Red Lobster, Panera Bread and Texas Roadhouse revealed their suppliers of romaine lettuce linked to E. coli outbreak and have since been dismissed from the list of at least 11 defendants in civil complaints connected to the outbreak. A total of 210 people were infected and five died from the outbreak, which reached 36 states.
Researchers from the University of Wisconsin-Madison and The Ohio State University have developed a strategy for keeping blood vessels open following angioplasties and bypasses. The researchers suggest that they can suppress smooth muscle cell growth while protecting endothelial cells and allow them to regrow after surgery. Read the full story.
New York-based Provista Diagnostics has announced completion of a 28-state pilot commercialization program for its Videssa Breast assay, a blood test designed to provide early breast cancer detection. The company, which aims to help patients with difficult-to-interpret or abnormal mammograms, is looking to expand the rollout through strategic partnerships and to conduct a prospective clinical study based on previous trials of the test.
Aravive Biologics' AVB-S6-500, being developed to treat patients with platinum-resistant recurrent ovarian cancer, received fast-track designation from the FDA. An early-stage trial of the candidate demonstrated favorable safety with no serious adverse events in healthy volunteers.
Development of pediatric medical devices may be encouraged by increasing Pediatric Medical Devices Consortia grants, creating new investment models and reforming the reimbursement landscape, industry stakeholders told the FDA during a two-day workshop. Berlin Heart President and CEO Bob Kroslowitz, who represented the Pediatric Working Group of AdvaMed, said these changes might need to be enacted by Congress and that the industry should call for bills that provide incentives, such as linking reimbursement to pediatric medical devices to improve prices for procedures carried out by Medicaid-funded clinical centers.
The European Medicines Agency granted Pfizer's lorlatinib promising innovative medicine status. Loratinib is currently under review for patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer who have already received a second-generation ALK tyrosine kinase inhibitor.
China's State Drug Administration granted approval to Roche Holding's Alecensa, or alectinib, as monotherapy for the treatment of patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer. In a late-stage trial, the drug achieved the primary endpoint of improving progression-free survival compared with Xalkori, or crizotinib, and the results helped alectinib get approved.
Harbour BioMed acquired the rights to Sichuan Kelun-Biotech Biopharmaceutical's anti-PD-L1 antibody A167 outside of greater China. The deal gives Kelun-Biotech up to $350 million from upfront and milestone payments, plus royalties.
An initial public offering has been filed by Principia Biopharma, which aims to raise up to $86.3 million to bring its lead candidate, PRN1008 -- a Bruton's tyrosine kinase inhibitor being evaluated in midstage trials for pemphigus, an autoimmune skin disease, as well as the bleeding disorder immune thrombocytopenic purpura -- into late-stage testing.
A marketing application was filed in Europe by Theratechnologies for Trogarzo, or ibalizumab-uiyk, for the treatment of adult patients with HIV-1 infection.
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