Drugs
AstraZeneca says the Phase 3 PACIFIC-2 trial of its Imfinzi (durvalumab) concurrently administered with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of progression-free survival versus chemoradiotherapy alone to treat patients with unresectable, Stage 3 non-small cell lung cancer. A company statement says that
FDA Policy/General
Law firm Cooley has added 14-year FDA veteran Son Nguyen to the firm’s Washington, DC office. At the agency, he most recently served as senior counsel in the Office of the Chief Counsel where he handled matters involving devices and combination products. Previously, Nguyen was FDA associate chief
Drugs
Manhattan Institute senior fellow Randall Lutter, a former FDA senior scientific and regulatory advisor, says there are many steps Congress should be taking to have a fuller understanding of drug shortages and to hold FDA accountable for its actions. In an Issue Brief, Lutter says congressional Democrats and Republicans have
Drugs
A new Reagan-Udall Foundation report, “Enhancing Post-Market Evidence Generation for Medical Products,” addresses barriers, proposes solutions, and makes recommendations to FDA and other stakeholders that aim to facilitate evidence generation in the postmarket setting. The report defines pragmatic evidence generation as conducting prospective clinical studies of medical products
Devices
Covidien has recalled its McGrath MAC Video Laryngoscope in a move to remove stolen defective models that have been offered for sale illegally by unauthorized third parties. The devices had been previously assigned for destruction, but were stolen and sold on social media platforms, a recall notice says. “After the
Drugs
House Energy and Commerce Committee Republicans are threatening FDA with a subpoena if it continues to delay submitting documents on what they consider “risky” research conducted at agency facilities. The committee has called for increased scrutiny of federal laboratory biosafety protocols following the Biden administration’s lack of transparency in
Drugs
BridgeBio Pharma says it will submit by 12/31 an NDA for acoramidis after releasing Phase 3 data from its ATTRibute-CM study of acoramidis in transthyretin amyloid cardiomyopathy (ATTR-CM). The study of the next-generation, small molecule stabilizer of transthyretin (TTR) demonstrated that it “improved clinical outcomes for
Drugs
Novo Nordisk says data from its Phase 3 SELECT cardiovascular outcomes trial assessing the effects of once-weekly semaglutide 2.4 mg (Wegovy) in adults with established cardiovascular disease and overweight or obesity without diabetes showed that the drug was associated with a 20% risk reduction in MACE [major adverse
Devices
FDA has cleared an InMed.AI 510(k) for NeuroShield, which the company describes as an automated brain geometry-based quantifying analytics tool that uses “AI/Deep Net/3D Convolutional Networks to support physicians as a clinical decision support tool for neurologists and neuroradiologists.” NeuroShield takes 3D magnetic resonance images
Drugs
FDA has approved a Pacira BioSciences supplemental NDA to expand Exparel’s (bupivacaine liposome injectable suspension) label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa. The drug was previously approved to produce postsurgical local analgesia via infiltration in patients
Devices
FDA has granted Brixton Biosciences a breakthrough device designation for its Coolio Therapy, which is intended to deliver long-lasting pain control in targeted areas with a single injection. The designation is based on data from animal models that the company says demonstrated the capability of the treatment to provide
Drugs
Neurocrine Biosciences says it is stopping the development of two drugs being evaluated for treating focal onset seizures and anhedonia after reporting what it called were “disappointing results” from Phase 2 studies. The investigational selective NaV 1.6 inhibitor, NBI-921352, licensed from Xenon Pharmaceuticals, did not demonstrate a meaningful
FDA Policy/General
Federal Register notice: FDA is announcing an 11/29 Medical Devices Advisory Committee — Molecular and Clinical Genetics Panel meeting. Panel members are scheduled to discuss and make recommendations on the design of multi-cancer detection in vitro diagnostic devices as well as potential study designs and study outcomes of interest
Drugs
The Puerto Rico federal court has entered a consent decree requiring Droguería Betances LLC (Betances), one of the territory’s largest pharmaceutical distributors, to pay $12 million and make extensive improvements to its compliance program. According to the Justice Department, the consent decree resolves an 11/3 complaint alleging that
Biologics
A BMJ investigation has raised concerns that the federal government’s vaccine adverse event system is not operating as planned and safety signals are likely being missed. The national Vaccine Adverse Event Reporting System (VAERS) is co-managed by FDA and the Centers for Disease Control and Prevention (CDC). Investigations
Biologics
FDA has approved a Valneva Austria BLA for Ixchiq, a vaccine for preventing chikungunya in individuals aged 18 years and above who are at heightened risk of exposure. Chikungunya, a mosquito-borne virus, has emerged as a global health threat, with over five million reported cases in the last 15
Biologics
FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel) to expand its current indication to include treating adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2
Devices
FDA has granted Owlet a de novo marketing authorization for its Dream Sock, an over-the-counter medical pulse oximetry device for infants. It is designed, Owlet says, to monitor and display a baby’s “Live Health Readings,” including pulse rate and oxygen saturation level, and to provide health notifications
Drugs
FDA has accepted for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Abbvie’s Humira. The submission was based on data from a Phase 4 clinical study (NCT05510063) that assessed the pharmacokinetic similarity
FDA Policy/General
Federal Register notice: FDA has determined that Akorn’s Cogentin (benztropine mesylate) Injection (1 mg/1 mL) was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Cogentin
Drugs
CDER director Patrizia Cavazzoni says the Office of Pharmaceutical Quality will reorganize effective 1/14/2024. She says the reorganization “streamlines the office’s core functions to bring added flexibility without compromising accountability.” Under the change, the Office of New Drug Products, Office of Lifecycle Drug Products, and Office of
Devices
FDA is notifying healthcare providers about labeling updates to Becton Dickinson’s (BD) Phasix and GalaFlex mesh products, which were cleared for the repair and reinforcement of soft tissue where weakness exists. The agency says it has become aware of increased use of surgical mesh products in breast surgery, but