Clinical Trial News

Jefferies analyst Peter Welford anticipates Novo Nordisk shares to drop at least 10%-15% due to disappointing Phase III CagriSema obesity data, showing 20.4% weight loss and potential tolerability issues. The firm maintains an Underperform rating with an $81.50 price target.

Zepbound, a weight loss drug by Eli Lilly & Co., is the first prescription medication approved by the FDA to treat obstructive sleep apnea (OSA) in adults with obesity. Studies show Zepbound, used with a reduced-calorie diet and exercise, significantly reduces OSA symptoms, including breathing pauses, compared to a placebo. The approval marks a significant advancement for OSA patients.

Zepbound, a weight loss drug by Eli Lilly & Co., is the first prescription medication approved by the FDA to treat obstructive sleep apnea (OSA) in adults with obesity. Studies show Zepbound, used with a reduced-calorie diet and exercise, significantly reduces OSA symptoms, including shallow breathing episodes. The approval reflects growing interest in weight loss drugs for conditions beyond obesity and diabetes.

The FDA authorized Zepbound, a weight loss drug by Eli Lilly & Co., for adults with obesity and moderate to severe obstructive sleep apnea (OSA). Studies showed Zepbound reduced OSA symptoms, with significant reductions in breathing pauses compared to a placebo. The drug is used with a reduced-calorie diet and exercise.

A 57-year-old woman with cirrhosis, Crohn disease, and chronic hepatitis B presented with abdominal pain and fatigue. Diagnosed with stage IV hepatocellular carcinoma (HCC), she was treated with lenvatinib due to her autoimmune disease. Lenvatinib was supported by the REFLECT trial, showing noninferior overall survival and superior progression-free survival compared to sorafenib. The patient had a partial response initially but discontinued treatment due to disease progression. Observational data suggest lenvatinib may be favorable for Child-Pugh B patients.

FDA approves Pfizer's BRAFTOVI (encorafenib) with cetuximab and mFOLFOX6 for metastatic colorectal cancer (mCRC) with BRAF V600E mutation. Based on BREAKWATER trial, the combination showed significant improvement in response rate and durability. This is the first BRAF-targeted therapy regimen for first-line treatment of BRAF V600E-mutant mCRC.

Humacyte's SYMVESS, a bioengineered vascular conduit, received FDA full approval for extremity arterial injury repair, offering high patency and low amputation/infection rates, with a trained sales team ready for commercial launch.

Pfizer's BRAFTOVI® (encorafenib) in combo with cetuximab and mFOLFOX6 approved by FDA for first-line treatment of metastatic colorectal cancer with BRAF V600E mutation, based on 61% overall response rate in Phase 3 BREAKWATER trial.

The FDA expanded Eli Lilly's Zepbound approval to treat moderate to severe obstructive sleep apnea in obese individuals, the first medication for the condition. Zepbound, aiding weight loss, reduced breathing interruptions and improved sleep apnea symptoms in a study. Insurance providers, including Medicare, may cover it for this dual condition.

Eli Lilly's Zepbound, a weight-loss drug, was approved by the FDA to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. Clinical trials showed Zepbound reduced breathing disruptions five times more than a placebo and led to significant weight loss. This approval may allow Zepbound to be covered by Medicare, similar to Novo Nordisk's Wegovy.