Infectious disease experts are weighing the need for booster shots of the Pfizer/BioNTech or Moderna mRNA-based vaccines for Americans who received Johnson & Johnson’s one-dose vaccine due to the increasing prevalence of the more contagious Delta coronavirus variant.

Two Labs

Traditional management tools have proven to be ineffective at managing costs for oncology drugs, leading to a hands-off management approach in the United States. But a recent survey from Two Labs – including 25 Pharmacy Directors and Medical Directors at US insurance companies representing 112.5 million covered lives – shows that the situation might be changing. The survey aimed to gather insight about what the industry looks like with increased levels of care management by covering traditional management tools, oncology-specific tools, systemic management tools and shifting risk, value frameworks, and pathways of care.

The U.S. Food and Drug Administration made the decision to grant Breakthrough Therapy Designation to Mirati Therapeutics’ adagrasib for the potential treatment of non-small cell lung cancer (NSCLC) in patients harboring the KRASG12C mutation after systemic therapy.

The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration, voted 13-4 that a regulatory decision on Incyte’s PD-1 inhibitor retifanlimab for the treatment of advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) should be deferred until further data are available from the clinical trial POD1UM-303.

Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved the PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. The EC also approved Libtayo in advanced basal cell carcinoma (BCC).

The successful use of messenger RNA (mRNA) vaccines for Covid-19 has led to a flurry of research studies designed to test these candidates in other illnesses. Translate Bio, for instance, launched a Phase I clinical trial with Sanofi’s vaccines global business unit Sanofi Pasteur to evaluate an mRNA-based investigational vaccine for the flu.

The University of Oxford is testing the anti-parasitic drug ivermectin as a possible treatment for Covid-19, as part of a British government-backed study that aims to aid recoveries in non-hospital settings.

Roche

Roche presented results from several Phase II and III trials at the 7th Congress of the European Academy of Neurology (EAN) Annual Meeting held virtually June 19-22.

GlaxoSmithKline and Vir Biotechnology said final results from a late-stage study of their monoclonal antibody confirmed sotrovimab significantly reduced hospitalization and death among high-risk Covid-19 patients when given early in the disease.

Washington D.C.-based global science and technology innovator Danaher announced a definitive agreement to acquire Aldevron for $9.6 billion.