The U.S. Food and Drug Administration approved Merck’s Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

Moderna Chief Executive Officer Stéphane Bancel sees significant growth opportunities for his company and messenger RNA-based vaccines.

Data from a mid-stage clinical study of an experimental vaccine candidate developed by Affinivax and Astellas Pharma for Streptococcus pneumoniae shows ASP3772 is well tolerated and generated an antibody response against the deadly bacterial infection.

Galapagos announced new post-hoc analyses for the Belgium-based company’s Phase III SELECTION program for the JAK1 inhibitor filgotinib for ulcerative colitis, touting rapid symptom improvement and sustained steroid-free remission. 

FDA

The U.S. Food and Drug Administration on July 6 declined to approve Provention Bio Inc.’s experimental diabetes drug, citing insufficient data, sending the company’s shares down about 28 percent

Johnson & Johnson said the company’s single-shot Covid-19 vaccine showed promise against the highly contagious Delta variant in a laboratory study.

Intellia Therapeutics and Regeneron Pharmaceuticals shook the biotech and CRISPR world on June 26, announcing positive early data from the first-ever patients to have their DNA edited with an in vivo CRISPR/Cas9 therapy delivered systemically.

Lilly

Eli Lilly’s investigational diabetes drug tirzepatide is showing significant promise in targeting A1C levels and weight loss in patients with type 2 diabetes, including those who had never been previously treated for the disease. In other positive clinical results presented at the American Diabetes Association’s 81st Scientific Sessions meeting, Novo Nordisk data demonstrated an investigational 2mg dose of injectable Ozempic (semaglutide) generated statistically significant and superior reductions in A1C compared to a 1mg dose of Ozempic.

A mixed schedule of vaccines where a shot of Pfizer’s Covid-19 vaccine is given four weeks after an AstraZeneca shot will produce better immune responses than giving another dose of AstraZeneca, an Oxford study said on June 28.

AstraZeneca Plc’s diabetes drug significantly reduced blood sugar levels in adolescents aged 10–17 with type 2 diabetes in a late-stage study, the UK-based drugmaker said.