Drugs
FDA has approved a BioXcel Therapeutics NDA for Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or Bipolar I or II disorder in adults. This is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade and “represents a
Biologics
FDA officials told the agency’s Vaccines and Related Biological Products Advisory Committee 4/6 that a decision will likely be made in June on whether a new Covid-19 booster composition is needed by November for what some health experts predict could be another Covid infection wave as people
Drugs
Amgen says that while it appreciates FDA’s issuance of a draft guidance on the assessment of presser effects of drugs, it has concerns about the agency’s recommendations to use ambulatory blood pressure monitoring for any drug intended for chronic use. The company comment says it is skeptical that
Drugs
Federal Register notice: FDA is announcing the following information collections that have been approved by OMB: * Reclassification Petitions for Medical Devices (OMB control # 0910-0138) * Pharmaceutical Distribution Supply Chain (0910-0806) * Environmental Impact Considerations (0910-0322) * Reporting Associated with Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of
Drugs
FDA has granted commercial licensure approval for a Novartis Durham, NC, multi-product gene therapy manufacturing facility. The company says the approval allows the state-of-the-art 170,000 square-foot Zolgensma facility to make, test, and release commercial Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy indicated for treating
Drugs
FDA is participating with the University of California San Francisco and Quantum Leap Healthcare Collaborative in an electronic health record (EHR) integration project that aims to streamline health data for clinical research trials. An EHR Intelligence story says that OneSource is an electronic data capture system based on open-source
Drugs
FDA says GlaxoSmithKline’s sotrovimab is no longer authorized to treat Covid-19 in any U.S. HHS region due to increases in the proportion of Covid-19 cases caused by the omicron BA.2 sub-variant. An agency update says Centers for Disease Control and Prevention data indicate that
Drugs
CDER director Patrizia Cavazzoni says FDA’s recent increased funding request for fiscal year 2023 would, if enacted, help address a Center priority to improve drug postmarket surveillance and oversight of marketed products. The budget request calls for an almost 10% increase — a $356 million boost over current authorized spending
Devices
FDA has approved a GE Healthcare PMA for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS2Anesthesia Delivery System. The company says it is the only manufacturer in the U.S. approved to offer general anesthesia delivery with the automatic software. The Et Control software
Drugs
FDA says it is advancing a framework to objectively rate pharmaceutical manufacturing sites’ Quality Management Maturity (QMM). The program is part of a Biden Administration 2021 plan to address the vulnerabilities and drug shortages in the nation’s pharmaceutical supply chains (see earlier story). The agency has defined QMM as
Drugs
FDA has granted priority review for Sanofi and Regeneron’s sBLA for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients age 12 and older with eosinophilic esophagitis. The companies say the PDUFA target action date for the application is 8/3. Dupixent has already been granted breakthrough
Drugs
A 9/8-9/20/21 FDA inspection at NDAL Mfg., Monterey, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A 3/28 Warning Letter says the specific violations were: * failure of the firm’s quality control unit to exercise its
Drugs
Commenting on an FDA draft guidance on immunogenicity information in human prescription therapeutic protein and select drug product labeling content and format, AstraZeneca says some clarification is needed on methodology adequacy, data sufficiency, and definitions of anti-drug antibody incidence versus prevalence. The company letter also says the change to
Devices
FDA says that given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete the transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or
Drugs
Seven senators have signed a letter calling for an investigation into the failure of the consulting firm McKinsey & Company to disclose potential conflicts of interest when the company was simultaneously working with FDA on issues related to opioids and for several opioid companies, including Purdue Pharma. The senators want
Drugs
FDA has lifted a clinical hold on an Immunome IND for its antibody cocktail (IMM-BCP-01) for treating Covid-19. The company says in a 3/30 quarterly financial report that is continuing clinical preparations ahead of a planned Phase 1b trial. The agency’s clinical hold precipitated a
Biologics
An FDA advisory committee is scheduled 4/6 to discuss what is the optimal strain composition for Covid-19 vaccines to address emerging variants. According to a just-posted briefing document, the panel will also discuss when and how frequently to consider strain composition changes, and what is the optimal
Devices
FDA has approved Abbott’s Aveir VR single-chamber leadless pacemaker for treating patients with slow heart rhythms. The device is implanted directly inside the heart’s right ventricle and the leadless pacemaker does not require an incision in the chest or cardiac leads to deliver therapy, according to the
Drugs
CDER’s Office of Surveillance and Epidemiology (OSE) now has access to a broader selection of validated data sources for its safety reviewers to use. “For example, a few years ago, we couldn’t analyze disparate impacts for patients who were pregnant, or for patients by race in observational studies,
Devices
Senators Bill Cassidy (R-LA) and Tammy Baldwin (D-WI) have introduced the Protecting and Transforming Cyber Health Care (PATCH) Act that would implement critical cybersecurity requirements for device manufacturers applying for premarket approval through FDA. The bipartisan PATCH Act would “ensure that innovative medical technologies are better protected from
Drugs
FDA has posted a one-item Form FDA-483 for Catalent Biologics (Bloomington, IN) from a 2020 inspection at the manufacturing site. The inspection report cited Catalent over its procedures to prevent microbiological contamination for sterile drug products. FDA said the firm did not always follow good aseptic techniques at
FDA Policy/General
Comments Extended on Carbadox Carcinogenic Concern 03/30/2022 Federal Register notice: FDA is extending the comment period of a 1/13 Federal Register notice seeking input on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox. Comments now can be submitted