Regulation

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).

Merck receives complete response letter from FDA for sBLAs for KEYTRUDA six-week dosing schedule

Merck said that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding its supplemental Biologics License Applications (sBLAs) seeking to update the dosing frequency for KEYTRUDA (pembrolizumab), to include a 400 mg dose infused over 30 minutes every-six-weeks (Q6W) option in multiple indications.

ALX Oncology’s ALX148 receives two fast track designations from FDA

ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, announced that the U.S. Food and Drug Administration (FDA) has granted two Fast Track designations for its lead candidate, ALX148, for the first-line treatment of patients with head and neck squamous cell carcinoma (HNSCC), and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction (gastric/GEJ) carcinoma.

PharmaMar, Jazz get FDA priority review for lurbinectedin in relapsed SCLC

PharmaMar and Jazz Pharmaceuticals have secured priority review for their synthetic compound lurbinectedin from the US Food and Drug Administration (FDA) for its use in relapsed small cell lung cancer (SCLC).