Clinical

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

Articles

Teplizumab is being evaluated to delay type 1 diabetes. The PDUFA date is August 17, 2022.

Provention Bio Resubmits Application for Teplizumab


Data is being presented at the 10th Annual IDWeek Virtual Conference, September 29 to October 3.


AstraZeneca Presents Positive Results for COVID-19 Monoclonal Antibody, RSV Treatments 

The flu program is the first in programs leveraging BioNTech’s mRNA technology for vaccines for other respiratory viruses, oncology, and genetic diseases.

Pfizer Begins Trial of mRNA-based Flu Vaccine

FDA has approved a new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

FDA approves Arzerra in combination with chlorambucil for patients with CLL for whom fludarabine-based therapy is considered inappropriate

FDA has approved the Timothy Grass Pollen Allergen Extract (Grastek, Merck) sublingual tablet as immunotherapy to treat grass pollen-induced allergic rhinitis with or without conjunctivitis in children as young as 5 years of age and adults up to the age of 65. The tablet is a new option for patients who decline allergy shots.

Timothy Grass Pollen Allergen Extract approved by FDA

In an examination of a type of treatment for allergic rhinitis and asthma that is used in Europe but not approved by FDA, researchers found moderate strength in the evidence from previous studies to support the use of sublingual immunotherapy for the treatment of these conditions, according to a review article in the March 27 issue of JAMA.

Sublingual immunotherapy for allergic rhinitis and asthma effective, JAMA reports

In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.

Leukotriene inhibitors associated with neuropsychiatric events

Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis

Drug Watch: Agents in late-stage development for the treatment of allergic rhinitis and sinusitis/rhinosinusitis (September 2007) (PDF)

Children who receive broad-spectrum antibiotics during their first year of life are at increased risk of developing childhood asthma.That was the conclusion of researchers who conducted a large, longitudinal, case-control study.

Use of broad-spectrum antibiotics during infancy associated with increased risk of pediatric asthma

A new formulation for immune globulin intravenous (human), 10% liquid, a polyvalent human immunoglobulin G approved for the treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.

Allergy, Immunology, and ENT