Drugs
FDA says its review of postmarket clinical trial data identified cases of serious liver injury in patients being treated for primary biliary cholangitis (PBC) with Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) who did not have cirrhosis of the liver. A 12/12 agency drug safety communication says FDA previously identified the
Drugs
Keros Therapeutics has halted some dosing in a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulmonary arterial hypertension (PAH) due to unexpected adverse events. The decision to stop dosing 3mg/kg and 4.5mg/kg treatment arms in the ongoing TROPOS
Drugs
A lengthy ProPublica investigative report says that despite India’s Glenmark Pharmaceuticals issuing several recalls for pills that don’t dissolve properly, FDA still hasn’t inspected the Madhya Pradesh facility that made the pills and hasn’t stopped the company from shipping other drugs made at the plant to
Drugs
In a lengthy interview with Time as part of the magazine’s designation of him as 2024 Man of the Year, president-elect Donald J. Trump gave an unclear answer to questions about whether his FDA would prevent access to medication abortions through abortion pills. Asked initially if he would
Drugs
The Association for Accessible Medicines (AAM) is urging Congress to pass pending legislation to allow FDA to disclose “sameness” information about a brand drug to potential generic drug makers. Without these disclosures, brand drug makers are allowed to game the approval system to claim a product’s inactive ingredients are
Drugs
FDA has launched the CDER Center for Real-World Evidence Innovation (CCRI) to coordinate, advance, and promote using real-world data and real-world evidence in regulatory decision-making across the Center. The agency says the CCRI will focus on these areas: scientific review and policy, coordinated outreach and engagement,
Drugs
An IQVIA analysis of novel active substance (NAS) approvals in the U.S., the European Union (EU), and Japan from 2014-2022 found that the U.S. approved more NASs and approved them earlier on average than the EU and Japan. The report says the U.S. has continued to
Drugs
Pfizer says data from the Phase 3 PATINA trial demonstrated that adding Ibrance (palbociclib) to current standard-of-care first-line maintenance therapy (following induction chemotherapy) resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with hormone receptor-positive (HR+), human epidermal growth factor
Drugs
Four industry stakeholders are recommending changes to an FDA draft guidance on incorporating voluntary patient preference information over the total product lifecycle. AbbVie says it partners with patients, patient organizations, caregivers, and clinicians to ensure that individual experiences, perspectives, needs, and priorities are part of the clinical development process. The
Drugs
A planned supplemental NDA submission from scPharmaceuticals of an autoinjector as an alternative to the current on-body infusor used with its Furoscix (furosemide injection) combination product may be delayed due to recently observed variability during shelf-life testing in one lot of the investigational product, according to the company.
Drugs
Speaking on their firm’s The Good Bot podcast, three Troutman Pepper attorneys discuss CDER’s new Emerging Drug Safety Technology Program (EDSTP) and how it can positively transform agency and company postmarketing pharmacovigilance efforts. Kyle Dolinsky told podcast host Brett Mason that the program’s objectives are to (1)
Drugs
FDA is convening its Vaccines and Related Biological Products Advisory Committee 12/12 to discuss whether currently available data indicate a potential safety concern in conducting respiratory syncytial virus (RSV) vaccine trials in infants and toddlers. The panel meeting was prompted by safety concerns raised in Moderna’s Rhyme Trial
Drugs
The National Institutes of Health (NIH) says its STOMP (study of tecovirimat for Mpox) trial found that the antiviral drug tecovirimat did not reduce the time to lesion resolution or have an impact on pain among adults with mild to moderate clade II mpox and a low risk of developing
Drugs
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Drugs
A Paragon Health Institute white paper presents guidelines that it says will protect the many benefits of artificial intelligence (AI) in healthcare without increasing risks to public health. “Patient safety is an overarching concern throughout,” the paper says, “as injury can be caused not only by faulty AI products but
Drugs
NeuroSense Therapeutics says it will begin a Phase 3 study by mid-2025 of PrimeC (ciprofloxacin and celecoxib) for treating amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease). The decision to proceed to a Phase 3 study is based on positive data from a Phase 2b study
Drugs
Johnson & Johnson says data from its Phase 3 CARTITUDE-4 study show a single infusion of Carvykti (ciltacabtagene autoleucel; cilta-cel) significantly increased minimal residual disease (MRD) negativity rates in patients with relapsed or refractory multiple myeloma who were lenalidomide-refractory and had received one to three prior lines
Drugs
A securities fraud case investigated by the FDA Office of Criminal Investigations has resulted in the conviction of two men for their roles in a scheme to lie to investors in CytoDyn, a firm purportedly developing leronlimab between 2018 and 2021 to treat HIV and Covid-19. A Justice Department
Drugs
An FDA review of records submitted by Guangzhou Four E’s Scientific Co., Ltd., in Guangdong, China, at the agency’s request, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 11/13 Warning Letter says the company’s quality control unit failed
Drugs
FDA has denied a Metacel Pharmaceuticals 8/18/2023 petition asking that the agency require ANDA sponsors relying on Ozobax (baclofen) oral solution as the reference-listed drug to conduct testing and provide data to address the safety of any flavoring ingredient and to reject any requests from generic drug
Drugs
FDA has published an International Council for Harmonization draft M15 guideline, General Principles for Model-Informed Drug Development. The document provides general recommendations for planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD) and establishes a harmonized assessment framework, including associated terminology, for MIDD evidence.
Drugs
Eli Lilly says data from its confirmatory Phase 3 BRUIN CLL-321 trial evaluating Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma met its primary endpoint of progression-free survival (PFS). The trial, which