Drugs
Texas federal judge Matthew J. Kacsmaryk’s unprecedented late-Friday decision against the 23-year-old approval of mifepristone (Mifeprex) (see earlier story) has provoked many reactions from across the spectrum that worry about FDA’s globally respected approval gold standard and the court’s ideological stance that is trumping
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The Department of Justice (DoJ) has officially appealed Texas federal judge Matthew J. Kacsmaryk’s 4/7 controversial court order (see earlier story) to undo FDA’s 2020 approval of mifepristone (Mifeprex). The 4/10-filed emergency motion to the Fifth Circuit Court of Appeals urges the court to immediately
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After an interim analysis showed disappointing data, Merck and Eisai say they are discontinuing the Phase 3 LEAP-003 trial evaluating Keytruda plus Lenvima for first-line treatment of adults with unresectable or metastatic melanoma. The decision is based on an independent data monitoring committee recommendation after it found that
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Horizon Therapeutics says it plans to discuss with FDA positive and statistically significant topline results from its randomized, double-masked, placebo-controlled Phase 4 clinical trial (NCT04583735) evaluating Tepezza for treating adults with chronic thyroid eye disease and low Chronic/Low Clinical Activity Score (CAS), which is a measure of
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FDA has granted Sumitomo Pharma Oncology an Orphan Drug Designation for TP-1287, an investigational oral CDK9 inhibitor for treating Ewing sarcoma. The rare type of cancer occurs in bones or in the soft tissue around the bones. “The disease occurs when a cell develops changes in its DNA that
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Janssen Biotech and Pharmacyclics have announced their decision to voluntarily withdraw two accelerated approval indications for Imbruvica (ibrutinib) — treating patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and treating patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least
Drugs
U.S. Representative Andy Kim (D-NJ) has reintroduced his Protecting Americans from Unsafe Drugs Act which would provide FDA with mandatory recall authority for any and all faulty or unsafe prescription and over-the-counter drugs. Over the years, several bills have been introduced to give the agency this
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FDA is exploring whether it can enter into a five-year contract with an entity that can perform “non-invasive high-resolution imaging and artificial intelligence image analysis to characterize freeze-dried pharmaceuticals and complex drug products to understand the impact of advanced manufacturing techniques, formulation, and process parameters on
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Yale University researchers say that as FDA broadens its use of accelerated approvals, it should be taking steps to increase public trust in that approval pathway. Writing in the New England Journal of Medicine, the researchers say the agency’s empowered stance on using accelerated approvals resonates with those who
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Members of the International Council for Harmonization Regulatory Assembly have approved the M7(R2) guideline, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, that emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to
Drugs
Rejecting a Covis Pharma proposal for a voluntary phased withdrawal of its preterm birth drug Makena (hydroxyprogesterone caproate injection) over several months, FDA commissioner Robert Califf and chief scientist Namandjé Bumpus said 4/6 that “Makena and its generics are no longer approved and cannot lawfully be distributed in interstate
Drugs
The Department of Justice says two men from New Braunfels, TX, pleaded guilty in a Texas federal court to selling non-controlled but dangerous substances through the mail. A department statement says Evan Field and Michael Diaz bought bulk quantities of drugs such as synthetic opioids and benzodiazepines and re-
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FDA has published a draft guidance, Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act, to assist applicants and manufacturers to provide FDA timely, informative notifications about changes in the production of certain finished drugs and biological products and
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FDA has released the form FDA-483 issued following a 7/11-8/18/22 inspection at QuVa Pharma, a Sugar Land, TX, outsourcing facility. The three inspection observations were: * employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions;
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FDA has published a draft guidance, Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making, which is the last in a series of four methodological patient-focused drug development guidances that describe how stakeholders can collect and submit patient experience data and other relevant information
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A 2001 and 2002 FDA inspection of the Aspire Pharmaceuticals dietary supplement and drug manufacturing facility in Somerset, NJ, identified significant violations of the Federal Food, Drug, and Cosmetic Act and its regulations. A just-released 11/22/22 Warning Letter said specific violations were: * failing to ensure that the
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A 4/3 Scorpion Capital LLC petition calls on FDA to withdraw approval for Harmony Biosciences’ Wakix (pitolisant) and take other actions against the drug. Wakix has been indicated to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. The Scorpion Web site says the firm “specializes in intensive,
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CDER has issued an updated Office of Clinical Pharmacology (OCP) Manual of Policies and Procedures (MAPP), “OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs,” with good review management principles and practices for submissions during the IND phase of drug development. The MAPP says it promotes excellence in
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OncoSec says the Phase 2 KEYNOTE-695 trial of its Tavo-EP proprietary interleukin 12 encoding plasmid delivered by intratumoral electroporation in combination with Merck’s Keytruda (pembrolizumab) in patients with advanced melanoma refractory to anti-PD-1 treatment failed to meet its primary endpoint of overall response rate. A
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Lilly researchers who evaluated an FDA 2012 program to promote greater transparency and increased communication between the agency and applicants of new molecular entity (NME) NDAs and original BLAs say the agency was consistent in meeting the program goals. Writing in Therapeutic Innovation & Regulatory Science, the researchers say they
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FDA has approved an emergency use authorization (EUA) to use InflaRx’s Gohibic (vilobelimab) injection to treat Covid-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation. An agency statement says the treatment targets a part of the immune system that
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FDA researchers are looking at the possibility of speeding biosimilar development through a streamlined approach in which pharmacokinetic (PK) and pharmacodynamic (PD) similarity data are submitted with comparative safety and immunogenicity data. An agency notice says investigators can collect PK and PD data from shorter, less costly studies, often enrolling