Regulation

Sanofi, Regeneron get FDA breakthrough therapy status for Dupixent to treat eosinophilic esophagitis

Sanofi and Regeneron Pharmaceuticals have secured breakthrough therapy status from the US Food and Drug Administration (FDA) for Dupixent (dupilumab) to treat patients 12 years and older with eosinophilic esophagitis (EoE).

Terns Pharmaceuticals Receives Fast Track Designation for TERN-201 as a Treatment for NASH

Terns Pharmaceuticals, Inc., a biopharmaceutical company focused on developing best-in-class single-agent and combination therapies to treat liver disease, announced that TERN-201, a semicarbazide-sensitive amine oxidase (SSAO) inhibitor, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of non-alcoholic steatohepatitis (NASH).

FDA approves Trelegy Ellipta as once-daily single inhaler triple therapy for asthma and COPD

GlaxoSmithKline and Innoviva announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm.

Novartis, Roche fined €444m in France over eye drug abusive practices

The French Competition Authority has imposed a €444m fine on three drugmakers Novartis, Roche and Genetech for implementing abusive practices to market costly eye injection over a cheaper drug.

Ascentage Pharma’s Bcl-2 inhibitor APG-2575 granted orphan drug Designation by FDA to treat chronic lymphocytic leukaemia

Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug Administration (FDA) has granted APG-2575, a novel Bcl-2 inhibitor being developed by the company, an Orphan Drug Designation (ODD) for the treatment of chronic lymphocytic leukemia (CLL). This is the second ODD granted for APG-2575, following the previous ODD granted by the FDA in July for the treatment of Waldenström Macroglobulinemia (WM).

Janssen gets expanded EC nod for blood cancer combo drug Imbruvica plus rituximab

Janssen Pharmaceutical, part of Johnson & Johnson, has secured approval from the European Commission (EC) for expanded use of Imbruvica (ibrutinib) in combination with rituximab for previously untreated adult patients with chronic lymphocytic leukaemia (CLL).

FDA approves Roche’s Gavreto to treat metastatic RET fusion-positive NSCLC

Roche has secured approval from the US Food and Drug Administration (FDA) for its Gavreto (pralsetinib) to treat adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

Eli Lilly gets FDA nod for additional doses of Trulicity to treat type 2 diabetes

Eli Lilly has secured approval from the US Food and Drug Administration (FDA) for two additional doses of Trulicity to treat type 2 diabetes.

Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer

AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the 1st-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.