A final rule has been released by the FDA for the simplification of its medical device classification and reclassification procedures. The rule clarifies that the agency can reclassify any device from Class III to either Class II or Class I, makes convening a panel to consult on a device reclassification optional and removes the two-form requirement for reclassification petitions.
Guardant Health and AstraZeneca entered into a multiyear agreement that will allow them to jointly develop blood-based companion diagnostic assays to determine non-small cell lung cancer patients' response to Tagrisso, or osimertinib.
Drugmakers are urging the FDA to clarify its guidance on postapproval changes for drugs and align it with International Council for Harmonization guidelines. "ICH Q12 is recognizing that too many changes require regulatory reporting and often at too high a reporting level, stifling innovation and creating potential global supply challenges," said Eli Lilly and Co.
The FDA has required Ampio Pharmaceuticals to conduct a new clinical study for Ampion in knee osteoarthritis patients to support its marketing application. A special protocol assessment that will expand the study from 150 to 300 patients is anticipated.
A select recall initiated by GE Healthcare involving its Carescape R860 inspiratory safety guards, intended to be used with a ventilator, has been classified by the FDA as Class I. The recall was issued because of a manufacturing defect that poses a risk of device disconnection from a patient's breathing circuit, which could lead to insufficient breathing support.
The FDA has named Adam Bros. Farms as a possible source in the ongoing E. coli outbreak from romaine lettuce, but the agency says other farms could be involved in the outbreak that sickened 59 in the US and 27 in Canada.
Vertex Pharmaceuticals received approval from Health Canada for Orkambi, or lumacaftor/ivacaftor, in patients ages 2 to 5 who have cystic fibrosis with two copies of the F508del mutation in the CFTR gene.
Akebia Therapeutics and Keryx Biopharmaceuticals have completed the merger of their companies and are doing business under Akebia Therapeutics. Akebia is still traded on the Nasdaq Capital Market, while Keryx has been delisted, and its shareholders will receive shares in the merged company.
The FDA granted fast-track designation to Eli Lilly and Co. and Incyte's baricitinib, which is being developed to treat patients with systemic lupus erythematosus.
AMAG Pharmaceuticals announced plans to acquire Perosphere Pharmaceuticals for up to $415 million, and AMAG said the acquisition would expand its hematology pipeline with access to Perosphere's ciraparantag, or PER977, a next-generation anticoagulant reversal drug. Perosphere could receive up to $140 million in payments linked to regulatory milestones achieved in the US and approval from European regulators.
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