BioSpace News Archive

Following its label expansion earlier this month, Medicare on Thursday said it will now cover the use of Novo Nordisk’s Wegovy in patients with overweight or obesity who have preexisting cardiovascular disease.

At Thursday’s Pharma Media Day, Bayer touted Nubeqa as the fastest growing androgen receptor inhibitor in the U.S., which will achieve blockbuster status this year.

Despite meeting its primary endpoint in a late-stage generalized myasthenia gravis trial, Roche and Chugai Pharmaceutical’s Enspryng did not demonstrate clinical benefit as expected, the companies announced Thursday.

Duvyzat, which will be sold in the U.S. by ITF Therapeutics, joins a growing market that includes recently approved gene therapy Elevidys and corticosteroid Agamree.

Oprah Winfrey this week shone the spotlight on these transformative GLP-1 medications. Now, it’s time for Medicare to cover them and expand access to millions of Americans.

Tegoprubart, Eledon Pharmaceuticals’ experimental anti-CD40L antibody, was part of the immunosuppressive treatment regimen used following the first-ever transplant of a kidney from a genetically modified pig to a human.

Justera Health Ltd. (CSE: VTAL) (OTC Pink: SCRSF) (“Justera” or the “Company”) announces the appointment of Tyler Burpee to the board of directors and the resignation of director Ian Kim for personal reasons, effective March 21st, 2024.

Iovance Biotherapeutics, Inc. announced that on March 22, 2024, the Company approved the grant of inducement stock options covering an aggregate of 97,700 shares of Iovance’s common stock to twenty new, non-executive employees.

Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.

Esperion (NASDAQ: ESPR) today announced that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients.