Pharma News

U.S. Food and Drug Administration permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the gastrointestinal (GI) tract.

New findings suggest that the molecule triggers a pathway that is normally used by the immune system to prevent excessive damage but may contribute to chronic white matter injury by completely blocking repair operations.

The International Diabetes Federation (IDF) estimates that there are 72.9 million
people with diabetes in India in 2017, which is projected to rise to 134.3 million by the
year 2045. The prevalence of diabetes in urban India, especially in large metropolitan
cities has increased from 2% in the 1970s to over 20% at present and the rural areas
are also fast catching up.

The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).

New data from WHO shows that 9 out of 10 people breathe air containing high levels of pollutants. Updated estimations reveal an alarming death toll of 7 million people every year caused by ambient (outdoor) and household air pollution.

Regeneron Pharmaceuticals, Inc. and Sanofi announced they will lower the net price of Praluent® (alirocumab) Injection in exchange for straightforward, more affordable patient access from Express Scripts. Praluent will become the exclusive PCSK9 inhibitor therapy on the Express Scripts national formulary. The agreement significantly simplifies the documentation necessary to secure insurance coverage and may help reduce out-of-pocket costs for eligible patients. Despite having the broadest U.S. formulary coverage of any PCSK9 inhibitor, many patients have been unable to access Praluent because of the complicated utilization management process required by some insurance companies and high patient out-of-pocket costs.

Cipla Limited, a global pharmaceutical company, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package, Phenylephrine Hydrochloride Injection USP, 10 mg/mL Single- Dose Vial and Exemestane Tablets, 25mg from the United States Food and Drug Administration (USFDA).

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U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued 13 warning letter to manufacturers, distributors, and retailers for selling e-liquids used in e-cigarettes that resemble kid-friendly food products, such as juice boxes, candy or cookies, some of them with cartoon-like imagery.