The CDC reports that a salmonella outbreak linked to beef products recalled by JBS Tolleson has expanded to 25 states, with 246 cases reported. States newly associated with the recall include Connecticut, Missouri and Massachusetts.
Novartis' Kymriah, or tisagenlecleucel, was recommended by the UK's National Institute for Health and Care Excellence for use in patients younger than 25 who have relapsed or refractory B-cell acute lymphoblastic leukemia. The drug will be funded by the National Health Service through the Cancer Drugs Fund.
A final guidance was published by the UK's National Institute for Health and Care Excellence endorsing for National Health Service funding Pfizer's Mylotarg, or gemtuzumab ozogamicin, in combination with daunorubicin and cytarabine, as a first-line treatment for patients age 15 and older with de novo CD33-positive acute myeloid leukemia.
The FDA has given Terumo Cardiovascular Group 510(k) clearance for its CDI Blood Parameter Monitoring System 550, a next-generation system that measures 12 critical blood parameters. The system comes with an improved probe design, an advanced optical fluorescence technology and a high-visibility LCD screen.
The FDA has granted Abbott clearance to market its DRG Invisible Trial System, which is designed to provide trial treatment with the company's dorsal root ganglion stimulation therapy to patients with complex chronic pain conditions. The system has also received CE mark approval from European regulators.
The European Commission has approved Exelixis and Ipsen Pharma's Cabometyx, or cabozantinib, as a monotherapy in adult patients with hepatocellular carcinoma who have received prior treatment with Bayer's Nexavar, or sorafenib.
Seattle Genetics' Adcetris, or brentuximab vedotin, being developed to treat patients with systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas in a first-line setting, was given breakthrough therapy status by the FDA.
Researchers found that young children with nonsevere fast-breathing pneumonia who received amoxicillin had significantly reduced treatment failure rates after three days, but had similar prevalence of treatment failure by day 4 and relapse by day 14, compared with those who were given placebo. The findings in JAMA Pediatrics prompted researchers to suggest the benefit of follow-up visits on day 4 in low-risk pediatric fast-breathing pneumonia.
United Therapeutics has agreed to pay $800 million upfront to Arena Pharmaceuticals in exchange for worldwide rights to the latter's ralinepag for pulmonary arterial hypertension, which is being tested in a late-stage trial. Aside from royalties from sales, Arena could receive $150 million if the drug gains approval from a key non-US market and $250 million if the inhaled version of the medication gains FDA approval.
The National Biosafety Committee in Pakistan discussed at a meeting Thursday recommendations for importing biotech canola and soybean. Approval of such imports would open the door to importing biotech seeds from the US, Canada, Argentina, Brazil and Chile, an official said.
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