Pharma News

An early-stage clinical trial is evaluating two licensed seasonal influenza vaccines, administered with or without novel adjuvants, for their safety and ability to generate an immune response. Adjuvants are compounds added to vaccines to induce stronger and longer-lasting immune responses. The Phase 1 study is enrolling healthy adult volunteers at eight sites across the United States. The trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

A team of researchers from the National Library of Medicine (NLM), part of the National Institutes of Health, and collaborating academic research institutions developed a method to measure a type of gene mutation involved in the evolution of cancer. This type of mutation, called “repeat instability,” may be useful in early cancer diagnosis. Findings were published this week in the Proceedings of the National Academy of Sciences.

U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

Researchers at the Indian Institute of Technology-Madras have found a way to develop non-animal models to test new cancer drugs.

Esophageal cancer or cancer of the food pipe is among common cancers that occur in India. Every year some 47,000 new cases are reported and 42,000 people die due to this cancer. Its occurrence is particularly high in the north-eastern states. It is often diagnosed late as its symptoms are not very specific and patients are treated for other causes. In such a situation, early diagnosis can help save lives.

The Committee recommended granting a conditional marketing authorisation for Vitrakvi* (larotrectinib), the first ‘histology-independent’ treatment in the European Union for solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. NTRK gene fusions occur very frequently in a number of rare cancers. For more information, please see the press release in the grid below.

The U.S. Food and Drug Administration approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection.

U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.