Devices
FDA has approved Roche’s human papillomavirus (HPV) self-collection solution, which the company says is one of the first available in the U.S. A company statement says the solution will expand access and screening options to help eliminate cervical cancer. “In a healthcare setting,” the statement says, “an
Drugs
An FDA 11/27-11/30/2023 inspection at Cohere Beauty’s Health Specialty drug manufacturing facility in Santa Fe Springs, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/15 Warning Letter says the specific violations were: * failure to establish
Drugs
In 2023, CDER approved 55 novel drugs either as new molecular entities through NDAs or new therapeutic biologics under BLAs. The Center’s Drug Trials Snapshot Summary Report 2023 says 36% of the novel drugs were first-in-class. Some 53% of the approvals were for the treatment of rare
Biologics
FDA has granted Juno Therapeutics accelerated approval for its BLA for Breyanzi (lisocabtagene maraleucel), a CAR T cell therapy for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The approval was based on data from the TRANSCEND-FL (NCT04245839)
Biologics
Rep. Mark Green (R-TN) has introduced the Vaccines in Trial and Liability Act of 2024 that would ensure Americans are protected from fraudulent vaccine trial data. The bill is “essential for the oversight and transparency of vaccine companies and the trial data they use to obtain emergency use authorizations
FDA Policy/General
Marking the 30th anniversary of the establishment of the FDA Office of Women’s Health (OWH), FDA commissioner Robert Califf and associate commissioner for women’s health Kaveeta Vasisht write in an online post that OWH has been “at the forefront of ensuring that the unique health needs of women
Drugs
Eisai and Biogen say that Eisai has initiated a rolling submission BLA for lecanemab-irmb (Eisai/Biogen’s Leqembi) subcutaneous autoinjector for weekly maintenance dosing. Leqembi is indicated for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of the disease (known as early Alzheimer’
Drugs
Parenteral Technologies is petitioning FDA to “publish a statement of enforcement expressly prohibiting the further use of misleading, confusing, and inadequate directions for over-the-counter single-ingredient liquid acetaminophen products for 2-3 years of age, 24-35 pound infants.” The petition calls for the removal and no further
Devices
FDA has cleared an Atraverse Medical 510(k) for its Hotwire radiofrequency (RF) guidewire, a device that enables zero exchange left-heart access while also acting as a rail for catheter-based therapy systems. The device, featuring universal sheath compatibility and “optimized RF technology,” is intended to “improve patient outcomes
Devices
Abbott is recalling (Class 1) its HeartMate 3 LVAS after reviewing complaints that identified blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff. “In all reported events, the issue was observed during implantation of the device,” a recall
Biologics
FDA has issued a complete response letter to Dynavax Technologies for its sBLA for a four-dose Heplisav-B vaccine (hepatitis B vaccine [recombinant] adjuvanted) regimen for adults on dialysis. A company statement says FDA said the application did not provide sufficient data to support the full evaluation of the
Devices
FDA has cleared an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that Indica says enables slides to be reviewed from any location the moment they are scanned, allowing pathologists to diagnose cases remotely without waiting on the physical transfer of slides. The clearance allows HALO
FDA Policy/General
Federal Register notice: FDA is amending its animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during January, February, and March. They are also being amended to improve their accuracy and readability. To view the notice, click here.
Devices
FDA says CTK Biotech’s ImmuView Covid-19 Antigen Home Test that is FDA authorized under an emergency use authorization now has a longer shelf life than previously authorized. “The expiration dates for these tests have been extended to reflect the longer shelf-life,” an agency notice says. The expiry
Drugs
FDA has extended by three months its review of an Ascendis Pharma NDA due to the company’s submission of additional information requested by the agency for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism. Because the late cycle submission constituted a major amendment, FDA has now extended the review action
Drugs
An 11/20-11/22/2023 FDA inspection at the Grupo Quimico SRL contract testing laboratory in Montevideo, Uruguay, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/30 Warning Letter says the specific violations were: * failing to ensure that laboratory records
FDA Policy/General
Federal Register notice: FDA is announcing that it issued Day One Biopharmaceuticals a priority review voucher for its recently approved pediatric disease product application. The agency determined that the company’s Ojemda (tovorafenib), approved 4/23 for treating certain patients six months of age and older with relapsed or refractory
Drugs
FDA has cleared a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respiratory infections and covers 21 viral and bacterial targets. It was previously authorized under an emergency use authorization as the QIAstat-Dx Respiratory SARS-CoV-2 Panel. “The
Drugs
A 10/30-11/20/2023 FDA inspection at Westwood Laboratories in Azusa, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/17 Warning Letter says the four specific violations were: * failure to thoroughly investigate any unexplained discrepancy or failure of
Drugs
United Therapeutics is asking FDA to withdraw its tentative approval of a Liquidia Technologies NDA for Yutrepia (treprostinil) and issue a complete response letter for the application. The 5/10 petition says that LGM Pharma, which United says is Liquidia’s sole active pharmaceutical ingredient (API) supplier, is the subject
Drugs
A California federal court has dismissed with prejudice a putative shareholders’ class action suit against AcelRx Pharms alleging that the company made false or misleading statements in marketing materials for its opioid pain killer Dsuvia (sufentanil) sublingual tablets to expand the target market, putting the company at risk for FDA
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