Drugs
FDA has approved a Baxter expanded indication for Clinolipid (lipid injectable emulsion) for use in pediatric patients, including preterm and term neonates. The proprietary mixed oil lipid emulsion is used to provide calories and essential fatty acids in parenteral (intravenous) nutrition when oral or enteral nutrition is not possible, insufficient
Devices
Philips Respironics has recalled (Class 1) its Trilogy Evo continuous ventilator devices due to a software issue that may cause a power malfunction. The product correction recall notifies customers to update the devices to the latest software version (1.05.06.00) to prevent “Battery Depleted” or “Loss of Power”
Drugs
Novo Nordisk says it will seek FDA approval by the end of the year for Mim8, its next-generation Factor 8a mimetic bispecific antibody that is intended to deliver sustained hemostasis for once-weekly or once-monthly prophylaxis for hemophilia A patients, with and without inhibitors. “Administered subcutaneously, Mim8 bridges
Drugs
FDA has granted Merus a breakthrough therapy designation for petosemtamab for treating patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed following treatment with platinum-based chemotherapy and an anti-programmed cell death receptor-1 or anti-programmed death ligand 1 antibody. The
Devices
FDA has issued a warning for healthcare providers and consumers not to use Cue Health’s Covid-19 tests in either home or patient care settings due to increased risk of false results. Users are recommended to consider retesting using a different Covid-19 test if a negative result was
Drugs
FDA has issued Eugia Pharma Specialties (an Aurobindo subsidiary) a seven-item Form-483 following a 5/3-concluded inspection at its sterile drug manufacturing facility in Rajasthan, India. The agency says the company’s procedures designed to prevent microbiological contamination of drug products are not followed, and they do
Drugs
FDA has accepted for priority review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The agency has set a user fee review action target date of
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for GlaxoSmithKline’s Jemperli (dostarlimab-gxly), indicated for treating adult patients with mismatch repair deficient recurrent or advanced endometrial cancer. The regulatory review period is 1,919 days, of which 1,428 days occurred during the
Biologics
FDA has told Moderna that it needs a couple more weeks to complete the review of its BLA for mRNA-1345, the company’s investigational respiratory syncytial virus vaccine, due to “administrative constraints.” The original user fee review action date was 5/12, and the agency now says it will
Devices
Megadyne is recalling and removing from the market all Mega Soft Pediatric Patient Return Electrodes after receiving reports of patient burn injuries in procedures where they were used. “A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential
Drugs
FDA has granted SN Bioscience a fast-track designation for its nanoparticle anticancer drug SNB-101 for treating small cell lung cancer (SCLC). The drug was previously granted orphan drug status for SCLC and pancreatic cancer 7/23 and February of this year, respectively. The company says the drug, an
Devices
Route 92 Medical is recalling (Class 1) several lots of its products containing the Tenzing 7 Delivery Catheters due to multiple instances of distal tip separation at the proximal marker band. The catheters that separated were made by an outside contract manufacturer, a recall notice says. “Additional investigations determined that
Drugs
FDA has granted Novartis a breakthrough therapy designation for Scemblix (asciminib) for treating adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Novartis says the designation was based on positive data from the Phase 3 ASC4FIRST study, in which Scemblix met both primary endpoints with
Devices
Vyaire Medical has recalled (Class 1) its Vyaire Twin Tube sample line 240 cm, Model Number V-707327, which is used in the company’s Vyntus CPX cardiopulmonary exercise test device. The Twin Tube line is connected to the adapter for the digital volume transducer that provides an exact determination
Drugs
RAPT Therapeutics has decided to close and unblind two Phase 2 trials of zelnecirnon (RPT193) following FDA clinical holds due to a serious adverse event reported in February. The Phase 2b trial of zelnecirnon (RPT193) in atopic dermatitis and a Phase 2a trial in asthma were halted by FDA after
Drugs
The Biotechnology Innovation Organization (BIO) says FDA should consider including greater discussion on the rationale for its draft guidance on the collection of race and ethnicity data in clinical trials and clinical studies for FDA-regulated medical products. In a comment letter, it says the discussion should include the consequences,
Devices
DuVal & Associates has submitted an amicus brief to the Supreme Court urging it to hear the appeal of two former Acclarent executives from a 1st Circuit Court of Appeals decision upholding their conviction on misdemeanor charges of distributing misbranded and adulterated medical devices. The appellate judges upheld the convictions
Drugs
FDA commissioner Robert Califf told a Senate Appropriations Committee hearing 5/8 that the agency is advising against enriched enrollment studies for opioid products going forward. Califf had been asked by Senator Joe Manchin (D-WV) what the agency’s position is following a 4/2023 advisory committee meeting that
Biologics
FDA has accepted for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The agency has set a
Devices
FDA has published a final guidance, Remanufacturing of Medical Devices, to clarify for the medical device industry the definition of “remanufacturing” for reusable medical devices needing maintenance or repair. The document says there has been a lack of clarity about the distinction between “servicing” and “remanufacturing” of a device. “Most
FDA Policy/General
A BMJ investigation says that while FDA says it takes conflicts of interest seriously, “financial entanglements with the drug industry are common among its leaders.” The article discusses current FDA commissioner Robert Califf and former commissioners Lester Crawford, Margaret Hamburg, and Scott Gottlieb. It notes that when Califf was confirmed,
Biologics
FDA says Exocel Bio in San Diego, CA, is selling unapproved exosome products through a Facebook page and YouTube channel. A 5/7 CBER letter cites examples of promotional statements that demonstrate the firm intends the products for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The