FDA to investigate tampons for lead, arsenic and other metals
The FDA has launched a study to examine the potential toxicity of metals that can be found within tampons—a regulated medical device, from the agency’s point of view.
The FDA has launched a study to examine the potential toxicity of metals that can be found within tampons—a regulated medical device, from the agency’s point of view.
Novo Nordisk has lifted the lid on a phase 1 trial of its oral amylin and GLP-1 receptor co-agonist, linking the candidate to 13.1% weight loss after 12 weeks—and highlighting the potential for further reductions in longer trials.
After first adding electrocardiogram support to its smartwatch nearly six years ago (!), Apple is continuing to add health features to its wearables. This week, it raised the curtain on plans to add sleep apnea detection to its Apple Watch as well as to bring long-anticipated over-the-counter hearing aid tech to its latest premium AirPods.
Carisma Therapeutics has been working for years to develop cell therapies using macrophages, immune cells that are better at attacking solid tumors than the T cells that currently dominate the industry. In a partnership with Moderna, now expanded to two undisclosed autoimmune targets, the biotech hopes to seriously simplify cell therapy by bypassing the need to culture patient cells out of the body.
On the heels of disappointing low-dose data results, Zealand Pharma is back with separate findings for its GLP-1/GLP-2 receptor dual agonist that have emboldened the biotech to push the candidate into phase 2b development.
Withings has received a clearance from the FDA for what it describes as the first device that can help diagnose a person with obstructive sleep apnea without the need for any wearable sensors, wires, masks or straps.
Merck & Co.’s long-running effort to land a punch on small cell lung cancer (SCLC) has racked up a small victory. The drugmaker’s Daiichi Sankyo-partnered antibody-drug conjugate (ADC) ifinatamab deruxtecan (I-DXd) showed promise in the setting, offering encouragement as a late-stage trial progresses.
The orthopedic robotics developer Think Surgical has collected its third FDA clearance in as many months, with a specialized version of its knee replacement system designed to be paired with an implant from Zimmer Biomet.
Terns Pharmaceuticals’ decision to drop its liver disease ambitions may yet pay off, after the biotech posted phase 1 data showing one of its other candidates induced 5% weight loss in a month.
AstraZeneca executives say they are “not worried” that the failure of tozorakimab in a phase 2 chronic obstructive pulmonary disease (COPD) trial will throw their plans for the anti-IL-33 monoclonal antibody off track.