Devices
A hard-hitting SC Media online post says even the most equipped health systems are unprepared to meet FDA’s new medical device cybersecurity safeguards. The post looks at FDA guidance to implement new requirements from the Consolidated Appropriations Act of 2023 and the six-month grace period given until
Devices
FDA has announced a voluntary Radiation Sterilization Master File Pilot Program to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. A notice says the pilot will be open to nine companies that sterilize single-use, PMA-
Devices
CDRH director Jeff Shuren acknowledged that new regulatory reforms from Congress will be needed for FDA and the medical device industry to experience transformative outcomes from the quickly developing artificial intelligence (AI) and software-driven medical device space. Speaking at an American Enterprise Institute panel on the future of AI,
Drugs
[Analysis by Jim Dickinson] He “does not second-guess FDA’s decision-making lightly,” writes mifepristone (Mifeprex) trial pro-life judge Matthew J. Kacsmaryk, a Trump appointee, in his 67-page condemnation of the abortion drug – but he relishes doing so. The historic order, the heaviest-ever to hit the
Drugs
Texas federal judge Matthew J. Kacsmaryk’s unprecedented late-Friday decision against the 23-year-old approval of mifepristone (Mifeprex) (see earlier story) has provoked many reactions from across the spectrum that worry about FDA’s globally respected approval gold standard and the court’s ideological stance that is trumping
FDA Policy/General
Federal Register notice: FDA has announced a 5/18 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfizer BLA for Abrysvo (respiratory syncytial virus vaccine). The submission is seeking an indication for preventing lower respiratory tract disease and severe lower respiratory tract disease caused by respiratory syncytial
FDA Policy/General
Federal Register notice: FDA has announced a 6/9 Peripheral and Central Nervous System Drugs Advisory Committee to review an Eisai supplemental BLA for Alzheimer’s drug Leqembi (lecanemab) solution for intravenous infusion. The submission includes a confirmatory study that seeks to convert the drug’s current accelerated approval to
FDA Policy/General
Federal Register notice: FDA is announcing a 5/12 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review a Sarepta Therapeutics BLA for delandistrogene moxeparvovec. The submission is seeking an indication for treating ambulatory patients with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. To
Devices
FDA has granted Reach Neuro a breakthrough designation for its Avantis platform, which the company says uses small electrical impulses delivered to the spinal cord to help restore shoulder, arm, and hand movement to patients impaired due to chronic stroke. The designation is based on data showing two study subjects
Drugs
The Department of Justice (DoJ) has officially appealed Texas federal judge Matthew J. Kacsmaryk’s 4/7 controversial court order (see earlier story) to undo FDA’s 2020 approval of mifepristone (Mifeprex). The 4/10-filed emergency motion to the Fifth Circuit Court of Appeals urges the court to immediately
Drugs
After an interim analysis showed disappointing data, Merck and Eisai say they are discontinuing the Phase 3 LEAP-003 trial evaluating Keytruda plus Lenvima for first-line treatment of adults with unresectable or metastatic melanoma. The decision is based on an independent data monitoring committee recommendation after it found that
Drugs
Horizon Therapeutics says it plans to discuss with FDA positive and statistically significant topline results from its randomized, double-masked, placebo-controlled Phase 4 clinical trial (NCT04583735) evaluating Tepezza for treating adults with chronic thyroid eye disease and low Chronic/Low Clinical Activity Score (CAS), which is a measure of
Drugs
FDA has granted Sumitomo Pharma Oncology an Orphan Drug Designation for TP-1287, an investigational oral CDK9 inhibitor for treating Ewing sarcoma. The rare type of cancer occurs in bones or in the soft tissue around the bones. “The disease occurs when a cell develops changes in its DNA that
Devices
Philips is recalling (Class1) certain reworked DreamStation breathing devices because some were assigned incorrect or duplicate serial numbers during initial programming. “This duplication can cause therapy to be delivered using the wrong prescription or factory default settings,” a recall notice says, adding that it may fail to deliver any therapy
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Imports and Electronic Import Entries” (OMB Control Number 0910-0046). The collection supports agency regulations governing import activities and related agency guidance. The regulations prescribe required data elements that respondents must submit when importing, or offering for
FDA Policy/General
Federal Register notice: FDA is adding quinacrine hydrochloride to its list of bulk drug substances (active pharmaceutical ingredients for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for exemptions from the
Drugs
Janssen Biotech and Pharmacyclics have announced their decision to voluntarily withdraw two accelerated approval indications for Imbruvica (ibrutinib) — treating patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and treating patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least
Drugs
U.S. Representative Andy Kim (D-NJ) has reintroduced his Protecting Americans from Unsafe Drugs Act which would provide FDA with mandatory recall authority for any and all faulty or unsafe prescription and over-the-counter drugs. Over the years, several bills have been introduced to give the agency this
Devices
Florida has won a $600,000 payment to the state’s Medicaid program under a multistate action against cochlear implants maker Advanced Bionics. The state’s action grew out of a Department of Justice (DoJ) $12 million whistleblower settlement earlier this year (see story) that resolved allegations that the firm
Drugs
FDA is exploring whether it can enter into a five-year contract with an entity that can perform “non-invasive high-resolution imaging and artificial intelligence image analysis to characterize freeze-dried pharmaceuticals and complex drug products to understand the impact of advanced manufacturing techniques, formulation, and process parameters on
Drugs
Yale University researchers say that as FDA broadens its use of accelerated approvals, it should be taking steps to increase public trust in that approval pathway. Writing in the New England Journal of Medicine, the researchers say the agency’s empowered stance on using accelerated approvals resonates with those who
Biologics
Researchers from the University of Rochester and around the world who are members of the RENOIR Clinical Trial Group say a Phase 3 trial of Pfizer’s investigational bivalent RSV (respiratory syncytial virus) prefusion F protein-based (RSVpreF) vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute