FDA Policy/General
Federal Register proposed rule: FDA is proposing to revise the requirements for the content and format of labeling for approved or conditionally approved new animal drugs to provide a more comprehensive set of requirements in one location in the Code of the Federal Register. Under the revision, certain requirements would
Devices
Windstone Medical Packaging has recalled (Class 1) its Local Lower Extremity Pack, In-House Ocular Pack and Closure Kit in response to Nurse Assist’s 2023 ongoing recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to sterility concerns. The recalled kits contain Nurse
Drugs
FDA has issued Viatris/Mapi Pharma a complete response letter on their NDA for GA Depot 40 mg, a long-acting glatiramer acetate being investigated as a once-monthly injection to treat relapsing forms of multiple sclerosis. The companies say they are reviewing the letter’s content and will be
Devices
Abbott is recalling its HeartMate Touch System (version 1.0.32) due to the risk of an unexpected pump stop or start. “Issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a ‘pump stop’ command is running,” a recall notice says. “When
FDA Policy/General
President Biden is seeking a $500 million boost in FDA’s spending in fiscal year 2025, which is 7.4% more than the current $6.7 billion spending level in FY 2024, according to just-released budget documents from the White House. The FY 2025 budget proposal says the president
Drugs
FDA has released a draft guidance entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” The document addresses drug clinical development for treating stages of sporadic Alzheimer’s disease (AD) that occur before the onset of overt dementia (Stages 1 through 3, which are also referred to as early AD)
FDA Policy/General
Federal Register notice: FDA is correcting a 2/22 notice announcing the availability of a final guidance entitled ‘‘Assessing Covid–19–Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for Covid–19 Prevention or Treatment.” The document was published with an incorrect
FDA Policy/General
Federal Register notice: FDA is announcing 5/9 Blood Products Advisory Committee meeting that will consider strategies to reduce the risk of transfusion-transmitted malaria by testing blood donations from donors at risk of malaria exposure. To view the notice, click here.
Drugs
Johnson & Johnson has filed a supplemental BLA for Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). The submission is based on data from the Phase 3 QUASAR program in patients who had an inadequate response or intolerance to conventional therapy, prior biologics or JAK
Devices
FDA’s Medical Imaging Drugs Advisory Committee has voted 16-2 in support of approving a Lumicell NDA for Lumisight (pegulicianine), an optical imaging agent for use in patients with breast cancer. The combination product is intended for use with the Lumicell Direct Visualization System as an intracavity, fluorescence-guided
Devices
FDA has cleared a Getinge 510(k) for the Vasoview Hemopro 3, a third-generation endoscopic vessel harvesting (EVH) device. The Vasoview Hemopro is primarily indicated for patients undergoing EVH for arterial bypass. Its 7 mm extended length endoscope and dissection tip allows for visualization of a surgical cavity, dissection
Drugs
FDA has approved a new indication for Novo Nordisk’s weight loss drug Wegovy (semaglutide) injection — reducing the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and being either obese or overweight. “Wegovy is now the first weight loss medication to also be approved to
Drugs
FDA is continuing to slow roll its review decision on Eli Lilly’s experimental Alzheimer’s drug donanemab by requiring the agency’s Peripheral and Central Nervous System Drugs Advisory Committee to discuss the company’s Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab
Drugs
Faced with disappointing data from the Phase 3 PHOENIX clinical trial of Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio (sodium phenylbutyrate and taurursodiol), the company says it is considering voluntarily withdrawing the drug. “Amylyx will continue to engage with regulatory authorities and the broader ALS community, including ALS specialists
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of an Eli Lilly emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for treating Covid-19. Lilly requested the revocation after telling FDA that all lots of bamlanivimab and etesevimab manufactured and labeled for use under the EUA have expired,
Drugs
KVK Research, Inc., a generic drug manufacturer in Bucks County, PA, has pleaded guilty to criminal charges that it introduced adulterated drugs into interstate commerce and consequently it has agreed to pay a $1.5 million penalty on those charges and $2 million to resolve civil liability under the False
Drugs
Novo Nordisk says a Phase 1 trial of a pill version of its experimental weight-loss drug amycretin found that trial participants lost 13.1% of their weight after 12 weeks. Reuters reports that the result compares to a 6% loss after 12 weeks and 15% after 68 weeks in
Drugs
FDA has granted accelerated approval to BeiGene USA’s Brukinsa (zanubrutinib) with obintuzumab (Genentech’s Gazyva) for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. An agency notice says the regimen was evaluated in a trial of 217 patients. Efficacy was based on the overall
Drugs
The Alliance for Regenerative Medicine (ARM) says it is concerned that an FDA draft guidance, Advanced Manufacturing Technologies Designation Program, “fails to provide a clear framework for the adoption of advanced manufacturing technologies (AMT) across the cell and gene therapy industry.” In its comment letter, ARM questions the agency’s
Drugs
FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) for combination use with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC) (bladder cancer). The approval is based on data from the Phase 3 CheckMate-901 trial which evaluated Opdivo in combination
Biologics
Six House members from California and Arizona, five Republicans and one Democrat, are asking FDA commissioner Robert Califf to “reconsider expediently the addition of coccidioidomycosis, also known as Valley Fever, to the current list of tropical diseases that qualify for a priority review voucher as directed in House Report 117-
Devices
FDA has classified as Class 1 a Medtronic Neurology recall of its Duet External Drainage and Monitoring System due to the potential for catheter disconnection from patient line stopcock connectors. The device is used to drain cerebrospinal fluid (CSF) to reduce intracranial pressure and CSF volume in people who have