Drugs
An 8/26-9/6/2024 FDA inspection at the Rechon Life Sciences drug manufacturing facility in Skane Lan, Sweden, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/30 Warning Letter says the specific violations were: * failure to establish and follow
Drugs
An FDA review of records submitted by Zhejiang Easyclean Daily Chemical Co., Ltd. in Hangzhou, China, in response to a 3/11/2024 agency request, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/14 Warning Letter says the specific violations were: * failure to
Devices
Having failed to appeal a federal court decision vacating the laboratory-developed test (LDT) rule it proposed, FDA has accepted that it does not have a role in regulating such tests. That’s the view of attorneys Steven Gonzalez and Allyson Mullen (both Hyman, Phelps & McNamara) in a post
Biologics
CBER director Vinay Prasad is embracing both surrogate endpoints for accelerated approval and overall survival data in confirmatory studies for rare disease products. Speaking at the 6/3 National Organization for Rare Disorders’ (NORD) Rare Disease Scientific Symposium, Prasad reassured companies, researchers and patients that FDA “will take action at
Drugs
FDA has approved a Bayer Healthcare Pharmaceuticals supplemental NDA for Nubega (darolutamide) for metastatic castration-sensitive prostate cancer (mCSPC). The drug was previously approved in combination with docetaxel for mCSPC. Approval was based on data from the ARANOTE (NCT02799602) trial in 669 patients with mCSPC. Patients received either darolutamide or
Drugs
FDA has accepted for priority review a Kura Oncology NDA for ziftomenib, a potential new treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring nucleophosmin 1 (NPM1) mutations. Ziftomenib is described as an investigational oral menin inhibitor, and it is the only therapy of its kind
Devices
FDA has given de novo authorization to Clarity’s Clarity Breast, described as a “novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram.” A company statement says most risk assessment models rely heavily on age and family history to predict risk.
Drugs
FDA deputy commissioner for strategic initiatives Lowell M. Zeta, who joined the agency’s leadership team in April, has now been given a second role — Special Counsel for FDA in the Office of the Chief Counsel (OCC). “In this dual role, Mr. Zeta provides legal and strategic counsel to the
Drugs
Congressman Jason Crow (D-CO) is leading a bipartisan group of lawmakers in a push to significantly expand federal funding for Amyotrophic Lateral Sclerosis (ALS) research in the upcoming 2026 fiscal year budget. The move aims to accelerate efforts on effective treatments and a cure for the neurodegenerative disease. In
Drugs
A new combination therapy involving AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) and pertuzumab (Genentech’s Perjeta) has significantly extended progression-free survival for patients with HER2-positive metastatic breast cancer, according to results from the Phase 3 DESTINY-Breast09 trial presented 5/31 at the American Society of
FDA Policy/General
A just-released FDA FY 2026 budget proposal shows that beginning 10/1 the agency’s overall budget would decrease by 4% ($271 million) to $6.8 billion. This includes $3.2 billion, an 11% or $400 million cut, in discretionary budget authority, and $3.6 billion in user fees,
Biologics
FDA has approved a Moderna BLA for mNexspike (mRNA-1283), the company’s next-generation vaccine against Covid-19 for use in all adults 65 and older, and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the CDC. The company notes
Drugs
A federal appeals court has upheld a freeze on layoffs across FDA and other major federal agencies, rejecting an effort by the Trump administration to lift the ban and likely setting the stage for a Supreme Court review. The court sided with a coalition of unions, advocacy groups, and municipalities
Devices
FDA has cleared a Hyperfine 510(k) for its next-generation AI-powered portable MRI system for the brain, the Swoop system. The clearance includes a new portable MRI scanner powered by the proprietary Optive AI software that helps to deliver high image quality and functionality, according to the company.
FDA Policy/General
FDA 6/2 launched a generative Artificial Intelligence (AI) tool called Elsa that is designed to help employees — from scientific reviewers to investigators — work more efficiently. The agency is already using Elsa to accelerate clinical protocol reviews, shorten scientific evaluations, and identify high-priority inspection targets. The tool is built
Drugs
FDA is making available a draft guidance entitled “M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver.” The International Council for Harmonization (ICH) document is the second in the ICH M13 series and describes the scientific and technical aspects of study design and data analysis to support
Drugs
FDA has issued Aurolife an 11-item Form FDA-483 following a 3/24-4/10 inspection at its Durham, NC manufacturing facility that cited significant GMP deficiencies. For example, FDA took issue with the responsibilities and procedures applicable to the quality control unit, which are not in writing or
Drugs
Advocacy group Public Citizen has petitioned FDA to take immediate action to protect unborn children from potential harm caused by the popular wakefulness-promoting drugs Provigil (modafinil) and Nuvigil (armodafinil). The petition urges FDA to contraindicate the use of these drugs, which are made by Apotex, and any approved generics
Drugs
AstraZeneca and Handa Pharmaceuticals have agreed to pay $51.4 million to resolve allegations they participated in a pay-for-delay scheme to block generic competition to AstraZeneca’s antipsychotic drug Seroquel XR. The lawsuit was brought in 2019 by direct purchaser plaintiffs who requested preliminary approval of the proposed
Devices
FDA has granted BiVACOR a breakthrough device designation for its titanium Total Artificial Heart (TAH). The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including a left ventricular assist device, are not viable, according to
Drugs
Restoring FDA’s and other health agencies’ credibility always starts at the top. So when HHS secretary Robert F. Kennedy Jr. is called out for citing nonexistent science as the partial basis for his recent Make America Healthy Again (MAHA) report (see story), how seriously will stakeholders and the public
Biologics
HHS has terminated a $590 million late-stage grant award to Moderna and its development of a vaccine candidate targeting the H5 avian influenza virus subtype. The termination news comes as the company announces “positive interim data” from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity