The FDA approved a label update of UCB's Cimzia, or certolizumab pegol, to include new data showing a negligible to low risk for drug transfer through placenta and a minimal risk for transfer through breast milk among pregnant women. The drug is currently approved as a treatment for adult patients with active psoriatic arthritis, moderate to severe active rheumatoid arthritis and active ankylosing spondylitis, as well as to ease the symptoms of Crohn's disease and maintain clinical response in adult patients with moderate to severe active disease who do not respond adequately to conventional therapy.
Novartis' Tasigna, or nilotinib, was approved by the FDA for an expanded indication that includes pediatric patients ages 12 months and older as a first- and second-line treatment for Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. Priority review for the new indication was granted based on data from two studies assessing nilotinib's safety and efficacy in 69 pediatric patients with Ph+ CML-CP.
An Australian study published in the New England Journal of Medicine evaluating the efficacy of the combo regimen of venetoclax and rituximab showed that the therapy reduced the risk of disease progression or death by 83% in patients with relapsed or refractory chronic lymphocytic leukemia compared with the combination of bendamustine and rituximab. Data from the international, multicenter late-stage study involved 389 patients with relapsed/refractory CLL who previously received up to three lines of therapy, including at least one chemotherapy treatment.
LEO Pharma's Kyntheum, or brodalumab, was recommended by the National Institute for Health and Care Excellence for National Health Service funding as a treatment for adult patients with severe plaque psoriasis who do not respond to or cannot take standard systemic therapies. The drug achieved complete skin clearance in 37% to 44% of patients at week 12 of treatment versus 19% to 22% of patients using ustekinumab, and continuous brodalumab use helped patients achieve sustained high levels of skin clearance through week 52.
A recall was issued by California Jerky Factory for more than 1,200 pounds of beef jerky products for potential underprocessing because of a possible processing deviation at the facility. The recalled products bear the establishment number Est. 18995 and were distributed to retail locations in Hawaii, Nevada and California and direct to customers online.
Orthofix International's G-beam Fusion Beaming system was granted 510(k) clearance by the FDA for use in treating patients with Charcot foot and has also been launched this week. The internal fixation system, which includes single-use sterile-packaged implants and an instrumentation tray, implants beams in the medial and lateral foot columns to align, stabilize and fixate the foot.
A trial of the Perceval sutureless aortic valve implant was initiated by LivaNova in China to support registration of the device in that country. The study, which will follow 160 patients for five and eight years, has a primary endpoint of one-year composite endpoint of major cardiac events in accordance with the Clinical Events Committee adjudication.
A final rule on the process of Individual Case Safety Reports for combination products was released by the FDA, extending the deadline for complying with the requirements outlined in the 2016 rule from July 19, 2018, to July 31, 2019, for companies who use the agency's Electronic Medical Device Reporting System and Adverse Event Reporting System and to Jan. 31, 2020, for those who use the Vaccine Adverse Event Reporting System. The agency also issued a separate draft guidance outlining its views on when companies can submit single postmarket safety reports for these products.
A study in the New England Journal of Medicine said Regeneron and Alnylam have discovered a new druggable target for severe liver diseases, including nonalcoholic steatohepatitis. "This target -- HSD17B13 -- from a human genetics perspective it really is the PCSK9 of NASH," said Alnylam CEO John Maraganore, and because the target showed promise, the companies will collaborate in a deal in which they will share research costs and commercial potential equally.
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