Earlier this year, while speaking with Fierce Medtech at the annual J.P. Morgan Healthcare Conference, Dexcom CEO Kevin Sayer noted that the continuous glucose monitor maker had recently changed its mission statement—swapping “health” for “diabetes” in its aim of “Empowering people to take control of health.”
CRISPR Therapeutics provided updated data from its ongoing Phase I CARBON trial of CTX110, its allogeneic “off-the-shelf” CAR-T therapy for CD19+ B-cell cancers. The data is based on 26 of 30 patients who, as of August 26, 2021, a data cutoff date, had received the therapy with at least 28 days of follow-up.
Enforcement Report - Week of September 1, 2021
BEERSE, Belgium--(BUSINESS WIRE)--The Janssen Pharmaceutical Companies of Johnson & Johnson today announced combination data from two studies and a long-term integrated analysis evaluating the use of Imbruvica® (ibrutinib) for the treatment of previously untreated patients with CLL. Results from a 48-month follow-up analysis of the Phase 3 E1912 clinical study reported a statistically significant difference in PFS and OS for ibrutinib plus rituximab compared to a standard chemoimmunotherapy regimen of FCR.1 Further, the latest integrated analysis from the Phase 3 RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115/1116) studies investigating the use of single-agent ibrutinib in CLL, reported at up to six years of follow-up, PFS, OS and response rates improved when ibrutinib was used in earlier lines of therapy.2 During this extended follow-up, ibrutinib was tolerated across all lines of therapy with 19 percent of patients discontinuing due to adverse events.2
Shares of Unum Therapeutics fell as much as 23 percent in premarket trading after the company announced late Tuesday the U.S. Food and Drug Administration (FDA) placed a clinical hold on its Phase I non-Hodgkin lymphoma trial due to safety concerns. This is the second clinical hold on this drug.
JIANGSU YEW Pharmaceutical Co. Ltd. Fails EDQM Inspection
Coming off the back of a series of trial deaths last year and the axing of its once-leading CAR-T treatment JCAR015 at the start of the year, Juno posted new data at ASCO showing some positive data for its second-chance CAR-T, although a death and some neurotoxicity were still present in the data set.
Actavis LLc Generic Fludarabine Phosphate Receives Approval In US