Novo Nordisk (NYSE:NVO) said today that it submitted a supplemental application to the FDA, asking to include cardiovascular data on the label of its Tresiba insulin degludec. The Danish insulin-maker asked to include data specifically from the Devote trial, which evaluated the cardiovascular safety of Tresiba compared to insulin glargine in patients with Type II diabetes. The […]
Pharmaceuticals
Mallinckrodt faces probe over price hikes for injectable pain-killer
Sen. Claire McCaskill (D-Mo.) penned a letter to Mallinckrodt Pharmaceuticals (NYSE:MNK) last week, probing for details about the company’s pricing strategies for its injectable pain-killer, Ofirmev. Mallinckrodt acquired Ofirmev in 2014, when it bought Cadence Pharmaceuticals in a $1.4 billion deal. In May of that year, Mallinckrodt hiked the pain-killer’s list price from $14.75 per vial to […]
Intensity Therapeutics begins human testing of intratumoral cancer drug
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 […]
X-Biotix to address antibiotic resistance with chemical scaffolds
X-Biotix Therapeutics launched today with technology from Harvard Medical School that the company said will aim to address the threat of antibiotic resistance. According to the multi-year collaboration and license agreement, the team plans to identify antibiotic scaffolds that target multi-drug-resistant Gram-negative pathogens. X-Biotix spun out of the privately-held biotech X-Chem, which develops novel small molecule therapeutics […]
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 […]
SteadyMed raises another $5m from key shareholder
SteadyMed (NSDQ:STDY) said today that 1 of its largest institutional shareholders exercised warrants to purchase additional shares of the company that the investor got in conjunction with the 1st tranche of a previous private placement. Thanks to the exercise, San Ramon, Calif.-based SteadyMed received an additional $5 million in proceeds. The company said it is slated […]
Study: Radiation may boost immunotherapy in mesothelioma treatment
Doctors in Pennsylvania reported this week that combining immunotherapy drugs with radiotherapy could help to more efficiently treat malignant pleural mesothelioma. The analysis from the University of Pennsylvania looked at studies that combined immunotherapy drugs like Merck‘s (NYSE:MRK) Keytruda with radiation therapy. The team concluded that radiotherapy may boost the cancer-killing effects of immunotherapies. Malignant pleural […]
FDA chief: Changing generics regulations could reel in drug prices
Part of the FDA commissioner’s job is to oversee the federal regulatory watchdog as it evaluates pharmaceuticals for safety and efficacy. Most FDA chiefs have avoided the topic of drug prices, given that it isn’t a clearly-stated part of the agency’s mission But just 2 weeks into the job, newly-confirmed FDA commish Dr. Scott Gottlieb proposed […]