The FDA will consider a supplemental marketing application filed by Sanofi Pasteur for the use of its 0.5 mL Fluzone Quadrivalent influenza vaccine in patients ages 6 months to 35 months. The vaccine is currently approved for children who are at least 36 months old.
The E. coli outbreak linked to romaine lettuce has spread to 19 states and sickened 84 people -- with 42 needing hospitalization and nine developing kidney failure, according to the CDC. The outbreak has been traced to the Yuma, Ariz., area, although the grower, supplier, distributor or brand of lettuce responsible for the outbreak has not yet been identified.
OrphoMed's ORP-101, for the treatment of irritable bowel syndrome with diarrhea, was granted fast-track status by the FDA. The company plans to initiate a midstage study of the drug by the end of the year.
The FDA granted fast-track status to Synlogic's SYNB1618, which is being developed to treat patients with phenylketonuria. The company expects interim data from a safety, tolerability and exploratory Phase I/IIa study of the candidate in healthy volunteers and PKU patients to be available later this year.
A biologics license application was filed with the FDA by AbbVie for its interleukin-23 inhibitor risankizumab, which is being developed to treat moderate to severe plaque psoriasis.
The FDA granted approval to Mumbai, India-based Zydus Cadila to market its methylprednisolone tablets USP in 4-, 8-, 16- and 32-mg strengths for the treatment of severe allergic reactions, arthritis, blood and immune system disorders, certain cancers, eye conditions and diseases of the skin, kidneys, intestines and lungs. Also approved by the agency was the company's cinacalcet hydrochloride tablets in 30-, 60- mg and 90-mg strengths to treat high blood parathyroid hormone levels in patients with chronic kidney disease on dialysis and high blood calcium in patients with cancer of the parathyroid glands.
Terumo's RelayPro Thoracic Stent-Graft System was launched on a limited basis in Europe. The device, which is narrower than the earlier-generation RelayPlus, is intended to facilitate thoracic endovascular aortic repair procedures in patients with narrower access vessels.
A safety communication was released by the FDA warning health care providers about the risk of tissue overheating in MR-guided laser interstitial thermal therapy devices, which could be caused by inaccurate magnetic resonance thermometry information being displayed during treatment, leading to possible errors in ablation assessment. The agency is reviewing data and recommends physicians consider alternative treatment options, while asking device manufacturers to promptly report adverse events for the devices.
A round of Series B financing pulled in $60 million for Corvidia Therapeutics. The company intends to report in the second half of the year data from a midstage trial of COR-001, which is being developed as a treatment for patients with dialysis-dependent advanced chronic kidney disease who have a genetic mutation that increases their inflammation risk.
Approximately 280,000 sterilized male Aedes aegypti mosquitoes were released in northeastern Brazil in March using drones, taking only five minutes to treat a 20-hectare area. The bioengineered, lab-bred mosquitoes, of the species that spreads diseases such as Zika, dengue and yellow fever, will mate with females without producing viable eggs, thus reducing the mosquito population.
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