Drugs
U.S. Senator Tammy Baldwin (D-WI) has written the four biggest drug companies marketing asthma inhalers and urged them to stop unfairly blocking generics from the market. In 1/29 letters (see below) to AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Teva, Baldwin called on the companies to stop improperly listing
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Merck says data from its Phase 3 KEYNOTE-564 trial evaluating Keytruda (pembrolizumab) as an adjuvant treatment in patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions showed a promising overall survival (OS) benefit. The
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FDA has issued a guidance entitled “Human Gene Therapy Products Incorporating Human Genome Editing.” The document provides recommendations about the information that should be included in an IND in order to assess the safety and quality of the investigational genome editing (GE) product, such as product design, product manufacturing and
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FDA has posted a document entitled “Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products” that outlines risk-based principles for the agency’s conduct of ongoing postmarketing safety surveillance for drug and biological products. The document, which was mandated by the Cures
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The International Council for Harmonization (ICH) has posted a guidance entitled “Q14 Guideline on Analytical Procedure Development.” The document describes science- and risk-based approaches for developing and maintaining analytical procedures suitable for evaluating drug substance and drug product quality. “When developing an analytical procedure, a minimal (also known as
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FDA is making available a revised draft guidance entitled “Conducting Remote Regulatory Assessments (RRA) — Questions and Answers.” The document clarifies the agency’s answers provided in a 2022 draft guidance regarding: (1) the benefits of an RRA, and any consequences for not participating; (2) how a facility will know an
Drugs
Azurity Pharmaceuticals has recalled one lot (# F230169A) of narcolepsy drug Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 mg after a report from a pharmacist said carbinoxamine maleate tablets were contained in a Zenzedi-labeled bottle. “Patients who take carbinoxamine instead of Zenzedi will experience undertreatment of their symptoms, which may
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FDA has told Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the company’s NDA for Yutrepia (treprostinil) inhalation powder for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The agency explained that
Drugs
A SheppardMullins report on top-of-mind issues for life sciences companies in 2024 highlights several programs and issues involving FDA. The report discusses: * CDER Office of Prescription Drug Promotion — A decline in enforcement letters continued, with four untitled letters and one Warning Letter issued to drug companies between 6/
Drugs
FDA is seeking nine drug companies to volunteer to test its new Quality Manufacturing Maturity (QMM) Prototype Assessment Protocol Evaluation Program, the next phase in CDER’s QMM program. A Federal Register announcement says the protocol is used to evaluate an establishment’s level of QMM. It includes a series
Drugs
FDA has released the form FDA-483 issued following a 10/16-11/9/2023 inspection at the Hybrid Pharma outsourcing facility in Deerfield Beach, FL. The 11 inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions; * procedures
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The CDER Office of Clinical Pharmacology has launched a new Web site for healthcare professionals (HCPs) to give examples of drugs that interact with CYP enzymes and transporter systems. The site says that clinically significant drug interactions involving CYP- or transporter system-based drug interaction classes are very common. It
Drugs
FDA has approved an expanded indication for Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) for treating pediatric patients aged one to 11 years with eosinophilic esophagitis (EoE). The approval expands the initial 5/2022 approval for EoE in patients aged 12 years and older. “EoE is a chronic, progressive disease
Drugs
FDA has released the form FDA-483 issued following a 9/18-10/24/2023 inspection at the STAQ Pharma of Ohio outsourcing facility in Columbus, OH. The two inspection observations were: * failing to conduct media fills that closely simulate aseptic production operations under the worst-case, most challenging, and
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CBER director Peter Marks and Office of Therapeutic Products director Nicole Verdun say that as of 12/31/2023, FDA was aware of 22 cases of T-cell cancers that occurred after treatment with chimeric antigen receptor (CAR) T-cell products. Writing in the New England Journal of Medicine, Marks
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FDA has published a guidance, Revising ANDA Labeling Following Revision of the RLD Labeling, to assist applicants and holders of ANDAs to update their labeling following revisions to the approved labeling of the reference-listed drug. The document provides recommendations for identifying reference-listed drug labeling updates and submitting ANDA
Drugs
CDER and CBER have accepted the first artificial intelligence-based and digital health technology-based project and the first project in neuroscience in the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program. An agency statement says the accepted letter of intent submission is for an automated depression
Drugs
FDA is buying a one-year subscription to digiM Solution’s I2S (Image to Simulation) integrated image processing platform based on the company’s proprietary cloud technology. A company announcement says I2S is an “end-to-end software combining data management, artificial intelligence image processing, structural analytics, and imaged-based
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Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the expanded use of innovative clinical trial approaches since they offer the potential for more patient-focused, efficient, timely, and targeted product development to support regulatory decision-making. Responding to an FDA call for comments on an upcoming workshop on
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FDA has published a guidance, ANDA Submissions — Amendments and Requests for Final Approval to Tentatively Approved ANDAs, to assist applicants in preparing and submitting amendments to tentatively approved ANDAs, including requests for final approval. The document provides recommendations on the timing and content of amendments to tentatively approved ANDAs to
Drugs
Lilly subsidiary Akouos says the Phase 1/2 AK-OTOF-101 study demonstrated pharmacologic hearing restoration within 30 days of administering AK-OTOF, a gene therapy, in the first trial participant, an individual with more than 10 years of profound hearing loss. A company statement says the first study participant
Drugs
Haleon is recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult due to concerns about microbial contamination. “In immunocompromised individuals, the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal