Drugs
Ascent Consumer Products is recalling one lot of its SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System following a confirmed test result of microbial contamination involving Staphylococcus aureus (S. aureus). “Use of the SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System contaminated with S. aureus can result in blood infections
Drugs
FDA has lifted a 12/2022-ordered clinical hold on Entrada Therapeutics’ Duchenne muscular dystrophy (DMD) therapy ENTR-601-44 and provided authorization to begin ELEVATE-44-102, a Phase 1b multiple ascending dose clinical study. The study of ENTR-601-44 in adult patients involves those with a confirmed
Drugs
Former CDER director Patrizia Cavazzoni is returning to her industry roots and rejoining Pfizer as the company’s chief medical officer. Cavazzoni spent seven years in CDER’s management, including the past four years as Center director after replacing Janet Woodcock who moved to a more senior role in the
Drugs
FDA has approved a Medtronic PMA for its BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI) for use in Parkinson’s patients. The device transmits electrical signals to specific parts of the brain affected by debilitating neurological disorders, like Parkinson’s. The BrainSense Adaptive technology is designed
Drugs
In a move that is attempting to reverse some of the damage to public health safety and regulatory reviews of innovative products, FDA is rehiring up to 300 scientists and reviewers, which is less than a third of about 1,000 agency staff that were terminated last week as part
Drugs
FDA has told Insmed that it does not currently plan to hold an advisory committee meeting to discuss the company’s NDA for brensocatib for patients with non-cystic fibrosis bronchiectasis. Insmed says brensocatib is the first in a new class of medicines called dipeptidyl peptidase 1 (DPP1) inhibitors for
Drugs
FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Opdivo (nivolumab) plus Yervoy (ipilimumab) for a first-line treatment option for adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The agency set a
Drugs
Drug compounding operations have filed suit against FDA in northern Texas federal court, seeking an order to reverse the agency decision last week to remove semaglutide (Novo Nordisk’s Wegovy and Ozempic) from the drug shortage list (see earlier story). “Arbitrarily dismissing evidence that the shortage persists, FDA removed semaglutide
Biologics
FDA has declined to approve an Invivyd request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of Covid-19 EUA for Pemgarda (pemivibart). The request sought authorization to provide a treatment option for mild-to-moderate Covid-19 in adults and adolescents who are immune compromised
Drugs
FDA has determined the shortage of semaglutide injection products (Novo Nordisk’s Wegovy and Ozempic) is resolved. “FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand,” an agency notice says. “Patients and prescribers may still see
Drugs
Pfizer has decided to discontinue the marketing of its hemophilia B gene therapy Beqvez (fidanacogene elaparvovec-dzkt) due to limited patient and physician interest in the $3.5 million one-time treatment. The product is intended for treating adults with moderate to severe hemophilia B who currently use factor IX
Drugs
FDA has accepted for priority review a Boehringer Ingelheim NDA for zongertinib (BI 1810631) for treating adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) mutations and who have received prior systemic therapy. The user fee review action target date is expected
Drugs
FDA has approved a Mirum Pharmaceuticals NDA for Ctexli (chenodiol) for treating adults with cerebrotendinous xanthomatosis (CTX), a very rare lipid storage disease. The genetic metabolic disorder is caused by a mutation in a gene called CYP27A1, “resulting in a deficiency of the enzyme that is important in the body’
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should revise its recommendations for sponsors requesting meetings concerning cellular and gene therapy products (CGTs) to better align with the drug user fee program’s commitment letter and existing agency procedures. PhRMA suggests this in just-posted comments on a draft
Drugs
CBER deputy director Celia M. Witten has left the agency, the latest high-ranking FDA official to depart as staff morale plunges in the wake of Trump Administration firings of probationary employees that began earlier this week (see story). According to a just-posted organization chart, Witten was one of
Drugs
Three Arnall Golden Gregory attorneys say that foreign drug and medical device companies are likely to see heightened FDA enforcement activity as part of the second Trump administration’s “America First” agenda. Writing in an online post, the attorneys present statistics on FDA overseas inspections before and after the Covid-
FDA Policy/General
HHS has appointed Robert Fox Foster as FDA’s next chief counsel. Foster previously served in the first Trump Administration as an HHS advisor to the Assistant Secretary for Preparedness and Response (4/2020 to 1/2021). He then moved to Capitol Hill to serve as a senior attorney on
FDA Policy/General
The White House says a list of more than 20 “prohibited words” that has been circulating at FDA may have misinterpreted the Trump administration’s gender ideology Executive Order. Reuters reports it was told by two sources familiar with the matter who requested anonymity out of fear of professional repercussions
Devices
Texas federal court judge Sean Jordan says a ruling will be issued in the consolidated suits against FDA over its final rule regulating laboratory-developed tests (LDTs) “as soon as the court can.” In a LinkedIn post, regulatory attorney Christine Bump, who attended the three-hour hearing on the suits,
Drugs
Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) have reintroduced their Safe and Affordable Drugs From Canada Act to “allow Americans to safely import prescription drugs from Canada — lowering costs, increasing access, and strengthening competition in the pharmaceutical market.” A statement issued by Grassley includes a link to
Devices
FDA has cleared an Ezra 510(k) for its Ezra Flash AI model for MRI imaging. The latest version of the device is intended to enhance imaging for neuro, abdomen and pelvis MRI images. It improves image quality by reducing noise within the image while maintaining diagnostic integrity, the company
Devices
FDA has granted PolarityBio a breakthrough therapy designation for SkinTE for treating Wagner Grade 1 diabetic foot ulcers (DFU). SkinTE is a human cellular and tissue-based product derived from a patient’s own skin to regenerate full-thickness skin with all of its layers (epidermis, dermis and hypodermis) and