Regulation

FDA advisory committee votes in favour of Lilly’s CYRAMZA as first-line treatment for metastatic EGFR-mutated NSCLC

Eli Lilly and Company announced that a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 6-5 that CYRAMZA (ramucirumab) plus erlotinib demonstrated a favorable benefit/risk profile for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC), based on the results of the positive Phase 3 RELAY study.

Lysogene receives FDA fast track designation for LYS-SAF302 gene therapy in MPS IIIA

Lysogene, a pioneering Phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its LYS-SAF302 program for the treatment of mucopolysaccharidosis Type IIIA (MPS IIIA).

Takeda’s ALUNBRIG gets FDA priority review for expanded indication in NSCLC

Takeda Pharmaceutical has secured priority review for ALUNBRIG (brigatinib) from the US Food and Drug Administration (FDA) for its expanded use as a first-line treatment for a type of non-small cell lung cancer (NSCLC).

Trulicity gets FDA nod for reducing CV risk in type 2 diabetes patients

Eli Lilly and Company (Lilly) has been granted approval for Trulicity (dulaglutide) from the US Food and Drug Administration (FDA) for reducing the risk of major adverse cardiovascular events (MACE) in adults having type 2 diabetes.

Lundbeck gets FDA nod for migraine prevention drug Vyepti

Lundbeck, a Danish pharmaceutical company, has secured approval from the US Food and Drug Administration (FDA) for its Vyepti as a preventive treatment for migraine in adult patients.

FORMA Therapeutics announces FT-4202 granted fast track designation and rare paediatric disease designation to treat sickle cell disease

FORMA Therapeutics, a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation and Rare Pediatric Disease designation for its lead clinical asset, FT-4202, in development as a disease-modifying treatment for sickle cell disease (SCD). FT-4202 is a selective pyruvate kinase-R (PKR) activator that exhibits the potential to beneficially impact both anemia and vaso-occlusive crises for people living with SCD.

FDA grants priority review to Genentech’s Tecentriq as first-line treatment of certain people with advanced NSCLC

Genentech, a member of the Roche Group, said that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing.

Seattle Genetics, Astellas get FDA breakthrough therapy status for Padcev plus Keytruda to treat bladder cancer

Seattle Genetics and Astellas Pharma have secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for Padcev in combination with Merck’s anti-PD-1 therapy Keytruda to treat advanced bladder cancer.

Pfizer’s VYNDAQEL gets EC approval for treatment of ATTR-CM

Pfizer has secured European approval for its oral transthyretin stabilizer VYNDAQEL (tafamidis) for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).