Several suppliers of branded ingredients said they were pleased with the FDA's decision to add eight nondigestible carbohydrates to the regulatory definition of fiber. The decision also allows food and beverage manufacturers to begin labeling updates as part of compliance with the Nutrition Facts label revisions final rule.
Sometimes working for your dad seems like destiny, but taking over the family business wasn't always the plan. There are many second- and third-generation medtech manufacturers run by executives following in their dads' footsteps -- and taking to heart lessons learned. For example, one of the lessons Eric Crainich learned from watching his dad run Design Standards was to try and look at what's next. "Markets are always changing," said Crainich, who is now president of the Charlestown, N.H.-based company. Thomas Osypka, president of Palm Harbor, Fla.-based Oscor, said his father gave him the advice to never get comfortable because you never know what lies ahead. Read the story.
The FDA lifted the clinical hold it placed in May on the Phase I/II trial of Solid Biosciences' Duchenne muscular dystrophy candidate SGT-001, saying the firm satisfactorily addressed its questions. The clinical hold was put in place after the first patient to receive the drug was hospitalized.
The FDA issued a complete response letter to Valeant Pharmaceuticals concerning its marketing application for Duobrii, or halobetasol propionate and tazarotene, lotion for plaque psoriasis. The agency's letter did not cite any deficiencies related to safety or efficacy of Duobrii but had questions about its pharmacokinetic data.
The FDA awarded fast-track status to ImmunoGen's mirvetuximab soravtansine, being developed to treat patients with medium to high folate receptor alpha-positive platinum-resistant ovarian cancer who have had up to three prior treatments and are eligible to receive a single-agent chemotherapy as their next line of treatment.
Data from Verastem's Phase Ib/II trial to assess the efficacy of duvelisib in combination with the chemotherapy regimen FCR, or fludarabine, cyclophosphamide and rituximab, as a first-line treatment for young patients with chronic lymphocytic leukemia was presented at the European Hematology Association's annual meeting. Results showed 76% of patients achieved bone marrow minimal residual disease negativity, with 26% attaining complete response and 68% achieving a partial response.
Health Canada plans to list the drug tramadol, which is metabolized by the liver into opioid compounds, as a Schedule I narcotic. The decision was based on a 2018 evidence report on tramadol's potential for problematic use, dependence and addiction.
The FDA has granted Johnson & Johnson Vision approval for its Idesign refractive studio, a technology designed to enable personalization of a Lasik procedure. The platform, which is indicated for monovision Lasik in patients with presbyopia myopia and approved for hyperopia, myopia and mixed astigmatism, enables clinicians to perform eye measurements using topography-integrated, wavefront-guided technology.
Microbot Medical has received word from the European Patent Office that it will grant the company a patent for its device designed for preventing stenosis in blood vessels.
Israeli firm DreaMed Diabetes' diabetes-management software Advisor Pro has been approved for marketing by the FDA. The software is designed to help health care providers manage type 1 diabetes patients who use continuous glucose monitoring and insulin pumps and provides insulin delivery recommendations.
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