FDA Policy/General
FDA Office of Privacy information specialist Elizabeth Booker Houston’s recent departure after five years at the agency has gone viral following her dramatic resignation announcement with a pointed message for the White House. The lawyer, public health professional, and stand-up comedian took to Instagram last weekend, according to
FDA Policy/General
Some FDA employees who received reduction-in-force (RIF) informational packets were given sensitive information about other employees as well as information about themselves. FedScoop reports it spoke to two agency employees who were affected by the RIF and said they knew of instances when fired workers received personally identifiable
Drugs
A 2/18-2/20 FDA inspection at Gussyup, doing business as Private Label Grooming in Henderson, NV, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 7/9 Warning Letter says the specific violations were: * failure of the firm’s quality control
Devices
A 9/10-9/13/2024 FDA inspection at the Spectra Therapy facility in Port Huron, MI, found multiple types of violations in the firm’s manufacturing of the LASERwrap system of therapeutic heating infrared lamps. A 7/22 Warning Letter says Quality System Regulation violations were: * failure to establish
Drugs
Novartis is reporting that its experimental antibody ianalumab, when combined with eltrombopag, significantly extended the time to treatment failure in patients with primary immune thrombocytopenia (ITP) who had previously received corticosteroids. The finding comes from the Phase 3 VAYHIT2 trial and marks another late-stage success for the drug in
Devices
Draeger is recalling (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide (CO₂) readings. The filters are used during anesthesia and mechanical ventilation to protect against bacterial and viral contamination. A recall notice says that misleading carbon dioxide readings could result in healthcare
FDA Policy/General
Infactory CEO Brooke Hartley Moy says she was not surprised when FDA’s internal artificial intelligence tool Elsa started producing fake research data. Interviewed for an online Cybernews report, Moy says AI models are still far from perfect and are known to hallucinate facts, oversimplify nuance, and generate confident nonsense.
Drugs
FDA has approved an Insmed NDA for Brinsupri (brensocatib) tablets as the first treatment for non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older. “There have been no approved therapies for NCFB,” an FDA release says. “Before today’s action, patients relied on antibiotics and symptom management, such
Drugs
Merck says the combination of Keytruda (pembrolizumab) and Pfizer’s Padcev (enfortumab vedotin-ejfv), given before and after surgery, significantly improved survival outcomes in patients with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy. In the Phase 3 KEYNOTE-905 (EV-303) trial, the regimen achieved statistically significant
Devices
Medical device manufacturers should be using FDA Warning Letters as a source of strategic intelligence that highlights recurring patterns, systemic gaps, and evolving priorities that can be used to strengthen compliance and drive operational excellence. That’s the view of “independent expert” Marcelo Trevino, writing in a MedDevice Online column.
Biologics
The emergency use authorization for Pfizer’s Covid-19 vaccine for children under five may not be renewed by FDA this fall, according to The Guardian. An internal email obtained by The Guardian indicates that Moderna may be asked to step in to fill the gap. If the agency action
Drugs
Less than two weeks after abruptly resigning, Vinay Prasad has returned to FDA to continue leading CBER at the request of commissioner Marty Makary and HHS secretary Robert F. Kennedy Jr. Prasad, who had come under attack from right-wing activist and commentator Laura Loomer, former Sen. Rick Santorum (R-
Drugs
Novartis says that it will seek FDA approval of its investigational drug ianalumab after it met the primary endpoint in two Phase 3 trials for Sjögren’s disease, a chronic autoimmune condition that can damage glands, skin, joints, kidneys, lungs, and other organs. Most patients experience dry eyes and mouth,
Drugs
FDA has accepted for priority review a GSK supplemental NDA for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoea in patients aged 12 and older. The agency has set a user fee review action target date of 12/11. If approved, gepotidacin would become the first oral option for
Biologics
IO Biotech is reporting that its investigational cancer vaccine Cylembio (imsapepimut and etimupepimut, adjuvanted), combined with Merck’s Keytruda (pembrolizumab), improved progression-free survival (PFS) compared with Keytruda alone in a pivotal Phase 3 trial for first-line treatment of advanced melanoma. While the results were clinically meaningful, according to
Devices
FDA has approved Nyxoah’s Genio system, a hypoglossal nerve stimulation (HGNS) therapy for certain patients with moderate to severe obstructive sleep apnea. The device is intended for adults with an Apnea-Hypopnea Index (AHI) between 15 and 65 events per hour. The company says Genio offers HGNS treatment by
Drugs
FDA has issued Dr. Reddy's Laboratories a seven-item Form FDA-483 after inspecting the firm’s sterile drug manufacturing facility in Andhra Pradesh, India. According to the FDA-483, the agency cited the following: * Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
Drugs
FDA has accepted for review an Arvinas and Pfizer NDA for vepdegestrant, a first-in-class oral PROteolysis TArgeting Chimera (PROTAC) therapy for treating estrogen receptor–positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer in patients who have previously received endocrine-based therapy. The agency has set a
Drugs
FDA has approved PharmaTher’s KETARx (ketamine), indicated for use in treating surgical pain. The company says the approval of KETARx “provides a strong foundation for expanding the development of ketamine across diverse therapeutic areas within the company's product pipeline.” It says. Tthese include mental health conditions like
Biologics
FDA has mandated significant labeling changes for Bluebird Bio’s Skysona (elivaldogene autotemcel), a gene therapy approved for treating early, active cerebral adrenoleukodystrophy (CALD), after seeing an increase in reports of life-threatening hematologic malignancies among patients who received the treatment. Skysona, a lentiviral autologous hematopoietic stem cell (HSC)-based
Drugs
FDA says a nationwide shortage of sodium chloride 0.9% injection products has officially ended. “This success is the result of close collaboration between the FDA, the Administration for Strategic Preparedness and Response, and our industry partners, who worked swiftly and strategically to expand manufacturing capacity and restore stability to
Devices
Becton Dickinson has recalled (Class 1 device correction) its BD Alaris Pump Module Model 8100 with Guardrails, Suite MX software versions, because the infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.