Posts in category: Business

FDA Approves Vyloy for the Treatment of Advanced Gastric and GEJ Cancer

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Vyloy™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.

• Gastric and gastroesophageal junction (G/GEJ) cancer is the fifth most commonly diagnosed cancer worldwide.
• Vyloy is the first and only CLDN18.2-targeted therapy approved in the U.S.

Source: Astellas Pharma US, Inc.

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FDA Approves Crexont Extended-Release Capsules for the Treatment of Parkinson’s Disease

Amneal Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approved Crexont (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD).

• Crexont is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediaterelease (IR) granules and extended-release (ER) pellets. Existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily “Good On” time, defined as “On” time without troublesome dyskinesia, as the disease progresses.
• There are approximately one million people with PD living in the U.S. and approximately 90,000 new cases diagnosed each year. One new patient is diagnosed with Parkinson’s disease every six minutes.

Source: Amneal Pharmaceuticals, Inc.

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FDA Approves Zituvio (sitagliptin) for the Treatment of Adult Patients with Type 2 Diabetes Mellitus
Zydus Lifesciences has announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for Zituvio (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg. Zituvio contains active ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Zituvio is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Zituvio is not recommended in patients with type 1 diabetes mellitus. Zituvio has not been studied in patients with a history of pancreatitis.

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