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Commenting on an FDA draft guidance on immunogenicity information in human prescription therapeutic protein and select drug product labeling content and format, AstraZeneca says some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
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
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,
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
Drugs
FDA has granted ASC Therapeutics a fast track designation for ASC618, a second-generation gene therapy for treating hemophilia A patients. The company received an IND approval in 2021 and an Orphan Drug Designation in 2020 for the therapy. The company describes ASC618 as an AAV8-based gene that “incorporates
Drugs
FDA has extended by three months its review of a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in infants and children. The agency extension provides more time for it to review requested additional analyses of data from Merck’ pediatric studies. The company notes no new studies have
Drugs
FDA says that it is now issuing electronic Certificates of Pharmaceutical Product (eCPPs) that also include a unique Quick Response (QR) code to permit quicker verification of the authenticity of eCPPs. “Anyone, including foreign governments, that receives an eCPP for human drug products exported from the U.S. FDA may
Drugs
While FDA continues to sift through public comments it requested (see earlier story) about how to comply with a court decision and move certain contrast agents from being regulated as drugs to devices, a new “legal insight” post sees Congress eventually stepping in to clarify that all contrast agents remain
Drugs
FDA says that it is considering exercising enforcement discretion for N-acetyl-L-cysteine (NAC)-containing products labeled as dietary supplements. But for the time being, the agency says it is still reviewing the issue and it denied two citizen petitions from the Council for Responsible Nutrition and the Natural
Drugs
A legislative proposal distributed as part of FDA’s budget request documents intends to “amend the 180-day exclusivity provisions to encourage timely marketing of first generics.” However, attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog, the result would be the opposite of
Drugs
FDA says it has been working on a project to identify and prioritize pharmaceutical quality/chemistry, manufacturing, and controls (PQ/CMC) information that would benefit from a structured submission approach. “This structured and standardized information is intended to be submitted in Module 3 of the Common Technical Document as defined
Drugs
Fewer FDA inspections over the past two years have also resulted in fewer data integrity citations at drug manufacturing facilities, but the agency doesn’t think for a moment that industry has rid itself of such concerns. FDA is prioritizing inspections of firms with the highest risk of finding compliance
Drugs
Lupin Pharmaceuticals, a manufacturer of branded and generic drugs, says FDA completed 3/30 an inspection at its Novel Laboratories wholly-owned subsidiary in Somerset, NJ, with 13 observations. “We are confident of addressing these observations and will work closely with the agency to address their concerns,” the company says
Drugs
FDA is warning patients and healthcare professionals not to use products intended to be sterile produced by North American Custom Laboratories, doing business as FarmaKeio Superior Custom Compounding, Richardson, TX. An agency announcement says FDA investigators recently inspected the compounding facility and observed conditions that could cause the drugs produced
Drugs
FDA and the Federal Trade Commission (FTC) have sent Warning Letters to seven companies for selling CBD (cannabidiol) products using research studies to claim or imply misleadingly that the products will cure, mitigate, treat, or prevent Covid-19. FDA says it has not approved or authorized any drug containing CBD
Drugs
FDA says Teva has recalled one lot of IDArubicin hydrochloride injection 5 mg/5 mL vial based on an internal inspection that found particulate matter in one vial of the product identified as silica and iron oxide. An agency notice says no other vials have been observed to contain the
Drugs
FDA is recommending that newborns and children through age 3 have follow-up thyroid monitoring within three weeks after receiving injections of contrast media containing iodine for X-rays and other medical imaging procedures. A 3/30 Drug Safety Communication says the recommendation is based on the agency’s recent
Drugs
The Department of Justice says Robert Schneiderman, Langhorne, PA, pleaded guilty in New Jersey federal court to two counts of an indictment charging him with one count of conspiracy to commit healthcare fraud and one count of conspiracy to violate the Anti-Kickback Statute. A department statement says that from
Drugs
Medical Device User Fee Act (MDUFA) investments made since 2002 have “paid off dividends with an increasing number of device innovators bringing their devices to the U.S. first, and a more robust pipeline of innovative new devices, which ultimately has led to more timely patient access,” CDRH director Jeff