Pharma News

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.

The U.S. Food and Drug Administration announced it has recently suspended the food facility registration of Topway Enterprises Inc., also doing business as Kazy’s Gourmet, of Houston, Texas. Topway now cannot sell or distribute any food into commerce. This action follows inspections conducted by the FDA and Texas Department of State Health Services (DSHS) earlier this year where serious sanitation issues were observed, including several samples confirming the presence of Listeria and pathogenic Listeria monocytogenes (L. monocytogenes).

U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.

Researchers have found that Dulaglutide, a commonly used drug for Type 2 diabetes, can be effective against cardiovascular and kidney diseases too. A clinical trial that followed more than 9,900 persons in 24 countries found that the drug reduced cardiovascular events and kidney problems in middle-aged and older people.

InvaGen Pharmaceuticals, Inc. a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited announced the receipt of final approval for its Abbreviated New Drug Application (ANDA) for Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg from the United States Food and Drug Administration (US FDA).

EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further increase transparency. Early interactions with medicine developers and provision of scientific advice are well-established processes with demonstrated added value in medicines regulation, and contribute positively to public health by helping to bring new, safe and effective medicines to patients. At the same time, EMA recognises the importance of guaranteeing the independence of the medicine assessment which takes place at a later stage.