Drugs
FDA has approved Takeda’s Entyvio (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease after induction therapy with intravenous Entyvio. Approval is based on data from the VISIBLE 2 Study, a Phase 3, placebo-controlled trial. “In VISIBLE 2, about half
Devices
The Advanced Medical Technology Association (AdvaMed) says FDA’s draft guidance on “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials” needs to address what sponsors should do in the case of persons who choose not to identify race or ethnicity or those
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should hold more meetings on innovative clinical trial approaches. In comments submitted to the agency following a workshop last month on such approaches, PhRMA says more discussion would be helpful on model-informed drug development, global harmonization, real-world evidence, novel
Drugs
AbbVie is announcing what it calls “positive” top-line results from SELECT-GCA, a Phase 3, placebo-controlled study, that showed the company’s arthritis drug Rinvoq (upadacitinib) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remission from week 12 through week 52
Drugs
GlaxoSmithKline says data from the ZOSTER-049 long-term follow-up Phase 3 trial of its Shingrix (recombinant zoster vaccine) demonstrated that it maintains efficacy against shingles for more than a decade in adults over age 50. A company statement says the trial found 79.7% efficacy in participants aged
Devices
Philips Respironics has recalled (Class 1) its Trilogy Evo ventilator and all software versions, except 1.05.06.00, due to the device’s potential for sudden loss of ventilation due to “battery depleted” or “loss of power” alarms while the unit has sufficient power. A recall notice says a
Drugs
FDA has approved Lumicell’s Lumisight (pegulicianine) for use in adults with breast cancer to assist in the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during a lumpectomy. An agency statement says Lumisight is a fluorescent imaging drug that is administered through
FDA Policy/General
Federal Register notice: FDA is announcing that it issued a priority review voucher to Orchard Therapeutics for its rare pediatric disease drug approval for Lenmeldy (atidarsagene autotemcel), indicated for treating children with pre-symptomatic late infantile, pre-symptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy. To view the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Expedited Programs for Serious Conditions — Drugs and Biologics.” The collection supports regulations governing FDA expedited programs that are established under 21 CFR Part 312, subpart E, and are intended to speed the availability of new therapies to
Drugs
FDA’s new Patient Medication Information (PMI), proposed in 5/2023, will eventually replace Medication Guides and Patient Package Inserts, according to CDER Office of Medical Policy regulatory counsel Christopher Diamant. Interviewed for a CDER Conversation, Diamant says PMI was developed after research showed that the existing Consumer Medication Information
Drugs
The Supreme Court has declined to hear an appeal of a 1st Circuit Court of Appeals decision holding that state consumer protection claims that rely on violations of the Federal Food, Drug, and Cosmetic Act (FFDCA) are impliedly preempted. Attorneys Gina Tincher and Stacy Carpenter (Polsinelli) write in an online
Drugs
Former FDA principal deputy commissioner Janet Woodcock is playing an advisory role at the Haystack Project, the nonprofit group has confirmed on its Web site. The group says it is dedicated to ensuring patient access to treatment options for the rare and especially ultra-rare community. Formed in 2016, Haystack
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it recognizes that data monitoring committees (DMCs) have a unique role in clinical trial oversight and can provide specialized expertise to evaluate emerging safety and efficacy data for ongoing clinical trials. Responding to an FDA draft guidance on the use of data
Drugs
FDA has approved a Genentech NDA for Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. “With an unprecedented 76% reduction in the risk of disease recurrence or death versus
Drugs
FDA has released the form FDA-483 issued following a 3/28-4/5 inspection at the Eugia Steriles Private Limited drug manufacturing facility in Andhra, Pradesh, India. It was the third form FDA-483 issued to a Eugia facility in 2024 so far. The three inspection observations on the
Drugs
FDA has posted its official notice that Oncopeptides’ accelerated-approval multiple myeloma drug Pepaxto (melphalan flufenamide) has been withdrawn for failure to demonstrate clinical benefit and safety and effectiveness. In February, the agency denied an Oncopeptides appeal seeking to stop CBER action aimed at causing the company to voluntarily withdraw
Drugs
FDA has denied an 11/2/2023 petition submitted by Hyman, Phelps & McNamara seeking permission to submit an ANDA for loperamide HCl capsules 1 mg and 4 mg, citing a reference to Johnson & Johnson’s Imodium capsules 2 mg. The agency’s 4/17 denial letter says that
Devices
CDRH has released two reports on medical device safety and innovation. The reports have summaries of the Center’s accomplishments and planned initiatives for the future. They say that over a decade ago CDRH established a new vision for the Center based on the pillars of safety and innovation. “We
Devices
Boston Scientific is recalling (Class 1) its embolic agent Obsidio Embolic by issuing a correction after an investigation determined that delivery of the device using the aliquot technique, a commonly used delivery method in embolization procedures, for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. To date,
Devices
Sen. Bill Cassidy (R-LA) is calling on FDA to justify its decision to expand its oversight over clinical decision support (CDS) software beyond its statutory authority. In a letter to FDA commissioner Robert Califf, Cassidy says the agency’s 9/2022 final guidance that seeks to regulate CDS as
Devices
Fresenius Kabi USA has recalled its Ivenix Infusion System’s pump software due to a necessary software update. “The reason for the recall is that multiple software anomalies were occurring that have the potential to result in serious patient harm or death,” a recall notice says. “To remedy this issue,
Drugs
Eli Lilly says it will file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea (OSA) based on just-announced data from the SURMOUNT-OSA Phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI)