies

Swissmedic has granted marketing authorization for Octapharma’s new fibrinogen concentrate product fibryga for the treatment of congenital and acquired fibrinogen deficiencies.

AstraZeneca’s Fasenra secures FDA orphan drug designation for EGPA

AstraZeneca’s respiratory biologic Fasenra (benralizumab) has secured the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).

Mundipharma’s Neulasta biosimilar Pelmeg secures approval in Europe

The Mundipharma network of independent associated companies has secured approval from the European Commission (EC) for its Pelmeg (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancy for chemotherapy.

Camurus gets EU nod for weekly and monthly Buvidal for opioid dependence

The European Commission (EC) has approved Camurus’ weekly and monthly Buvidal (prolonged release buprenorphine) for the treatment of opioid dependence in adults and adolescents from 16 years of age.