Pharma News

Eli Lilly and Company announced results from a first-of-its-kind study of lebrikizumab specifically designed for people with skin of color and moderate-to-severe atopic dermatitis, commonly called eczema. In this study, treatment with lebrikizumab, an investigational medicine, showed improvement in skin clearance and itch relief. These late-breaking results from a Phase 3 study are being presented today at the American Academy of Dermatology (AAD) Annual Meeting.

The U.S. Food and Drug Administration approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. Wegovy should be used in addition to a reduced calorie diet and increased physical activity. Cardiovascular disease is a group of diseases of the heart and blood vessels.

Drug Safety Symposium 2024 unfolded as a beacon of innovation, collaboration, and excellence in the realm of Pharmacovigilance, Regulatory Affairs, and Quality Assurance. Held on February 14th -15th, 2024 at the Holiday Inn & Suites, the symposium marked a milestone in advancing drug safety standards and fostering transformative dialogue within the pharma industry.

Medical devices industry is considered as one of Indias sunrise sectors. India is amongst the worlds fastest emerging Medical Device market with exports from the sector growing steadily at a CAGR of around 14 percent since FY 2019-20. The market for medical device industry in India is currently estimated to be of the size of USD 11 billion and it is expected to cross USD 30 billion mark by 2050.

Novo Nordisk announced the headline results from the kidney outcomes trial FLOW. The announcement follows the decision to stop the trial early due to efficacy, which was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee. The double-blind trial compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD).

Each year, approximately 2,000 people die annually of gallbladder cancer (GBC) in the U.S., with only one in five cases diagnosed at an early stage. With GBC rated as the first biliary tract cancer and the 17th most deadly cancer worldwide, pressing attention for proper management of disease must be addressed. For patients diagnosed, surgery is the most promising curative treatment.

Strides Pharma Science Limited (Strides) announced that its step‐ down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Gabapentin Tablets USP, 600 mg and 800 mg, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC.

FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva (denosumab).

The U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels.