Bayer (ETR:BAYN) said yesterday that the FDA approved a supplemental biologics license application for the BetaConnect Navigator and myBetaApp – software for its electronic BetaConnect auto-injector. The company’s BetaConnect auto-injector administers Betaseron for patients with relapsing-remitting multiple sclerosis. The newly-approved software allows patients to connect their device with the myBetaApp on their mobile device or computer […]
Food & Drug Administration (FDA)
Novo Nordisk seeks to include cardiovascular data in Tresiba insulin label
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 […]
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 […]
FDA cybersecurity workshop offers long-term solutions for medical device sector
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration’s latest workshop on medical device cybersecurity issues, held May 18 and 19, 2017, firmly established myriad challenges in mitigating this risk, and that no easy or quick fixes are yet available to help manufacturers and other stakeholders address these challenges. Get the full story […]
FDA Commissioner asks staff for ‘more forceful steps’ to stem the opioid crisis
By: Scott Gottlieb, M.D. As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases […]
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 […]
BioCorRx to meet with the FDA for injectable, sustained-release opioid addiction therapy
BioCorRx (OTC:BICX) said today that the FDA has granted the anti-addiction developer a pre-investigational new drug meeting, scheduled for Sept. 19. The Anaheim, Calif.-based company said it is slated to review the development and marketing plan for BICX101, an injectable, sustained-release formulation of naltrexone as a therapy for opioid addiction and alcohol use disorders. At […]
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 […]
FDA launches medical device cybersecurity workshop
By Stewart Eisenhart, Emergo Group Effectiveness of ongoing efforts to address medical device cybersecurity risks will depend on whether stakeholders can properly balance security, safety and usability issues as well as understand end-user environments, according to speakers at a new US Food and Drug Administration workshop. Get the full story here at the Emergo Group’s […]
Trump proposes deep cuts to Medicaid, NIH funding
President Donald Trump’s proposed budget would slash Medicaid funding and cut support for major biomedical research programs at the National Institutes of Health and the Centers for Disease Control & Prevention. The budget blueprint drew condemnation from healthcare advocates and lawmakers from both sides of the aisle. Senate majority whip Sen. John Cornyn (R-Texas) reportedly said earlier […]
