Drugs
Eli Lilly and and Incyte say they plan to file in the second half of this year a supplemental NDA for baricitinib in alopecia areata after reporting positive data from a second Phase 3 trial (BRAVE-AA1). They say the data are consistent with findings from the first Phase 3
Biologics
FDA has granted Lexeo Therapeutics a fast track designation for LX1001, an adeno-associated virus (AAV) mediated gene therapy for treating apolipoprotein E4- (APOE4) associated Alzheimer’s disease. The central nervous system-administered therapy is being evaluated in an ongoing Phase 1 clinical trial. “APOE is the major transporter of
Devices
FDA says that Becton, Dickinson and Company (BD) is recalling 30 specified lots of its ChloraPrep Hi-Lite Orange 26mL applicator (2% w/w chlorhexidine gluconate and 70% v/v isopropyl alcohol) in the U.S. and U.S. territories. An agency announcement says the product is used as an
Drugs
FDA has granted accelerated approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR as determined by an FDA-approved test.
Devices
FDA has granted 510(k) clearance to the Orthofix Forza titanium TLIF spacer system. The company says the Forza spacer with nanovate technology is a titanium 3D-printed interbody featuring an optimized design, porosity, and surface that allows bone to grow into and through the spacer. “Interbody implants are spacers
Biologics
FDA has granted Allogene Therapeutics a Regenerative Medicine Advanced Therapy designation for ALLO-715 and its use in relapsed/refractory multiple myeloma. The designation was based on data demonstrating that the CAR T therapy ALLO-715 directed at B-cell maturation antigen can “achieve deep clinical responses while eliminating the
Biologics
Researchers from the Precision Vaccines Program at Boston Children’s Hospital and the University of Houston say they are using a $25 million grant from the National Institutes of Health Helping to End Addiction Long-term initiative to develop an adjuvant opioid use disorder vaccine. A University of Houston announcement
Drugs
FDA says there were 10 section 505(j) ANDAs subject to priority review approved in the second quarter of FY 2021 (January-March) and six approved in the first quarter (October-December). A report, required under the FDA Reauthorization Act of 2017, also shows 58 awaiting FDA action in the
Drugs
In an unprecedented move, FDA has released an inspection report less than 24 hours after it completed an inspection of Emergent BioSolutions’ Baltimore manufacturing plant that shows troubling findings which led to an agreement to shut down operations until corrections are implemented (see earlier story). The plant is key to
Devices
FDA has approved Medtronic’s Pipeline Flex embolization device with Shield Technology. The company says it developed Shield Technology, a proprietary breakthrough in biomaterial science, to advance flow diversion therapy by introducing the first surface-modified implant device that demonstrates a reduction in material thrombogenicity. The Pipeline device has been
Biologics
FDA has denied a 5/20/20 Cell2in petition calling on the agency to update one or more guidance documents to identify real-time glutathione (GSH) monitoring methods as an acceptable means of measuring potency for purposes of submitting a BLA for cell-based therapies, including stem cell therapies. The
Devices
FDA has cleared a LivaNova 510(k) for B-Capta, an in-line, blood-gas monitoring system integrated into its S5 heart-lung machine. The device is designed to monitor arterial and venous blood gas parameters during long and complex pediatric and adult cardiopulmonary bypass procedures, the company says. B-
Devices
FDA has cleared a Johnson & Johnson Vision 510(k) for its next generation Veritas Vision System, a phacoemulsification (cataract surgery) device that allows surgeons to guide through any lens density with less surge and more stability, according to the company. The new system also is intended to improve ergonomics
Biologics
A California Law Review article by two Yale Law School professors makes the case that FDA should “reboot” its rules to proactively disclose all safety and efficacy data for drugs and vaccines with minimal redactions, deploying data use agreements to ensure the most sensitive data is handled appropriately. The professors
Biologics
CBER director Peter Marks says there will be no further extensions to FDA’s intent to exercise enforcement discretion on IND and premarket approval requirements for certain regenerative medicine products. The enforcement discretion initially was to expire 11/2020 but was extended to 5/2021. In an online post, Marks
Drugs
The International Council for Harmonization (ICH) management committee has released a draft version of the ICH E6 good clinical practice guideline that continues to be developed by an expert working group. ICH says it determined that sharing the draft of the principles “would facilitate transparency and common understanding. Although public
Biologics
A 4/20 European Medicines Agency (EMA) safety review says Johnson & Johnson’s (Janssen) Covid-19 vaccine continues to have a favorable benefit-risk profile but it should carry a warning in its product information about rare and unusual blood clots with low blood platelets. The EMA’s conclusions
Drugs
FDA has placed a clinical hold on a proposed KalVista Pharmaceuticals Phase 2 clinical trial of KVD824 for preventing hereditary angioedema attacks. The agency has requested further information and analysis on certain KVD824 preclinical studies submitted to support the planned trial, the company says. Modifications were also proposed for the
Devices
FDA says a Medtronic 3/3 recall of 93 units of its Bio-Console 560 extracorporeal blood pumping console due to possible electrical failure causing the pump to stop is a Class 1 recall. An agency notice says the units were distributed between 4/1/09 and 2/12. The
Drugs
FDA and industry negotiators met 1/21 and 1/27 to continue discussions on proposals from each side to enhance the review process. The sides acknowledged the need to continue discussing overall proposed resource requests at future negotiation meetings. The 1/21 meeting summary lists these topics that were discussed:
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below:Hou Fu Biotech, Jiangsu, China (4/12): FDA tested the firm’s Panrosa Instant Hand Sanitizer and determined it is adulterated because
Devices
FDA has cleared a Zimmer Biomet 510(k) for the Rosa Partial Knee System for robotically-assisted partial knee replacement surgeries. The device features proprietary 2D to 3D X-Atlas imaging technology and real-time, intraoperative data collection on soft-tissue and bone anatomy to improve bone cut accuracy and