Regulation

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.

FDA approves Tagrisso as first-line treatment for EGFR-mutated non-small cell lung cancer

The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (osimertinib) as the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.

Roche’s Hemlibra gets FDA breakthrough status in haemophilia A without inhibitors

Roche has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Hemlibra (emicizumab) to treat people with haemophilia A without factor VIII inhibitors.

BMS’ Opdivo and Yervoy combo gets FDA approval for firstline RCC

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) combination of immuno-oncology drugs Opdivo (nivolumab) and Yervoy (ipilimumab) as first-line treatment for patients with a type of advanced renal cell carcinoma (RCC), or kidney cancer.

FDA approves Clovis’ Rubraca for recurrent ovarian cancer

The US Food and Drug Administration (FDA) has approved Clovis Oncology’s Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

US and European regulators accept AstraZeneca’s applications for cancer treatments

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted AstraZeneca’s applications for cancer treatments moxetumomab pasudotox and Lynparza (olaparib).

FDA approves new indication for Amgen’s leukemia drug Blincyto

The US Food and Drug Administration (FDA) has approved Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission in adults and children.

Fennec Pharmaceuticals’ Pedmark gets FDA breakthrough status

Fennec Pharmaceuticals has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for Pedmark to prevent cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).