Drugs
Vanda Pharmaceuticals has filed a lawsuit against FDA that seeks a declaratory judgment giving the company protection under the First Amendment to promote Hetlioz (tasimelteon) for the off-label use of treating jet lag. The drug is currently approved for treating non-24-hour sleep-wake disorder, and Vanda had
Biologics
Former CBER director Peter Marks, who recently resigned due to pressure from the Trump administration over vaccines, told Time in a 4/8 interview that he was seeing “an increasing anti-vaccine tone” before he left. “I was hoping to work through it, but it was very clear to me
FDA Policy/General
FDA has approved an Argenx BLA for a new option for patients to self-inject Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for treating generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). Vyvgart Hytrulo is now approved as a 20-to-30-second subcutaneous injection administered
Biologics
FDA has granted Arcturus Therapeutics a fast-track designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, for protecting against disease caused by influenza A H5N1. The vaccine, which is formulated with Arcturus’ proprietary LUNAR delivery technology, is designed to make many copies of mRNA within the
Drugs
FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) for combination first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). Approval was based on data from the CHECKMATE-9DW (NCT04039607) trial in 668 adults with unresectable or metastatic HCC. The primary efficacy outcome
Drugs
U.S. senator Rand Paul (R-KY) has introduced legislation to streamline the approval process for biosimilars by “eliminating costly and redundant clinical study requirements.” The Expedited Access to Biosimilars Act is intended to “increase market competition, lower drug prices, and increase access to more life-saving treatments,” Paul says
FDA Policy/General
In a further blow to FDA morale, a 4/11 address to the agency’s White Oak, MD staff by HHS secretary Robert F. Kennedy Jr. was filled with unusual statements about the “Deep State” and accusations about employees becoming industry “sock puppets.” The Kennedy address failed on all levels
Devices
Daxor Corp. has filed a 510(k) seeking FDA clearance for its next-generation blood volume analyzer, Daxor BVA. The new device “represents a significant leap forward in diagnostic technology, offering direct quantification of intravascular blood, red blood cell, and plasma volume,” according to the company. It says that compared
Drugs
Sen. Richard Blumenthal (D-CT) and Rep. Brian Fitzpatrick (R-PA) have introduced the Bolstering Research and Innovation Now (BRAIN) Act to advance research for brain cancer and improve brain tumor treatment and care. A statement (includes links to the bill text) issued by Blumenthal lists three bipartisan Senate co-
Drugs
FDA says it is phasing out the animal testing requirement for monoclonal antibodies and some other drugs. A 4/10 statement says animal testing would be replaced with “more effective, human-relevant methods. The new approach is designed to improve drug safety and accelerate the evaluation process, while reducing animal
FDA Policy/General
Hundreds of U.S. biomedical innovators and investors are urging the Senate to help restore critical FDA staff that were recently laid off so that institutional knowledge at the agency is not lost. In a 4/6 letter to senator Bill Cassidy (R-LA), the stakeholders say that having an
Drugs
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Drugs
Johnson & Johnson is reporting new icotrokinra (JNJ-2113) data from a subgroup analysis of ICONIC-LEAD, a Phase 3 registrational study in moderate-to-severe plaque psoriasis patients. The data show adolescents treated with once-daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16
FDA Policy/General
Attorneys Sarah Wicks and Anne Walsh (Hyman, Phelps & McNamara) say the recent and drastic reduction in force at FDA “is quickly becoming an information bottleneck — one that threatens to erode the transparency that stakeholders rely on.” Writing in their firm’s FDA Law Blog, Wicks and Walsh say that
FDA Policy/General
FDA has decided to allow some product review staff and supervisors to resume working from home at least two days a week, the Associated Press reports in a story based on conversations with three anonymous agency staffers. The story says an email on the subject was sent on 4/8
Drugs
Alzheon says its Phase 3 valiltramiprosate trial in early Alzheimer’s disease (AD) patients did not meet its primary endpoint of slowing cognitive decline in the overall population. While it missed the endpoint, the company says promising results emerged in a prespecified subgroup of patients at the mild cognitive impairment
Devices
FDA has cleared the Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System for people over age 18 with diabetes in the U.S. A company statement says the G7 15 Day is the longest-lasting CGM system with 15.5 days of wear. The company says the system has
Devices
FDA has cleared an Intuitive 510(k) for the SP SureForm 45 stapler for use with its da Vinci SP surgical system in thoracic, colorectal, and urologic procedures. The device features the company’s SmartFire technology, which continuously monitors tissue compression before and during firing,” the company says, adding that
Drugs
Responding to an FDA draft guidance on considerations for using artificial intelligence (AI) to support regulatory decision-making for drug and biological products, Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the agency’s efforts with the draft. The association’s 4/7 comment letter lays out
Devices
FDA has cleared a Zeiss Medical Technology 510(k) for its Intrabeam 700, a robotic-assisted platform to support intraoperative radiation therapy for use in neurooncology and breast cancer therapy. In oncological treatments, the device ensures that the target area is optimally resected, and that healthy tissue is spared as
Drugs
Hyman, Phelps & McNamara attorney Kurst Karst is raising concerns about recent staff cuts at FDA that “eradicated” the Office of Generic Drugs’ Division of Policy Development (DPD). The division’s functions are critical to the development and approval of generic drugs, he says in a 4/9 FDA Law
Biologics
FDA has accepted for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for treating wet age-related macular degeneration (wet AMD), a serious eye condition where abnormal blood vessels grow under the retina, potentially leaking blood or fluid and causing rapid