Drugs
A 3/19-3/30/18 FDA inspection at the Mariposa Labs drug manufacturing facility in Boise, ID, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/14 Warning Letter says the firm also manufactured unapproved and misbranded drug products. Specific CGMP violations noted
Drugs
CDER clinical pharmacologists are helping drug developers use computational models to achieve safe and effective dosing recommendations for patients taking more than one drug. In a Regulatory Science Impact Story, CDER says physiologically based pharmacokinetic models “make it possible to simulate clinical trials that support dosing recommendations, as well as
Drugs
Celgene has submitted an NDA for ozanimod for treating adults with relapsing forms of multiple sclerosis (RMS). Ozanimod is described by the company as an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 and 5. The drug causes lymphocyte retention in
Biologics
FDA has released a final guidance on “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.” The document provides CBER recommendations on the use of standards in product development and control as well as the use of such standards in
Drugs
FDA has issued Sun Pharmaceutical (Gujarat, India) a three-page Form 483 after a February inspection cited GMP deviations for finished pharmaceuticals. For example, the inspection form says Sun failed to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any
Drugs
Bayer and Janssen Pharmaceuticals have agreed to pay $775 million to settle about 25,000 claims against blood thinner Xarelto (rivaroxaban) and alleged serious and sometimes fatal bleeding episodes. Bayer expects its liability insurance to cover part of the settlement costs. While the companies say the claims are without merit
Drugs
FDA has issued a safety alert about cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. “Although the system’s overall design features help safeguard patients, Medtronic is developing updates to further mitigate these cybersecurity vulnerabilities,” the alert
Drugs
FDA has made available a draft guide entitled “Rare Diseases: Natural History Studies for Drug Development.” The document is intended to help inform the design and implementation of natural history studies that can be used to support safe and effective drug and biological product development for rare diseases. Specifically, it
Drugs
CDER’s Office of Clinical Pharmacology (OCP) says that in 2019 it will focus on current health issues related to the opioid epidemic, antimicrobial resistance, and rare diseases. In its latest annual report, OCP says the application of pharmacogenomic information will continue to play an important role in clinical trial
Drugs
FDA has issued a safety alert on the investigational use of AbbVie/Genentech’s Venclexta (venetoclax) for treating patients with multiple myeloma based on data showing an increased death risk for patients on the therapy compared to those on an active control. Earlier this month, the agency placed a partial
Drugs
FDA has issued Lexicon Pharmaceuticals and Sanofi a complete response letter on their NDA for investigational Zynquista (sotagliflozin), a dual SGLT1 and SGLT2 inhibitor for adults with Type 1 diabetes in combination with insulin. Without disclosing FDA’s concerns, the companies say they will work closely with the agency to
Drugs
FDA has issued Recro Pharma a complete response letter for intravenous (IV) meloxicam for managing moderate to severe pain. The letter focused on onset and duration of IV meloxicam, noting that the delayed onset fails to meet the prescriber expectations for IV drugs, according to the company. It also cited
Drugs
Indiana University School of Medicine researcher Xiongbin Lu is reporting several important findings related to triple negative breast cancer and its treatment. Unlike the three most common forms of breast cancer, he says, triple negative breast cancer has no approved targeted therapies for treatment. In a paper, Lu and University
Drugs
Biogen and Eisai have discontinued global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. Their decision is based on a futility analysis conducted by an independent
Drugs
As part of the FDA program to use real-world evidence based on real-world data for safety and efficacy decisions involving drugs, demonstration projects will cover data, real-world evidence tools, and real-world evidence study design. CDER Office of Medical Policy director Jacqueline Corrigan-Curray reviewed in a
Drugs
FDA has granted Enzyvant rare pediatric disease and fast track designations for RVT-801, an investigational enzyme replacement therapy. RVT-801 was previously granted an orphan drug designation and is currently in preclinical development for Farber disease, a rare condition for which there are no approved treatments. RVT-801 is
Drugs
Novo Nordisk has submitted two NDAs to FDA for oral semaglutide, the first once-daily glucagon-like peptide-1 receptor agonist in a pill. The company says one NDA was submitted seeking approval as an adjunct to diet and exercise to improve blood sugar in adults with Type 2 diabetes.
Drugs
FDA has approved a Jazz Pharmaceuticals NDA for Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Once-daily Sunosi is approved with doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5
Drugs
FDA Anesthetic and Analgesic Drug Products Advisory Committee chair Raeford Brown, a University of Kentucky professor, and Public Citizen Health Research Group founder and senior advisor Sidney Wolfe are calling on HHS and FDA to immediately impose a moratorium on FDA approval of any new or reformulated opioids. The two
Drugs
CDER director Janet Woodcock says the Center reorganization first announced 7/2018 has been approved. “The reorganization aims to transform and strengthen the way FDA fulfills its public health and regulatory role,” she says in a staff memo. The organizational changes take effect 3/31. The changes involve the Office
Drugs
FDA imposed its most restrictive distribution program on the nation’s first postpartum depression (PPD) drug for adult women, Sage Therapeutics’ intravenous Zulresso (brexanolone). The severe restrictions in its Risk Evaluation and Mitigation Strategy (REMS) is due to concerns about serious risks, including excessive sedation or sudden loss of consciousness
Drugs
The DC federal court has granted an FDA motion for a voluntary remand of Vanda Pharmaceuticals’ suit challenging the agency requirement to perform nine-month large animal studies of its tradipitant before beginning studies in humans. (Tradipitant is a potential treatment for several human conditions including gastroparesis). The court declined