Intensity Therapeutics said today that the 1st patient was treated in a Phase I/II trial of its intratumorally-administered cancer therapy, INT230-6. The company’s plans to evaluate the safety of its cancer-killing agent in patients with tumors that are treated at the surface of the skin, including breast cancer and melanoma. Intensity Therapeutics also plans to […]
Clinical Trials
FDA deals setback to Sunovion for inhaled COPD therapy
The FDA issued a complete response letter to Sunovion Pharmaceuticals in regards to the new drug application for its eFlow chronic obstructive pulmonary disease drug-device combo. The investigational eFlow closed-system nebulizer delivers a long-acting muscarinic antagonist bronchodilator, glycopyrrolate, to reduce airflow obstruction in COPD patients. The company said it plans to work with the FDA to determine […]
Medtech stories we missed this week: May 26, 2017
From Merck’s new licensing agreement to surgical study data being touted, here are medtech stories we missed this week but thought were still worth mentioning. 1. Merck inks exclusive licensing agreement for Alzheimer’s antibody Merck announced in a May 25 press release that it has entered an exclusive worldwide license agreement with Teijin Pharma. The […]
Anika launches late-stage supplemental Cingal study
Anika Therapeutics (NSDQ:ANIK) said yesterday that it enrolled the 1st patient in a supplemental Phase III efficacy and safety trial of its Cingal hyaluronic acid-corticosteroid combination viscosupplement. The Bedford, Mass.-bsaed company is evaluating Cingal as a treatment for osteoarthritis-related knee pain. The supplemental late-stage trial is slated to enroll patients at 30 European sites and randomize […]
Colorectal cancer patients treated with SIR-spheres more likely to be candidates for resection
Treatment with Sirtex Medical‘s (ASX:SRX) Y-90 resin microspheres and chemotherapy was associated with a statistically significant gain in potentially curative liver resectability, according to data published earlier this week. The results come 1 week after the Australian company reported that its radioactive microspheres had no effect in improving survival in patients with colorectal cancer in its […]
Ultrasound-drug combo treats pulmonary embolism in less time with fewer drugs
When venous clots break off and travel through a patient’s circulatory system, they can become trapped in the lung and block blood flow. This strains the heart’s ability to pump blood through the lungs and can ultimately lead to heart failure. Traditionally, patients with pulmonary embolisms are treated overnight with systemic infusions of tissue plasminogen […]
Liquidia touts Phase I data for sustained-release post-surgical pain reliever
Liquidia Technologies touted initial data from its LIQ865 Phase I trial, which evaluated its sustained-delivery formulation of bupivacaine for post-surgical pain relief. The trial was the 1st evaluation of the company’s formulation in humans. Researchers assessed the safety, pharmacokinetic profile and pharmacodynamic response of a single-ascending dose in healthy adult males. Initial data showed that […]
FDA approves 1st cancer drug based on genetics, not tissue type
In a landmark decision, the FDA approved Merck‘s (NYSE:MRK) immunotherapy Keytruda yesterday as the 1st cancer treatment indicated for any solid tumor with a specific genetic feature, regardless of tissue type. Traditionally, the location where a cancer originates in a patient’s body determines the course of treatment. The move to treat cancers based on genetic biomarkers […]
Medtronic launches study of In.Pact Admiral drug-coated balloon in end-stage renal disease
Medtronic (NYSE:MDT) said today that the 1st patient was enrolled in a study of its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The FDA approved the investigational device exemption study to evaluate the device as a treatment for failing arteriovenous fistulas in end-stage renal disease patients. “We are delighted to enroll and treat […]
ATS Roundup: Emulate models viral infection in “asthma-on-a-chip”
Emulate‘s small airway-lung chip could help researchers study viral-induced exacerbations of asthma, according to data presented this week at the American Thoracic Society’s annual meeting. The studies were conducted as part of the company’s partnership with (NYSE:MRK). The collaborative project was designed to enable development of new anti-inflammatory treatments for patients with asthma, according to Emulate. […]