Devices
FDA has granted Quidel a de novo marketing authorization (see approval letter) for its Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set. This is the first Covid-19 antigen test to be made available outside of an Emergency Use Authorization, according to CDRH director Jeff Shuren.
Biologics
FDA has accepted a Mesoblast BLA resubmission for remestemcel-L for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). The agency has set a user fee review action target date of 8/2. In 2020, FDA issued a complete response letter on the original BLA and
Devices
An FDA safety update indicates that it has received reports about squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. The update provides more information following a 9/2022 safety communication about reports of cancers, including SCC and various lymphomas that are not the same
Drugs
FDA has extended the PDUFA review date for BioMarin’s BLA for Roctavian (valoctocogene roxaparvovec) gene therapy for adults with severe hemophilia A to 6/30. The agency said it had determined that the company’s submission of the three-year data analysis from the ongoing Phase 3 GENEr8-1
Drugs
An FDA Clinical Pharmacology Corner online post highlights four recent articles demonstrating how the agency says it is using proactive and innovative regulatory research to tackle the nation’s opioid crisis. The post references two articles published in 12/2022 that discuss the agency’s collaborative and innovative research into
Biologics
An FDA review of the Web site operated by Thomas Advanced Medical and other materials indicated that the firm is marketing products derived from either human umbilical cord, umbilical cord blood, or amniotic tissue, which the company refers to as “regenerative therapy solutions” or “stem cell derived biological products.” A
Devices
FDA has cleared an Abbott 510(k) for its Alinity i TBI test, the first commercially available laboratory blood test for traumatic brain injury (TBI). The test runs on Abbott's Alinity i laboratory instrument. The test “offers a new reliable result in 18 minutes to help clinicians quickly
Drugs
FDA has announced a 3/30 workshop entitled “Immune Globulin (IG) Hypersensitivity Reactions: Root Causes and Mitigation” that is intended to address “excessive numbers” of hypersensitivity reactions for specific product lots. While hypersensitivity is listed as a possible reaction to IG products, increased reports have led to voluntary market withdrawals
Drugs
Researchers from Johns Hopkins University and elsewhere say drug manufacturers should update labels for drugs that received accelerated approval and don’t contain all the information required by FDA. In an article accepted for publication in Pharmacotherapy, the researchers report that their review of labels of all drugs with indications
Devices
FDA says that more testing and analysis are needed to determine if several toxic compounds are present in additional hemodialysis and peritoneal dialysis systems. Updating its 5/6/22 letter to healthcare providers on the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids
Devices
FDA has granted Neuromod Devices a de novo request to market Lenire, the first bimodal neuromodulation device for treating tinnitus. The device comprises a controller, a tongue stimulator, and Bluetooth headphones. The handheld controller controls the timing, intensity and synchronization of the sound and tongue stimuli, according to the company.
Drugs
Aclaris Therapeutics says a Phase 2 clinical study investigating the efficacy and safety of zunsemetinib (ATI-450), an investigational oral MK2 inhibitor, and its use in patients with moderate to severe hidradenitis suppurativa (HS), did not meet its primary endpoint of change from baseline in inflammatory nodule/abscess count. The
Drugs
The Association for Accessible Medicines (AAM) says that while some FDA changes to a draft guidance on pre-submission facility correspondence (PFC) related to prioritized generic drug submissions are helpful, it believes that additional changes are needed. The association’s comment letter says the revised draft guidance provides some additional
Biologics
FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for Dupixent (dupilumab) for treating adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care (H1 antihistamine treatment). The company describes CSU as an inflammatory skin
Drugs
The National Cancer Institute says it has four concerns about an FDA guidance that requires studies of oncologic investigational agents to enroll additional patients on multiple dose levels to assess activity for dose optimization, before the therapy’s clinical effectiveness has been established and before the tolerability of therapy has
Biologics
FDA has accepted for priority review an Eisai and Biogen supplemental BLA for Leqembi (lecanemab-irmb) 100 mg/mL injection that is intended to support the conversion of the therapy’s 1/6 accelerated approval to a traditional approval for treating Alzheimer’s Disease (AD). The agency has set a
EIRs/483s
Two recent medical product cases could be a harbinger of more Department of Justice (DoJ) deferred prosecution agreements (DPAs) as a vehicle to resolve False Claims Act (FCA) suits, according to lawyers from Troutman Pepper. Earlier this year, Pennsylvania-based Jet Medical agreed to a $745,000 DPA to resolve
Drugs
FDA has announced a 4/12 Nonprescription Drugs Advisory Committee meeting to discuss the adequacy of efficacy data available for over-the-counter (OTC) use of oral phenylephrine as a nasal decongestant. Panel members are also scheduled to discuss whether oral nasal decongestants phenylephrine hydrochloride and phenylephrine bitartrate should be
Drugs
Incyte says it will discontinue the Phase 3 LIMBER-304 myelofibrosis trial after a pre-planned interim analysis performed by an independent data monitoring committee determined that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population. It says safety considerations were not a
Devices
FDA has cleared an Abbott 510(k) for its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring system sensors for integration with automated insulin delivery (AID) systems. Abbott says it modified the sensors to allow their integration with AID systems. AID systems assist patients with managing daily
Drugs
In response to a World Health Organization (WHO) warning about contaminated medications, including children’s cough/cold syrups found in Gambia with unacceptable amounts of diethylene glycol (DEG) and ethylene glycol (EG), CDER director Patrizia Cavazzoni says the agency is stepping up its actions to prevent contaminated drug products from
Drugs
Novartis has petitioned FDA to require potential generic copies of multiple sclerosis drug Mayzent (siponimod fumaric acid) oral tablets to meet certain requirements before being approved. Mayzent was approved 3/2019 for treating relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive