Drugs
Novartis says it will seek FDA approval next year for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) — to slow disease progression in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer after treatment with androgen receptor pathway inhibition (ARPI) and before taxane-based
Drugs
FDA has posted a final guidance entitled “E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials.” The International Council for Harmonization guidance provides recommendation on the use of selective safety data collection that may be applied in specific pre-approval
Drugs
FDA has accepted for review a Protalix BioTherapeutics and Chiesi BLA resubmission for PRX–102 (pegunigalsidase alfa) for treating adult patients with Fabry disease. Last year, the agency issued a complete response letter on the BLA, which at the time did not cite any safety or efficacy concerns regarding the
Drugs
FDA has posted a draft guidance entitled “ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.” The document addresses generic drug user fee program enhancements related to the content, timing, and assessment of a pre-submission facility correspondence (PFC). Under the latest user fee commitment letter, FDA says
Drugs
FDA has published a draft guidance entitled “Statistical Approaches to Establishing Bioequivalence” that is intended to provide recommendations for submitting bioavailability and bioequivalence (BE) data in INDs, NDAs, ANDAs and related supplements. The document provides input for sponsors who intend to use equivalence criteria in analyzing in vivo or in
Drugs
Gregory Conigliaro, a former co-owner of now-closed New England Compounding Center (NECC), has been sentenced in Boston federal court to one year in prison for his role in conspiring to defraud FDA. In 2018, Conigliaro was convicted following a 41-day jury trial for his role in the
Drugs
FDA has lifted a clinical hold against Beam Therapeutics and its BEAM-201 for treating relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma. The company says it filed the IND at the end of June for the specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T
Drugs
Lilly says its investigational Alzheimer’s drug donanemab reduced brain amyloid plaque levels versus baseline by 65.2% compared with 17% for Biogen’s Aduhelm (aducanumab-avwa) in the Phase 3 TRAILBLAZER-ALZ 4 study. A company announcement says donanemab met all primary and secondary endpoints for the six-month
Drugs
FDA has accepted for priority review an Innoviva NDA for intravenous Sul-Dur (sulbactam and durlobactam) for treating infections caused by Acinetobacter baumannii-calcoaceticus complex (ABC), including multi-drug resistant and carbapenem-resistant strains. Sulbactam is a β-lactam antibiotic and durlobactam is designed as a broad-spectrum β-lactamase
Drugs
Argenx has agreed to purchase a Priority Review Voucher from Bluebird Bio for $102 million, which Argenx plans to use for a planned BLA for efgartigimod, its first-in-class neonatal Fc receptor blocker that is being studied in autoimmune diseases. A year ago, FDA approved Argenx’s Vyvgart (intravenous
Drugs
Attorney George O’Brien (Mayer Brown) says FDA should take a more nuanced approach to orphan drug exclusivity (ODE), which has been in limbo since the 9/2021 11th Circuit Court of Appeals decision in Catalyst Pharms v. Becerra that struck down the agency’s indication-specific interpretation of ODE.
Drugs
FDA has released the form FDA-483 issued following a 9/13-9/30 inspection at the Qualgen sterile drug production facility in Edmond, OK. The nine inspection observations were: * failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit; * failing to
Drugs
A bipartisan letter from four senators is urging FDA commissioner Robert Califf and HHS secretary Xavier Becerra to step up efforts to help resolve amoxicillin and other drug shortages. “The record high levels of respiratory illnesses have spiked demand for amoxicillin and other essential medicines, and patients and providers continue
Drugs
FDA has accepted for priority review a Regeneron Pharmaceuticals supplemental BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH). The agency has set a user fee review action date of 3/30/2023.
Drugs
The Department of Justice says two owners of Synergy Medical, based in New Jersey, have admitted before a federal judge their roles in a $38 million compounded medication healthcare fraud scheme. A department statement says Samantha Zaretsky, of Wayne, NJ, and Lee Nichols, of Fair Haven, NJ, each pleaded guilty
Drugs
Merck has filed suit in Maryland federal court claiming that Johns Hopkins University (JHU) improperly obtained patents that emerged from a research collaboration between the two for Merck’s cancer drug Keytruda (pembrolizumab). The suit says Merck and JHU partnered to design and conduct a clinical study administering Keytruda to
Drugs
FDA says Lilly’s bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize two prevalent Omicron subvariants. An agency statement says the company and its authorized distributors have paused the commercial distribution of bebtelovimab until further notice from FDA. The
Drugs
Eisai and Biogen are reporting new data from a lecanemab Alzheimer’s Phase 3 trial that suggest treated patients with early Alzheimer’s disease had reduced brain amyloid levels and moderately less decline on clinical measures of cognition and function than patients on placebo at 18 months, but they experienced
Drugs
FDA has approved Ferring Pharmaceuticals’ Rebyota (fecal microbiota) for preventing recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older. It is for use after an individual has completed antibiotic treatment for recurrent CDI, an agency release says. FDA says Rebyota is prepared from stool donated
Drugs
A 4/12-4/20 FDA inspection at Arbor Centers for EyeCare (David Lubeck, MD), Orland Park, IL, identified objectionable conditions in the center’s work as sponsor/investigator for two clinical investigations. An 11/18 Warning Letter says the inspection was conducted as part of the agency’s Bioresearch
Drugs
Lexicon Pharmaceuticals says a CDER proposed order to delay a hearing and deny approval of the company’s NDA for sotagliflozin oral tablets to treat Type 1 diabetes mellitus (T1DM) “is unfounded based on the facts of the data presented by Lexicon: an effective drug for TIDM, with additional efficacy
Drugs
Several stakeholders are suggesting ways they believe an FDA draft regulation on nonprescription drug products with an additional condition for nonprescription use (ACNU) can be improved. Public Citizen Health Research Group says concerns raised by stakeholders in countries in which pharmacists enable patients to get medicines without a doctor’s