Regulation

FDA approves updated label of Relypsa’s Veltassa hyperkalemia drug

The US Food and Drug Administration (FDA) has approved Relypsa’ supplemental new drug application (sNDA) for Veltassa (patiromer) for oral suspension in the treatment of hyperkalemia, or elevated blood potassium levels.

Roche’s Tecentriq combo gets FDA priority review to treat lung cancer

Roche’s cancer immunotherapy Tecentriq (atezolizumab) in combination with chemotherapy has been granted priority review in the US for the treatment of a specific type of metastatic lung cancer.

Novartis’ Tafinlar/Mekinist combo gets FDA nod for anaplastic thyroid cancer

Novartis Pharmaceuticals has secured approval from the US Food and Drug Administration for its Tafinlar (dabrafenib) and Mekinist (trametinib) combination therapy to treat anaplastic thyroid cancer (ATC).

FDA expands approval of Novartis’ Kymriah CAR-T therapy

Novartis has secured a second approval for Kymriah (tisagenlecleucel) in the US for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma who had more than two lines of systemic therapy.

AstraZeneca’s Tagrisso gets positive EU CHMP opinion for first-line treatment of EGFR-mutated NSCLC

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Tagrisso (osimertinib) to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

Omeros’ OMS721 gets FDA breakthrough therapy designation for HSCT-TMA

Omeros’ MASP-2 inhibitor OMS721 has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

AbbVie seeks US approval for psoriasis drug risankizumab

AbbVie has submitted a biologics license application (BLA) to the US Food and Drug Administration seeking approval of risankizumab for the treatment of moderate to severe plaque psoriasis.

FDA expands GSK’s Trelegy Ellipta indication in COPD

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who had an acute worsening of respiratory symptoms.

Alnylam signs settlement agreement with Dicerna to resolve trade secret misappropriation claims

Alnylam Pharmaceuticals has entered into a settlement agreement with Dicerna Pharmaceuticals to resolve trade secret misappropriation claims against Dicerna, and counterclaims asserted by Dicerna, in pending litigation in the Superior Court of Middlesex County, Massachusetts.